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From: TSS (216-119-162-66.ipset44.wt.net)
Subject: USDA BSE Surveillance Plan: Background On Assumptions and Statistical Interences (FAQ's) and {lies}
Date: September 13, 2004 at 8:56 am PST

-------- Original Message --------
Subject: USDA BSE Surveillance Plan: Background On Assumptions and Statistical Interences (FAQ's) and {lies}
Date: Mon, 13 Sep 2004 11:02:42 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy


BSE: Recent Information

09/10/04 USDA BSE Surveillance Plan: Background On Assumptions and
Statistical Interences (FAQ's)

In an effort to be as transparent as possible, USDA is providing answers
to some common
questions about the surveillance plan and the data that it will
generate. A more detailed
discussion of these issues is available at
http://www.aphis.usda.gov/lpa/issues/bse/BSEOIG.pdf.
What is the purpose of the enhanced BSE surveillance
program?
The goal of the enhanced surveillance program is to test as many cattle
as possible in the
targeted population for BSE. The data obtained will be used to help
determine
parameters around the prevalence level of BSE in the United States.
These prevalence
estimates will allow USDA to determine whether risk-management policies
currently in
place are adequate or need to be changed.
What assumptions or estimations were made in
developing the surveillance plan?
USDA made certain assumptions and estimates in order to develop a
feasible surveillance
plan. Historical evidence has shown that BSE is more likely to be found
in the targeted
population  those animals exhibiting some type of clinical signs. USDA
used this
evidence and made the assumption that all cases would be found in the
targeted
population for the purpose of formulating a surveillance plan. In order
to set goals for
testing levels, USDA also estimated how many animals were in this
targeted population.
Data from multiple sources was used to develop the estimate, including
foreign animal
disease investigations and slaughter data from the Food Safety and
Inspection Service.
How did USDA choose its target population?
USDA has conducted an active BSE surveillance program in the United
States since
1990. To design its surveillance activities, USDA examined historical
evidence in
Europe, focusing on the population where the disease is most likely to
be found, if it is
present. The targeted population has evolved over time as more is
learned about BSE. In
1990, USDAs surveillance focused on animals reported as exhibiting
either signs of a
central nervous system disorder or classical clinical signs of BSE. In
1993, the program
was expanded to include samples from non-ambulatory animals, and in 2001
the program
was again expanded to include samples from animals that had died from
unknown causes.
While USDA understands that the disease is not necessarily limited to
animals in this
population, it is believed this is the population where the disease is
most likely to be
found, if it is present.
How much of the U.S. cattle population fits the target
population description?
The estimated adult cattle population in the United States is 45
million, with an estimated
446,000 of those animals fitting the targeted high-risk category. This
means the target
cattle population is approximately 1 percent of the overall cattle
population.
Why has USDA assumed that all BSE cases would be in
the targeted population?
The assumption that all the cases would be found in the targeted
population was a
qualifying assumption made for purposes of designing a surveillance
plan. Experience in
Europe has demonstrated that targeting surveillance efforts at certain,
high-risk
populations is the most effective way to identify BSE if it is present.
One way to explain
this approach is that we are biasing our sampling toward the population
where we are
most likely to find the disease, thus helping to ensure that if disease
is present at a certain
level it will be detected. This approach is not necessarily limited to
BSE  similar
concepts are used in many disease control programs such as the
brucellosis eradication
program. In the case of BSE, the population in which we are most likely
to find disease
are adult animals that demonstrate some clinical abnormality that could
be consistent
with BSE, and therefore this is the population we continue to target in
our surveillance.
Targeting the population where disease is most likely to be diagnosed,
if it is present, is
the most efficient way to approach surveillance. This approach requires
fewer samples to
reach similar conclusions, because it is based on the assumption that if
you cannot find
disease in the targeted, or most likely, population (i.e, animals with
some type of clinical
signs), it will be even more unlikely to be found in the non-targeted
population (i.e.,
clinically normal animals). This approach has been evaluated and
supported by Harvard,
the International Review Team, and is consistent with OIE guidelines.
For a more detailed discussion about this topic, including statistical
implications of the
assumptions and data collected under the surveillance plan, see
http://www.aphis.usda.gov/lpa/issues/bse/BSEOIG.pdf.
Will the surveillance program provide prevalence data?
The enhanced surveillance program will provide data that will assist
USDA in any
estimations of prevalence specifically within the targeted cattle
population. The data
would need to undergo further calculations to extrapolate any
information about the
entire cattle population. There are ways to estimate prevalence rates
applicable to the
broader populations, but these methods have their limitations. USDA is
considering
which, if any, of these approaches would be used at the conclusion of
the surveillance
plan to estimate BSE prevalence.
Is the program a random sampling?
No. Truly randomized sampling means that every animal in the target
population must
have an equal chance of being selected for sampling. USDA is testing as
many cattle as
possible from the target population.
USDA is working hard to ensure appropriate access to all aspects of the
target
population. As part of the enhanced surveillance program, USDA is
reaching out to
producers, renderers, slaughter facility operators, and others to
encourage participation
from all levels of industry. Initial surveillance data in June and July
2004 suggest that we
are maintaining appropriate access to the target population.
Why is the program voluntary?
The majority of USDAs enhanced BSE surveillance program is voluntary in
nature. The
exception is that collection of samples from cattle condemned prior to
slaughter is
mandatory. An entirely mandatory surveillance program would have
required federal
rule-making and would have inhibited implementation.
In order to reach the appropriate level of testing, USDA has built upon
previous
cooperative efforts with producers, renderers and others to obtain
samples from the
targeted populations. Initial testing levels indicate that the voluntary
program is
effective; an appropriate number of samples are being collected from
different categories
of cattle and a variety of testing sites.

http://www.aphis.usda.gov/lpa/issues/bse/BSEOIGFAQ.pdf
09/10/04 USDA BSE Surveillance Plan: Background On Assumptions and
Statistical Inferences

USDA BSE Surveillance Plan: Background
On Assumptions and Statistical Inferences
1. Surveillance history
Active surveillance for BSE has been conducted in the United States
since 1990.
Initially, surveillance was conducted by testing brain samples obtained
from animals
reported as exhibiting either central nervous system signs or classic
clinical signs of BSE.
In 1993, the surveillance was expanded to include samples obtained from
non-ambulatory
animals. This approach, criticized internationally as excessive at that
time, was
implemented to address concerns that an unrecognized TSE of cattle might
exist in the
US cattle population. In 2001, in response to the findings in the
initial Harvard risk
assessment, the surveillance program was again expanded to include
additional samples
obtained from animals that had died for unexplained reasons.
Total BSE tests conducted, fiscal year basis
Fiscal year Total tests
1990 40
1991 175
1992 251
1993 736
1994 692
1995 744
1996 1,143
1997 2,713
1998 1,080
1999 1,302
FY 2000 2,681
FY 2001 5,272
FY 2002 19,990
FY 2003 20,543
FY 2004 **
Partial year, through May 2004
17,121
In 2001, a goal was established to detect one BSE-infected animal in a
population of a
million adult cattle. Given that the United States has an adult cattle
population of
approximately 45 million, if BSE were present in this cattle population
at the one in a
million level, we could assume that we would have 45 infected animals.
To achieve a 95
percent confidence level in detecting at least one case from a random
sample of adult
cattle, we would have to randomly sample and test approximately 3
million animals from
the population of 45 million.
However, based on the assumption of negligible detectable presence of
BSE in the
normally appearing adult cattle population, USDA has focused on a subset
of the cattle
population more likely to have BSE if it exists in the United States 
adult cattle
exhibiting some type of clinical sign that could be considered
consistent with BSE. This
allows us to conduct more efficient, targeted, and effective
surveillance. At that time,
non-ambulatory cattle were defined as the primary targeted high-risk
population. This
definition was based on the surveillance experience of European
countries that have BSE.
Their experience and testing schemes have proven non-ambulatory cattle
to be an
appropriate and efficient population for active targeted surveillance.
For example, in
Switzerland, testing of fallen stock (dead cattle) and emergency
slaughter cattle (cattle
killed for reasons other than routine slaughter) revealed a BSE
prevalence of 0.2 percent
in 1999 and 0.12 percent in 2000. In comparison, Switzerlands BSE
prevalence in
routine healthy slaughter populations was 0.004 percent in 1999 and 0
percent in 2000.
BSE surveillance in France during 2001 identified 91 cases (19.4 percent
of those tested)
from cattle exhibiting central nervous system clinical signs, and 100
BSE cases (0.07
percent of those tested) from the 133,889 nonambulatory cattle tested.
French testing of
apparently healthy slaughter cattle found 83 BSE cases (0.003 percent of
those tested)
from the 2,382,225 tested. These data indicate the presence of infected
cattle can be
determined more efficiently by testing the population most likely to
exhibit the disease,
thereby supporting the decision to conduct a program of targeted
surveillance rather than
one of simple random sampling.
The expected number of animals in the targeted high-risk population was
required to
estimate an appropriate sample size. At that time, as stated,
non-ambulatory animals
were considered the primary targeted population, so an estimate of the
number of
nonambulatory cattle in the United States was needed. The American
Association of
Bovine Practitioners (Hansen et al., 1999) surveyed their members and
estimated that
195,000 head of cattle become non-ambulatory per year.1
Initially, an assumption was made that the 45 potential cases of BSE (1
per million adult
cattle population) would all be found in the high-risk cattle
population. Dividing the
potential cases into this estimate of the high-risk population
(45/195,000) gives an
assumed prevalence of 0.023 percent. This was the level of disease that
needed to be
detected in the high-risk population. Using Cannon and Roes formula to
determine the
sample size required to detect disease at a prevalence of 0.023 percent
with 95 percent
confidence, a sample size of 12,500 was derived.2
The assumption that all the cases would be found in the targeted
population was a
qualifying assumption made for purposes of designing a surveillance
plan. The previous
results giving no evidence of BSE in the United States, the low risk of
BSE in the United
States based on historical steps taken to mitigate risk, and the fact
that current testing
methodology can only detect the disease either a few months before or,
more likely, after
an animal begins to exhibit clinical signs all contributed to the
decision to use this
qualifying assumption.
It is important to note that no estimations of prevalence are done when
designing these
surveillance plans. The surveillance plans were designed solely to
detect BSE if it exists
in the U.S. cattle population at or above a specified prevalence with a
specified degree of
confidence. The objective of the surveillance plan is not to estimate
prevalence of BSE
in the U.S. cattle population. Certain assumptions of possible
prevalence must be made
to assist in developing surveillance plans and establishing targets or
goals. After
sufficient data are obtained, then estimation of possible prevalence or
bounds around the
possible prevalence rate can be calculated.
Sampling at this level will not disprove that BSE may occur at a lower
prevalence level,
but it should allow detection of a case if BSE truly exists at a level
of one or more cases
per million in the adult cattle population given the underlying
assumptions including:
1. the majority of cases of detectable BSE would occur in the targeted
population
2. the samples collected are broadly representative of the targeted
population
3. the testing system, as implemented, has a high sensitivity and
specificity.
2. Current surveillance plan
On June 1, 2004, USDA launched an intensive surveillance program for
BSE, with the
goal of testing as many cattle as possible in the targeted population
for BSE. This
program is built on previous surveillance efforts, and is planned to be
a one-time effort
that will provide a snapshot of the domestic cattle population.3
The intent of this intensive surveillance effort is to provide
sufficient data and
information to assist in a determination of whether risk management
policies  for both
animal health and public health  are adequate or whether they need to
be changed. The
data obtained in this effort will be used to help determine parameters
around the probable
prevalence level of BSE in the United States. A specific, exact
calculation of true
prevalence of BSE is not necessary to enable us to make the
determination of whether
risk management policies need to be changed. These decisions can be
made, for
example, with information that simply estimates the upper bounds of a
prevalence level.
We would like to clarify that, at this time, there have been no
sampling-based,
quantitative estimates of the prevalence of BSE in the United States.
Certain assumptions
have been made to assist in developing the surveillance plan, but this
is very different
from calculating or estimating the prevalence of BSE in the United States.
Experience in Europe, as described previously, has demonstrated that
targeting
surveillance efforts at certain populations is the most effective way to
identify BSE if it is
present. One way to explain this approach is that we are biasing our
sampling towards
the population where we are most likely to find the disease, thus
helping to ensure that if
disease is present at a certain level it will be detected. This approach
is not necessarily
limited to BSE  similar concepts are used in many disease control
programs such as the
brucellosis eradication program. In the case of BSE, the population in
which we are most
likely to find disease are adult animals that demonstrate some clinical
abnormality that
could be consistent with BSE, and therefore this is the population we
continue to target in
our surveillance.
Targeting the population where disease is most likely to be diagnosed,
if it is present, is
the most efficient way to approach surveillance. This approach requires
fewer samples to
reach similar conclusions, because it is based on the assumption that if
you cannot find
disease in the targeted, or most likely, population (i.e., animals with
some type of clinical
signs), it will be even more unlikely to be found in the non-targeted
population (i.e.,
clinically normal animals). This approach has been evaluated and
supported by the
Harvard Center for Risk Analysis4, the International Review Team5, and
is consistent
with OIE guidelines6.
One goal of the surveillance program may include determining estimates
of what level of
BSE could exist in the U.S.  i.e., determining parameters around a
possible prevalence
level - depending on the data obtained through this program. But the
surveillance plan is
a sample design that meets confidence level goals for detecting BSE if
it is present at a
specified level in the sampled population. It does not estimate
prevalence. It is intended
to help determine if BSE exists in the national herd and collect data
for further analysis.
In order to develop the sample design in the surveillance plan, certain
assumptions or
estimations were necessary. One of these assumptions is that BSE is more
likely to be
found in the targeted population. Data from testing within the European
Union in 2002
supports this assumption, with a conclusion that it is 29.4 times more
likely to diagnose
disease in the targeted population than in the clinically normal population.
Our surveillance plan is designed  and this has been confirmed by
Harvard Universitys
Center for Risk Analysis4  to detect the presence of BSE with 99
percent certainty if as
few as five targeted high-risk cattle had BSE. The basis of this
calculation is the same as
described in the previous section, with the difference being the
estimated number of
animals in the targeted high-risk population. Clearly, if BSE were
circulating in the U.S.
cattle population, there might be infected animals that were not
exhibiting clinical signs
and therefore would not be included in our targeted high-risk
population. Some such
animals might have detectable BSE but most would not.
We appreciate the limits of our calculations and understand fully that
there are additional
calculations that would need to be done to extrapolate any assumptions
or specifications
about the targeted population to the entire U.S. cattle population.
There are several ways
to estimate or infer prevalence rates among the broader populations,
each with
advantages and disadvantages. Some examples of these approaches are
described later in
this document. As we gather data from our surveillance efforts, these
approaches and
others will be evaluated for their use in our calculations and
decision-making processes.
Another approach to surveillance is focusing sampling on clinically
normal animals.
This is not an efficient way to conduct surveillance, if the intent of
surveillance is to
detect the disease if it is present. The following points explain the
drawbacks and
misleading assumptions of this type of approach:
The earliest point at which current testing methods can detect a
positive case of
BSE is approximately 3 months before the animal begins to demonstrate
clinical signs.
Also, the incubation period for this disease  the time between initial
infection and the
manifestation of clinical signs  is generally very long, on average
about 5 years.
With current testing methodology, therefore, there is a long period
during which
testing an animal infected with BSE would produce a false negative
result. This is
especially likely if the animal is clinically normal at the time samples
are obtained for
testing.
Based on these facts, and using the BSE simulation model as developed by
Harvard4, we can estimate the false negative rates for testing normal
adult cattle. This
model predicts that a testing program that tests all animals at
slaughter would produce 
when used on infected animals  a false negative test rate of 92 percent
for clinically
normal adult cattle, and a false negative test rate of greater than 99
percent for clinically
normal young cattle under 30 months of age. In other words, if 100
infected clinically
normal adult animals were tested, only 8 of them would test positive.
In comparison, current testing methodology is very sensitive when used in
clinically affected cattle. Comparatively, a false negative rate in this
population would be
less than 1 percent. In other words, if 100 infected clinically affected
animals were
tested, more than 99 of them would test positive.
The exceedingly high rate of false negative results in the clinically normal
population, in combination with its likelihood of extremely low disease
prevalence,
would impede statistical evaluation of the presence or absence of
disease. More
importantly, a testing program with such a high rate of false negatives
would have
negligible benefit from a public health standpoint and would be
extremely misleading for
the public and consumer, as it could provide false assurances of the
absence of disease.
The key to surveillance is to look where the disease is most likely to
be present and
detectable. As outlined in the previous paragraphs, there is a
significantly better chance
of finding the disease if you look within the high-risk population. Our
targeted
surveillance program, focused on testing animals with some type of
clinical signs, is the
most efficient and effective way to detect the disease if it is present
in the United States.
3. Statistical inferences and current plan
The current enhanced surveillance plan will provide data on the targeted
population as
described. Direct statistical inferences from these data can be made to
the targeted
population with the assumption that the animals tested are
representative of the targeted
population. For example, if 268,500 samples were obtained randomly from
a target
population of 446,000, and if no positives were found after completion
of the testing
plan, then we could state that we were 99 percent confident that there
were less than 5
positive animals in the target population. Direct statistical inferences
related to the
remainder of the cattle population would require huge sampling efforts.
For example,
making a similar statistical inference using data obtained from sampling
the apparently
normal adult slaughter cattle population would require approximately 3
million random
samples to be tested. Extrapolations of data from the targeted
population may be used,
however, to provide estimates of prevalence in the broader U.S. cattle
population.
We made certain assumptions initially to assist in developing the
surveillance plan and
establishing general targets or goals. As addressed earlier, a
qualifying assumption was
made that all cases would be found in the targeted population for
purposes of designing
the initial surveillance plan. If another assumption was made  for
example, that a
certain number of cases would be found in the normal adult population 
that too would
be simply an assumption for purposes of developing a plan. No
statistical inferences
could be drawn from such an assumption. All approaches in developing a
plan are
assumptions and none of them are known with certainty. After testing is
complete, any
assumption might be accepted, or it could be demonstrated to be
completely wrong,
depending on the data gathered in the surveillance effort. The validity
of the underlying
assumptions can and will be evaluated during the implementation of the
surveillance plan
and after the completion of the surveillance effort. However, the
assumptions made to
develop the surveillance system in the United States were based on the
best current
scientific knowledge of BSE and the cattle industry.
Additional details on specific aspects of the current surveillance plan
that can impact the
statistical calculations are addressed in the remainder of this section.
These include
descriptions of the target population estimates, the issue of random
selection or access to
animals, and finally a brief description of some approaches to
extrapolating the data
results from the targeted population to the broader U.S. cattle population.
Target population estimates:
For the purposes of developing the surveillance plan, we estimated the
targeted high-risk
population, based on data available to us at the time. We emphasize that
this was an
initial estimate; as we progress through the surveillance program, we
will have better
information and may be able to develop more accurate estimates.
Animals that fit our targeted population may be found in many different
locations. If, for
example, they exhibit clinical signs as described and subsequently die
on the farm, they
could then be transported to rendering facilities, salvage slaughter
(3D/4D) plants, or
other disposal facilities. Animals that initially exhibit subtle
clinical signs may be sent to
slaughter for human consumption or for salvage slaughter. As we
attempted to estimate
the targeted population, we had to make certain choices about data
sources so as to avoid
creating significant overlap, or double counting. For example, if we
chose to use
estimated numbers of animals picked up by rendering facilities and 3D/4D
plants, these
numbers could overlap significantly with any type of on-farm data available.
Consequently, we chose to use NAHMS7data to estimate on-farm
mortalities, reports of
FAD investigations conducted by APHIS to represent on-farm CNS
disorders, and FSIS
slaughter data from 20028 to reflect the animals with perhaps earlier or
more subtle
clinical signs.
Table 1.  Summary of high-risk population estimate
High-risk population Estimated number Source of data
On-farm mortalities 251,532 NAHMS dairy and beef surveys7
On-farm CNS 129 FAD investigations
At slaughter 194,225 FY02 FSIS numbers8
Total 445,886
When assessing FSIS data, certain codes for ante-mortem condemnation
clearly needed
to be included in our estimates. These included CNS signs, dead on
arrival, moribund,
tetanus, and non-ambulatory (if specified). We recognized that the
condemnation code
for injuries was not so clear-cut, however, since it could represent
different scenarios,
including: animals condemned on ante-mortem inspection; animals
condemned on postmortem
inspection; or part of the carcass passing post-mortem inspection after
trimming.
For the purposes of developing our estimate, we assumed that some cattle
in this group
could have injuries resulting from neurological deficits consistent with
BSE, such as
ataxia. This group would also include animals with injuries that are not
likely related to
BSE, for example bruising due to rough handling or a lesion associated
with an old
injury. Since there are no data available to help refine this group, we
decided to include
all of these animals in the high-risk population. Inclusion of all of
these animals results
in an overestimate, and this provides a more conservative (or larger)
sample size than
needed to meet our specified detection levels. We chose to err on the
side of
overestimation of the size of the high-risk population rather than
underestimation.
Table 2.  At slaughter (high-risk categories) from FSIS data
Code Disposition Number FY02 Number FY03
Emaciation Post-mortem condemn 3,275 4,488
Tetanus Ante-mortem condemn 2 25
CNS Disorder Ante-mortem condemn 135 133
Dead Condemn 17,438 20,971
Injury Passed 163,980 191,294
Injury Post-mortem condemn 3,119 4,074
Injury Ante-mortem condemn 19 17
Moribund Ante-mortem condemn 6,257 6,154
ALL 194,225 227,156
The estimates of the high-risk population were based on 2002 FSIS data
available at the
time the plan was developed (Table 2). We continue to evaluate ongoing
condemnation
data to monitor our estimate, and will make adjustments as necessary.
Recent monthly
data for 2004 appear to indicate that the number of injuries and
post-mortem condemns is
declining, while ante-mortem condemns appear to be increasing. For
example, in May
2003, a total of 31,077 injuries were reported, with 318 condemned
post-mortem and
none condemned ante-mortem. In May 2004, a total of 15,318 injuries were
reported,
with 75 condemned post-mortem and 6 condemned ante-mortem. Specifically
for the
injuries, this may indicate that the population that truly fits our
target  i.e., those animals
that had neurological deficits sufficient to lead to injuries  are now
being condemned
ante-mortem or not being presented for slaughter.
Regulatory changes that have been implemented since the beginning of
2004 have also
had an impact regarding categorization of high-risk cattle and movement
of these
animals. Monitoring the BSE surveillance data will help ensure that
these changes do not
result in relevant subpopulations being excluded from the BSE
surveillance program.
These changes may, however, result in adjusting the estimates of the
high-risk population
to reflect the current makeup of subpopulations.
We believe that our inclusion of these animal numbers in our estimates
was appropriate.
While we also recognize that it could be an overestimation of this
segment of the
population, choosing to err on the conservative side with an
overestimation will not
jeopardize the sampling plan  in fact, increasing the sample size
increases the effective
confidence level of the plan. We will monitor the ongoing condemnation
data, our
sample collection data, and testing results throughout the entire
surveillance effort. If
there is any indication that sampling should be done in other segments
of the estimated
population, we will be able to incorporate those changes as necessary.
The sub-population of cattle in the United States that was estimated as
high risk for
BSE consists of approximately 1 percent of the adult cattle population.
In comparison,
Eurostats data indicate that the sub-populations of cattle identified by
European Union
(EU) members for high-risk sampling (clinical signs of BSE, fallen
stock, and casualty
slaughter) range from less than 1 percent to approximately 4 percent of
the adult cattle
population9. The average was 1.87 percent of the population (Table 3).
The differences
result from a number of factors including management and production
practices, data
collection methods, and categorization of cattle. While it is difficult
to make accurate
comparisons given the differing management practices, our estimate
nevertheless appears
consistent with the range of what is seen in European countries.
Table 3.  High-risk cattle tested in EU, 20029
Country
High-risk
population
tested
Percent of
adult cattle
population
Austria 9,513 0.95
Belgium 14,573 0.97
Denmark 22,093 2.45
Finland 12,020 3.01
France 133,889 1.22
Germany 276,748 4.19
Greece 1,653 0.55
Ireland 26,614 0.78
Italy 55,496 1.63
Netherlands 44,335 2.46
Portugal 2,630 0.33
Spain 52,293 1.54
Sweden 30,388 4.34
Switzerland 16,469 1.94
UK 73,417 1.39
Total 772,131 1.87
Randomness of selection and ensuring access to targeted animals:Randomized
sampling is the basis for inference to a population of interest that
helps reduce the
potential for bias. Randomized sampling depends on the availability of a
list frame or
some other method of randomizing the selection of sample elements
(systematic
sampling, area sampling, etc.). Every animal in the targeted population
must have a
known probability (non-zero) of being selected for sampling in a truly
random scheme.
USDA weighed the options for randomized sampling in the targeted
population, but
decided that none of these were viable approaches for sampling this
population.
Consequently, there will be no random sampling but rather an attempted
census of
animals from the target population that are available for testing.
Taking a census of the
target population would eliminate any sampling error and make detection
levels certain.
However, not all animals in the target population may be available for
surveillance, thus
the census is expected to be incomplete.
It could be argued that inference to the entire targeted population
without the
randomization process and using a partial census introduces the
potential for bias.
However, the potential for bias cannot be assessed without more data
about the targeted
population and the population of tested animals. For example, if animal
identification
were in place, we could compare the tested group characteristics to the
targeted
population using criteria such as age, breed, and geographical location.
However,
because the United States does not yet have a completed national animal
identification
system, this is not feasible. Minimally, the geographic distribution of
the tested animals
could be compared to the distribution of the respective dairy and beef
cattle populations.
Further, the characteristics of the sampled population could be compared
to generally
expected distributions with regard to other demographic characteristics.
If substantial
gaps are apparent, resources can be moved and outreach efforts can be
increased to
remedy any apparent gaps in testing. These comparisons are being done on
a routine
basis with the data gathered in the surveillance effort, and outreach
efforts or other
approaches will be used to address any apparent gaps in distribution.
Efforts are
underway to learn more about the number, disposition, and distribution
of portions of the
target population. For example, VS is in the second year of a national
probability based
survey project to study the distribution of non-ambulatory cattle.
Population based
survey results such as these also could be used to assess the potential
for bias in the target
population surveillance.
The lack of availability of all targeted animals for surveillance and
the potential for bias
due to non-random sampling can potentially substantially affect the
inference that can be
made from the surveillance data. However, the effect of nonrandom
sampling is
minimized by our plan to test all available animals. Without regulatory
requirements for
reporting down or dead animals, we must focus on increasing our current
efforts to
identify and test the targeted population. The primary objective of the
surveillance is to
detect disease if it is present at a specified level with a desired
confidence level. The
impact of the sampling issues may result in unquantifiable changes in
the detection
criteria. If a BSE case is detected, then the impact will not be an
issue. If no cases are
detected, then the exact confidence we have that the disease is below
the specified
detection level will have to be based on the examination of the
assumption that the
animals tested are representative of the targeted population.
USDA is conducting significant efforts to ensure appropriate access to
all aspects of the
targeted population. We anticipate that a majority of the animals to be
tested will come
from animal disposal facilities, such as rendering facilities or salvage
slaughter plants.
We are also working to ensure that an adequate number of animals that
are nonambulatory
or dead on the farm are available for testing. While a significant number of
these will be available through the animal disposal facilities
previously addressed, we are
further enhancing efforts to encourage producers to contact authorities
when they have a
dead or non-ambulatory animal that meets our targeted population
definition. As part of
the enhanced surveillance program, USDA is reaching out to producers,
renderers,
slaughter facility operators, and others to encourage their
participation. In addition, cost
recovery options are also available to help address additional costs
that may be incurred
by participation in the surveillance effort. The combination of risk
mitigation regulations
promulgated in 2004 and their effect on the disposition patterns of
animals, as well as our
campaign to encourage reporting of high-risk animals for testing, means
that samples
may not follow the distribution of the high-risk population as reported
in Table 1. Initial
surveillance data in June and July 2004 suggest that we are maintaining
appropriate
access to the targeted population.
Approaches to extrapolate data to broader cattle population:
There are various methods that could be used to extrapolate the data
obtained from our
targeted surveillance program to the broader cattle population as a
whole. While no
decisions have been made about which, if any, of these approaches would
be used, these
examples can illustrate the options available.
One example of an extrapolation of collected data would be as follows.
As previously
mentioned, based on summary data from testing within the European Union
in 20029,
detectable cases of BSE were 29.4 times more common in targeted
high-risk animals
sampled than in apparently normal animals sampled. This ratio is based
on detectable
BSE. It is possible that BSE may be present but not at a detectable
level. This discussion
regarding approaches to estimating prevalence in the broader cattle
population assumes
detectable BSE.
The ratio based on European data can be used to extrapolate data on
expected prevalence
in additional populations. If we sample 268,500 targeted high-risk
animals and find no
cases of BSE, then we are 99 percent confident that at most there are
not 5 or more cases
in the targeted high-risk population of 446,000. Using the ratio of
29.4, we would then
expect 0.15 detectable cases per 446,000 animals in the apparently
normal population, or
2.2 cases in the 6.4 million adult animals slaughtered annually. This is
an extremely low
possible prevalence level, and detection of disease at this level in the
apparently normal
adult animal population would be extremely difficult. This would require
sampling of
approximately 4.5 million, 5.1 million, or 5.8 million animals to detect
this prevalence
level at a confidence level of 90 percent, 95 percent, or 99 percent,
respectively.
Without testing a very large sample of normal adult animals, no
statistical inferences can
be made about the prevalence of BSE in the adult population. Any
statements of
prevalence after completion of testing of the high-risk population would
have to be based
on the extrapolation from the high-risk population to the normal adult
population. For
example, if we sample 268,500 high-risk animals and find no positive
animals, then
assuming at most 2.2 infected animals in the normal adult population, we
could conclude
there are no more than 7.2 positive animals in the adult population or
about 1 per million
(7.2 divided by 6.86 million).
The Harvard Center for Risk Analysis evaluated USDAs BSE surveillance
plan, and
described 2 approaches for extrapolating the data. These can be found on
APHIS web
site at: www.aphis.usda.gov/lpa/issues/bse/BSE_Harvard03-12-04.pdf. The
first
approach described is similar to that outlined in the previous
paragraph, using European
data as a base for comparison. The second approach described utilizes
the modified
version of their computer simulation model initially developed in their
2001 risk analysis.
Yet another approach is a model, called BSurvE, developed by scientists
in the United
Kingdom and New Zealand. This model has been supported by the EU, and was
submitted to the OIE for consideration in their amendments to the BSE
chapter of the
OIE Code. According to the developers, this model estimates BSE
prevalence in a
national cattle population from surveillance data obtained by a country,
accounting to the
inherent biases and limitations of conducting surveillance only on
animals after they are
dead. As has been previously discussed in this paper, test results from
BSE surveillance
within various subpopulations of cattle (such as the U.S. defined
high-risk population)
cannot provide direct statistically valid estimates of the true
prevalence of BSE in the
national cattle population due to inherent biases and lack of random
sampling. The
BSurvE model makes use of historic data from European countries,
combined with
knowledge about BSE gained through research, to make an estimate of the true
prevalence, with confidence limits around that prevalence, of BSE in the
national
standing cattle population. This prevalence estimate is based on a
countrys BSE
surveillance data and demographic information of the cattle population
in that country.
The model also provides a way to evaluate the adequacy of the
surveillance program
within a country and guidance in efficient allocation of resources
between various
surveillance streams (clinical suspects, fallen stock, casualty
slaughter, healthy slaughter)
in terms of case detection success and cost effectiveness.
The BSurvE model shows promise of being an excellent tool to utilize
within the US
BSE surveillance program; however, it is still under evaluation and
going through the
international peer review process.
4. Sampling from the normal adult population
In accordance with the recommendations from the International Review
Team, a limited
number of samples will be obtained from the apparently normal adult
cattle population
presented at slaughter. The recommendation noted that some sampling in
this population
will help encourage disease reporting at the farm level.
Results from these samples are not used to quantify detection levels of
the surveillance
plan. Any estimates of possible prevalence levels in this population
would be derived
from alternative approaches or extrapolations of data about the normal
adult population
as described above.
In addition to these samples as outlined, there may be other samples
obtained from
animals that do not meet the definition of our targeted high-risk
population. All samples
that are of diagnostic quality will be tested. However, data from
samples obtained from
animals that do not meet the definition of the targeted population will
not be used in any
statistical analysis nor will they be used to help quantify any
detection levels as
described.
5. Actions if positives are found
The current surveillance plan is intended to detect disease if it is
present at a certain
prevalence with a specified degree of confidence. If cases of BSE are
found through this
effort, it may or may not invalidate assumptions or approaches we have
taken.
Investigation into the nature of the case, such as the type of animal
and possible cause,
would also provide information important to the future design of the
surveillance plan.
Depending on the specific findings, a decision would be required
regarding the need to
estimate prevalence. Depending on that decision, the surveillance
approach may or may
not be altered. If the surveillance program were altered, the
assumptions would be reevaluated
and restated, the approach would be redefined, and appropriate detection
levels
would also be re-evaluated.
References:
(1) Hansen, Don and Bridges, Victoria. A Survey Description of Down-cows
and Cows
with Progressive or Non-progressive Neurological Signs Compatible with a
TSE from
Veterinary-client Herd in 38 States. The Bovine Practitioner; 33(2);
179-187, 1999.
(2) Cannon, R.M. and Roe, R.T. Livestock Disease Surveys: A Field Manual for
Veterinarians. Canberra: Australian Government Publishing Service; 1982.
(3) APHIS BSE Surveillance Plan 2004 :
www.aphis.usda.gov/lpa/issues/bse/BSE_Surveil_Plan03-15-04.pdf
(4) Gray, George, and Cohen, Joshua; Harvard Center for Risk Analysis,
Harvard School
of Public Health; Comments on USDA BSE surveillance plan.
www.aphis.usda.gov/lpa/issues/bse/BSE_Harvard03-12-04.pdf
(5) Report on Measures Relating to BSE in the United States; Secretarys
Foreign
Animal and Poultry disease Advisory Committee Subcommittee
(International Review
Team) www.aphis.usda.gov/lpa/issues/bse/US_BSE_Report.pdf
(6) OIE, Terrestrial Animal Health Code 2003, Appendix 3.8.4:
www.oie.int/eng/normes/MCode/A_00155.htm
(7) APHIS, VS, National Animal Health Monitoring System (NAHMS):
www.aphis.usda.gov/vs/ceah/cnahs/nahms/index.htm
(8) USDA, FSIS Animal Disposition Reporting System (ADRS); Fiscal Year
(FY) 2002
Slaughter and Condemnation Data:
www.fsis.usda.gov/ophs/adrsdata/2002/adrsfy02.htm
(9) European Commission: Report on the Monitoring and Testing of
Ruminants for the
Presence of Transmissible Spongiform Encephalopahty (TSE) in 2002:
europa.eu.int/comm./food/food/biosafety/bse/annual_report_2002_en.pdf

http://www.aphis.usda.gov/lpa/issues/bse/BSEOIG.pdf

LIES

USDA INC. : HOW AGRIBUSINESS WAS HIJACKED
REGULATORY POLICY AT THE U.S. DEPARTMENT OF AGRICULTURE {FULL TEXT}

snip...

PACKING USDA
What has happened in USDA goes beyond a process of capture intended to
restrict competition.
Thanks to its political influence, Big Agribusiness has been able to
pack USDA with appointees who
have a background of working in the industry, lobbying for it, or
performing research or other functions
on its behalf. These appointees have helped to implement policies that
undermine the regulatory
mission of USDA in favor of the bottom-line interests of agribusiness.
In other words, public
health and livelihoods are at stake.
To see that agribusiness has packed USDA with its apparent
representatives, one has only to look
at the biographies on the Departments website of its roughly 45 top
officials, including the Secretary,
Deputy Secretary, Under Secretaries, Assistant Secretaries, Deputy Under
Secretaries, Deputy
Assistant Secretaries and heads of key offices. Many of the biographies
cite previous work with
agribusiness companies and their trade associations, lobbying firms and
research arms, including university
research centers bankrolled by the food industry. Additional research
makes clear that there
are approximately as many industry people among the appointees as there
are career civil servants.
Here are some examples of appointees with past industry ties (unless
otherwise noted, the source for
each affiliation is the individuals biography on the USDA website):

snip...end

http://www.competitivemarkets.com/pdf/USDAagencyCapture.pdf
http://www.vegsource.com/talk/madcow/messages/92885.html
http://www.competitivemarkets.com/ocm1.html

HARVARD STUDY bought and paid for by your local cattle dealer
(USDA paid Harvard $800,000 for study) there 'gold standard' study
they use as the bible of all BSE studies.

original Risk Assessmen November 26, 2001)

http://www.aphis.usda.gov/lpa/issues/bse/bse-riskassmt.html


SUPPRESSED PEER review of Harvard study October 31, 2002

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf

Report of the Secretarys Advisory Committee on Foreign Animal and
Poultry Diseases

Measures Relating to Bovine Spongiform Encephalopathy
in the United States

February 13, 2004

Concerns Regarding Differing Opinions on Risk

The Subcommittee made many additional recommendations. However, the
Committee cannot adequately resolve the differing BSE risk assessment
presented by the Subcommittee as compared to the assessment by Harvard
University. A major discrepancy exists with the Subcommittees
conclusions that BSE continues to circulate, or even amplify, in the US
and North America, when compared with the Harvard risk assessment. The
Committee must have this issue of risk resolved prior to completing its
recommendations to the Secretary. It is imperative that the Secretary
has the best available science and more precise risk assessments in
order to make appropriate regulatory decisions.

Recommendations by the Committee

· Prior to implementing regulatory changes in addition to what USDA
and FDA have already announced, the Committee recommends that
representatives of Harvard University be asked to review the
Subcommittee Report and its findings (Harvard and the Subcommittee
should communicate directly and come to consensus if possible) in light
of the risk model they have previously developed and report back to the
Secretary and this Committee;
· Immediately develop and implement an enhanced national surveillance
program for BSE to increase testing of high risk animals (cattle showing
symptoms of central nervous system disease, non-ambulatory cattle, and
cattle that die on farms); this action will further the scientific
evaluation of risk for BSE in the U.S. and North America;
· Concurrent with an enhanced surveillance for BSE, a comprehensive
system must be implemented to facilitate adequate pathways for dead and
non-ambulatory cattle to allow for collection of samples, and for
proper, safe disposal of carcasses; this must be done to ensure
protection of public health, animal health and the environment; such as
system will require expending federal resources to assist with costs for
sampling, transport and safe disposal;

snip...

http://www.aphis.usda.gov/lpa/issues/bse/bse_sec_adv_comm.doc

REPORT ON MEASURES RELATING TO
BOVINE SPONGIFORM ENCEPHALOPATHY (BSE)
IN THE UNITED STATES

2 February 2004

http://www.aphis.usda.gov/lpa/issues/bse/US_BSE_Report.doc


Subject: INTERNATIONAL BSE/TSE EXPERT SAYS "We believe that the
infection in North America took place at least 10 years
Date: February 5, 2004 at 9:18 am PST


Mad cow has home on U.S. ranges

International experts say the disease is "indigenous" to North America, and
it will take drastic measures to stop its spread.

Kihm said he thought that infection of the North American herd had begun
before the disease was diagnosed extensively in Britain and linked to
human deaths but that it only recently had spread to detectable levels
in Canada and the United States.

"We believe that the infection in North America took place at least 10
years ago," Kihm said. "You need one cycle before you have a few animals
positive, and you don't see them in the first cycle. You need a second
or a third."

The findings were presented to a USDA subcommittee appointed by Veneman.
Some members expressed frustration.

http://www.oregonlive.com/special/madcow/index.ssf?/special/oregonian/madcow/040205_home.html


[PDF] GAO-02-183: Mad Cow Disease: Improvements in the Animal Feed Ban
...


http://www.gao.gov/new.items/d02183.pdf

Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working
Group on the Assessment of the Geographical Bovine Spongiform
Encephalopathy (BSE) Risk (GBR) were asked by the European Commission
(EC) to provide an up-to-date scientific report on the GBR in the United
States of America, i.e. the likelihood of the presence of one or more
cattle being infected with BSE, pre-clinically as well as clinically, in
USA. This scientific report addresses the GBR of USA as assessed in 2004
based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached
domestic cattle in the middle of the eighties. These cattle imported in
the mid eighties could have been rendered in the late eighties and
therefore led to an internal challenge in the early nineties. It is
possible that imported meat and bone meal (MBM) into the USA reached
domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle
imports from BSE risk countries were slaughtered or died and were
processed (partly) into feed, together with some imports of MBM. This
risk continued to exist, and grew significantly in the mid 90s when
domestic cattle, infected by imported MBM, reached processing. Given the
low stability of the system, the risk increased over the years with
continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is
likely but not confirmed that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent. As long as there are no
significant changes in rendering or feeding, the stability remains
extremely/very unstable. Thus, the probability of cattle to be
(pre-clinically or clinically) infected with the BSE-agent persistently
increases.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html


THE MAD COW DOWNER THAT WALKED

Dave Louthan - Killed the Mad Cow
http://maddeer.org/video/embedded/louthan.html

Senator Michael Machado from California

''USDA does not know what's going on''.

''USDA is protecting the industry''.

''SHOULD the state of California step in''


Stanley Prusiner

''nobody has ever ask us to comment''

''they don't want us to comment''

''they never ask''


i tried to see Venemon, after Candian cow was discovered with BSE.
went to see lyle. after talking with him... absolute ignorance... then
thought i should see Venemon... it was clear his entire policy was to
get cattle boneless beef prods across the border... nothing else
mattered... his aids confirmed this... 5 times i tried to see Venemon,
never worked... eventually met with carl rove the political... he is the
one that arranged meeting with Venemon... just trying to give you a sense
of the distance... healh public safety... was never contacted... yes i
believe that prions are bad to eat and you can die from them...END


Dr. Stan bashing Ann Veneman - 3 minutes


http://maddeer.org/video/embedded/08snip.ram


Recall Authority and Mad Cow Disease: Is the Current System Good for
Californians?

Tuesday, February 24, 2004
JOINT HEARING


AGRICULTURE AND WATER RESOURCES HEALTH AND HUMAN SERVICES AND SELECT
COMMITTEE ON GOVERNMENT OVERSIGHT - MACHADO, ORTIZ, and SPEIER, Chairs
Choose a RealPlayer video --->
Selected excerpts:

Opening Statement by Senator Michael Machado

http://maddeer.org/video/embedded/machado.html

HERE IS THE TEXAS MAD COW THAT WENT TO THE RENDER WITHOUT BEING TESTED
AND OTHER MULTIPLE FLAWS IN THE SYSTEM;

July 13, 2004

IG Audit Finds Multiple Flaws in Mad Cow Surveillance Plan
Rep. Waxman raises questions about the effectiveness and credibility of
USDA's response to mad cow disease, citing an audit by the USDA
Inspector General that finds systemic deficiencies in the Department's
surveillance plan and new evidence that USDA misled the public in the
wake of the detection of an infected cow in Washington State.

- Letter to USDA

http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_july_13_ig_let.pdf

http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_july_13_ig_let.pdf


IG Draft Audit

http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_july_13_ig_rep.pdf

http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_july_13_ig_rep.pdf


May 13, 2004

Failure To Test Staggering Cow May Reflect Wider Problems
Rep. Waxman raises concerns that the recent failure of USDA to test an
impaired cow for BSE may not be an isolated incident, citing the failure
of USDA to monitor whether cows condemned for central nervous system
symptoms are actually tested for mad cow disease.

- Letter to USDA

http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf


http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf


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

THAT ONE TEXAS MAD COW IS ONLY TIP OF ICE BURG;

No mad cow results for nearly 500 cows

By Steve Mitchell
United Press International
Published 8/11/2004 11:23 AM


WASHINGTON, Aug. 11 (UPI) -- The U.S. Department of Agriculture failed
to test for mad cow disease or collect the correct portion of the brain
on nearly 500 suspect cows over the past two years -- including some in
categories considered most likely to be infected -- according to agency
records obtained by United Press International.

The testing problems mean it may never be known with certainty whether
these animals were infected with the deadly disease. Department
officials said these animals were not included in the agency's final
tally of mad cow tests, but the records, obtained by UPI under the
Freedom of Information Act, indicate at least some of them were counted...

snip...

--

Steve Mitchell is UPI's Medical Correspondent. E-mail sciencemail@upi.com
Copyright © 2001-2004 United Press International

http://www.upi.com/view.cfm?StoryID=20040810-042935-2066r

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[20 August 2004]


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/catindex_en.html


From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science
to date about the known TSEs in the USA (let alone the undocumented TSEs
in cattle), it is my opinion, every other Country that is dealing with
BSE/TSE should boycott the USA and demand that the SSC reclassify the
USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the
SSC to _flounder_ any longer on this issue, should also be regarded with
great suspicion as well. NOT to leave out the OIE and it's terribly
flawed system of disease surveillance. the OIE should make a move on CWD
in the USA, and make a risk assessment on this as a threat to human
health. the OIE should also change the mathematical formula for testing
of disease. this (in my opinion and others) is terribly flawed as well.
to think that a sample survey of 400 or so cattle in a population of 100
million, to think this will find anything, especially after seeing how
many TSE tests it took Italy and other Countries to find 1 case of BSE
(1 million rapid TSE test in less than 2 years, to find 102 BSE cases),
should be proof enough to make drastic changes of this system. the OIE
criteria for BSE Country classification and it's interpretation is very
problematic. a text that is suppose to give guidelines, but is not
understandable, cannot be considered satisfactory. the OIE told me 2
years ago that they were concerned with CWD, but said any changes might
take years. well, two years have come and gone, and no change in
relations with CWD as a human health risk. if we wait for politics and
science to finally make this connection, we very well may die before any
decisions
or changes are made. this is not acceptable. we must take the politics
and the industry out of any final decisions of the Scientific community.
this has been the problem from day one with this environmental man made
death sentence. some of you may think i am exaggerating, but you only
have to see it once, you only have to watch a loved one die from this
one time, and you will never forget, OR forgive...yes, i am still very
angry... but the transmission studies DO NOT lie, only the politicians
and the industry do... and they are still lying to this day...TSS

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

Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA [takes a few minutes to load]


https://web01.aphis.usda.gov/BSEcom.nsf/BSEFrameset?OpenFrameSet&Frame=BottomFrame&Src=_25t156hb3dtmisrjjconjcc9n6ph6ccr66oqjgdpo74qm6e1l68qjcp9hc4o30dhgckq34phfc8rjgoj16orjep9ic8o66c9i64s3achl6pi68cpg60r38eb675i3ujrgcln48rr3elmmarjk4p0nat3f8pp62rb5cg0_


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

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

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

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


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

PART 2


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

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1
File Format: PDF/Adobe Acrobat - View as HTML
Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of
those who provided comments in response to Docket No. ...
Meager 8/18/01 Terry S. Singeltary Sr ...


www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf

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

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

# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of
2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food
Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm

Dockets Entered On October 2, 2003 Table of Contents, Docket #,
Title, 1978N-0301,

OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr.
Vol #: 1, ...

www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


Daily Dockets Entered on 02/05/03

DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2.
... Vol#: 1.

03N-0009 Federal Preemption of State & Local Medical Device Requireme. ...


www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm


Docket Management

Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater

Comment Number: EC -1

Accepted - Volume 1


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html


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


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


Daily Dockets - 04/10/03

... 00D-1662 Use of Xenotransplantation Products in Humans.
EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...
www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm - 05-20-2003
- Cached


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 1
Terry S. Singeltary Sr.
Vol #:
1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1

2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

APE 5 National Renderers Association, Inc. Vol#: 2

APE 6 Animal Protein Producers Industry Vol#: 2

APE 7 Darling International Inc. Vol#: 2

EMC 1 Terry S. Singeltary Sr. Vol#: 3

http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm

Send Post-Publication Peer Review to journal:


Re: RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States


Email Terry S. Singeltary:


flounder@wt.net

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported that BSE

transmission to the 129-methionine genotype can lead to an alternate

phenotype that is indistinguishable from type 2 PrPSc, the commonest

sporadic CJD. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?


http://www.neurology.org/cgi/eletters/60/2/176#535


Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA






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