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From: TSS ()
Subject: TSE Conference Agenda Agenda for 26 - 29 June 2006, Renaissance Penta Vienna, Austria
Date: May 7, 2006 at 8:19 am PST

Agenda for Transmissible Spongiform Encephalopathies
26 - 29 June 2006, Renaissance Penta Vienna, Austria

--------------------------------------------------------------------------------

Transmissible Spongiform Encephalopathies Conference Agenda

Day One - 27 June 2006 | Day Two - 28 June 2006

--------------------------------------------------------------------------------

08.00 Registration and Coffee
09.00 Chairperson's Opening Remarks
Prion Clearance and Decontamination for Manufacturing Environments
09.05 OPENING ADDRESS

Recent progress in prion biology
Transmissible spongiform encephalopathies (TSE) are fatal neurodegenerative diseases of humans and animals. The underlying infectious agent, the prion, accumulates not only in the central nervous system (CNS) but also in secondary lymphoid organs. The role of the immune system in peripheral prion pathogenesis, while focusing on the mechanisms by which extraneural and extralymphatic prion infectivity develops will be discussed. Interestingly, the same pro-inflammatory cytokines and homeostatic chemokines that are involved in lymphoid neogenesis and compartmentalisation of immune cells appear to represent the crucial molecular switches responsible for the establishment of extraneural prion reservoirs.
Professor Adriano Aguzzi, Institute of Neuropathology, University Hospital of Zürich, Switzerland
09.35 Removal and concentration of TSE infectivity from blood by use of PRDT affinity ligands incorporated into a filter device by Macopharma
Using a high throughput selection method, Pathogen Removal and Diagnostics Technologies, PRDT, has obtained high affinity ligands that strongly bind both the abnormal form of the prion protein and TSE infectivity from both brain and blood. Impregnated into filters these resins have been incorporated by Macopharma into a stand alone device for removing TSE infectivity from red blood cells.
Dr Robert Rohwer, Director of Molecular Neurovirology Unit,University of Maryland, Baltimore, USA
10.05 Critical factors influencing prion clearance and decontamination
The unique biochemical properties of prions pose both challenges and opportunities for its clearance and decontamination. During therapeutic protein purification, prion particles can be removed by exploring their similarities with impurities. During equipment sanitisation, prion particles can be inactivated by unfolding of their native protein structure. Examples will be provided in support of both scenarios and discussed in the context of new information on blood infectivity.
Dr Kang Cai, Virology/TSE, Research and Development, Talecris Biotherapeutics, USA
10.35 Morning coffee and poster / exhibition viewing time
11.00 TSE agent properties affecting TSE inactivation
TSE strains are inactivated at different temperatures, dependent on strain of TSE agent but are also affected to a lesser extent by the phenotype of the PrP protein of the host animal. Greater thermostability can be induced by protein dehydration or fixation, leading to increased problems with TSE inactivation. Hence the mechanisms of TSE inactivation and their practical limits are being defined. These and other findings also suggest that diversity in the chemical structure of the TSE agent is required, which is covalently encoded and independent of the host.
Dr Robert A. Somerville, Neuropathogenesis Unit, Institute for Animal Health, UK
11.30 Preparation of soluble infectious samples from scrapie- infected brain: A new tool to study the clearance of TSE agents during plasma fractionation
This study describes a simple and fast protocol to prepare infectious material from scrapie- infected brains that is not contaminated with PrPTSE aggregates. This fraction is likely the most relevant material for endogenous spiking of human blood in validation experiments aimed at demonstrating procedures to remove or inactivate TSE infectious agents.
Professor Maurizio Pocchiari, Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, Italy
12.00 Technology Tutorial
Technology providers will host interactive educational tutorials which address the benefits of their technology in the filed of TSE’s. If you would like to host a tutorial, please contact: lily.chong@informa.com.
12.30 Lunch and poster / exhibition viewing time
Basic Science and Current Disease Trends
14.00 KEYNOTE

Variant Creutzfeldt-Jakob disease and its transmission by blood
vCJD represents the first known example of transmission of a prion agent from a non-human species to man. Since its identification, the number of vCJD cases in the UK has continued to increase, with additional cases identified over the past 10 years in France, Ireland, Canada, USA, Saudi Arabia, Japan, Netherlands, Italy, Spain and Portugal. 3 cases of probable vCJD transmission have occurred via blood transfusion and a recent risk assessment indicated that some plasma products produced in the UK might contain vCJD infectivity. Many uncertainties in this area could be addressed if a sensitive and specific screening test for vCJD was available. However, there will be major ethical dilemmas concerning the implementation of vCJD screening, since at present there is no effective treatment or prophylaxis for this devastating disorder.
Professor James Ironside, Director of Laboratories,National CJD Surveillance Unit, University of Edinburgh, UK
14.30 Interaction of prions with other pathogenic insults
During the years or decades of prion disease incubation, the at-risk individuals are certain to encounter diverse pathological insults, such as viral and bacterial infections or inflammatory processes. Whether prion disease incubation time or otherwise the pathology of other diseases is affected by the co-infection process is unknown. In this work, we will show the effect of viral infection or induction of EAE on prion disease pathology.
Dr D. Ruth Gabizon, Department of Neurology, Hadassah University Hospital, Israel
15.00 Prion in muscle from scrapie and BSE contaminated small ruminants
In a first study susceptible genotype sheep were experimentally contaminated by oral or intracranial route (IC) using scrapie. In those animals, as well as in naturally scrapie-affected sheep (same scrapie isolate), PrPsc was detected not only in nerves – including intramuscular fibres – but also in a particular myocyte subset. In a second study PrPsc presence in muscle was investigated in goats. In natural scrapie affected goats from 3 different flocks, consistent PrPsc deposits were observed in various muscles. PrPsc was observed in muscle since 21 months old in apparently healthy animals.
Dr Olivier Andreoletti, Animal Health Department, French National Veterinary School, France
15.30 Afternoon tea and poster / exhibition viewing time
16.00 Pathophysiology of human prion diseases: Distribution of PrPSc and beyond
Human prion diseases are fatal neurodegenerative disorders. An essential part of the infectious agent, termed prion, is composed of an abnormal protein, PrP(Sc). In the course of the disease, PrP(Sc) deposits mainly in the central nervous system and to a lesser extent in non-neuronal tissues. Patterns of PrP(Sc) depositions both in the central nervous system and in peripheral organs may influence clinical symptoms and depend on various factors including host genotype.
Professor Markus Glatzel, Director, Institute of Neuropathology,University Hamburg, Germany
16.30 TSE - Appreciation of surveillance and measures
The sourcing of ruminant material with negligible risk for TSE is crucial for any use in the pharmaceutical industry. Specified risk materials have been identified for cattle and small ruminants. However, importance also must be given to the national TSE situation of a given country. The risk assessment should include an appreciation of the risk factors, the regulatory measures and the surveillance system in place. The results on the full implementation of the measures have to be assessed.
Dr Lukas Perler, Head Technical Advice, Swiss Federal Veterinary Office, Switzerland
17.00 Cell culture models of prions to study transmission and to detect prions
Cell culture models susceptible to prions represent relevant and useful experimental models. They allow the study of TSE molecular events, they can be used to detect the presence of infectivity and to validate therapeutic approaches. However, to date, only a few models are available and there is a real need in models able to propagate human prions and the BSE agent.
Professor Sylvain Lehmann, Institute of Human Genetics, French National Center for Scientific Research (CNRS), France
17.30 End of day one followed by a drinks reception

Transmissible Spongiform Encephalopathies Conference Agenda

Day One - 27 June 2006 | Day Two - 28 June 2006

--------------------------------------------------------------------------------

08.30 Morning Coffee
09.00 Chairperson's Opening Remarks
Advances in TSE Detection
09.05 Immunoassay for the detection of resistant prion protein (PrPres) in human plasma using an original combination of chemical ligands
Streptomycin was found to aggregate PrPres in BSE or CJD brain samples after PK digestion. Another molecule, Calix-6-Arene sulfonate, was found to bind efficiently to PrPres aggregated by streptomycine, due to its "molecular basket" structure. A microplate immunoassay prototype for the detection of PrPres in human blood has been designed using the combined properties of these two molecules, with final specific antigenic detection using an anti-PrP monoclonal(s). Detection in blood of asymptomatic carriers and a test for excluding blood donations from such apparently healthy donors are next objectives. Further studies and technical improvements are therefore required before it may become a routine test for blood banking and/or human CJD diagnosis.
Dr Hervé Perron, Research Director, R&D Immunoassay and Proteomics Department, BioMérieux, France
09.35 Safety measures protecting humans againts prion contamination: reduction of risk evaluated for oral exposure and for instrument contamination
Dr Jean-Philippe Deslys, Coordinator of the European Network of Excellence NeuroPrion and Head of the Prion Research Group, French Atomic Energy Commission, France
10.05 Detection of prion proteins in body fluids
Our group specialises in developing innovative technologies to detect prion proteins in animals and humans. We will present new data on the distribution of prion proteins in body fluids and on the detection of molecular markers after prion infection. These findings will be discussed in regard to prion transmission.
Dr Ralph Zahn, Chief Executive Officer, Alicon AG, Switzerland
10.35 Morning coffee and poster / exhibition viewing time
11.00 Diagnostic assays for the detection of prions in blood
The detection of PrPSc in blood of TSE infected animals and humans have been hampered by the low levels and lack of protease resistance of PrPSc in blood. We have developed proprietary technologies based on the ELISA and FACS platform for the detection of disease associated prion proteins in plasma and serum using the conformation specific antibody 15B3 which recognises protease sensitive forms of PrP.
Dr Alex J. Raeber, Director of Research, Prionics AG, Switzerland
11.30 The use of Seprion for TSE blood screening
The novel Seprion ligand system has been used for separating abnormal amyloid from the normal protein counterpart. The ligand has been incorporated into a EU and UDSA approved TSE assay which has 100% sensitivity and specificity. The potential of the ligand as a tool for CJD blood screening will be presented with an update on our scrapie time course studies.
Dr Stuart Wilson, Scientific Director, Microsens Biotechnologies, UK
12.00 Technology Tutorial
Technology providers will host interactive educational tutorials which address the benefits of their technology in the filed of TSE’s. If you would like to host a tutorial, please contact: lily.chong@informa.com.
12.30 Lunch and poster / exhibition viewing time
14.00 Application of the scrapie cell assay (SCA) to discriminate between different mouse prion strains and to determine the kinetics of in vitro generation of prions
The scrapie cell assay is a rapid, cell-based method for the quantification of certain mouse prion strains. The assay can be readily performed in octuplicate on 80 samples in parallel and completed in two weeks, with a standard error of around 20%. Using the SCA we have determined that in vitro incubation of a small amount of scrapieinfected brain homogenate with PrPC (provided by normal mouse brain homogenate) under the conditions described by Lucassen et al. (Biochemistry, 42: 4127-35; 2003), generates a >10 fold increase of infectivity within 8 hrs.
Dr Sukhvir P. Mahal, Department of Infectology, Scripps Florida, USA
14.30 Quantification of PrPres
Extensive efforts are undertaken to develop tests for the detection of PrPres in live animals or for the screening of human blood. Several assays are basing upon immunochemical principles. By means of a sandwich ELISA with two monoclonal antibodies we’ve tested possibilities to quantify PrPres in different biological samples. This application allows the semi-quantitative screening of PrPres in these samples.
Dr Ingolf Lachmann, Business Unit Manager Protein Diagnostics, AJ Roboscreen GmbH, Germany
Industry Best Practices
15.00 TSE-safety of human urine-derived pharmaceuticals
Human-derived pharmaceuticals originating from urine are now receiving a similar amount of regulatory attention as blood products. The need and the measures taken by Ferring Pharmaceuticals and other companies to ensure the safety of products such as urinary-derived gonadotrophins and urokinase will be described.
Dr Peter A McAnulty, Senior Director, Non-Clinical Development, Ferring Pharmaceuticals A/S, Denmark
15.30 Afternoon tea and poster / exhibition viewing time
Regulatory Perspectives
16.00 KEYNOTE

US approaches to prevent contamination of FDA-regulated products with the agents of Transmissible Spongiform Encephalopathies (TSEs)
The US Food and Drug Administration (FDA) regulates vaccines, human blood and tissue products, drugs, surgical devices, cosmetics, many foods, animal feeds and veterinary drugs. FDA, uses regulations and guidance to help prevent contamination of regulated products with agents causing various TSEs: bovine spongiform encephalopathy, Creutzfeldt-Jakob Disease (CJD) and variant CJD.
Dr David M. Asher, Chief, Laboratory of Bacterial, Parasitic and Unconventional Agents, Division of Emerging and Transfusion- Transmitted Diseases, Office of Blood Research and Review, CBER FDA, USA
16.30 TSE regulatory aspects in the EU
In order to minimise the risk of transmission of BSE or other animal transmissible spongiform encephalopathy (TSE) agents via medicinal products, a guideline (“Note for Guidance on Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products”)is available to the pharmaceutical industry. A couple of revisions of this guideline have taken place and a new one is under preparation. The topics under revision will be detailed in presentation.
Dr Sol Ruiz, Division of Biologicals and Biotechnology, Spanish Medicines Agency, Spain

Rapporteur for the TSE guideline at the European Medicines Agency and also for the TSE certification system at the European Pharmacopoeia
17.00 Reference reagents for pre-mortem vCJD diagnostic tests
Homogenates from vCJD tissues have been spiked into cryo-depleted plasma at a range of concentrations within and beyond the current known levels of detection. To extend the range of samples available we have collaborated with the Veterinary Laboratories Agency (Weybridge, UK) to collect blood from scrapie infected and uninfected sheep. This blood has been fractionated into plasma, buffy coats and red blood cells. Preliminary studies using some of the samples described above have indicated their value in evaluating assay sensitivity and within and between laboratory variability.
Dr Jillian Cooper, CJD Department, National Institute for Biological Standards and Control, (NIBSC), UK
17.30 End of Conference

http://www.ibc-lifesci.com/cod/oinfo_lower.asp?pid=UKCCQZ202&pname=body


GREETINGS,

16.30 TSE - Appreciation of surveillance and measures
The sourcing of ruminant material with negligible risk for TSE is crucial for any use in the pharmaceutical industry. Specified risk materials have been identified for cattle and small ruminants. However, importance also must be given to the national TSE situation of a given country. The risk assessment should include an appreciation of the risk factors, the regulatory measures and the surveillance system in place. The results on the full implementation of the measures have to be assessed.
Dr Lukas Perler, Head Technical Advice, Swiss Federal Veterinary Office, Switzerland


snip...

16.00 KEYNOTE

US approaches to prevent contamination of FDA-regulated products with the agents of Transmissible Spongiform Encephalopathies (TSEs)
The US Food and Drug Administration (FDA) regulates vaccines, human blood and tissue products, drugs, surgical devices, cosmetics, many foods, animal feeds and veterinary drugs. FDA, uses regulations and guidance to help prevent contamination of regulated products with agents causing various TSEs: bovine spongiform encephalopathy, Creutzfeldt-Jakob Disease (CJD) and variant CJD.
Dr David M. Asher, Chief, Laboratory of Bacterial, Parasitic and Unconventional Agents, Division of Emerging and Transfusion- Transmitted Diseases, Office of Blood Research and Review, CBER FDA, USA

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



Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de

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

Greetings List Members,

I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.

I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.

"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."

and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.

(understand, these are taken from my notes for now.
the spelling of names and such could be off.)

[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.

[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]

[host Richard]
could you repeat the question?

[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[not sure whom ask this]
what group are you with?

[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.

[not sure who is speaking]
could you please disconnect Mr. Singeltary

[TSS]
you are not going to answer my question?

[not sure whom speaking]
NO

from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;

[unknown woman]
what group are you with?

[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?

at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.

IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;

RBARNS@ORA.FDA.GOV
301-827-6906

he would be glad to give you one ;-)

Rockville Maryland,
Richard Barns Host

BSE issues in the U.S.,
How they were labelling ruminant feed?
Revising issues.

The conference opened up with the explaining of
the U.K. BSE epidemic winding down with about 30
cases a week.

although new cases in other countries were now
appearing.

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product,
heightened interest in U.S.

A recent statement in Washington Post, said the
New Administration (old GW) has a list of issues.
BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greater
interest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S.
it would be economically disastrous
to the render, feed, cattle, industries,
and for human health.

(human health-they just threw that in cause i was listening. I will now
jot down some figures in
which they told you, 'no need to write them down'.
just hope i have them correct. hmmm, maybe i hope
i don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOT
occurred.

sizeable number of 1st time FAILED INITIAL INSPECTION,
have not been reinspected (70% to 80%).

Compliance critical, Compliance poor in U.K.
and other European Firms.

Gloria Dunason
Major Assignment 1998 goal TOTAL compliance.
This _did not_ occur. Mixed level of compliance,
depending on firm.

Rendering FDA license and NON FDA license

system in place for home rendering & feed
76% in compliance
79% cross contamination
21% DID NOT have system
92% record keeping
less than 60% total compliance

279 inspectors
185 handling prohibited materials

Renderer at top of pyramid, significant
part of compliance.
84% compliance

failed to have caution statement render
72% compliance & cross contamination
caution statement on feed, 'DO NOT FEED TO CATTLE'

56 FIRMS NEVER INSPECTED

1240 FDA license feed mills
846 inspected

"close to 400 feed mills have not been inspected"

80% compliance for feed.

10% don't have system.

NON-FDA licensed mills
There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ???
4,344 ever inspected.
"FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only half
gotten to"

"700 Firms that were falitive, and need to be
re-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by end
of January or 30 days, and other states 60 days.
to change feed status??? Contract check and ask
questions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question.
then all B.S.eee broke loose, and i lost my train
of thought for a few minutes. picked back up here]

someone asking about nutritional supplements and
sourcing, did not get name. something about inspectors
not knowing of BSE risk??? the conference person assuring that Steve
Follum? and the TSE advisory Committee were
handling that.

Some other Dr. Vet, whom were asking questions
that did not know what to do???

[Dennis Wilson]
California Food Agr.
Imports, are they looking at imports?

[Conference person]
they are looking at imports,
FDA issued imports Bulletin.

[Linda Singeltary ??? this was a another phone in
question, not related i don't think]
Why do we have non-licensed facilities?

(conference person)
other feed mills do not handle as potent drugs???

Dennis Blank, Ken Jackson
licensed 400
non FDA 4400 inspected of a total of 6000 to 8000,

(they really don't know how many non licensed Firms
in U.S. they guess 6000 to 8000??? TSS)

Linda Detwiler
asking everyone (me) not to use emergency BSE number,
unless last resort.
(i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not'

Warren-Maryland Dept. Agr.
Prudent to re-inspect after 3 years.
concerned of Firms that have changed
owners.

THE END

TSS

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############

Subject:
USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL
Jan. 9, 2001
Date:
Wed, 10 Jan 2001 14:04:21 -0500
From:
"Gomez, Thomas M."
Reply-To:
Bovine Spongiform Encephalopathy
To:
BSE-L@uni-karlsruhe.de


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

USDA/APHIS would like to provide clarification on the following point
from
Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.

[Linda Detwiler asking everyone (me) not to use emergency BSE number,
unless
last resort. (i thought of calling them today, and reporting the whole
damn
U.S. cattle herd ;-) 'not']

Dr. Detwiler was responding to an announcement made during the call to
use
the FDA emergency number if anyone wanted to report a cow with signs
suspect
for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants
to
use the FDA emergency number as a last resort to report cattle suspect
for
BSE. What Mr. Singeltary failed to do was provide the List with Dr.
Detwiler's entire statement. Surveillance for BSE in the United States
is a
cooperative effort between states, producers, private veterinarians,
veterinary hospitals and the USDA. The system has been in place for
over 10
years. Each state has a system in place wherein cases are reported to
either the State Veterinarian, the federal Veterinarian in Charge or
through
the veterinary diagnostic laboratory system. The states also have
provisions with emergency numbers. Dr. Detwiler asked participants to
use
the systems currently in place to avoid the possibility of a BSE-suspect
report falling through the cracks. Use of the FDA emergency number has
not
been established as a means to report diseased cattle of any nature.

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############

Subject:
Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE
CALL Jan.9, 2001
Date:
Wed, 10 Jan 2001 13:44:49 -0800
From:
"Terry S. Singeltary Sr."
Reply-To:
Bovine Spongiform Encephalopathy
To:
BSE-L@uni-karlsruhe.de
References:
1


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

Hello Mr. Thomas,

> What Mr. Singeltary failed to do was provide
> the List with Dr. Detwiler's entire statement.

would you and the USDA/APHIS be so kind as to supply
this list with a full text version of the conference
call and or post on your web-site?
if so when, and thank you.
if not, why not?

> The system has been in place for over 10 years.

that seems to be a very long time for a system to be in
place, and only test 10,700 cattle from some 1.5 BILLION head (including
calf crop). Especially since French
are testing some 20,000 weekly and the E.U. as a whole,
are testing many many more than the U.S., with less
cattle, same risk of BSE/TSEs.

Why does the U.S. insist on not doing massive testing
with the tests which the E.U. are using?
Why is this, please explain?

Please tell me why my question was not answered?

> U.S. cattle, what kind of guarantee can you
> give for serum or tissue donor herds?

It was a very simple question, a very important
question, one that pertained to the topic of
BSE/feed, and asked in a very diplomatic way.
why was it not answered?

If all these years, we have been hearing that
pharmaceutical grade bovines were raised for
pharmaceuticals vaccines etc. But yet the
USA cannot comply with feed regulations of
the ruminant feed ban, PLUS cannot even
comply with the proper labelling of the feed,
cross contamination etc.
Then how in the world can you Guarantee the feed
fed to pharmaceutical grade bovine, were actually
non ruminant feed?

Before i was ask to be 'disconnected',
i did hear someone in the background
say 'we can't'-- have him ask the question again.

could you please be so kind, as to answer these
questions?

thank you,
Terry S. Singeltary Sr. Bacliff, Texas USA

P.S. if you will also notice, i did not post that
emergency phone number and do not intend on passing
it on to anyone. I was joking when i said i should
call and report the whole damn U.S. Herd. So please
pass that on to Dr. Detwiler, so she can rest easily.

BUT, they should be reported, some are infected with TSE.
The U.S. is just acting as stupid as Germany and other
Countries that insist they are free of BSE.

TSS

Subject: Report on the assessment of the Georgraphical BSE-risk of the
USA July 2000 (not good)
Date: Wed, 17 Jan 2001 21:23:51 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de

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

Greetings List Members and ALL EU Countries,

Because of this report, and the recent findings
of the 50-state BSE Conference call, I respectfully
seriously suggest that these Countries and the SSC
re-evaluate the U.S.A. G.B.R. to a risk factor of #3.

I attempted to post this to list in full text,
but would not accept...

thank you,
kind regards,
Terry S. Singeltary Sr., Bacliff, Texas USA

Report on the assessment of the Geographical BSE-risk of the USA
July
2000

PART II

REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE
RISK OF THE UNITED STATES OF AMERICA

- 29 -

Report on the assessment of the Geographical BSE-risk of the USA
July
2000

EXECUTIVE SUMMARY

OVERALL ASSESSMENT

The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent.

Stability: Before 1990 the system was extremely unstable because feeding
of MBM to cattle happened, rendering was inappropriate with regard to
deactivation of the BSE-agent and SRM and fallen stock were rendered for
feed. From 1990 to 1997 it improved to very unstable, thanks to efforts
undertaken to trace imported animals and exclude them from the feed
chain and intensive surveillance. In 1998 the system became neutrally
stable after the RMBM-ban of 1997.

External challenges: A moderate external challenge occurred in the
period before 1990 because of importation of live animals from
BSE-affected countries, in particular from the UK and Ireland. It cannot
be excluded that some BSE-infected animals have been imported by this
route and did enter the US rendering and feed production system. The
efforts undertaken since 1990 to trace back UK-imported cattle and to
exclude them from the feed chain reduced the impact of the external
challenge significantly.

Interaction of external challenges and stability: While extremely
unstable, the US system was exposed to a moderate external challenge,
mainly resulting from cattle imports from the UK. It can not be excluded
that BSE-infectivity entered the country by this route and has been
recycled to domestic cattle. The resulting domestic cases would have
been processed while the system was still very unstable or unstable and
would hence have initiated a number of second or third generation cases.
However, the level of the possible domestic prevalence must be below the
low detection level of the surveillance in place.

As long as there are no changes in stability or challenge the
probability of cattle to be (pre-clinically or clinically) infected with
the BSE-agent will remain at the current level.

JUSTIFICATION

1. DATA

The available information was suitable to carry out the GBR risk
assessment.

- 30 -

Report on the assessment of the Geographical BSE-risk of the USA
July
2000

2. STABILITY

2.1 Overall appreciation of the ability to identify BSE-cases and to
eliminate animals at risk of being infected before they are processed

· Before 1989, the ability of the system to identify (and
eliminate) BSE cases was limited.
· Since 1990 this ability is significantly improved, thanks to a
good BSE-surveillance and culling system (contingency plan).
· Today the surveillance should be able to detect clinical
BSE-cases within the limits set by an essential passive surveillance
system, i.e. some cases might remain undetected.

2.2 Overall appreciation of the ability to avoid recycling
BSE-infectivity, should it enter processing

· Before 1997 the US rendering and feed producing system would not
have been able to avoid recycling of the BSE agent to any measurable
extent. If the BSE-agent was introduced the feed chain, it could
probably have reached cattle.
· After the introduction of the RMBM-to-ruminants-ban in August
1997 the ability of the system to avoid recycling of BSE-infectivity was
somewhat increased. It is still rather low due to the rendering system
of ruminant material (including SRM and fallen stock) and the persisting
potential for cross-contamination of cattle feed with other feeds and
hence RMBM.

2.3 Overall assessment of the Stability

· Until 1990 the US BSE/cattle system was extremely unstable as
RMBM was commonly fed to cattle, the rendering system was not able to
reduce BSE-infectivity and SRM were rendered. This means that incoming
BSE infectivity would have been most probably recycled to cattle and
amplified and the disease propagated.
· Between 1990 and 1995 improvements in the BSE surveillance and
the efforts to trace back and remove imported cattle gradually improved
the stability but
the system remained very unstable.
In 1998 the system became unstable because of an RMBM-ban introduced in
1997. After 1998 the ban was fully implemented and the system is
regarded to be neutrally stable since 1998. The US system is therefore
seen to neither be able to amplify nor to reduce circulating or incoming
BSE-infectivity.

3. CHALLENGES

A moderate external challenge occurred in the period 1980-1989 because
of importation of live animals from the UK. imports from other countries
are regarded to have been negligible challenges.
· As a consequence of this external challenge, infectivity could
have entered the feed cycle and domestic animals could have been exposed
to the agent. These domestic BSE-incubating animals might have again
entered processing, leading to an internal challenge since 1991.
· This internal challenge could have produced domestic cases of
BSE, yet prevalence levels could have been below the detection limits of
the surveillance system until now. (According to US calculations, the
current surveillance

-31 -

Report on the assessment of the Geographical BSE-risk of the USA July
2000

system could detect clinical incidence of 1-3 cases per year per million
adult cattle, i.e. in absolute numbers 43-129 cases per year). Between
1990 und 1995, with the exclusion of the imported animals from Europe
from the feed chain, the effect of the external challenges decreased.

4. CONCLUSION ON THE RESULTING RISKS

4.1 Interaction of stability and challenqe

· In the late 80s, early 90s a moderate external challenges met an
extremely unstable system. This would have amplified the incoming
BSE-infectivity and propagated the disease.
· With the exclusion of the imported animals from Europe from the
feed chain between 1990 and 1995 the effect of the external challenge
decreased.
· Before 1998 an internal challenge, if it developed, would have
met a still unstable system (inappropriate rendering, no SRM ban, RMBM
ban only after 1997) and the BSE-infectivity could have been recycled
and amplified.
· After 1998 the neutrally stable system could still recycle the
BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity
circulating in the system would probably not be amplified.

4.2 Risk that BSE-infectivity enters processing

· A very low processing risk developed in the late 80s when the
UK-imports were slaughtered or died. It increased until 1990 because of
the higher risk to be infected with BSE of cattle imported from the UK
in 1988/89, as these animals could have been processed prior to the
back-tracing of the UK-imports in 1990.
· From 1990 to 1995 a combination of surviving non-traced UK
imports and some domestic (pre-)clinical cases could have arrived at
processing resulting in an assumed constant low but non-negligible
processing risk.
· After 1995 any processing risk relates to assumed domestic cases
arriving at processing.
· The fact that no domestic cases have been shown-up in the
BSE-surveillance is reassuring - it indicates that BSE is in fact not
present in the country at levels above the detection limits of the
country's surveillance system. This detection level has been calculated
according to US-experts to be between 1 & 3 clinical cases per million
adult cattle per year.

Note: The high turnover in parts of the dairy cattle population with a
young age at slaughter makes it unlikely that fully developed clinical
cases would occur (and could be detected) or enter processing. However,
the theoretical infective load of the pre-clinical BSE-cases that
under this scenario could be processed, can be assumed to remain
relatively low.

4.3 Risk that BSE-infectivity is recycled and propagated

· During the period covered by this assessment (1980-1999) the
US-system was not able to prevent propagation of BSE should it have
entered, even if this ability was significantly improved with the
MBM-ban of 1997.
· However, since the likelihood that BSE-infectivity entered the
system is regarded to be small but non-negligible, the risk that
propagation of the disease
took place is also small but not negligible.

- 32 -

Report on the assessment of the Geographical BSE-risk of the USA
July
2000

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

5.1 The current GBR

The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent.

5.2 The expected development of the GBR

As long as there are no changes in stability or challenge the
probability of cattle to be (pre-clinically or clinically) infected with
the BSE-agent remains at the current level.

5.3 Recommendations for influencin.q the future GBR

· As long as the stability of the US system is not significantly
enbanced above neutral levels it remains critically important to avoid
any new external
challenges.
· All measures that would improve the stability of the system, in
particular with regard to its ability to avoid recycling of the
BSE-agent should it be present in the cattle population, would reduce,
over time, the probability that cattle could be infected with the
BSE-agent. Possible actions include:
removal of SRMs and/or fallen stock from rendering, better rendering
processes, improved compliance with the MBM-ban including control and
reduction of cross-contamination.
· Results from an improved intensive surveillance programme,
targeting at risk sub-populations such as adult cattle in fallen stock
or in emergency slaughter, could verify the current assessment.

snip... end...TSS

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

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

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Last updated: 19 July 2005
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report
Summary
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 90’s 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.


Publication date: 20 August 2004

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_it.html


http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf


http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf


2005-2006

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE
QUARTERLY ENFORCEMENT REPORT October 1, 2005 through December 31, 2005


snip....


CARGILL MEAT SOLUTIONS 00086K M DODGE CITY, KS X X On 10/11/05, a
withholding action concerning labels for Advanced Meat Recovery System
product was taken in accordance with 9 CFR Part 500.8.


EXCEL CORP 00086R M FORT MORGAN, CO 2/22/05 X X On 8/11/04, a withholding
action concerning labels for Advanced Meat Recovery System product was taken
in accordance with 9 CFR Part 500.8. On 12/22/04, plant appealed the
withholding action. Appeal was denied on 1/25/05.


00245L M LEXINGTON, NE 3/12/04 3/18/04 X 5/4/05 X X On 3/10/05, a
withholding action concerning labels for Advanced Meat Recovery System
product was taken in accordance with 9 CFR Part 500.8.

9/16/05 9/29/05 X X TYSON FRESH MEATS INC. 09268 M PASCO, WA X X On 7/28/04,
a withholding action concerning labels for Advanced Meat Recovery System
product was taken in accordance with 9 CFR Part 500.8.

TYSON FRESH MEATS INC. X X 00245D M EMPORIA, KS On 12/23/04, a withholding
action concerning labels for Advanced Meat Recovery System product was taken
in accordance with 9 CFR Part 500.8.


DESERET MEAT 04852 M SPANISH FORK, UT 7/20/05 8/1/05 X X 12/29/05 The
enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


NORTHERN PACKING COMPANY INC. 00571 M BRIAR HILL, NY 12/9/05 12/23/05 X X X
X The enforcement action included, as a basis, failure of the establishment
to comply with Agency requirements concerning specified risk material.


A.J. CEKAK'S MEAT MARKET 9/1/05 9/20/05 X X X On 9/1/05, an enforcement
action
21562 M
concerning failure to meet regulatory ORD, NE requirements for Escherichia
coli Biotype 1 (E. coli) was taken. The enforcement action included, as a
basis, failure of the establishment to comply with Agency requirements
concerning specified risk material.


ALTA VISTA LOCKER
10/5/05 10/26/05 X X The enforcement action included, as a 31931 M basis,
failure of the establishment toALTA VISTA, KS comply with Agency
requirements
concerning specified risk material.


BROWN'S PROCESSING 13100 M13100 P ELSBERRY, MO 8/8/05 8/16/05 X X X 11/16/05
The enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


CHAMPLAIN BEEF INC 2/28/05 3/4/05 3/8/05 X X X
08547 M
WHITEHALL, NY
10/17/05 X X X The enforcement action included, as a basis, failure of the
establishment to comply with Agency requirements concerning specified risk
material.


FIVE STAR PACK INC. 9/1/05 9/9/05 X X 12/29/05 On 9/1/05, an enforcement
action
08725 M08725 P
concerning failure to meet regulatory GOLDEN CITY, MO requirements for
Escherichia coli Biotype 1 (E. coli) was taken. The enforcement action
included, as a basis, failure of the establishment to comply with Agency
requirements concerning specified risk material. FRESH FARMS BEEF 12/16/05
12/28/05 X X X The enforcement action included, as a 18579 M basis, failure
of the establishment toRUTLAND, VT comply with Agency requirements
concerning specified risk material.


GOETZ AND SONS WESTERN 11/15/05 11/23/05 12/1/05 X X
MEATS INC
06245 M06245 P
EVERETT, WA
12/17/05 12/28/05 X X X On 12/17/05, firm violated a regulatory control
action by selling U.S.D.A retained product.


H AND P MEATS 21352 M SOUTH PITTSBURG, TN 7/28/05 8/8/05 8/17/05 8/19/05 X X
The enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


HOPKINS PACKING COMPANY 11069 M BLACKFOOT, ID 7/28/05 8/1/05 X X The
enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


NORTHWEST PREMIUM MEATS LLC 11032 M11032 P NAMPA, ID 7/26/05 7/29/05 X X
11/15/05 The enforcement action included, as a basis, failure of the
establishment to comply with Agency requirements concerning specified risk
material.


PARADISE LOCKER MEATS 31865 M31865 P TRIMBLE, MO 9/21/05 10/7/05 X X The
enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material. PARAGON
SPRAY DRYING, LLC 31762 M31762 P WAUKON, IA 9/6/05 9/12/05 X X X The
enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


RANDALL MEAT COMPANY 10669 M HOT SPRINGS, AR 7/1/05 7/28/05 10/12/05
10/24/05 X X X The enforcement action included, as a basis, failure of the
establishment to comply with Agency requirements concerning specified risk
material.


S & S MEAT COMPANY 01046 M01046 P KANSAS CITY, MO 8/4/05 8/19/05 X X
11/16/05 The enforcement action included, as a basis, failure of the
establishment to comply with Agency requirements concerning specified risk
material.


STEAK MASTER 21159 M21159 P ELWOOD, NE 11/4/05 11/17/05 X X X The
enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


THE MEAT SHOP 31561 M BENSON, VT 8/18/05 9/6/05 9/9/05 X X X X X The
enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


THEURER'S QUALITY MEATS, INC 31647 M31647 P LEWISTON, UT 7/27/05 7/29/05 X X
The enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


TOOELE VALLEY MEATS 20594 M20594 P GRANTSVILLE, UT 7/25/05 8/1/05 X X The
enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


WALNUT VALLEY PACKING LLC 32007 M32007 P EL DORADO, KS 12/15/05 12/30/05 X X
X The enforcement action included, as a basis, failure of the establishment
to comply with Agency requirements concerning specified risk material.


YODER BROTHERS MEAT PROCESSING 17301 M PARIS, TN 10/3/05 10/12/05 X X The
enforcement action included, as a basis, failure of the establishment to
comply with Agency requirements concerning specified risk material.


full text 54 pages ;


http://www.fsis.usda.gov/PDF/QER_Q1_FY2006.pdf


UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE
QUARTERLY ENFORCEMENT REPORT July 1, 2005 through September 30, 2005


snip...


52 pages

http://www.fsis.usda.gov/PDF/QER_Q4_FY2005.pdf


TSS




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