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From: TSS ()
Subject: MAY SCRAPIE REPORT 2007 (OHIO still topping the list, what about CJD?)
Date: July 9, 2007 at 12:30 pm PST

MAY SCRAPIE REPORT 2007 (OHIO still topping the list, what about CJD?)


OHIO has had a serious problem with scrapie for YEARS!

DOES anyone have any ideas as to why, IF TSE occur spontaneously (as some would wish us to believe), why they spontaneously happen more often in OHIO than any other state, in regards to scrapie ???


what is the reason for this phenonimum $


MAY SCRAPIE REPORT 2007

http://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/monthly_scrapie_rpt.pps


Ohio State University Fact Sheet
Veterinary Preventive Medicine
1900 Coffey Road, Columbus, Ohio 43210

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

Update on Testing for Scrapie

http://ohioline.osu.edu/vme-fact/0004.html


Opinion of the Scientific Panel BIOHAZ: Protocol for the evaluation of rapid
post mortem tests to detect TSE in small ruminants [1]
Last updated: 22 June 2007 Publication Date: 22 June 2007

Adopted on 7 June 2007. (Question N° EFSA-Q-2007-055)


Summary

Annex X to Regulation (EC) No 999/2001 lays down rules for the prevention,
control and eradication of certain transmissible spongiform encephalopathies
and lists the approved rapid tests which may be used within the framework of
the EU monitoring programmes. The approval of these tests was based on SSC
and EFSA evaluation protocols and its recommendations on the suitability or
otherwise of the evaluated tests for inclusion in the EU programme for TSE
monitoring.

The EC will now launch a new open call for expressions of interest, for
rapid tests for use in the framework of TSE monitoring. This call is
intended to cover tests for TSE detection ante- and post-mortem in cattle
and sheep and goats. Evaluation of these tests is based on a protocol
developed by TSE testing experts and covers different steps including a
pre-assessment, an assessment of the application dossier, a laboratory
evaluation, approval of the package insert and a field trial. EFSA was asked
by the EC to revise and update the three current protocols for the
evaluation of TSE tests in ruminants taking into account the experience
gained in past evaluation rounds.

This opinion reports on the revised protocol for the evaluation of post
mortem TSE tests in small ruminants.

In 2003 the European Commission (EC) (DG SANCO and DG JRC and its IRMM) and
EFSA, started evaluation of rapid tests for TSE epidemio-surveillance in
small ruminants. During the previous evaluation process, differences were
observed between tests in terms of analytical sensitivity. However, the
significance of such differences both in term of field diagnostic
sensitivity and biological relevance could not be scientifically assessed at
the time of evaluation. Moreover, following the implementation of active
surveillance programs in the EU using tests that were validated, a new type
of TSE (atypical scrapie cases/NOR98) not previously recognized in the EU,
was detected in small ruminants. Currently atypical/Nor98 has been detected
in a large number of European countries and approximately constitutes 80% of
test positive cases identified in EU. Data collected in this EU active
surveillance program clearly indicate that all the validated tests do not
perform equally toward atypical cases and that difference in performance
result in under- or non recognition of various types of scrapie.

The EFSA Scientific Panel on Biological Hazards (BIOHAZ) has agreed on a
revised evaluation protocol which takes into account the experience gained
in past evaluation rounds and knowledge accumulated from the active
surveillance program. New tests have to successfully pass all stages of the
evaluation process. Progress to the next stage requires successful
completion of the previous stage and therefore the process can be suspended
at any stage of the evaluation.

This protocol ensures that newly approved tests will not be inferior to
previously approved BSE post mortem screening tests. In addition to previous
evaluation criteria, the revised protocol considers each test’s performance
with respect to (i) detection of classical scrapie, atypical scrapie and BSE
in sheep and (ii) detection of preclinical cases and (iii) limitations posed
by analytical sensitivity in comparison with bioassay. The criteria in this
revised protocol introduce more comprehensive and higher standards than have
previously been approved for validation of small ruminant post mortem TSE
tests for classical scrapie and BSE as well as for atypical scrapie.
Considering data available about abnormal PrP distribution in the three
recognized small ruminants TSE forms (BSE, classical scrapie and atypical
scrapie) the use of brainstem appears to be the best compromise for
detection of all TSE agents in small ruminants. In consequence, officially
confirmed (by CRL and NRL) positive/negative brainstem will be used for the
evaluation of tests.

The BIOHAZ panel recommends that tests already approved for the detection of
TSE in small ruminants should be required to participate in the new
evaluation in order to confirm their robustness and their ability to fulfil
the additional performance requirements (e.g. atypical cases and analytical
sensitivity). This re-iterates a recommendation of their recent Opinion on
the EU TSE Community Reference Laboratory report on batch testing of TSE
rapid tests: sample selection and test sensitivity issues[2] . It is further
recommended that tests that are not able to meet requirements for detection
of all types of TSE (classical scrapie, BSE and atypical scrapie) not be
considered for testing small ruminants in the field. Tests that fail to meet
a requirement in respect of a particular tissue type (lymphoid/CNS) should
not be recommended for application on that tissue. Finally, taking into
account the experience gained in the TSE test batch testing protocol and
because knowledge in the TSE field is rapidly evolving, the BIOHAZ panel
recommends that a system of periodic re-assessment of test approval based on
both test field performance and evolving EU policy objectives should be
considered by the Risk Managers.


____________________________
[1] For citation purposes: Scientific Opinion of the Panel on Biological
Hazards on a request from the European Commission on a protocol for the
evaluation of rapid post mortem tests to detect TSE in small ruminants. The
EFSA Journal (2007) 509, 1-31
[2] For citation purposes: Opinion of the Scientific Panel on Biological
Hazards on a request from the European Commission on the CRL report on batch
testing of TSE rapid tests: sample selection and test sensitivity issues,
The EFSA Journal (2007), 443, 1-18.


http://www.efsa.europa.eu/en/science/biohaz/biohaz_opinions/biohaz_op_ej509_post_mortem_smru.html


Opinion

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/ej509_postmortem_smru.Par.0001.File.dat/biohaz_op_ej509_post_mortem_smru_en.pdf

Summary

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/ej509_postmortem_smru.Par.0002.File.dat/biohaz_op_ej509_post_mortem_smru_summary_en.pdf


Subject: NOR98-LIKE STRAIN OF SCRAPIE FOUND IN WYOMING
Date: April 11, 2007 at 12:47 pm PST

PRESS RELEASE

March 16, 2007

Wyoming Livestock Board

2020 Carey Avenue 4th Floor

Cheyenne, Wyoming 82002

For more information contact: Dr. Walter Cook at (307) 631-2974 [weekend] or
(307) 777-6443 [weekday]

*****FOR IMMEDIATE RELEASE*****

NOR98-LIKE STRAIN OF SCRAPIE FOUND IN WYOMING

CHEYENNE, Wyo. - On Friday, March 16, 2007, the Wyoming Livestock Board
(WLSB) was notified by officials of the USDA Animal Plant Health Inspection
Service (APHIS) that an adult female sheep had tested positive for a form of
scrapie consistent with the Nor98 strain. The ewe was slaughtered in
Michigan, where it was tested as part of USDA’s regulatory scrapie slaughter
surveillance program and traced back to a flock in Wyoming. The results of
this case are distinctly different from those seen for bovine spongiform
encephalopathy (BSE) or classical scrapie.

Scrapie is a transmissible spongiform encephalopathy and falls into the same
category of diseases as chronic wasting disease, found in deer and elk, and
bovine spongiform encephalopathy, found in cattle. The disease is limited to
sheep and goats and takes years to affect an animal after it has been
infected. Scrapie causes sheep to itch and scratch (scrape) wool off, change
their behavior and lose body condition; it ultimately ends in death.

Nor98-like scrapie differs from classical scrapie in the distribution of
brain lesions and in the course of disease progression and epidemiology.
Some sheep that are genetically resistant to the classic form of the disease
may be susceptible to the Nor98-like strain. Oddly, Nor98-like scrapie is
usually diagnosed during surveillance in animals without clinical signs.
There are no known human health risks associated with either form of
scrapie.

This is the first time a Nor98-like strain of scrapie has been documented in
the United States. It gets the "Nor98-like" name because it is similar to a
case first diagnosed in Norway in 1998. This strain of scrapie is a rare
disease even in Europe. Since 1998, fewer than 300 cases have been diagnosed
in all of Europe. It is usually seen in single animals and does not tend to
become widespread in a flock. In contrast, in flocks infected by classical
scrapie typically more than 10 percent of the genetically susceptible
animals test positive.

"This provides evidence that the surveillance program is working," said
Bryce Reece, executive director of the Wyoming Wool Growers Association. "It
also indicates that the program is on the cutting-edge of science to detect
such a rare disease during standard surveillance."

The Wyoming Livestock Board does not expect the Nor98-like strain of scrapie
to become a major disease problem for the sheep industry in Wyoming. Risk is
limited because diagnosis of Nor98-like scrapie is usually an incidental
event, with even highly-exposed flock mates of the positive animal normally
unaffected.

The infected ewe lambed in it in what is considered a low-risk,
range-lambing environment. Nonetheless, the WLSB, APHIS and the Wyoming Wool
Growers Association plan to assertively pursue this case to make sure that
this strain of scrapie is extinguished and does not establish itself in the
U.S.

The agencies continue to encourage producers to monitor their sheep for
signs of scrapie and other diseases, and to notify their veterinarian if
they discover anything unusual.

The positive ewe was purchased as an adult within the last several years and
moved to a Wyoming flock near the Black Hills. The producer was notified and
his flock quarantined as a precautionary measure. An epidemiologic
investigation is ongoing and the producer has been cooperative. The case
fits the pattern found in Europe - a single, older sheep that was not
exhibiting clinical signs of scrapie.

The regulatory scrapie slaughter surveillance program is a targeted
slaughter surveillance program for sheep and goats designed to identify
infected animals and flocks. USDA is conducting this surveillance as part of
a program to eradicate scrapie from the United States by the end of 2010.
Reece said that the sheep industry supports this program and is committed to
eliminating scrapie from the United States.

###


http://wlsb.state.wy.us/NewReleases/07Mar16FINALNOR98LIKESCRAPIEPRESSRLS.pdf

SCRAPIE UPDATE USA AS OF MARCH 2007 NOR98 INCLUDED

http://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/monthly_scrapie_rpt.pps


NOR98-LIKE STRAIN OF SCRAPIE FOUND IN WYOMING (1791 lines)
From: Terry S. Singeltary Sr. <[log in to unmask]>
Date: Wed, 11 Apr 2007 15:08:15 -0500


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0704&L=sanet-mg&T=0&P=8315

Published online before print October 20, 2005

Proc. Natl. Acad. Sci. USA, 10.1073/pnas.0502296102
Medical Sciences

A newly identified type of scrapie agent can naturally infect sheep with
resistant PrP genotypes

( sheep prion | transgenic mice )

Annick Le Dur *, Vincent Béringue *, Olivier Andréoletti , Fabienne Reine *,
Thanh Lan Laï *, Thierry Baron , Bjørn Bratberg ¶, Jean-Luc Vilotte ||,
Pierre Sarradin **, Sylvie L. Benestad ¶, and Hubert Laude *
*Virologie Immunologie Moléculaires and ||Génétique Biochimique et
Cytogénétique, Institut National de la Recherche Agronomique, 78350
Jouy-en-Josas, France; Unité Mixte de Recherche, Institut National de la
Recherche Agronomique-Ecole Nationale Vétérinaire de Toulouse, Interactions
Hôte Agent Pathogène, 31066 Toulouse, France; Agence Française de Sécurité
Sanitaire des Aliments, Unité Agents Transmissibles Non Conventionnels,
69364 Lyon, France; **Pathologie Infectieuse et Immunologie, Institut
National de la Recherche Agronomique, 37380 Nouzilly, France; and
¶Department of Pathology, National Veterinary Institute, 0033 Oslo, Norway


Edited by Stanley B. Prusiner, University of California, San Francisco, CA,
and approved September 12, 2005 (received for review March 21, 2005)

Scrapie in small ruminants belongs to transmissible spongiform
encephalopathies (TSEs), or prion diseases, a family of fatal
neurodegenerative disorders that affect humans and animals and can transmit
within and between species by ingestion or inoculation. Conversion of the
host-encoded prion protein (PrP), normal cellular PrP (PrPc), into a
misfolded form, abnormal PrP (PrPSc), plays a key role in TSE transmission
and pathogenesis. The intensified surveillance of scrapie in the European
Union, together with the improvement of PrPSc detection techniques, has led
to the discovery of a growing number of so-called atypical scrapie cases.
These include clinical Nor98 cases first identified in Norwegian sheep on
the basis of unusual pathological and PrPSc molecular features and "cases"
that produced discordant responses in the rapid tests currently applied to
the large-scale random screening of slaughtered or fallen animals.
Worryingly, a substantial proportion of such cases involved sheep with PrP
genotypes known until now to confer natural resistance to conventional
scrapie. Here we report that both Nor98 and discordant cases, including
three sheep homozygous for the resistant PrPARR allele (A136R154R171),
efficiently transmitted the disease to transgenic mice expressing ovine PrP,
and that they shared unique biological and biochemical features upon
propagation in mice. These observations support the view that a truly
infectious TSE agent, unrecognized until recently, infects sheep and goat
flocks and may have important implications in terms of scrapie control and
public health.


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

Author contributions: H.L. designed research; A.L.D., V.B., O.A., F.R.,
T.L.L., J.-L.V., and H.L. performed research; T.B., B.B., P.S., and S.L.B.
contributed new reagents/analytic tools; V.B., O.A., and H.L. analyzed data;
and H.L. wrote the paper.

A.L.D. and V.B. contributed equally to this work.

To whom correspondence should be addressed.

Hubert Laude, E-mail: laude@jouy.inra.fr

www.pnas.org/cgi/doi/10.1073/pnas.0502296102


http://www.pnas.org/cgi/content/abstract/0502296102v1

Subject: SCRAPIE UPDATE USA As of December 31, 2006 with OHIO topping out the list again
Date: March 11, 2007 at 6:14 pm PST

Infected and Source Flocks

As of December 31, 2006, there were 78 scrapie infected and source flocks (Figure 3). There were 2 new infected and source flocks reported in December (Figure 4) with a total of 15 flocks reported for FY 2007 (Figure 5). The total number of infected and source flocks that have been released in FY 2007 is 14 (Figure 6), with 4 flocks released in December. The ratio of infected and source flocks released to newly infected and source flocks for FY 2007 = 0.93:1. In addition, as of December 31, 2006, 80 scrapie cases have been confirmed and reported by the National Veterinary Services Laboratories (NVSL), of which 8 were RSSS cases (Figure 7). This total includes 22 newly confirmed cases in December 2006 (Figure 8). Eighteen cases of scrapie in goats have been reported since 1990 (Figure 9). The last goat case was reported in March 2006. New infected flocks, source flocks, and flocks released for FY 2007 are depicted in Chart 3. New infected and source statuses from 1997 to 2006 are depicted in Chart 4.


http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.html


Scrapie Program FY 2006
Revised February 5, 2007


http://www.aphis.usda.gov/vs/nahps/scrapie/yearly_report/yearly_report_2006.ppt


PLEASE note the high rate of scrapie in Ohio as at December, 31, 2006. I have been concerned about this for years, and questioned it several times over the years, Scrapie and CJD in Ohio ???


Item # Date Time Lines Subject
011956 2002-11-06 09:17 765 Re: SCRAPIE/CJD OHIO ???


https://lists.aegee.org/cgi-bin/wa?A2=ind0211&L=BSE-L&P=R3874&X=448C1D33204F216F58&Y=flounder9%40verizon.net

010952 2001-11-15 15:49 651 Re: U.S.A.--NEW SCRAPIE ERADICATION RULES $ OHIO $ sporadic CJDs ?

https://lists.aegee.org/cgi-bin/wa?A2=ind0111&L=BSE-L&P=R2745&X=448C1D33204F216F58&Y=flounder9%40verizon.net

010951 2001-11-15 11:48 582 U.S.A.--NEW SCRAPIE ERADICATION RULES $ OHIO $ sporadic CJDs ?

https://lists.aegee.org/cgi-bin/wa?A2=ind0111&L=BSE-L&P=R2162&X=448C1D33204F216F58&Y=flounder9%40verizon.net

010701 2001-08-02 14:10 193 Global Compliance of TSE regulations? & sCJD's, scrapie and feed mils in OHIO ?

https://lists.aegee.org/cgi-bin/wa?A2=ind0108&L=BSE-L&P=R346&X=448C1D33204F216F58&Y=flounder9%40verizon.net

Subject: Re: SCRAPIE/CJD OHIO ???
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
Date: Wed, 6 Nov 2002 09:17:33 -0600
Content-Type: text/plain

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

Date: Thu, 2 Aug 2001 14:10:25 -0700
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Global Compliance of TSE regulations? & sCJD's,
scrapie and feed mils in OHIO ?

Greetings All,

if you read # 8, answer # 2,

http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/FSISDir9000.1Att2.pdf

if one country refused (potential BSE risks for whatever reason) but can
import to another Country that see no risk from same product, how can
global compliance take place ?

(maybe i misunderstood this)

and still don't understand how U.S. can have BSE Free status with the
'passive' surveillance that has only tested 13,916 cows in 13 years???

i don't mean to sound like broken record again, but if one refuses to
test in sufficient numbers, one can stay BSE free for a long time. much
longer than ones that are testing to find.

when U.S. ruminant-to-ruminant feed ban is still being violated to date.
most recent posted;

Bruce A. Burgett, General Manager The Carrollton Farmers Exchange 204
Second Street, N.W. Carrollton, OH 44615

WARNING LETTER WL-CIN-8669-01 JULY, 12, 2001

Dear Mr. Burgett:

snip...

Our inspection found your firm failed to label feeds that contain, or
may contain, prohibited materials with the required cautionary statement
"DO NOT FEED TO CATTLE OR OTHER RUMINANTS". We suggest this statement be
distinguished by different type size or color or other means of
highlighting the statement so it is easily noticed by the purchaser.

There are no written procedures for cleaning out or flushing equipment
after mixing feeds containing prohibited material. Additionally, you do
not have records documenting that the system was cleaned or flushed in
accordance with any written procedures.

You should establish adequate procedures and verify that the
flush/clean-out method you use cleans out the remainder of preceding
batches containing prohibited materials. Note: If you flush with feed
ingredients, or sequence with non-ruminant feed, you must also label
these products with the required cautionary statement "Do not feed to
Cattle or Other Ruminants".

Your customer records are not sufficient to track the distribution of
products that contain, or may contain, prohibited material

snip...

end

http://www.fda.gov/foi/warning_letters/g1506d.pdf

other mad cow feed violations can be located at;

http://63.75.126.221/scripts/wlcfm/resultswl.cfm

simply type in 'animal protein'

I cannot digest the fact the U.S. is BSE/TSE free in U.S. cattle with
the testing to date and violations to date of feed ban.

another thing i have noticed, look at the number of feed ban violations
in the state of OHIO. Ohio is the number one violator (reporting).

'then' look at the amount of SCRAPIE in that state;

SCRAPIE *** SIS Status Report: 27-JUL-01 *** STATE: OH

http://www.aphis.usda.gov/vs/scrapie/sis_stat_inf.html

then consider the cross contamination risks posed in the 'warning
letters' of violators in feed mils?

now let's look at CJD stats;


CREUTZFELDT-JAKOB DISEASE
(CJD, Jakob-Creutzfeldt syndrome, Subacute Spongiform Encephalopathy)
REPORTING INFORMATION
• Class A(3)
• Report by close of work week
• Confidential Case Report Card (3812.11, rev. 12/81) or telephone

http://www.odh.ohio.gov/pdf/idcm/cjd.pdf

(3) diseases of significant public health concern -- report by the close of the working week after the existence of a case,
suspect case or positive laboratory result is known

Creutzfeldt-Jakob disease A(3)
(CJD)

http://www.odh.ohio.gov/pdf/idcm/intro1.pdf


Creutzfeldt-Jakob Disease: became a reportable disease in Ohio in July 1998.

http://www.odh.ohio.gov/ASSETS/ED3681CFCC914F5C89CB6185E52DD6D3/00tech.pdf

http://www.odh.ohio.gov/ASSETS/A5AAE31AA81542268A4D9D146201E4E7/02tech.pdf


CJD stats Ohio

(you must take into consideration not everybody knows of this site, and
not everyone has computers, so there is probably many more)

http://www.fortunecity.com/healthclub/cpr/349/oh.htm

then look at Ohio's 'official' CJD statistics, (there is none)...

Two diseases, Creutzfeldt-Jakob Disease (CJD) and cyclosporiasis, became
reportable in July, 1998, and will be included in the 1998 Annual Summary.

http://www.odh.state.oh.us/data/inf_dis/prevmonthly/1999/02/pmfeb99.htm#annsum

seems Ohio CJD reporting system has flaws, 0 cases of CJD reported in
Ohio, latest stats below;

http://www.odh.state.oh.us/Data/Inf_Dis/idann/Idsum98/98annsummary.pdf

http://www.odh.state.oh.us/Data/Inf_Dis/idann/Idsum98/98-94.pdf


Annual Summary of Infectious Diseases Ohio 1999

http://www.odh.ohio.gov/ASSETS/539761D62CCA40E48633F4887F66CAE9/fullrpt99.pdf


UPDATE...TSS


Annual Summary of Infectious Diseases Ohio 2005

2001* 2002* 2003* 2004 2005

CREUTZFELDT-JAKOB DISEASE (CJD) 7 7 9 11 10


REPORTED CASES OF SELECTED NOTIFIABLE DISEASES BY AGE IN YEARS, OHIO, 2005


0−4 5−9 10−14 15−19 20−29 30−39 40−49 50−59 60 + UNKNOWN TOTAL


CREUTZFELDT-JAKOB DISEASE (CJD) 0 0 0 0 0 1 1 1 7 0 10


http://www.co.franklin.oh.us/board_of_health/health_stats/2005AnnualSummary.pdf


tss 2007 ........continued


Ohio feed ban violations 'highest documented',

Scrapie in the state of Ohio 'highest documented',

cross contamination in Ohio 'highest documented',

sCJD seems to be rising in Ohio and other States.

could there be a link to all this and the sporadic CJD cases that are
not documented in the state of Ohio, especially since the most recent
findings of the potential link between some strains of Scrapie and some
strains of sporadic CJDs.

Proc. Natl. Acad. Sci. USA, Vol. 98, Issue 7, 4055-4059, March 27, 2001

Medical Sciences Ex vivo propagation of infectious sheep scrapie agent
in heterologous epithelial cells expressing ovine prion protein

D. Vilette*,, O. Andreoletti, F. Archer*, M. F. Madelaine*, J. L.
Vilotte§, S. Lehmann¶, and H. Laude*

http://www.pnas.org/cgi/content/full/98/7/4055?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&titleabstract=Ex+vivo+propagation+of+infectious+sheep+scrapie&fulltext=Ex+vivo+propagation+of+infectious+sheep+scrapie&searchid=QID_NOT_SET&stored_search=&FIRSTINDEX=0

Sheep consumption: a possible source of spongiform encephalopathy in humans.

http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=3915057&dopt=Abstract

something to ponder...

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


Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: U.S.A. 'MAD COW' FEED BAN WARNING LETTERS 'UPDATE' September 4,
2001


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office Central Region 6751 Steger Drive Cincinnati,
OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771

WARNING LETTER

WL-CIN-9475-01 August 21, 2001

HAND DELIVERY REOUESTED

Barbara J. Hinton, President The Hyland Co., Inc. P.O. Box 29 Ashland,
KY 41105-0029

Dear Ms. Hinton:

From 7/24-27/2001 representatives from the Food and Drug Administration
(FDA) and the State of Kentucky conducted an inspection of your feed
mill. The inspection found significant deviations from the requirements
set forth in Title 21, Code of Federal Regulations, Part 589.2000
-Animal Proteins Prohibited in Ruminant Feed. This regulation is
intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE).

The inspection found your firm failed to label feeds that contain, or
may contain, prohibited materials with the required cautionary statement
"Do not feed to Cattle or Other Ruminants". We suggest this statement be
distinguished by different type size or color or other means of
highlighting the statement so it is easily noticed by the purchaser.

Your procedures for cleaning out and/or flushing equipment after mixing
feeds containing prohibited material are not adequate to prevent the
cross-contamination of feeds not formulated to contain prohibited material.

You should establish adequate procedures and verify that the
flush/clean-out method you use cleans out the remainder of preceding
batches containing prohibited materials. Note: If you flush with feed
ingredients, or sequence with non-ruminant feed, you must also label
these products with the required cautionary statement "Do not feed to
Cattle or Other Ruminants".

The deviations from regulations as noted above cause products being
manufactured and distributed by your facility to be adulterated within
the meaning of Section 402(a)(4) and misbranded within the meaning of
Section 403(0 of the Federal Food, Drug, and Cosmetic Act (the Act).

This letter is not intended to be an all-inclusive list of deficiencies
at your facility. As a manufacturer of materials intended for animal
feed use, you are responsible for assuring that your overall operation
and the products you manufacture and distribute are in compliance with
the law. We have enclosed a copy

Page 1

snip...

http://www.fda.gov/foi/warning_letters/g1650d.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office Central Region 675t Steger Drive Cincinnati,
OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771

WARNING LETTER

WL-CIN-8748-01

CERTIFIED MAIL RETURN RECEIPT REQUESTED

August 17, 2001

Mark W. Roesner, Owner/President Copley Feed & Supply 1468 S. Cleveland
Massilion Road CopIcy, OH 44321

Dear Mr. Roesner:

On 6/19,21/2001 a Food and Drug Administration investigator conducted an
inspection of your medicated feed mill located at 1468 S. Cleveland
Massilion Road, Copley, OH. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant
Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Our inspection
found your firm failed to label feeds that contain, or may contain,
prohibited materials with the required cautionary statement "Do not feed
to Cattle or Other Ruminants"· We suggest this statement be
distinguished by different type size or color or other means of
highlighting the statement so it is easily noticed by the purchaser. It
also revealed that your customer records are not sufficient to track the
distribution of products that contain, or may contain, prohibited
material The deviations from the BSE regulations, as noted above, cause
products being manufactured and distributed by your facility to be
adulterated within the meaning of Section 402(a)(4) and misbranded
within the meaning of Section 403(f) of the Act.

This letter is not intended to be an all-inclusive list of deficiencies
at your facility. As a manufacturer of materials intended for animal
feed use, you are responsible for assuring that your overall operation
and the products you manufacture and distribute are in compliance with
the law. We have enclosed a copy of the FDA's Small Entity Compliance
Guide to assist you with complying with the regulation. You should take
prompt action to correct these violations, and you should establish a
system whereby violations do not recur. Failure to promptly correct
these violations may result in regulatory action without further notice.
Such actions include seizure and/or injunction.

snip...

http://www.fda.gov/foi/warning_letters/g1646d.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office Central Region 6751 Steger Drive Cincinnati,
OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771

WARNING LETTER

WL-CIN-9099-01

CERTIFIED MAIL RETURN RECEIPT REQUESTED

August 16, 2001

Charles A. Holdten, CEO/President Agri-Mark Farmers Co-op, Inc. 813
Clark Avenue Ashland, OH 44805

Dear Mr. Holdten:

On 7/10,12-13/2001 two Food and Drug Administration investigators
conducted an inspection of your medicated feed mill located at 6800
Chestnut Street, Sterling, OH. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed.
This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE).

Our inspection found your firm failed to label feeds that contain, or
may contain, prohibited materials with the required cautionary statement
"Do not feed to Cattle or Other Ruminants". We suggest this statement be
distinguished by different type size or color or other means of
highlighting the statement so it is easily noticed by the purchaser.

It also revealed that your customer records are not sufficient to track
the distribution of products that contain, or may contain, prohibited
material

The deviations from the BSE regulations, as noted above, cause products
being manufactured and distributed by your facility to 0e adulterated
within the meaning of Section 402(a)(4) and misbranded within the
meaning of Section 403(f) of the Act.

This letter is not intended to be an all.inclusive list of deficiencies
at your facility. As a manufacturer of materials intended for animal
feed use, you are responsible for assuring that your overall operation
and the products you manufacture and distribute are in compliance with
the law. We have enclosed a copy of the FDA's Small Entity Compliance
Guide to assist you with complying with the regulation. You should take
prompt action to coneet these violations, and you should establish a
system whereby violations do not recur. Failure to promptly correct
these violations may result in regulatory action, such as seizure and/or
injunction, without further notice.

Our investigators also found that you mixed and distributed a cattle
feed containing Lincomycin, a drug not indicated for use in cattle.
Further, you did not flush the mixer, storage bins, and bulk truck used
in the manufacture of the feed containing Lincomycin. The failure to
adequately flush this equipment immediately following this feed caused
the subsequent cross-contamination of the cattle feed, dairy cow feed
and calf feeds that were handled in this equipment after the original
product. You should implement procedures and/or practices to prevent the
recurrence of this type of violation.

You should notify this office in writing within fifteen (15) working
days of the receipt of this letter of the steps you have taken to bring
your firm into compliance with the law. Your response should include an
explanation of each step being taken to correct the CGMP violations and
prevent their recurrence. If corrective action cannot be completed
within 15 working days, state the reason for the delay and the date by
which the corrections will be completed. Include copies of any available
documentation demonstrating that corrections have been made.

Your response should be directed to Stephen J. Rabe, Compliance Officer
at the address listed above.

District Director Cincinnati District

Attachment: Small Entity Compliance Guide

Cc: Scott A. Crossen, Branch Manager Agri-Mark Farmers Co-op, Inc. 6800
Chestnut Street Sterling, OH 44276

http://www.fda.gov/foi/warning_letters/g1645d.pdf

sadly disgusted in Bacliff, Texas USA Terry S. Singeltary Sr.

Date: Tue, 9 Oct 2001 16:18:47 -0700
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: RUMINANT-TO-RUMINANT FEED BAN WARNING LETTER/Scrapie in Ohio?

Greetings List Members,

Am i the only one that finds it odd that the State of Ohio has so many
of these mad cow feed ban violations?

out of some 50 in 2001, Ohio has had some 27 of the violations.

what gives?

or, are they just the honest ones reporting?

what about all the Scrapie in this State?

should there not be concern for cross contamination's?

14 Records Found for State(s) OH.

14 (infected FLOCKS)

http://cofcs18.aphis.usda.gov/scrapie/reports/sisinfect.php

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office Central Region 6751 Steger Drive Cincinnati,
OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771

WARNING LETTER

WL-CIN-7703-01 September 20, 2001

CERTIFIED MAIL RETURN RECEIPT REQUESTED

William P. Herrington, President Buckeye Feed Mills, Inc. (dba) Buckeye
Nutrition 330 East Schultz Avenue Dalton, OH 44618

Dear Mr. Herrington:

Food and Drug Administration (FDA) investigators conducted an inspection
of your feed mill from April 5-24, 2001. The inspection found
significant and serious deviations from the requirements set forth in
Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins
Prohibited in Ruminant Feed. This regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy
(BSE). These deviations caused products manufactured by your firm to be
adulterated and misbranded.

The violations are as follows:

Our investigators documented that you did not flush or sequence the
incoming receiving pit conveyor systems and ingredient storage bins
after the receipt of ruminant meat and bone meal to avoid contamination
of ingredients that were used in ruminant feeds.

Further, the investigators found that your firm failed to label feeds
that contain, or may contain, prohibited materials with the required
cautionary statement "Do not feed to Cattle or Other Ruminants".

There are no written procedures for cleaning out or flushing the
receiving pit conveyor system and ingredient storage bins. Additionally,
you do not have records documenting that the system was cleaned or
flushed in accordance with any written procedures.

Your procedure for sequencing/flushing of the mixers (MOP-004 rev. date
2/2/98) allows for feeds containing ruminant meat and bone meal to be
followed by horse and rabbit feeds that should bear the cautionary
statement but do not.

Page I

snip...

http://www.fda.gov/foi/warning_letters/g1779d.pdf

TSS

NEW SCIENTIST MAGAZINE 4/02/01

NEW SCIENTIST EDITORIAL PAGE 3

MAD SHEEP DISEASE?

IF THERE is one categorical pronouncement you
can safely make about prion diseases like BSE
or CJD, it is that one should not make
categorical pronouncements. "British beef is
safe" and "there is no BSE in Germany" come
to mind. Now there are two more: "scrapie is
safe", and "people don't catch sporadic CJD".
Scrapie is the most widespread prion
disease, infecting untold numbers of
sheep worldwide. Sporadic CJD is the
old-fashioned pre-BSE kind that is supposed
to happen spontaneously in unlucky people.
But a surprise observation in France suggests
some sCJD cases--though by no means all--may
be linked to scrapie after all (see p 4).

For years, British authorities asserted that
BSE was harmless because it was a form of
scrapie. In fact, the only evidence scrapie
is safe is some broad-brush epidemiology, good
as far as it goes but unable to reveal
occasional risks for some people from some
sheep. Alarm bells should have rung in 1980
when researchers gave monkeys scrapie by
feeding them infected brains. But that
research, like so much other work on
prion diseases, was never followed up.
We still have little idea what BSE does
in pigs and chickens. The Queniborough
vCJD outbreak (see p 5) would be easier
to understand if we knew how much brain
we must eat to be infected. As for scrapie,
it shouldn't take a chance finding to
tell us that there may be dangerous sheep
out there.

Suspect symptoms

What if you can catch old-fashioned CJD by
eating meat from a sheep infected with
scrapie?

Exclusive from New Scientist magazine

Four years ago, Terry Singeltary watched his
mother die horribly from a degenerative brain disease.................

full text url follows
By Debora MacKenzie

Suspect Symptoms

http://www.newscientist.com/hottopics/bse/suspectsymptoms.jsp

if url dead, go here for 'SUSPECT SYMPTOMS'

you can access article here also;

http://www.organicconsumers.org/meat/scrapiecjd.cfm

http://www.vegancowboy.org/TSS-SuspectSymptoms.html

Then follow up with PNAS studies from which
new scientist article written from;

Published online before print March 20, 2001
Proc. Natl. Acad. Sci. USA, 10.1073/pnas.041490898

Adaptation of the bovine spongiform encephalopathy agent to primates and
comparison with Creutzfeldt- Jakob disease: Implications for human health
Corinne Ida Lasmézas*, [dagger] , Jean-Guy Fournier*, Virginie Nouvel*,
Hermann Boe*, Domíníque Marcé*, François Lamoury*, Nicolas Kopp [Dagger
] , Jean-Jacques Hauw§, James Ironside¶, Moira Bruce [||] , Dominique
Dormont*, and Jean-Philippe Deslys*


Edited by D. Carleton Gajdusek, Centre National de la Recherche
Scientifique, Gif-sur-Yvette, France, and approved December 7, 2000
(received for review October 16, 2000)

Abstract

There is substantial scientific evidence to support the notion that
bovine spongiform encephalopathy (BSE) has contaminated human beings,
causing variant Creutzfeldt-Jakob disease (vCJD). This disease has
raised concerns about the possibility of an iatrogenic secondary
transmission to humans, because the biological properties of the
primate-adapted BSE agent are unknown. We show that (i) BSE can be
transmitted from primate to primate by intravenous route in 25 months,
and (ii) an iatrogenic transmission of vCJD to humans could be readily
recognized pathologically, whether it occurs by the central or
peripheral route. Strain typing in mice demonstrates that the BSE agent
adapts to macaques in the same way as it does to humans and confirms
that the BSE agent is responsible for vCJD not only in the United
Kingdom but also in France. The agent responsible for French iatrogenic
growth hormone-linked CJD taken as a control is very different from vCJD
but is similar to that found in one case of sporadic CJD and one sheep
scrapie isolate. These data will be key in identifying the origin of
human cases of prion disease, including accidental vCJD transmission,
and could provide bases for vCJD risk assessment.

Introduction

The recognition of a variant of the human transmissible spongiform
encephalopathy (TSE) Creutzfeldt-Jakob Disease (vCJD) in the U.K. in
1996 raised the major concern that it would correspond to human
infection with the agent responsible for bovine spongiform
encephalopathy (BSE; ref. 1). Transmission of BSE to macaques provided
the first experimental evidence as it produced a disease close to vCJD
in humans (2). Strain typing in inbred mice (consisting of measuring the
incubation period and establishing lesion profiles corresponding to the
strain-specific distribution of brain vacuolation) allows reliable
identification of TSE strains (3). This method, together with
biochemical methods, has revealed a single phenotype for the agents of
BSE and the British cases of vCJD (4-6). Mice expressing only the bovine
prion protein (PrP) were highly susceptible to vCJD and BSE, which
induced the same disease (7). Thus, it is now well established that BSE
has caused vCJD, probably by alimentary contamination. In this respect,
the finding of abnormal PrP labeling in the gastrointestinal tract and
lymphatic tissues of orally BSE-contaminated lemurs shows that the BSE
agent can infect primates by the oral route (8). About 1 million
contaminated cattle may have entered the human food chain, and the
future number of vCJD cases could range from 63 to 136,000 depending on
the incubation period of BSE in humans (9). Unlike sporadic CJD (sCJD)
and iatrogenic CJD (iCJD) linked to the administration of contaminated
growth hormone extracted from human hypophyses, in vCJD, the infectious
agent seems to be widely distributed in lymphoid organs, as pathological
PrP (PrPres) can be detected in tonsils, lymph nodes, spleen, and
appendix even in the preclinical phase of the disease (10, 11). This
raises a public health issue with regard to the risk of iatrogenic
transmission of vCJD through surgical instruments, grafts, blood
transfusion, or parenteral administration of biological products of
human origin. However, this risk is difficult to assess, because it
largely depends on factors such as the virulence of the BSE agent
adapted to primates and the efficiency of secondary transmission to
humans by a peripheral route such as the i.v. one. A further issue is
whether vCJD accidentally acquired from humans would be recognized. The
latter poses the question of a phenotypic variation of the BSE agent
after successive transmissions in humans: does it retain its strain
characteristics, and does it induce a pathology similar to that observed
in the previous host? A 9-year history of transmission of BSE to
primates and mice enables us today to clarify a number of these
important points.

Although BSE has mainly affected the U.K., two definite cases and one
probable case of vCJD have now been reported in France in people who
have never resided in the U.K. (12, 13). We strain-typed the first of
these cases to establish its origin. Strain typing in C57BL/6 mice of
BSE, French, and British vCJD was compared with that of BSE passaged in
nonhuman primates, thus allowing us to study the effect of serial
passages in primates. Comparisons were also made with French cases of
sCJD and iCJD and two strains of scrapie (one of French and one of U.S.
origin). Our findings provide experimental demonstration that the same
agent, namely that responsible for the cattle disease BSE, has caused
vCJD both in France and in the U.K., in line with biochemical data and
with the fact that, until 1996, about 10% of the beef consumed in France
was imported from the U.K. We found that the BSE agent in nonhuman
primates is similar to that causing vCJD in humans and tends to evolve
rapidly toward a primate-adapted variant. Furthermore, we showed that
the strain responsible for iCJD is closely related to that of one
patient with sCJD, and, more unexpectedly, that these agents were
similar to the French scrapie strain studied (but different from the
U.S. scrapie strain). This finding requires a cautious interpretation
for several reasons, not least because of the inevitably limited number
of TSE strains that can be studied by such a cumbersome method as strain
typing. Nonetheless, it also prompts reconsideration of the possibility
that, in some instances, sheep and human TSEs can share a common origin.

snip...

http://www.pnas.org/cgi/content/full/041490898v1

STATEMENT OF DR HELEN GRANT MD FRCP
ISSUED 13/05/1999

BSE INQUIRY

http://www.bseinquiry.gov.uk/files/ws/s410.pdf
http://www.bseinquiry.gov.uk/files/ws/s410x.pdf

http://www.bseinquiry.gov.uk/evidence/ws/ws8.htm

CWD to CJD in humans (why not?), as easy as BSE/Scrapie;

The EMBO Journal, Vol. 19, No. 17 pp. 4425-4430, 2000
© European Molecular Biology Organization

Evidence of a molecular barrier limiting
susceptibility of humans, cattle and sheep to
chronic wasting disease

G.J. Raymond1, A. Bossers2, L.D. Raymond1, K.I. O?Rourke3,
L.E. McHolland4, P.K. Bryant III4, M.W. Miller5, E.S. Williams6, M.
Smits2
and B. Caughey1,7

1NIAID/NIH Rocky Mountain Laboratories, Hamilton, MT 59840,
3USDA/ARS/ADRU, Pullman, WA 99164-7030, 4USDA/ARS/ABADRL,
Laramie, WY 82071, 5Colorado Division of Wildlife, Wildlife Research
Center, Fort Collins, CO 80526-2097, 6Department of Veterinary Sciences,
University of Wyoming, Laramie, WY 82070, USA and 2ID-Lelystad,
Institute for Animal Science and Health, Lelystad, The Netherlands
7Corresponding author e-mail: bcaughey@nih.gov Received June 7, 2000;
revised July 3, 2000; accepted July 5, 2000.

Abstract

Chronic wasting disease (CWD) is a transmissible
spongiform encephalopathy (TSE) of deer and elk,
and little is known about its transmissibility to other
species. An important factor controlling
interspecies TSE susceptibility is prion protein (PrP)
homology between the source and recipient
species/genotypes. Furthermore, the efficiency with which
the protease-resistant PrP (PrP-res) of one
species induces the in vitro conversion of the normal PrP
(PrP-sen) of another species to the
protease-resistant state correlates with the cross-species
transmissibility of TSE agents. Here we
show that the CWD-associated PrP-res (PrPCWD) of cervids
readily induces the conversion of recombinant cervid PrP-sen
molecules to the protease-resistant state in accordance
with the known transmissibility of CWD between cervids. In contrast,
PrPCWD-induced conversions of human and bovine PrP-sen were
much less efficient, and conversion of ovine PrP-sen was
intermediate. These results demonstrate a barrier at the
molecular level that should limit the susceptibility of these non-cervid
species to CWD.

snip...

Clearly, it is premature to draw firm conclusions about CWD
passing naturally into humans, cattle and sheep, but the present
results suggest that CWD transmissions to humans would be as
limited by PrP incompatibility as transmissions of BSE or sheep
scrapie to humans. Although there is no evidence that sheep
scrapie has affected humans, it is likely that BSE has caused variant
CJD in 74 people (definite and probable variant CJD cases to
date according to the UK CJD Surveillance Unit). Given the
presumably large number of people exposed to BSE infectivity,
the susceptibility of humans may still be very low compared with
cattle, which would be consistent with the relatively inefficient
conversion of human PrP-sen by PrPBSE. Nonetheless, since
humans have apparently been infected by BSE, it would seem prudent
to take reasonable measures to limit exposure of humans
(as well as sheep and cattle) to CWD infectivity as has been
recommended for other animal TSEs.

snip...

http://www.emboj.org/current.shtml

Scrapie to Humans?


Neuroepidemiology. 1985;4(4):240-9. Related Articles, Links


Sheep consumption: a possible source of spongiform encephalopathy in humans.

Davanipour Z, Alter M, Sobel E, Callahan M.

A fatal spongiform encephalopathy of sheep and goats (scrapie) shares many characteristics with Creutzfeldt-Jakob disease (CJD), a similar dementing illness of humans. To investigate the possibility that CJD is acquired by ingestion of contaminated sheep products, we collected information on production, slaughtering practices, and marketing of sheep in Pennsylvania. The study revealed that sheep were usually marketed before central nervous system signs of scrapie are expected to appear; breeds known to be susceptible to the disease were the most common breeds raised in the area; sheep were imported from other states including those with a high frequency of scrapie; use of veterinary services on the sheep farms investigated and, hence, opportunities to detect the disease were limited; sheep producers in the area knew little about scrapie despite the fact that the disease has been reported in the area, and animal organs including sheep organs were sometimes included in processed food. Therefore, it was concluded that in Pennsylvania there are some 'weak links' through which scrapie-infected animals could contaminate human food, and that consumption of these foods could perhaps account for spongiform encephalopathy in humans. The weak links observed are probably not unique to Pennsylvania.


http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=3915057&dopt=Abstract


ALSO, see new reports of Scrapie in Pennsylvania ;

http://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/monthly_scrapie_rpt.pps


o.k., lets look into this a bit further ;

: J Infect Dis 1980 Aug;142(2):205-8


Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates.

Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.

Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation.

PMID: 6997404
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract


EVIDENCE OF SCRAPIE IN SHEEP AS A RESULT OF FOOD BORNE EXPOSURE

This is provided by the statistically significant increase in the incidence of sheep scrape from 1985, as determined from analyses of the submissions made to VI Centres, and from individual case and flock incident studies. ........


http://www.bseinquiry.gov.uk/files/yb/1994/02/07002001.pdf


again, ORAL TRANSMISSION OF THE SCRAPIE AGENT TO PRIMATE BY THEIR NON-FORCED CONSUMPTION OF KNOWN INFECTIOUS TISSUES, transmission studies have never been done on man. so to say, or imply that scrapie has never transmitted to man either orally or 'friendly fire' is an incorrect statement i.e. it just aint so. ...TSS

or by 'friendly fire' ;


Dormont*, and Jean-Philippe Deslys* et al, that The agent responsible
for French iatrogenic growth hormone-linked CJD taken as a control is
very different from vCJD but is similar to that found in one case of
sporadic CJD and one sheep scrapie isolate;

http://www.pnas.org/cgi/content/full/041490898v1


AS implied in the Inset 25 we must not _ASSUME_ that
transmission of BSE to other species will invariably
present pathology typical of a scrapie-like disease.

snip...

http://www.bseinquiry.gov.uk/files/yb/1991/01/04004001.pdf


snip...end
full text ;

http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf


VERY VERY IMPORTANT THING TO REMEMBER


>> Differences in tissue distribution could require new regulations
>> regarding specific risk material (SRM) removal.


Research Project: Study of Atypical Bse

Location: Virus and Prion Diseases of Livestock

Project Number: 3625-32000-073-07
Project Type: Specific C/A

Start Date: Sep 15, 2004
End Date: Sep 14, 2007

Objective:
The objective of this cooperative research project with Dr. Maria Caramelli
from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct
comparative studies with the U.S. bovine spongiform encephalopathy (BSE)
isolate and the atypical BSE isolates identified in Italy. The studies will
cover the following areas: 1. Evaluation of present diagnostics tools used
in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison
of the U.S. BSE isolate and other typical BSE isolates with atypical BSE
cases. 3. Studies on transmissibility and tissue distribution of atypical
BSE isolates in cattle and other species.

Approach:
This project will be done as a Specific Cooperative Agreement with the
Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del
Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance
program to analyze the effectiveness of the U.S diagnostic tools for
detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE
isolate with atypical BSE isolates will provide further characterization of
the U.S. BSE isolate. Transmission studies are already underway using brain
homogenates from atypical BSE cases into mice, cattle and sheep. It will be
critical to see whether the atypical BSE isolates behave similarly to
typical BSE isolates in terms of transmissibility and disease pathogenesis.
If transmission occurs, tissue distribution comparisons will be made between
cattle infected with the atypical BSE isolate and the U.S. BSE isolate.
Differences in tissue distribution could require new regulations regarding
specific risk material (SRM) removal.


http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490


3.57 The experiment which might have determined whether BSE and scrapie were
caused by the same agent (ie, the feeding of natural scrapie to cattle) was
never undertaken in the UK. It was, however, performed in the USA in 1979,
when it was shown that cattle inoculated with the scrapie agent endemic in
the flock of Suffolk sheep at the United States Department of Agriculture in
Mission, Texas, developed a TSE quite unlike BSE. 32 The findings of the
initial transmission, though not of the clinical or neurohistological
examination, were communicated in October 1988 to Dr Watson, Director of the
CVL, following a visit by Dr Wrathall, one of the project leaders in the
Pathology Department of the CVL, to the United States Department of
Agriculture. 33 The results were not published at this point, since the
attempted transmission to mice from the experimental cow brain had been
inconclusive. The results of the clinical and histological differences
between scrapie-affected sheep and cattle were published in 1995. Similar
studies in which cattle were inoculated intracerebrally with scrapie inocula
derived from a number of scrapie-affected sheep of different breeds and from
different States, were carried out at the US National Animal Disease Centre.
34 The results, published in 1994, showed that this source of scrapie agent,
though pathogenic for cattle, did not produce the same clinical signs of
brain lesions characteristic of BSE.

http://www.bseinquiry.gov.uk/report/volume2/chaptea3.htm#820543

The findings of the initial transmission, though not of the clinical or
neurohistological examination, were communicated in October 1988 to Dr
Watson, Director of the CVL, following a visit by Dr Wrathall, one of the
project leaders in the Pathology Department of the CVL, to the United States
Department of Agriculture. 33


http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf

http://www.bseinquiry.gov.uk/report/volume2/chaptea3.htm#820546

The results were not published at this point, since the attempted
transmission to mice from the experimental cow brain had been inconclusive.
The results of the clinical and histological differences between
scrapie-affected sheep and cattle were published in 1995. Similar studies in
which cattle were inoculated intracerebrally with scrapie inocula derived
from a number of scrapie-affected sheep of different breeds and from
different States, were carried out at the US National Animal Disease Centre.
34 The
results, published in 1994, showed that this source of scrapie agent, though
pathogenic for cattle, did not produce the same clinical signs of brain
lesions characteristic of BSE.

3.58 There are several possible reasons why the experiment was not performed
in the UK. It had been recommended by Sir Richard Southwood (Chairman of the
Working Party on Bovine Spongiform Encephalopathy) in his letter to the
Permanent Secretary of MAFF, Mr (now Sir) Derek Andrews, on 21 June 1988, 35
though it was not specifically recommended in the Working Party Report or
indeed in the Tyrrell Committee Report (details of the Southwood Working
Party and the Tyrell Committee can be found in vol. 4: The Southwood Working
Party, 1988-89 and vol. 11: Scientists after Southwood respectively). The
direct inoculation of scrapie into calves was given low priority, because of
its high cost and because it was known that it had already taken place in
the USA. 36 It was also felt that the results of such an experiment would be
hard to interpret. While a negative result would be informative, a positive
result would need to demonstrate that when scrapie was transmitted to
cattle, the disease which developed in cattle was the same as BSE. 37 Given
the large number of strains of scrapie and the possibility that BSE was one
of them, it would be necessary to transmit every scrapie strain to cattle
separately, to test the hypothesis properly. Such an experiment would be
expensive. Secondly, as measures to control the epidemic took hold, the need
for the experiment from the policy viewpoint was not considered so urgent.
It was felt that the results would be mainly of academic interest. 38


http://www.bseinquiry.gov.uk/report/volume2/chaptea3.htm#820550

http://www.bseinquiry.gov.uk/report/volume2/chaptea3.htm


USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...

http://www.seac.gov.uk/minutes/95.pdf


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html

There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/http://www.neurology.org/cgi/eletters/60/2/176#535


BRITISH MEDICAL JOURNAL

BMJ

http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406


BMJ

http://www.bmj.com/cgi/eletters/320/7226/8/b#6117


JOURNAL OF NEUROLOGY

MARCH 26, 2003

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


doi:10.1016/S1473-3099(03)00715-1
Copyright © 2003 Published by Elsevier Ltd.
Newsdesk

Tracking spongiform encephalopathies in North America

Xavier Bosch

Available online 29 July 2003.


Volume 3, Issue 8, August 2003, Page 463


“My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my
mom to hvCJD (Heidenhain variant CJD)
and have been searching for answers ever since. What I have found is that we
have not been told the truth. CWD
in deer and elk is a small portion of a much bigger problem.”
............................


http://www.thelancet.com/journals/laninf/article/PIIS1473309903007151/fulltext

http://download.thelancet.com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf


see history of cjd questionnaire

http://brain.hastypastry.net/forums/showthread.php?t=2408


SPORADIC CJD, the big lie

see full text ;


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0705&L=sanet-mg&T=0&P=25276


TSS




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