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From: TSS ()
Subject: Re: Feds skipped key mad cow disease test in 2004 case USDA changes its protocols after animal initially had been cleared
Date: June 17, 2005 at 12:55 pm PST

In Reply to: Re: Feds skipped key mad cow disease test in 2004 case USDA changes its protocols after animal initially had been cleared posted by TSS on June 17, 2005 at 11:56 am:

-------- Original Message --------
Subject: re-Possible mad cow case shocks cattle industry
Date: Sat, 20 Nov 2004 14:25:55 -0600
From: "Terry S. Singeltary Sr."
To: viewpoints@chron.com
CC: george.haj@chron.com, ken.lanterman@chron.com, steve.rassenfoss@chron.com, readerrep@chron.com, hci@chron.com


Greetings Houston Chronicle;

in your 11/19/04 article;

Possible mad cow case shocks cattle industry


The animal is not in the food supply, and the test results may
take a week


And feed regulations enacted in 1997 supposedly make it impossible for
cattle to catch the disease by eating feed after that date.

By NELSON ANTOSH
Copyright 2004 Houston Chronicle


I have written to Nelson Antosh with this data before, but he seems to
not be concerned with this. so i will attempt to get someone else at
Houston Chronicle with this data.

I know this is too long to get published, but I implore that your paper,
in some way,
gets this data to the public, in some fashion or form, for them to make
there own minds up.
THE medical and surgical arena needs to take proper precautions.

Eye procedure raises CJD concerns

By Steve Mitchell
Medical Correspondent

Washington, DC, Nov. 18, 2004 (UPI) --


http://www.washtimes.com/upi-breaking/20041118-030642-2974r.htm


> The animal is not in the food supply,
>

we were told this about the last cow in dec 03;

We contend that QFC knew which Advantage Card customers purchased the
suspect meat, and could have easily called to warn them, said Berman.
Instead, QFC used a series of spurious excuses to hide their failure to
act.

On Dec. 23, the U.S. Department of Agriculture ordered the recall of
approximately 10,410 pounds of raw beef that may have been infected with
bovine spongiform encephalopathy (BSE), which if consumed by humans can
lead to the always-fatal Cruetzfeldt-Jakobs Disease (vCJD).

According to the complaint, QFC at first mistakenly believed it did not
have any of the affected beef and took no action to remove the product
from its shelves. The store later removed the beef on Dec. 24, but then
did little to warn those who earlier purchased the meat, the suit claims.

It wasnt until Dec. 27 that the grocery chain posted small signs with
information about the recall, the complaint alleges.

The Crowsons contacted QFC when they suspected they had purchased the
potentially tainted meat, but QFC would not confirm their suspicions for
two more weeks, the suit states. According to Berman, the family had to
file a written request before QFC would confirm their fears.

According to health experts, Cruetzfeldt-Jakobs Disease can have an
incubation period of as long as 30 years. There is no test to determine
if infection took place after possible exposure, nor is there any
treatment once one is infected. The condition is always fatal.

http://www.hagens-berman.com/frontend?command=PressRelease&task=viewPressReleaseDetail&iPressReleaseId=654


WHAT about the TEXAS no one speaks of ?

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

- Letter to USDA

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


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

FOR IMMEDIATE RELEASE
Statement
May 4, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


Statement on Texas Cow With Central Nervous System Symptoms

http://www.fda.gov/bbs/topics/news/2004/NEW01061.html


THE consumer groups I have been following state that it is long over due
to act.
YOUR paper printed a story about the death of my Mom to the hvCJD
phenotype,
and there is much data out now that proves indeed the USA has had a TSE
problem
much longer than any wishes to recognize, but most importantly, there
appears
to be more than one strain of TSE in cattle than that of BSE and it is
molecularly
similar to sporadic CJD. This has grave implications for the medical and
surgical
arena and to further ignore these findings and refuse to make all human
CJD/TSEs
reportable Nationally and Internationally will only further spread this
fatal
and hideous disease. URGENT data that just came out last week this paper
and every other paper should put on the front page ;

Ref: MRC/62/04

Under strict embargo until 19.00 British Time Thursday 11 November 2004


GENETIC MAKE-UP MAY DETERMINE WHAT TYPE OF CJD OCCURS WHEN HUMANS ARE
INFECTED WITH BSE

New research published today (19.00 hours Thursday 11th November) by a
team from the Medical Research Council (MRC) Prion Unit offers an
explanation about why only people with a particular genetic make-up have
so far developed vCJD. It also provides evidence that other types of
BSE-derived prion infection with a different pattern of symptoms might
occur in humans. The findings are published in the journal Science.

Variant CJD (vCJD) is the human disease thought to be caused by eating
food contaminated with the infectious agent, known as a prion,
responsible for the epidemic of BSE or mad cow disease in cattle. So
far, everyone known to have developed vCJD has been of a particular
genetic type  known as MM. Until now it has been a mystery why everyone
that has developed vCJD is of the MM type and one possibility is that
they are simply the first to develop the disease when infected with BSE,
and that people with the other genetic types1 (known as VV and MV)
infected with BSE prions will also develop vCJD, but some years later.

In a series of experiments spanning more than ten years, the MRC team
has been studying mice genetically modified so that they make human
prion proteins  which are used to model human susceptibility to BSE.
The team has now shown that mice with the human VV genetic type do
become infected when given BSE or vCJD prions, but manifest a different
form of the disease which looks quite different to vCJD and has a novel
prion strain type.

Remarkably, when these novel prions were used to infect mice of the MM
genetic type, the mice either developed a disease very like vCJD, or
else a pattern of disease that looks like so-called sporadic CJD  the
classical form of CJD. This form has been known about for many years,
is seen all over the world and has not hitherto been associated with
BSE. However, the new strain identified in the mice, being called type
5, has not been seen yet in people and we do not know what pattern of
disease it would cause. It could look like one of the forms of classical
or sporadic CJD or perhaps be yet another different variant form.

The work from the MRC team suggests that type 4 prions, the type
associated with vCJD, can only propagate themselves in people that make
the M form of the protein. It seems the V form of the protein just
cannot adopt the particular molecular shape that characterises type 4.

The studies in mice also suggest that if these prions were to pass from
person to person (for example by blood transfusion) then, depending on
the genetic type of the person becoming infected, at least three
different patterns of disease might result: type 2 (which is seen in
sporadic CJD); type 4 (which causes vCJD) or type 5 (which may cause a
new pattern of disease).

Professor John Collinge, Director of the MRC Prion Unit, which is based
at University College London, said: These mouse studies give us vital
clues about the behaviour of prions and how they appear to modify and
adapt depending on the genetic makeup of the individual they are infecting.

We always have to be cautious about making direct comparison to the
human condition, but our work strongly suggests that we can not assume
only those with one genetic profile are vulnerable to BSE infection.

At this stage it is not possible to say how this should alter estimates
of those likely to become ill, but our findings do suggest we should be
taking steps to draw up a more sophisticated system of categorizing the
disease so that we dont mistake BSE related infection for a version of
sporadic CJD.

ENDS

For more information call the MRC press office on 020 7 637 6011

Notes to Editors

1The human prion protein comes in two common forms, known as M and V.
Because everyone has two copies of this gene, there are three possible
genetic types: MM, MV and VV.

Paper - Human Prion protein v129 prevent expression of vCJD phenotype 
Science On line 11.11.04

Prions are rogue forms of one of the bodys own proteins  known as the
prion protein  which are misshapen. There are several different rogue
or misshapen forms that can infect humans, and these different types of
prions are known as strains. This is analogous to different strains of
other germs such flu virus causing influenza or strains of salmonella
causing different forms of food poisoning for example.

The strain of prion causing vCJD is known as type 4, types 1-3 cause the
different forms of sporadic or classical CJD. Each strain causes a
different pattern or type of disease. It is known that prion strains can
change or mutate when they pass between different animals.

The Medical Research Council (MRC) is a national organisation funded by
the UK tax-payer. Its business is medical research aimed at improving
human health; everyone stands to benefit from the outputs. The research
it supports and the scientists it trains meet the needs of the health
services, the pharmaceutical and other health-related industries and the
academic world. MRC has funded work which has led to some of the most
significant discoveries and achievements in medicine in the UK. About
half of the MRCs expenditure of £430 million is invested in its 40
Institutes, Units and Centres. The remaining half goes in the form of
grant support and training awards to individuals and teams in
universities and medical schools. Web site at: http://www.mrc.ac.uk
.

http://www.mrc.ac.uk/index/public-interest/public-press_office/public-press_releases_2004/public-11_november_2004.htm


Send Post-Publication Peer Review to journal:


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

disease in the United States


Email Terry S. Singeltary:


flounder@wt.net

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

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

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

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

phenotype that is indistinguishable from type 2 PrPSc, the commonest

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

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

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

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

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

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

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

intracerebral inoculation. With the known incubation periods in other

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

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

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

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

should be drastic measures to safeguard the medical and surgical arena

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

CJDs in the USA are type 2 PrPSc?


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


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

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


ONE YEAR LATER;


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)
Publication date: 20 August 2004

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

* 167 kB Report


* 105 kB 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 90s when
domestic cattle, infected by imported MBM, reached processing. Given the
low stability of the system, the risk increased over the years with
continued imports of cattle and MBM from BSE risk countries.

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

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

EVEN our own UTMB "Claudio Soto (UTMB)" says;

For personal use. Only reproduce with permission from Elsevier Ltd.
511
Newsdesk

Stanley Prusiner first put forward the
protein-only hypothesis of prion
propagation in 1982. Now, 22 years
later, his research group has moved a
step closer to proving once and for all
that the infectious properties of prions
are due to the propagation of protein
misfolding. The present article from
Prusiners group comes close to being
this final proof, Claudio Soto
(University of Texas Medical Center,
TX, USA) told The Lancet Neurology.
However, a number of technical
issues minimise my enthusiasm.
Most experts agree that the
hypothesis would be proven if a
synthetic infectious protein engineered
in vitro was shown to be capable of
causing disease in vivo. Prusiners
team, which is based at the University
of California, San Francisco,
engineered Escherichia coli to express a
truncated version of mouse prion
protein; E Coli does not normally
produce prion proteins.
The researchers then folded the
protein into a beta-sheet rich conformation
that was likely to be infectious
and injected the protein into
transgenic mice that make the same
mutated prion fragment (called
TG9949 mice). 380 days later, one of
the mice showed symptoms of a prionlike
disease. By 660 days, all the mice
had neurological symptoms. Importantly,
TG9949 mice that were injected
with saline as controls failed to show
any signs of disease 620 days after
injection (Science 2004; 305: 67376).
Sotos main criticism is that
Prusiners team injected the synthetic
prion into a transgenic model that
expresses high levels of the truncated
version of the prion protein. It is
well-known in the field that most of
this type of animal develop clinical
signs and scrapie-like pathology
spontaneously, says Soto. The
injection of the recombinant protein
may have merely accelerated a process
that was set to occur spontaneously
anyway. For me it would have been
very convincing if the disease was
transmitted to wild-type animals in a
first passage. In addition, Soto notes
that the disease characteristics were
different to those normally obtained in
these animals.
Unsurprisingly, Prusiner is more
upbeat: The finding represents a
renaissance in prion biology. For the
first time, we can create prions in the
test tube, which will change the way
scientists do experiments in the field.
We now have a tool for exploring the
mechanism by which a protein can
spontaneously fold into a shape that
causes disease.
James Butcher
Protein-only prion proposal
Neurology Vol 3 September 2004 http://neurology.thelancet.com

PLUS ;

Still, some said the evidence was not sufficient.

Dr Bruce Chesebro, chief of the Laboratory of
Persistent Viral Diseases at the federal Rocky Mountain
Laboratories, said the experiment showed that
the prion produced something in the mice. But he
said it was still unclear whether the prion was causing
the infection or just exposing an underlying
infectious process.
Dr Laura Manuelidis, a neuropathologist at the Yale
University Medical School, one of Dr Prusiner's most
vocal critics, said the prion strain that turned up in the
experiment looked like a mouse prion frequently used
in Dr Prusiner's laboratory. She said that meant that
something else might have caused the infection.
"Basically I think the data look like contamination,"
Dr Manuelidis said, possibly stemming from "inadequately
washed instruments."

http://users.erols.com/nafv/fvpage03.pdf

US SENATOR AND PROFESSOR PRUSINER SLAM USDA ''DAMNING TESTIMONY''


Senator Michael Machado from California


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

''USDA is protecting the industry''.

''SHOULD the state of California step in''


Stanley Prusiner

''nobody has ever ask us to comment''

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

''they never ask''


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


Dr. Stan bashing Ann Veneman - 3 minutes


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


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

Tuesday, February 24, 2004
JOINT HEARING


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

Opening Statement by Senator Michael Machado

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


Elisa Odibashian - Consumers Union

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


Anthony Iton - Alemeda County Health

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


USDA's "memorandum of understanding"

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


Dave Louthan - Killed the Mad Cow

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


Dennis Laycraft - Canadian Cattlemen's Association

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


Stanley Prusiner - Discoverer of Prions

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


Steven DeArmond - Professor of Neuropathology

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


Entire 5 hour hearing - The California Channel
(scroll down to "022404 Senate Info-Hearing")

http://www.calchannel.com/february2004.htm


85%+ of all CJD 'sporadic/spontaneous' did not happen without a
route and source. There are many of both right here in the USA.

THIS data below warrants yours/mine/everyone's urgent attention, regardless
what the industry says. TO further delay telling the public this, will
only continue
to spread the agent ;

PRODUCT
Product is custom made deer feed packaged in 100 lb. poly bags. The
product has no labeling. Recall # V-003-5.
CODE
The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated
September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 6 tons.
DISTRIBUTION
OH.

END OF ENFORCEMENT REPORT FOR October 20, 2004

PRODUCT
Product is custom made steer/cattle feed packaged in 100 lb. poly bags.
The product has no labeling. Recall # V-001-5.
CODE
The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated
September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 80 1û2 tons of steer/cattle feed.
DISTRIBUTION
OH.

_______________________________

PRODUCT
Product is custom made sheep/goat feed packaged in 100 lb. poly bags.
The product has no labeling. Recall # V-002-5.
CODE
The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated
September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 8 tons.
DISTRIBUTION
OH.

_______________________________

END OF ENFORCEMENT REPORT FOR October 20, 2004

http://www.fda.gov/

PRODUCT
a) Product is 9 Mile Steer Feed, packaged in white poly weaved
bags, each containing 100 lbs. A white label tied to the
inlet of each bag with twine identifies the product. Recall
# V-187-4;
b) Product is 9 Mile Pig and Sow Feed, packaged in white poly
weaved bags, each bag containing 100 lbs. A white label tied
to the inlet of each bag with twine identifies the product.
Recall # V-188-4.
CODE
The products contain no code date.
RECALLING FIRM/MANUFACTURER
Farmers Elevator, Co., Houston, OH, by telephone and letters dated
September 8, 2004. Firm initiated recall is ongoing.
REASON
Products may contain protein derived from mammalian tissues which is
prohibited in ruminant (steer) feed. FDA regulation, if the feed is
intended for non-ruminants (pigs), the bag labels must bear the
statement ìDo not feed to cattle or other ruminantsî.
VOLUME OF PRODUCT IN COMMERCE
700 lbs. Steer feed and 1,500 lb. Pig and sow fed.
DISTRIBUTION
OH.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html

PRODUCT
a) Premier Catfish Food, packaged in 50 pound bags (white paper
with an orange label). Recall #V-190-4;
b) Happy Fisherman Fish Food, pellet form, 50 pound bags.
Recall # V-191-4.
CODE
a) T1 Best By 08/27/05;
b) T21 Best By 11 DEC 05 and T11 Best By 02 OCT 05.
RECALLING FIRM/MANUFACTURER
Sunshine Mills, Inc., Tupelo, MS, by telephone beginning on April 14,
2004. Firm initiated recall is complete.
REASON
The catfish food contains prohibited material (meat & bone meal) but
does not contain the cautionary statement, "Do not feed to cattle or
other ruminants" on the label.
VOLUME OF PRODUCT IN COMMERCE
1,092  50 pound bags.
DISTRIBUTION
TX and MO.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html


Public Health Service
Food and Drug Administration

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700


VIA HAND DELIVERY

Our Reference No. 1000123954

June 23, 2004

Ronald M. Foster, Manager
Randall C. Boyce, Manager
Trevor O. Foster, Manager
George P. Foster, Manager
Fresno Farming LLC
P.O. Box 457
1000 Davis Street
Livingston, California

WARNING LETTER

Dear Mssrs. Foster, Boyce, Foster, and Foster:

The U.S. Food and Drug Administration (FDA) conducted an inspection of
your medicated animal feed mill operation, Fresco Farming LLC, located
in Traver, California from April 14, 2004 through May 6, 2004, and found
significant deviations from the requirements set forth in Title 21, Code
of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal
Proteins Prohibited in Ruminant Feed. The regulation is intended to
prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). Because you failed to follow this rule, products
you manufactured and distributed are adulterated within the meaning of
Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)
because they were prepared, packed, or held under insanitary conditions
whereby they may have been rendered injurious to health.

Our inspection found the following violations of 21 C.F.R. 589.2000:

1. Failure to provide for measures to avoid commingling or
cross-contamination of products that contain or may contain protein
derived from mammalian tissues into animal protein or feeds that may be
used for ruminants to comply with 21 C.F.R. 589.2000(e)(1)(iii).

* Your firm uses a vacuum system to clean up spilled product in the
tunnel area. This tunnel area houses the two receiving conveyor
systems and the elevators for the two conveyor systems. When
product, including ruminant meat and bone meal, is spilled onto
the floor of this area, the spilled product is vacuumed up by the
vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant
meat and bone meal. Your firm admitted that it was unaware of the
vacuum system discharging into the conveyor systems designated as
free of ruminant meat and bone meal and that this had been in
place since April 2003. Your firm remedied this problem during
FDAs April/May 2004 inspection by removing the discharge hose
connection to the conveyer system that your firm had designated as
free of ruminant meat and bone meal .
* Your firm uses a dust collection system that pulls dust from
systems that receive both ruminant meat and bone meal and feed
ingredients intended for ruminants. This dust system then
discharged collected product back into the two conveyor systems
via a cross connection, thereby making it likely that ruminant
meat and bone meal became commingled with ruminant feed
ingredients. Your firm admitted that it was unaware of the cross
connection and that it had been in place since April 2003. Your
firm removed the cross connection during FDAs April/May 2004
inspection.

2. Failure to maintain written procedures specifying the clean-out
procedure or other means, and specifying the procedures for separating
products that contain or may contain protein derived from mammalian
tissue from all other protein products from the time of receipt until
the time of shipment, to comply with 21 C.F.R. 589.2000(e)(1)(iv). This
observation was also noted during FDAs July/August 2003 inspection of
your firm.

* There are no written procedures for separating products that
contain prohibited material from ingredients used in ruminant
feeds from the time of receipt until the time of shipment.
* The written procedure for cleaning out or flushing equipment after
mixing feeds containing prohibited material was not adequate to
prevent contamination of ruminant feed with prohibited material.

3. Failure to maintain records sufficient to track materials that
contain protein derived from mammalian tissues throughout their receipt,
processing, and distribution to comply with 21 C.F.R. 589.2000(e)(1)(i).
This observation was also noted during FDAs July/August 2003 inspection
of your firm.

* Specifically, your firm has failed to develop and implement
complete written procedures to separate ruminant meat and bone
meal from feed ingredients intended for ruminants from the time of
receipt until the time of distribution. The written procedures
that do exist fail to address the use of equipment common to
ruminant meat and bone meal and ruminant feed ingredients.

The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for use as animal
feed, you are responsible for assuring that your overall operation and
the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct these violations, and you
should establish a system whereby such violations do not recur. Failure
to promptly correct these violations may result in regulatory action
without further notice, such as seizure and/or injunction.

You should notify this office in writing within fifteen (15) working
days of receiving 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 violations and
prevent their recurrence. If corrective actions cannot be completed in
fifteen (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.

Please send your reply to the U.S. Food and Drug Administration,
Attention: Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay
Parkway, Alameda, California 94502-7070. If you have questions regarding
this letter, please contact Ms. Kishida at (510) 337-6824.

Sincerely,

/s/

CD Moss, Acting DD for
Barbara J. Cassens
District Director
San Francisco District

cc:
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
C. Michael Blasco, Feed Mill Manager
Fresno Farming LLC
P.O. Box 430
Traver, California 93673

http://www.fda.gov/foi/warning_letters/g4849d.htm


Public Health Service
Food and Drug Administration

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


July 12, 2004

WARNING LETTER
CHI-16-04

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Donald E. Hamilton, President/Owner
Illini Feeds, Inc.
P.O. Box 86, 1145 State Hwy. 94
Aledo, Illinois 61231

Dear Mr. Hamilton:

On February 19 and 20, 2004, the Food and Drug Administration (FDA)
conducted an inspection of your animal feed handling facility located at
1145 State Highway 94, Aledo, Illinois. The inspection found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins
Prohibited in Ruminant Feed. This regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy
(BSE). The deviations cause the swine feed manufactured by your facility
to be misbranded within the meaning of Section 403(a)(1) of the Federal
Food, Drug, and Cosmetic Act (the Act).

Our investigation found that salvaged pet food containing prohibited
material was added as an ingredient to the swine products manufactured
at your facility. During the inspection, our investigator found that you
failed to label your non-ruminant products with the required caution
statement - Do not feed to cattle or other ruminants. [21 CFR
589.2000(d)(1)]

The above is not intended to be an all-inclusive list of violations. As
a manufacturer of materials intended for use in animal feed, you are
responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law.

You should take prompt action to correct this violation, and you should
establish a system whereby such violations do not recur. Failure to
promptly correct this violation may result in regulatory action without
further notice, such as seizure and/or injunction.

During the inspection, you told the investigator that you would put the
required cautionary statement on your products that contain prohibited
material, and maintain tracking documents for all incoming ingredients,
including animal proteins prohibited in ruminant feed. Please notify
this office in writing within 15 working days of receiving this letter
of any further steps you have taken to assure that your firm is in
compliance with the law. Your response should also include an
explanation of each step taken to correct the violations, and prevent
their recurrence. Please include copies of any available documentation
such as written procedures, corrected labeling, etc., demonstrating that
corrections have been made. If corrections cannot be completed within 15
working days, state the reason for the delay and the date by which the
corrections will be completed.

Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the above address.

Sincerely,

/s/

Scott J. MacIntire
District Director

http://www.fda.gov/foi/warning_letters/g4840d.htm


Public Health Service
Food and Drug Administration

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


June 15, 2004

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. David W. Bernauer
CEO and Chairman of the Board
Walgreen co.
200 Wilmot Rd.
Deerfield, IL 60015

Dear Mr. Bernauer:

Inspection of your firms warehouse at 5100 Lake Terrace N.E., Mt.
Vernon, Illinois, by the Illinois Department of Public Health and the
U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and
March 2, 2004, documented numerous insanitary conditions which caused
the food and drug products stored there to become adulterated.

Our inspection showed that the food and drug products stored and held at
your facility violated the Federal Food, Drug, and Cosmetic Act (the
Act), rendering them adulterated. These adulterated fwd and drug
products: a) consisted in whole or in part of filthy substances,
including rodent fecal pellets, rodent hair, and insects, in violation
of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had
been held under insanitary conditions whereby they have become
contaminated with rodent filth, in violation of Sections 402(a)(4) and
501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].

Evidence of rodent activity documented throughout the old and new
warehouse included dead mice in traps, excreta pellets, and gnawed paper
material observed in, on, and near food and drugs stored in the
warehouse. Rodents gnaw holes were observed into several packaged food
products with rodent hairs at gnaw holes into products. Many more fecal
pellets were on food and drug packages and still more were found near
the stored foods, drugs, and cosmetics in the warehouse.

Other conditions observed during the inspection that could be
contributing factors to rodent infestation include damaged and/or poorly
fitting rail and truck dock doors, gaps around a conduit entry into the
building, and the structural condition of the concrete and expansion
gaps at floor/wall/support beam junctions in various areas of the
warehouse allowing the entry or harborage of pests. Additionally, the
investigators observed cobwebs, dead insects, dust, debris, product
spillage, and papers in the warehouse, indicating a general lack of good
sanitation practices.

Also, products that contain or may contain animal protein prohibited
ruminant feed (BSE material) failed to bear the caution statement, Do
not feed to cattle or other ruminants. Specifically, pet food products
were salvaged, repackaged, and donated to [redacted] and other similar
organizations in the area, without the proper labeling and agreement
that they would not be used for ruminants. Please refer to Title 21,
Code of Federal Regulations, Section 589.2000, concerning these
requirements.

Our laboratory confirmed the findings of rodent excreta, rodent hairs on
product gnaw holes, and rodent gnawed fibers (packaging material)
sampled from the warehouse during the inspection.

The above listed violations are not intended to be all-inclusive. It is
your responsibility to assure adherence with each requirement of the Act
and its implementing regulations. The investigators reported that you
destroyed food products that showed evidence of contamination and began
to take some steps to correct the insanitary conditions in your
facility. We request that you take prompt action to correct all violations.

Please provide this office, within 15 working days of receipt of this
letter, a detailed response stating the actions you plan to take and
have taken to correct and prevent the recurrence of these objectionable
conditions. Provide the time within which corrections will be completed,
reasons why any corrective action cannot be completed, and documentation
to show that corrections have been made. Failure to take prompt action
to correct all violations may result in regulatory action without
further notice. Such action includes seizure and/or injunction.

Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the Chicago District Office.

Sincerely,

/s/

Scott J. MacIntire
District Director

cc:
Stephen J. Lawrence,
Distribution Center Manager
Walgreen Co.
5100 Lake Terrace NE
Mount Vernon, IL 62864-9665

http://www.fda.gov/foi/warning_letters/g4853d.htm

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

_______________________________

PRODUCT

a) Bulk whole corn. Recall # V-150-4;
b) Bulk rolled corn. Recall # V-151-4;
c) Bulk rolled corn with added fat. Recall # V-152-4.

CODE

No coding information is used.

RECALLING FIRM/MANUFACTURER

Fresno Farming LlC, Traver, CA, by letters on June 30, 2004. Firm
initiated recall is ongoing.

REASON
Corn for feed may be contaminated with RUMINANT MEAT AND BONE MEAL.

VOLUME OF PRODUCT IN COMMERCE
Unknown.

DISTRIBUTION
Unknown.
____________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html


PLUS THESE TSE BLOOD VIOLATIONS ;

PRODUCT
Source Plasma. Recall # B-0004-5.
CODE
Units BY0081013, BY0081234, BY0081539, BY0081749, BY0082116, BY0082324,
BY0082909, BY0082977.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Bryan, LLC, Bryan, TX, by facsimile dated November 6,
2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in western Europe, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
NY.

___________________________________

PRODUCT
Source Plasma. Recall # B-0038-5.
CODE
Units CS0179785, CS0195693.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, LLC, College Station, TX, by letter dated January
2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.

_______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0041-5.
CODE
Unit 2372493 (split unit).
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
March 7, 20, and 27, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for
Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # 0044-5;
b) Fresh Frozen Plasma. Recall # B-0045-5.
CODE
a) and b) Unit 2374447.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
January 22, and February 21, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was at risk for
Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0049-5;
b) Recovered Plasma. Recall # B-0050-5.
CODE
a) and b) Unit 2368943.
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile dated
February 13, 2003, and April 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in western Europe, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Vienna, Austria, and TX.
_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0056-5;
b) Cryoprecipitated AHF. Recall # B-0057-5;
c) Recovered Plasma. Recall # B-0058-5.
CODE
a), b), and c) Unit number 2372945.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
February 25, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, and Switzerland.

_______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0059-5;
Recovered Plasma. Recall # B-0060-5.
CODE
a) and b) Unit number 2348391.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
February 12, and 19, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Austria.

_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0080-5;
b) Fresh Frozen Plasma. Recall # B-0081-5.
CODE
a) and b) Unit 2356608.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
March 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for
Creuztfeldt Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________

END OF ENFORCEMENT REPORT FOR October 20, 2004

http://www.fda.gov/

PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall B-0008-5.
CODE
Unit number 6684748 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by telephone on October
28, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0025-5;
b) Cryoprecipitated AHF, Recall # B-0026-5;
c) Plasma Cryoprecipitate Reduced, Recall # B-0027-5.
CODE
a), b), and c) Unit 20GM75704.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID, by telephone on April 4,
2003 and by letter dated August 6, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for
Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MT.
_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0036-5;
b) Fresh Frozen Plasma. Recall # B-0037-5.
CODE
a) and b) Unit number 2383755.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
February 4, 2003, and August 13, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.


RECALLS AND FIELD CORRECTIONS: BIOLOGICS  CLASS III

_______________________________

PRODUCT
Recovered Plasma. Recall # B-0012-5.
CODE
Unit numbers D03-02509 and D04-00404.
RECALLING FIRM/MANUFACTURER
Metrowest Medical Center, Farmingham, MA, by letter on August 10, 2004.
Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
_______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html

BUT MOST IMPORTANTLY, this has hit ever paper around except
houston chronicle, and if it would, it would be buried like the recent
few sentences buried about the new vCJD case in Ireland. THIS has
major ramifications for all of us, but nobody prints it;

11 November 2004

Genetic make-up may determine what type of CJD occurs when humans are
infected with BSE

New research published by a team from the Medical Research Council (MRC)
Prion Unit offers an explanation about why only people with a particular
genetic make-up have so far developed vCJD. It also provides evidence
that other types of BSE-derived prion infection with a different pattern
of symptoms might occur in humans. The findings are published in the
journal Science.

Variant CJD (vCJD) is the human disease thought to be caused by eating
food contaminated with the infectious agent, known as a prion,
responsible for the epidemic of BSE or mad cow disease in cattle. So
far, everyone known to have developed vCJD has been of a particular
genetic type known as MM. Until now it has been a mystery why everyone
that has developed vCJD is of the MM type and one possibility is that
they are simply the first to develop the disease when infected with BSE,
and that people with the other genetic types1 (known as VV and MV*)
infected with BSE prions will also develop vCJD, but some years later.

In a series of experiments spanning more than ten years, the MRC team
has been studying mice genetically modified so that they make human
prion proteins which are used to model human susceptibility to BSE. The
team has now shown that mice with the human VV genetic type do become
infected when given BSE or vCJD prions, but manifest a different form of
the disease which looks quite different to vCJD and has a novel prion
strain type.

Remarkably, when these novel prions were used to infect mice of the MM
genetic type, the mice either developed a disease very like vCJD, or
else a pattern of disease that looks like so-called sporadic CJD the
classical form of CJD. This form has been known about for many years, is
seen all over the world and has not hitherto been associated with BSE.
However, the new strain identified in the mice, being called type 5, has
not been seen yet in people and we do not know what pattern of disease
it would cause. It could look like one of the forms of classical or
sporadic CJD or perhaps be yet another different variant form.

The work from the MRC team suggests that type 4 prions, the type
associated with vCJD, can only propagate themselves in people that make
the M form of the protein. It seems the V form of the protein just
cannot adopt the particular molecular shape that characterises type 4.

The studies in mice also suggest that if these prions were to pass from
person to person (for example by blood transfusion) then, depending on
the genetic type of the person becoming infected, at least three
different patterns of disease might result: type 2 (which is seen in
sporadic CJD); type 4 (which causes vCJD) or type 5 (which may cause a
new pattern of disease).

Professor John Collinge, Director of the MRC Prion Unit, which is based
at University College London, said: These mouse studies give us vital
clues about the behaviour of prions and how they appear to modify and
adapt depending on the genetic makeup of the individual they are infecting.

We always have to be cautious about making direct comparison to the
human condition, but our work strongly suggests that we can not assume
only those with one genetic profile are vulnerable to BSE infection.

At this stage it is not possible to say how this should alter estimates
of those likely to become ill, but our findings do suggest we should be
taking steps to draw up a more sophisticated system of categorizing the
disease so that we dont mistake BSE related infection for a version of
sporadic CJD.

For more information call the MRC press office on 020 7 637 6011

Notes to Editors

*The human prion protein comes in two common forms, known as M and V.
Because everyone has two copies of this gene, there are three possible
genetic types: MM, MV and VV.

Paper - Human Prion protein v129 prevent expression of vCJD phenotype
Science On line 11.11.04

Prions are rogue forms of one of the bodys own proteins known as the
prion protein which are misshapen. There are several different rogue or
misshapen forms that can infect humans, and these different types of
prions are known as strains. This is analogous to different strains of
other germs such flu virus causing influenza or strains of salmonella
causing different forms of food poisoning for example.

The strain of prion causing vCJD is known as type 4, types 1-3 cause the
different forms of sporadic or classical CJD. Each strain causes a
different pattern or type of disease. It is known that prion strains can
change or mutate when they pass between different animals.

The Medical Research Council (MRC) is a national organisation funded by
the UK tax-payer. Its business is medical research aimed at improving
human health; everyone stands to benefit from the outputs. The research
it supports and the scientists it trains meet the needs of the health
services, the pharmaceutical and other health-related industries and the
academic world. MRC has funded work which has led to some of the most
significant discoveries and achievements in medicine in the UK. About
half of the MRCs expenditure of £430 million is invested in its 40
Institutes, Units and Centres. The remaining half goes in the form of
grant support and training awards to individuals and teams in
universities and medical schools.


©2004 Medical Research Council

http://www.mrc.ac.uk/public-11_november_2004

BSE prions propagate as either variant CJD-like or sporadic CJD-like
prion strains in transgenic mice expressing human prion protein

Emmanuel A. Asante, Jacqueline M. Linehan, Melanie Desbruslais, Susan
Joiner, Ian Gowland, Andrew L. Wood, Julie Welch, Andrew F. Hill, Sarah
E. Lloyd, Jonathan D.F. Wadsworth and John Collinge1

MRC Prion Unit and Department of Neurodegenerative Disease, Institute of
Neurology, University College, Queen Square, London WC1N 3BG, UK 1
Corresponding author e-mail: j.collinge@prion.ucl.ac.uk

Received August 1, 2002; revised September 24, 2002; accepted October
17, 2002

Abstract


Variant CreutzfeldtJakob disease (vCJD) has been recognized to date
only in individuals homozygous for methionine at PRNP codon 129. Here we
show that transgenic mice expressing human PrP methionine 129,
inoculated with either bovine spongiform encephalopathy (BSE) or variant
CJD prions, may develop the neuropathological and molecular phenotype of
vCJD, consistent with these diseases being caused by the same prion
strain. Surprisingly, however, BSE transmission to these transgenic
mice, in addition to producing a vCJD-like phenotype, can also result in
a distinct molecular phenotype that is indistinguishable from that of
sporadic CJD with PrPSc type 2. These data suggest that more than one
BSE-derived prion strain might infect humans; it is therefore possible
that some patients with a phenotype consistent with sporadic CJD may
have a disease arising from BSE exposure...

http://embojournal.npgjournals.com/cgi/content/full/21/23/6358


THE new findings of BASE in cattle in Italy of Identification of a
second bovine amyloidotic spongiform encephalopathy: Molecular
similarities with sporadic Creutzfeldt-Jakob disease


http://www.pnas.org/cgi/content/abstract/0305777101v1


Adaptation of the bovine spongiform encephalopathy agent to primates
and comparison with Creutzfeldt- Jakob disease: Implications for
human health

THE findings from 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* 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


Characterization of two distinct prion strains
derived from bovine spongiform encephalopathy
transmissions to inbred mice

Sarah E. Lloyd, Jacqueline M. Linehan, Melanie Desbruslais,
Susan Joiner, Jennifer Buckell, Sebastian Brandner,
Jonathan D. F. Wadsworth and John Collinge

Correspondence
John Collinge
j.collinge@prion.ucl.ac.uk

MRC Prion Unit and Department of Neurodegenerative Disease, Institute of
Neurology,
University College, London WC1N 3BG, UK
Received 9 December 2003
Accepted 27 April 2004

Distinct prion strains can be distinguished by differences in incubation
period, neuropathology and biochemical properties of disease-associated
prion protein (PrPSc) in inoculated mice. Reliable comparisons of mouse
prion strain properties can only be achieved after passage in
genetically identical mice, as host prion protein sequence and genetic
background are known to modulate prion disease phenotypes. While
multiple prion strains have been identified in sheep scrapie and
Creutzfeldt Jakob disease, bovine spongiform encephalopathy (BSE) is
thought to be caused by a single prion strain. Primary passage of BSE
prions to different lines
of inbred mice resulted in the propagation of two distinct PrPSc types,
suggesting that two prion strains may have been isolated. To investigate
this further, these isolates were subpassaged in a single line of inbred
mice (SJL) and it was confirmed that two distinct prion strains had been
identified. MRC1 was characterized by a short incubation time (110±3 days),
a mono-glycosylated-dominant PrPSc type and a generalized diffuse
pattern of PrP-immunoreactive deposits, while MRC2 displayed a much
longer incubation time (155±1 days), a di-glycosylated-dominant PrPSc
type and a distinct pattern of PrP-immunoreactive deposits and neuronal
loss. These data indicate a crucial involvement of the host genome in
modulating
prion strain selection and propagation in mice. It is possible that
multiple disease phenotypes may also be possible in BSE prion infection
in humans and other animals.

http://vir.sgmjournals.org/cgi/content/abstract/85/8/2471


THE recent discoveries of previously unidentified strains of
Scrapie such as 221C44 and the Nor9845;

FULL TEXT APPRX. 91 PAGES

UK Strategy for Research and
Development on Human and Animal
Health Aspects of Transmissible
Spongiform Encephalopathies

2004-2007

http://www.mrc.ac.uk/pdf-uk_strategy_v5.2.pdf


IP/04/1324

Brussels, 28 October 2004


Commission submits French Research Findings on TSE in a goat to Expert
Panel

Following the findings by a research group in France that they suspect
the presence of a TSE infection in a goats brain which tests cannot
distinguish from BSE, the European Commission has submitted data
received from the French authorities to the Community Reference
Laboratory (CRL) for TSEs based in Weybridge, England, for an evaluation
by an expert panel. TSEs are transmissible spongiform encephalopathies,
namely BSE affecting cattle, and scrapie affecting goats and sheep. The
expert panel will evaluate, over the next two weeks or so, the
scientific evidence to see if it indicates the presence of BSE in the
goat. This isolated incident does not present a risk to public health as
the goat and its herd did not enter the food and feed chain.

snip...

http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/04/1324&format=HTML&aged=0&language=EN&guiLanguage=en


According to Nov. 2 Yomiuri Newspaper, researchers of the Prion
Disease Research Center, the National Institute of Animal Health
of Japan reported in the International Symposium of Prion Diseases
held in Sendai from October 31 to November 2., 2004, that they
detected prion in the adrenal gland and peripheral (sciatic and
peroneal) nerves of the 11th BSE case of Japan (a 94-months old
cow found dead on the farm on March 4 this year).

http://www.maff.go.jp/www/press/cont2/20041101press_7.htm
(only in Japanese)

Sendai and the International
Symposium of
Prion Diseases held here from October 31 to November 2.,2004

Abstract

ORAL 8

Bovine spongiform encephalopathy (BSE) in Japan

Takashi Yokoyama, Kumiko M. Kimura, Morikazu Shinagawa
Prion Disease Research Center, National Institute of Animal Health, Japan

Bovine spongiform encephalopathy (BSE) has become an important problem
not only for animal industry, but also for public health. In Japan, BSE
was first recognized in September 2001 by fallen stock surveillance.
Since October 2001, BSE examination for all cattle slaughtered at
abattoirs has started. In April 2004, all dead cattle examination (over
24 months) has been conducted at livestock hygiene service center.
Samples positive in enzyme linked immunosorbent assay (ELISA) are
further subjected to western blot (WB) and immunohistochemistry (IHC).
Thirteen BSE cases have been reported by September 2004. Twelve cases
were classified as typical BSE, and the remained one was an atypical
BSE. Variant forms of BSE with atypical histopathological and/or
biochemical phenotype were reported in Italy and France. Further study
is required for BSE prion characteristics.
To characterize BSE prion properties, brain homogenates of Japanese BSE
cases were intracerebrally inoculated into wild-type mice. The first
case (BSE/Chiba) was successfully transmitted to rodents. The mean
incubation periods (409.0 days) in this experiment was preferably longer
than that of previously reported. PrPSc distribution, prion titer, mice
susceptibility and/or storage condition of sample might be influenced the
result. Recently, we introduced transgenic mice that overexpress a
bovine PrP gene to overcome the species barrier problem. These mice are
expected to accelerate the transmission experiment of BSE prion.
Transmission of atypical BSE case is undergoing by using these
transgenic mice.

http://www.knt.co.jp/ec/2004/prion/E2.htm

Japan Consumer Press online


Nippon shouhisha shinbun

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


Last modified, Tue, 09 Nov 2004 04:42:49 GMT


BSE death cow's anomalous prion detected from peripheral nerve
tissue, suprarenal gland

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


First time from non-Specified Risk Material, or SRM


By JCPRESS

National Institute of Animal Health Animal announced on November 1 that
it had detected the anomalous prion protein that was the etiologic agent
of the mad cow disease, or BSE, or bovine spongiform encephaalopathy,
from the peripheral nerve tissue and the suprarenal gland of the cow of
the age in the mad cow disease for the dying infection 94 months on
March 9 this year.

Japan is obligating the removal of the Specified Risk Material, or SRM
such as the head, the spinal cord, the vertebral columns, and the small
intestines that accumulate the anomalous prion protein easily as a BSE
(bovine spongiform encephaalopathy) measures.

Because the mad cow disease etiologic agent was detected from a tissue
different from the Specified Risk Material, or SRM, the review of the
Specified Risk Material, or SRM might be urged on the Japanese Government.

------------------------------------------------------------------------
http://www.jc-press.com/En/Latest%20News/200411/20041109BSE%20death%20cow%27s%20anomalous%20prion.htm


International Symposium of PRION DISEASES for food and drug safety
http://www.knt.co.jp/ec/2004/prion/
national institute of animal health(only in Japanese)
http://niah.naro.affrc.go.jp/index-j.html
The statement of the Ministry of Health, Labour and Welfare
(only in Japanese)
http://www.maff.go.jp/www/press/cont2/20041101press_7.htm
Yomiuri on line (only in Japanese)
http://www.yomiuri.co.jp/science/news/20041102i503.htm
Asahi on line(only in Japanese)
http://www.asahi.com/special/bse/TKY200411010291.html
Mainichi on line(only in Japanese)
http://www.mainichi-msn.co.jp/shakai/jiken/disease/news/20041102ddm041040128000c.html

TO flounder any longer will only further spread this agent to both man
and animal...

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

CJD WATCH

http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm


CJD Watch message board

http://disc.server.com/Indices/167318.html

TSS





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