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From: TSS ()
Subject: Re: Geographical BSE Risk: EFSA consults on revision of assessment methodology
Date: November 21, 2006 at 8:23 am PST

In Reply to: Geographical BSE Risk: EFSA consults on revision of assessment methodology posted by TSS on November 21, 2006 at 8:12 am:

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Tuesday, November 21, 2006 10:17 AM
Subject: re-Geographical BSE Risk: EFSA consults on revision of assessment methodology

a sad day. i think any weakening of the BSE GBR risk assessments, especially
for USA, is a huge mistake. i think the BSE GBR should be revised to include
all TSE i.e. TSE GBR.


> the need not to overstate risk in countries with a low BSE prevalence but
large cattle

> populations;


what about understating the risk???


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

PERSPECTIVE

On the Question of Sporadic

or Atypical Bovine SpongiformEncephalopathy and

Creutzfeldt-Jakob Disease

Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§

Strategies to investigate the possible existence of sporadic

bovine spongiform encephalopathy (BSE) require

systematic testing programs to identify cases in countries

considered to have little or no risk for orally acquired disease,

or to detect a stable occurrence of atypical cases in

countries in which orally acquired disease is disappearing.

To achieve 95% statistical confidence that the prevalence

of sporadic BSE is no greater than 1 per million (i.e., the

annual incidence of sporadic Creutzfeldt-Jakob disease

[CJD] in humans) would require negative tests in 3 million

randomly selected older cattle. A link between BSE and

sporadic CJD has been suggested on the basis of laboratory

studies but is unsupported by epidemiologic observation.

Such a link might yet be established by the discovery

of a specific molecular marker or of particular combinations

of trends over time of typical and atypical BSE and various

subtypes of sporadic CJD, as their numbers are influenced

by a continuation of current public health measures that

exclude high-risk bovine tissues from the animal and

human food chains. ......


PLEASE READ FULL TEXT ;


http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e

3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit
Hall


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


but i think science has pretty much proven the USA has a serious problem
from all TSEs ;


Conclusions

This study reveals remarkable international differences in the HTSE panorama that

change with time, as seen from deaths in eleven countries in the period 1993-2002.

Knowledge of possible biases in the study cohort is vital for future applications of this

dataset, both in clinical/epidemiological research and in public health surveillance.


snip...

FULL TEXT 19 PAGES ;


http://www.biomedcentral.com/content/pdf/1471-2458-6-278.pdf


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

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


snip...

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

Page 5 of 98

8/3/2006

snip...

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

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

03-025IFA
03-025IFA-2

snip...

TSS

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

snip...end

full text 33 PAGES ;

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

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

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/

1: J Infect Dis. 1994 Apr;169(4):814-20.

Intracerebral transmission of scrapie to cattle.

Cutlip RC, Miller JM, Race RE, Jenny AL, Katz JB, Lehmkuhl HD, DeBey BM,
Robinson MM.

USDA, Agriculture Research Service, National Animal Disease Center, Ames, IA
50010.

To determine if sheep scrapie agent(s) in the United States would induce a
disease in cattle resembling bovine spongiform encephalopathy, 18 newborn
calves were inoculated intracerebrally with a pooled suspension of brain
from 9 sheep with scrapie. Half of the calves were euthanatized 1 year after
inoculation. All calves kept longer than 1 year became severely lethargic
and demonstrated clinical signs of motor neuron dysfunction that were
manifest as progressive stiffness, posterior paresis, general weakness, and
permanent recumbency. The incubation period was 14-18 months, and the
clinical course was 1-5 months. The brain from each calf was examined for
lesions and for protease-resistant prion protein. Lesions were subtle, but a
disease-specific isoform of the prion protein was present in the brain of
all calves. Neither signs nor lesions were characteristic of those for
bovine spongiform encephalopathy.

MeSH Terms: Animals Brain/microbiology* Brain/pathology Cattle Cattle
Diseases/etiology* Cattle Diseases/pathology Encephalopathy, Bovine
Spongiform/etiology* Encephalopathy, Bovine Spongiform/pathology
Immunoblotting/veterinary Immunohistochemistry Male Motor Neurons/physiology
Prions/analysis Scrapie/pathology Scrapie/transmission* Sheep Sleep Stages
Time Factors

Substances: Prions

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8133096&dopt=Citation

9/13/2005

Page 16 of 17

Intracerebral transmission of scrapie to cattle FULL TEXT PDF;

SNIP...

Discussion

WE conclude that American sources of sheep scrapie are transmissible to
cattle by direct intracerebral inoculation but the disease induced is NOT
identical to BSE as seen in the United Kingdom. While there were
similarities in clinical signs between this experimental disease and BSE,
there was no evidence of aggressiveness, hyperexcitability, hyperesthesia
(tactile or auditory), or hyperemetria of limbs as has been reported for BSE
(9). Neither were there extensive neurologic lesions, which are primary for
BSE, such as severe vacuolation of neurons and neuropil or neuronal necrosis
and gliosis. Although some vacuolation of neuropil, chromotolysis in
neurons, and gliosis were seen in the brains of some affected calves, these
were industinguishable from those of controls. Vacuolated neurons in the red
nucleus of both challenged and normal calves were considered normal for the
bovines as previously described (50).

PrP-res was found in ALL CHALLENGED CALVES REGARDLESS OF CLINCIAL SIGNS, and
the amount of PrP-res positively related to the length of the incubation.
...

snip...

WE also conclude from these studies that scrapie in cattle MIGHT NOT BE
RECOGNIZED BY ROUTINE HISTOPATHOLOGICAL EXAMINATION OF THE BRAIN AND SUGGEST
THAT DETECTION OF PrP-res by immunohistochemistry or immunoblotting is
necessary to make a definitive diagnosis. THUS, undiagnosed scrapie
infection could contribute to the ''DOWNER-COW'' syndrome and could be
responsible for some outbreaks of transmissible mink encephalopathy proposed
by Burger and Hartsough

(8) and Marsh and harsough (52). ...

snip...

Multiple sources of sheep affected with scrapie and two breeds of cattle
from several sources were used inthe current study in an effort to avoid a
single strain of either agent or host. Preliminary results from mouse
inoculations indicate multiple strains of the agent were present in the
pooled inoculum (unpublished data). ...

Transmission of the sheep scrapie to cattle was attempted in 1979 by using
intracerebral, intramuscular, subcutaneous, and oral routes of inoculation
of 5, 8- to 11-month old cattlw with a homologous mixture of brain from 1
affected sheep (61, 62). ONE of the 5 cattle develped neurologic signs 48
months after inoculation. Signs were disorientation, incoordination, a
stiff-legged stilted gait, progressive difficulty in rising, and finally in
terminal recumbency. The clinical course was 2.5 months. TWO of the 5 cattle
similarly inoculated with brain tissue from a goat with scrapie exhibited
similar signs 27 and 36 months after incoluation. Clinical courses were 43
an 44 days. Brain lesions of mild gliosis and vacuolation and mouse
inoculation data were insufficient to confirm a diagnosis of scrapie. This
work remained controversial until recent examination of the brains detected
PrP-res in all 3 cattle with neurologic disease but in none of the
unaffected cattle (62). Results of these studies are similar to ours and
underscore the necessity of methods other than histopathology to diagnose
scrapie infection in cattle. We believe that immunologic techniques for
detecting PrP-res currently provide the most sensitive and reliable way to
make a definitive diagnosis...

http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf

Visit to USA ... info on BSE and Scrapie

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

http://www.ngpc.state.ne.us/cgi-bin/ultimatebb.cgi?ubb=get_topic;f=12;t=000385

12/10/76 AGRICULTURAL RESEARCH COUNCIL REPORT OF THE ADVISORY COMMITTE ON
SCRAPIE Office Note CHAIRMAN: PROFESSOR PETER WILDY

snip...

A The Present Position with respect to Scrapie A] The Problem

Scrapie is a natural disease of sheep and goats. It is a slow and inexorably
progressive degenerative disorder of the nervous system and it ia fatal. It
is enzootic in the United Kingdom but not in all countries.

The field problem has been reviewed by a MAFF working group (ARC 35/77). It
is difficult to assess the incidence in Britain for a variety of reasons but
the disease causes serious financial loss; it is estimated that it cost
Swaledale breeders alone $l.7 M during the five years 1971-1975. A further
inestimable loss arises from the closure of certain export markets, in
particular those of the United States, to British sheep.

9/13/2005

Page 17 of 17

It is clear that scrapie in sheep is important commercially and for that
reason alone effective measures to control it should be devised as quickly
as possible.

Recently the question has again been brought up as to whether scrapie is
transmissible to man. This has followed reports that the disease has been
transmitted to primates. One particularly lurid speculation (Gajdusek 1977)
conjectures that the agents of scrapie, kuru, Creutzfeldt-Jakob disease and
transmissible encephalopathy of mink are varieties of a single "virus". The
U.S. Department of Agriculture concluded that it could "no longer justify or
permit scrapie-blood line and scrapie-exposed sheep and goats to be
processed for human or animal food at slaughter or rendering plants" (ARC
84/77)" The problem is emphasised by the finding that some strains of
scrapie produce lesions identical to the once which characterise the human
dementias"

Whether true or not. the hypothesis that these agents might be transmissible
to man raises two considerations. First, the safety of laboratory personnel
requires prompt attention. Second, action such as the "scorched meat" policy
of USDA makes the solution of the acrapie problem urgent if the sheep
industry is not to suffer grievously.

snip...

76/10.12/4.6

http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf

THE infamous USA SPORADIC CJDs, something to ponder;

IF the USA TSE in cattle all does not look like UK BSE, why would all USA
human TSE look like UK nvCJD???

over 20 strains of scrapie documented to date with new atypical strains now
being documented in sheep and goat i.e. BSE.

atypical strains of BSE/TSE showing up in cattle in different countries?

ALL animals for human/animal consumption must be tested for TSE.

ALL human TSEs must be made reportable Nationally and Internationally, OF
ALL AGES...

IN a time when FSIS/APHIS/USDA/FDA et al should be strengthening the TSE
regulations, it seems corporate interest has won out again over sound
science and consumer protection from an agent that is 100% fatal for the
ones that go clinical. With the many different atypical TSEs showing up in
different parts of the world, and with GWs BSE MRR policy (the legal policy
of trading all strains of TSEs), the battle that has waged for the last 25
years to eradicate this agent from this planet will be set back decades, if
not lost for good. ...

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005


http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

THE SEVEN SCIENTIST REPORT ***


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf

Full Text

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

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

http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama


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


BRITISH MEDICAL JOURNAL


BMJ


http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2

BMJ


http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1

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

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Tuesday, November 07, 2006 11:21 AM
Subject: MAD COW FDA FEED WARNING LETTER NO. 2007-NOL-01 October 26, 2006
H.J. Baker & Bro., Inc.


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

Subject: MAD COW FDA FEED WARNING LETTER NO. 2007-NOL-01 October 26, 2006
H.J. Baker & Bro., Inc.
Date: November 7, 2006 at 9:08 am PST
Food and Drug Administration

New Orleans District

404 BNA Drive, Building 200, Suite 500

Nashville, TN 37217

Telephone: 615-366-7801

Facsimile: 615-366-7802

October 26, 2006

WARNING LETTER NO. 2007-NOL-01

FEDERAL EXPRESS

OVERNIGHT DELIVERY

Mr. Christopher V. B. Smith

Corporate President, CEO

H. J. Baker & Bro., Inc.

228 Saugatuck Avenue

Westport, Connecticut 06880

Dear Mr. Smith:

On June 6, 8, 12-15, and 23, 2006, a U.S . Food and Drug Administration
(FDA) investigator inspected

your animal feed protein supplement manufacturing facility, located at 603
Railroad Avenue,

Albertville, Alabama. The inspection revealed significant deviations from
the requirements set forth in

Title 21, Code ofFederal 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). You failed to follow the requirements of
this regulation, resulting

in products being manufactured and distributed by your facility because they
are adulterated within the

meaning of Section 402(a)(4) [21 USC 342(a)(4)] of the Federal Food, Drug,
and Cosmetic Act (the

Act) and misbranded within the meaning of Section 403(a)(1) [21 USC
343(a)(1)] of the Act.

Our investigation determined adulteration resulted from the failure of your
firm to establish and

implement measures sufficient to prevent commingling or cross-contamination
. The adulterated feed

was subsequently misbranded because it was not properly labeled.
Specifically, we found :

" Your firm failed to establish and use cleanout procedures or other means
to prevent carry-over of

products which contain or may contain protein derived from mammalian tissues
into animal protein

or feeds which may be used for ruminants, as required by 21 CFR
589.2000(e)(1)(iii)(B) .

Specifically, you failed to establish and use such measures for a screw
auger installed in February

2005 . This auger is used to convey both prohibited and non-prohibited
material to bulk storage bins.

In addition, you failed to follow the cleanout procedure your firm had
developed for the receiving

systems. Your feed is, therefore, adulterated under Section 402(a)(4) [21
USC 342(a)(4)] of the Act.

" You failed to label all products which contained or may have contained
prohibited materials with the

BSE cautionary statement, "Do not feed to cattle or other ruminants," as
required by 21 CFR

589.2000(e)(1)(i) . Such products are misbranded under Section 403(3) [21
USC 343(a)(1)] of the

Act. These misbranded products include the three Pro-Pak products mentioned
below, as well as

Page 2 - H. J . Baker & Bro., Inc., Albertville, Alabama Warning Letter No.
2007-NOL-O 1

those bulk loads of individual feed ingredients processed through this
common screw auger and

distributed between the time it was installed in February 2005, and June 9,
2006 .

This letter is not intended to serve as an all-inclusive list of violations
at your facility. As a

manufacturer of materials intended for animal feed use, you are responsible
for ensuring 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 violations do not recur. Failure to
promptly correct these violations may result in regulatory action, such as
seizure and/or injunction, without further notice.

We acknowledge your June 16, 2006, voluntary recall of three products you
manufactured from

February 2005 to June 2006. The three products recalled were: Pro-Lak
Protein Concentrate for

Lactating Dairy Animals; Pro-Amino II for PreFresh and Lactating Cows; and,
Pro-Pak Marine & Animal Protein Concentrate for Use in Animal Feed. Recall
effectiveness checks and other measures

will determine the merit of this recall . We recognize you now label all
products with the required BSE

cautionary statement and we also acknowledge your intent, given verbally to
New Orleans District

management of the FDA, to discontinue the production of supplements which do
not contain prohibited

materials. In your written response to this letter, please confirm in
writing you have taken these steps.

You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law, including the steps we acknowledge above and
any additional steps you have taken. Your response should include an

explanation of each step taken to correct the 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
corrections have been made.

Your reply should be directed to Kari L. Batey, Compliance Officer, at the
address above. If you have

questions regarding any issue in this letter, please contact Ms. Batey at
(615) 366-7808.

Sincerely,

,

Carol S . Sanchez

Acting District Director

New Orleans District

Enclosure: Form FDA 483

cc: Craig R. Waterhouse

Plant Manager

H.J. Baker & Bros., Inc.

603 Railroad Avenue

Albertville, Alabama 35951-3419


http://www.fda.gov/foi/warning_letters/g6104d.pdf


TSS


MORE 2006 FEED BAN VIOLATIONS BELOW, ''IN COMMERCE'' ;


Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
Date: September 6, 2006 at 7:58 am PST

PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV


http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html


Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS

______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS

______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN

END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006

###


http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html


Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


CJD WATCH MESSAGE BOARD
TSS
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html


Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration

New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217

Telephone: 615-781-5380
Fax: 615-781-5391


May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed 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). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).

Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.

This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring 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 violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.

You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the 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
corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez
Acting District Director
New Orleans District


http://www.fda.gov/foi/warning_letters/g5883d.htm


look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused
7% (1 of 14) of the cows to come down with BSE;


Risk of oral infection with bovine spongiform encephalopathy agent in
primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.


snip...


BSE bovine brain inoculum

100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg

Primate (oral route)* 1/2 (50%)

Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)

RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)

PrPres biochemical detection

The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was

inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of

bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.

Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula


Published online January 27, 2005

http://www.thelancet.com/journal/journal.isa


It is clear that the designing scientists must

also have shared Mr Bradley's surprise at the results because all the dose

levels right down to 1 gram triggered infection.


http://www.bseinquiry.gov.uk/files/ws/s145d.pdf


2

6. It also appears to me that Mr Bradley's answer (that it would take less
than say 100

grams) was probably given with the benefit of hindsight; particularly if one

considers that later in the same answer Mr Bradley expresses his surprise
that it

could take as little of 1 gram of brain to cause BSE by the oral route
within the

same species. This information did not become available until the "attack
rate"

experiment had been completed in 1995/96. This was a titration experiment

designed to ascertain the infective dose. A range of dosages was used to
ensure

that the actual result was within both a lower and an upper limit within the
study

and the designing scientists would not have expected all the dose levels to
trigger

infection. The dose ranges chosen by the most informed scientists at that
time

ranged from 1 gram to three times one hundred grams. It is clear that the
designing

scientists must have also shared Mr Bradley's surprise at the results
because all the

dose levels right down to 1 gram triggered infection.


http://www.bseinquiry.gov.uk/files/ws/s147f.pdf


Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]


http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram


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


2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)


http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml


TSS

#################### https://lists.aegee.org/bse-l.html
####################

USDA Testing Protocols and Quality Assurance Procedures

In November 2004, USDA announced that its rapid screening test produced an
inconclusive BSE test result. A contract laboratory ran its rapid screening
test on a brain sample collected for testing and produced three high
positive reactive results. As required, the contract laboratory forwarded
the inconclusive sample to APHIS’ National Veterinary Services Laboratories
(NVSL) for confirmation. NVSL repeated the rapid screening test, which again
produced three high positive reactive results. Following established
protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC)
test, which was interpreted as negative for BSE.

Faced with conflicting results between the rapid screening and IHC tests,
NVSL scientists recommended additional testing to resolve the discrepancy
but APHIS headquarters officials concluded that no further testing was
necessary since testing protocols were followed and the confirmatory test
was negative. In our discussions with APHIS officials, they justified their
decision to not do additional testing because the IHC test is
internationally recognized as the "gold standard" of testing. Also, they
believed that

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

conducting additional tests would undermine confidence in USDA’s testing
protocols.

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

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

We attribute the failure to identify the BSE positive sample to rigid
protocols, as well as the lack of adequate quality assurance controls over
its testing program. Details of our concerns are discussed in Findings 3 and
4.

snip...

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

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

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

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

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

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

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

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

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

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

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

Subject: OIE WEAKENS BSE GUIDELINES EVEN MORE FOR TRADE PURPOSES, putting humans further 'at risk' globally
Date: May 24, 2006 at 7:17 pm PST

Intl Decision On BSE Standards Seen Helping US Trade Case

WASHINGTON (Dow Jones)--The U.S. will now have a much stronger case to make that there is virtually no mad-cow disease risk here thanks to a decision Wednesday by the Paris-based World Organization for Animal Health to relax country standard requirements. Previously, a country had to wait seven years after its discovery of mad-cow disease, or bovine spongiform encephalopathy, before it could be considered in the "negligible risk" category -- the category for countries with the least BSE risk.

That has now been changed and countries must wait until 11 years after birth date of the last native-born cow discovered with the disease. The U.S. reported finding its latest BSE case in March, but U.S. Department of Agriculture officials say the infected cow was more than 10 years old when it died.

Under the previous guidelines of the World Organization for Animal Health, known commonly as OIE, the U.S. would have had to wait until 2013 before it could be recognized as a "negligible risk" country. Under the new guidelines, approved Wednesday by unanimous vote, there will be little or no waiting. "For the U.S., this is much better," said Alex Thiermann, an OIE chairman.

He also called the new age-based guideline more "realistic." Ron DeHaven, head of USDA's Animal and Plant Health Inspection Service, called the new guidelines "a significant change," in a telephone interview with Dow Jones Newswires, prior to the OIE vote. DeHaven who is currently in Paris for the OIE annual meeting, said, "When we found the (BSE) case is not nearly as relevant as when that animal was born."

Michael David, head of USDA's National Center for Import and Export, agreed and explained that an infected cow's age can point to when there was a spread of the disease. There are three OIE risk categories: "negligible," "controlled" and "undetermined." The U.S. would prefer to be considered "negligible" because it provides negotiators with a stronger case for countries to reopen borders to U.S. beef. A "negligible" standing also carries with it fewer costly safety restrictions than the other categories.

The U.S. has reported finding three cases of BSE in cattle -- one in December 2003, a second in June 2005 and a third in March 2006. However, USDA officials said only the two latest cases count under the new OIE guidelines. The first BSE case, officials said, was in an animal about 6 years old, but that animal was born and infected in Canada before being sent to the U.S. David said that first BSE discovery "was an imported case and it really doesn't matter because we can show that it came from Canada.

The two that mattered to us are two native cases and one was born 12 years ago ... and the second one is at least 10 years old." Despite the infected animal's origin, the December 2003 BSE discovery was and still is very important to many beef-importing nations. Most importing countries, including Japan, South Korea and China, shut their borders to U.S. beef in December 2003.

Japan has since eased its ban and then reinstated it, but even when the country resumes importing again it will maintain restrictions on U.S. beef that are far stricter than OIE guidelines. The USDA's David said Japan registered an official objection with the OIE on the BSE standard changes approved Wednesday, but the country did not vote against them.

China and the U.S. are in negotiations now to resume beef trade, but China's refusal to accept USDA claims that it is a "negligible risk" country complicated talks held in mid-May. USDA officials now have a much stronger argument that U.S. beef products are among the least risky for BSE in the world, but an official OIE confirmation of "negligible" status for the U.S. could be as much as two years away, David said. The process is long and complex, requiring well detailed explanations of such things as a country's BSE surveillance program.

-By Bill Tomson; Dow Jones Newswires; 202-646-0088; bill.tomson@dowjones.com


http://www.cattlenetwork.com/content.asp?contentid=39753


Bse Oie Chapter 2.3.13

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

C H A P T E R 2 . 3 . 1 3 .

BOVINE SPONGIFORM ENCEPHALOPATHY

Article 2.3.13.1.

The recommendations in this Chapter are intended to manage the human and animal health risks

associated with the presence of the bovine spongiform encephalopathy (BSE) agent in cattle (Bos taurus

and B. indicus) only.

1) When authorising import or transit of the following commodities and any products made from these

commodities and containing no other tissues from cattle, Veterinary Administrations should not

require any BSE related conditions, regardless of the BSE risk status of the cattle population of the

exporting country, zone or compartment:

snip...

2005 OIE Terrestrial Animal Health Code


http://www.oie.int/downld/SC/2005/bse_2005.pdf


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)

Report

Summary
Summary of the Scientific Report

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

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

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

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


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


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


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


CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf


What GAO Found
United States Government Accountability Office
Why GAO Did This Study
Highlights
Accountability Integrity Reliability
www.gao.gov/cgi-bin/getrpt?GAO-05-101.
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact Robert A.
Robinson at (202) 512-3841 or
robinsonr@gao.gov.
Highlights of GAO-05-101, a report to
congressional requesters
February 2005
MAD COW DISEASE
FDA's Management of the Feed Ban Has
Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness
FDA has made needed improvements to its management and oversight of the
feed-ban rule in response to GAO's 2002 report, but program weaknesses
continue to limit the effectiveness of the ban and place U.S. cattle at risk of
spreading BSE. Improvements made include FDA establishing a uniform
method of conducting compliance inspections and training FDA inspectors,
as well as state inspectors who carry out inspections under agreements with
FDA, on the new method. FDA also implemented new data-entry procedures
that are designed to more reliably track feed-ban inspection results.
Consequently, FDA has a better management tool for overseeing compliance
with the feed-ban rule and a data system that better conforms to standard
database management practices. However, various program weaknesses
continue to undermine the nation's firewall against BSE. For example:
. FDA acknowledges that there are more feed manufacturers and
transporters, on-farm mixers, and other feed industry businesses that are
subject to the feed ban than the approximately 14,800 firms inspected to
date; however, it has no uniform approach for identifying additional
firms.
. FDA has not reinspected approximately 2,800, or about 19 percent, of
those businesses, in 5 or more years; several hundred are potentially
high risk. FDA does not know whether those businesses now use
prohibited material in their feed.
. FDA's feed-ban inspection guidance does not include instructions to
routinely sample cattle feed to test for potentially prohibited material as
part of the compliance inspection. Instead, it includes guidance for
inspectors to visually examine facilities and equipment and review
invoices and other documents.
. Feed intended for export is not required to carry a caution label "Do not
feed to cattle or other ruminants," when the label would be required if
the feed were sold domestically. Without that statement, feed containing
prohibited material could be inadvertently or intentionally diverted back
to U.S. cattle or given to foreign cattle.
. FDA has not always alerted USDA and states when it learned that cattle
may have been given feed that contained prohibited material. This lapse
has been occurring even though FDA's guidance calls for such
communication.
. Although research suggests that cattle can get BSE from ingesting even a
small amount of infected material, inspectors do not routinely inspect or
review cleanout procedures for vehicles used to haul cattle feed.
More than 5 million cattle across
Europe have been killed to stop the
spread of bovine spongiform
encephalopathy (BSE), commonly
called mad cow disease. Found in
26 countries, including Canada and
the United States, BSE is believed
to spread through animal feed that
contains protein from BSE-infected
animals. Consuming meat from
infected cattle has also been linked
to the deaths of about 150 people
worldwide. In 1997, the Food and
Drug Administration (FDA) issued
a feed-ban rule prohibiting certain
animal protein (prohibited
material) in feed for cattle and
other ruminant animals. FDA and
38 states inspect firms in the feed
industry to enforce this critical
firewall against BSE. In 2002, GAO
reported a number of weaknesses
in FDA's enforcement of the feed
ban and recommended corrective
actions. This report looks at FDA's
efforts since 2002 to ensure
industry compliance with the feed
ban and protect U.S. cattle.
What GAO Recommends
GAO recommends FDA, among
other things, develop procedures
for finding additional firms subject
to the feed-ban and using tests to
augment inspections. FDA said the
study was thorough but disagreed
on four of nine recommendations.
GAO continues to believe that,
given the discovery of BSE in North
America and the oversight gaps
described in the report, the
recommended actions are needed
to protect U.S. cattle from BSE.


3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,
but Oversight Weaknesses Continue to Limit Program Effectiveness.
GAO-05-101, Feb. 25.
http://www.gao.gov/cgi-bin/getrpt?GAO-05-101
Highlights - http://www.gao.gov/highlights/d05101high.pdf


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

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

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

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


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


PART 2


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

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


Gerald Wells: Report of the Visit to USA, April-May 1989

snip...

The general opinion of those present was that BSE, as an
overt disease phenomenon, _could exist in the USA, but if it did,
it was very rare. The need for improved and specific surveillance
methods to detect it as recognised...

snip...

It is clear that USDA have little information and _no_ regulatory
responsibility for rendering plants in the US...

snip...

3. Prof. A. Robertson gave a brief account of BSE. The US approach
was to accord it a _very low profile indeed_. Dr. A Thiermann showed
the picture in the ''Independent'' with cattle being incinerated and thought
this was a fanatical incident to be _avoided_ in the US _at all costs_...

snip...

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


To be published in the Proceedings of the
Fourth International Scientific Congress in
Fur Animal Production. Toronto, Canada,
August 21-28, 1988

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

R.F. Marsh* and G.R. Hartsough

.Department of Veterinary Science, University of Wisconsin-Madison, Madison,
Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service, Thiensville, Wisconsin 53092

ABSTRACT
Epidemiologic investigation of a new incidence of
transmissible mink encephalopathy (TME) in Stetsonville, Wisconsin
suggests that the disease may have resulted from feeding infected
cattle to mink. This observation is supported by the transmission of
a TME-like disease to experimentally inoculated cattle, and by the
recent report of a new bovine spongiform encephalopathy in
England.

INTRODUCTION

Transmissible mink encephalopathy (TME) was first reported in 1965 by Hartsough
and Burger who demonstrated that the disease was transmissible with a long incubation
period, and that affected mink had a spongiform encephalopathy similar to that found in
scrapie-affecied sheep (Hartsough and Burger, 1965; Burger and Hartsough, 1965).
Because of the similarity between TME and scrapie, and the subsequent finding that the
two transmissible agents were indistinguishable (Marsh and Hanson, 1969), it was
concluded that TME most likely resulted from feeding mink scrapie-infecied sheep.
The experimental transmission of sheep scrapie to mink (Hanson et al., 1971)
confirmed the close association of TME and scrapie, but at the same time provided
evidence that they may be different. Epidemiologic studies on previous incidences of
TME indicated that the incubation periods in field cases were between six months and
one year in length (Harxsough and Burger, 1965). Experimentally, scrapie could not be
transmitted to mink in less than one year.
To investigate the possibility that TME may be caused by a (particular strain of
scrapie which might be highly pathogenic for mink, 21 different strains of the scrapie
agent, including their sheep or goat sources, were inoculated into a total of 61 mink.
Only one mink developed a progressive neurologic disease after an incubation period of
22 mon..s (Marsh and Hanson, 1979). These results indicated that TME was either caused
by a strain of sheep scrapie not yet tested, or was due to exposure to a scrapie-like agent
from an unidentified source.


OBSERVATIONS AND RESULTS

A New Incidence of TME. In April of 1985, a mink rancher in Stetsonville, Wisconsin
reported that many of his mink were "acting funny", and some had died. At this time, we
visited the farm and found that approximately 10% of all adult mink were showing
typical signs of TME: insidious onset characterized by subtle behavioral changes, loss of
normal habits of cleanliness, deposition of droppings throughout the pen rather than in a
single area, hyperexcitability, difficulty in chewing and swallowing, and tails arched over
their _backs like squirrels. These signs were followed by progressive deterioration of
neurologic function beginning with locomoior incoordination, long periods of somnolence
in which the affected mink would stand motionless with its head in the corner of the
cage, complete debilitation, and death. Over the next 8-10 weeks, approximately 40% of
all the adult mink on the farm died from TME.
Since previous incidences of TME were associated with common or shared feeding
practices, we obtained a careful history of feed ingredients used over the past 12-18
months. The rancher was a "dead stock" feeder using mostly (>95%) downer or dead dairy
cattle and a few horses. Sheep had never been fed.

Experimental Transmission. The clinical diagnosis of TME was confirmed by
histopaihologic examination and by experimental transmission to mink after incubation
periods of four months. To investigate the possible involvement of cattle in this disease
cycle, two six-week old castrated Holstein bull calves were inoculated intracerebrally
with a brain suspension from affected mink. Each developed a fatal spongiform
encephalopathy after incubation periods of 18 and 19 months.

DISCUSSION
These findings suggest that TME may result from feeding mink infected cattle and
we have alerted bovine practitioners that there may exist an as yet unrecognized
scrapie-like disease of cattle in the United States (Marsh and Hartsough, 1986). A new
bovine spongiform encephalopathy has recently been reported in England (Wells et al.,
1987), and investigators are presently studying its transmissibility and possible
relationship to scrapie. Because this new bovine disease in England is characterized by
behavioral changes, hyperexcitability, and agressiveness, it is very likely it would be
confused with rabies in the United Stales and not be diagnosed. Presently, brains from
cattle in the United States which are suspected of rabies infection are only tested with
anti-rabies virus antibody and are not examined histopathologically for lesions of
spongiform encephalopathy.
We are presently pursuing additional studies to further examine the possible
involvement of cattle in the epidemiology of TME. One of these is the backpassage of
our experimental bovine encephalopathy to mink. Because (here are as yet no agent-
specific proteins or nucleic acids identified for these transmissible neuropathogens, one
means of distinguishing them is by animal passage and selection of the biotype which
grows best in a particular host. This procedure has been used to separate hamster-
adapted and mink-udapted TME agents (Marsh and Hanson, 1979). The intracerebral
backpassage of the experimental bovine agent resulted in incubations of only four months
indicating no de-adaptation of the Stetsonville agent for mink after bovine passage.
Mink fed infected bovine brain remain normal after six months. It will be essential to
demonstrate oral transmission fiom bovine to mink it this proposed epidemiologic
association is to be confirmed.

ACKNOWLEDGEMENTS
These studies were supported by the College of Agricultural and Life Sciences,
University of Wisconsin-Madison and by a grant (85-CRCR-1-1812) from the United
States Department of Agriculture. The authors also wish to acknowledge the help and
encouragement of Robert Hanson who died during the course of these investigations.

REFERENCES
Burger, D. and Hartsough, G.R. 1965. Encephalopathy of mink. II. Experimental and
natural transmission. J. Infec. Dis. 115:393-399.
Hanson, R.P., Eckroade, R.3., Marsh, R.F., ZuRhein, C.M., Kanitz, C.L. and Gustatson,
D.P. 1971. Susceptibility of mink to sheep scrapie. Science 172:859-861.
Hansough, G.R. and Burger, D. 1965. Encephalopathy of mink. I. Epizoociologic and
clinical observations. 3. Infec. Dis. 115:387-392.
Marsh, R.F. and Hanson, R.P. 1969. Physical and chemical properties of the
transmissible mink encephalopathy agent. 3. ViroL 3:176-180.
Marsh, R.F. and Hanson, R.P. 1979. On the origin of transmissible mink
encephalopathy. In Hadlow, W.J. and Prusiner, S.P. (eds.) Slow transmissible
diseases of the nervous system. Vol. 1, Academic Press, New York, pp 451-460.
Marsh, R.F. and Hartsough, G.R. 1986. Is there a scrapie-like disease in cattle?
Proceedings of the Seventh Annual Western Conference for Food Animal Veterinary
Medicine. University of Arizona, pp 20.
Wells, G.A.H., Scott, A.C., Johnson, C.T., Cunning, R.F., Hancock, R.D., Jeffrey, M.,
Dawson, M. and Bradley, R. 1987. A novel progressive spongiform encephalopathy
in cattle. Vet. Rec. 121:419-420.

MARSH

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf


Greetings,


SO, the already terribly flawwed OIE BSE surveillance system is too burdensome for trade.
Aint that just too bad. SO, they decide to make it even weaker. The damn thing never worked
anyway. ALL one has to do is look at the documented BSE Countries that went by it. Did them
a lot of good.

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 has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they should do everyone a favor and dissolve there organization. With Science like this, Japan would be fully justified in declining to be a member. ...


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

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


http://www.fsis.usda.gov/OPPDE/Comments/20...2006-0011-1.pdf

WE all know OIE caved into USDA BSE demands of a MRR region, which is nothing more than a legal tool to trade all strains of TSE globally. So for the US to ask the OIE for BSE status is a hoot. WE all know what the status is, it is BSE GBR III and should be BSE GBR IV due to the lies, cover-up, and terribly flawed June 2004 enhanced BSE Surveillance program. ...


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

Report
Summary
Summary of the Scientific Report

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

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

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

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


Publication date: 20 August 2004


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

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


[Last updated 08 September 2004]
[Publication Date 20 August 2004]


http://www.efsa.europa.eu/en/science/tse_a...sments/573.html

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


http://www.fsis.usda.gov/OPPDE/Comments/20...2006-0011-1.pdf


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

http://www.fda.gov/ohrms/dockets/dockets/0...34-01-vol45.pdf


http://www.fda.gov/ohrms/dockets/dockets/0...00490-vol40.pdf


THE SEVEN 1/2 SCIENTIST REPORT *** ;-)


http://www.fda.gov/ohrms/dockets/dockets/0...44-Attach-1.pdf


https://web01.aphis.usda.gov/regpublic.nsf/...8d?OpenDocument


http://www.fda.gov/ohrms/dockets/dockets/0...83-01-vol35.pdf


Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/...8d?OpenDocument

03-025IF 03-025IF-631 Linda A. Detwiler [PDF]


http://www.fsis.usda.gov/OPPDE/Comments/03...3-025IF-631.pdf

Specified Risk Materials (SRMs)

I am in full support of the interim final rule which prohibits SRMs from

being included in food for human consumption. In addition to the list of

tissues published in this rule, I am requesting that additional tissues be

added to the list. These would include dura

("sheath") covering the spinal cord and the ENTIRE INTESTINE (from pylorus

to rectum). The scientific justification is provided below. THESE SRMs

should also be prohibited from ANY FDA regulated food or product intended

for human consumption, including but not limited to flavorings, extracts,

etc. ...

Dr. Linda Detwiler comments in full;


http://www.fsis.usda.gov/OPPDE/Comments/03...3-025IF-634.pdf

sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken.

MOST countries that went by these OIE guidelines all eventually went down with BSE. ...TSS


http://www.oie.int/downld/SC/2005/bse_2005.pdf

THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures.

IF they are not going to be science based, they should do everyone a favor and dissolve there organization. ...

WHAT ABOUT RISK FACTORS TO OUR EXPORTING/IMPORTING PARTNERS FROM ALL OTHER TSEs IN THE USA, WITH RELATIONS TO SRMs ???


a.. BSE OIE

see full text ;


http://p079.ezboard.com/fwolftracksproduct...picID=470.topic

http://blogs.nature.com/news/blog/2006/06/...an_incubat.html

MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA, MS, AL, GA, AND TN 11,000+ TONS


Date: August 16, 2006 at 9:19 am PST


http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html

MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67


http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html


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

#################### https://lists.aegee.org/bse-l.html ####################


THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they should do everyone a favor and dissolve there organization. ...

WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ???

a.. BSE OIE

see full text ;

http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic

IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence of these agencies are so inept, either through ignorance and or just too overweight with industry reps., they then should be all done away with and a single agency brought forth, and if not, how will you correct this ongoing problem ?

Thank you,
I am sincerely disgusted,

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



http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf


http://blogs.nature.com/news/blog/2006/06/cjdrelated_disease_can_incubat.html


http://www.scienceblog.com/cms/comment/reply/10204/1969



THINK ABOUT IT PLEASE, JUST FOR ONE MINUTE, ALL THAT HAS BOASTED ABOUT GOING BY THOSE SAME O.I.E. BSE SAFEGUARDS ALL THESE YEARS, MOST ALL HAVE GONE DOWN WITH BSE, SO WHAT DOES THAT TELL YOU ???


it tells me that the O.I.E. BSE safeguards are terribly flawed.........terry


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






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