OIE UPDATE BOVINE SPONGIFORM ENCEPHALOPATHY UNITED STATES OF AMERICA MAY
15, 2012
Information received on 15/05/2012 from Dr John Clifford, Deputy
Administrator, Animal and Plant Health Inspection Service, United States
Department of Agriculture, Washington, United States of America
Summary
Report type Follow-up report No. 1 Start date 19/04/2012 Date of first
confirmation of the event 23/04/2012 Report date 15/05/2012 Date submitted to
OIE 15/05/2012 Reason for notification Reoccurrence of a listed disease Date of
previous occurrence 2006 Manifestation of disease Sub-clinical infection Causal
agent Prion (atypical BSE) Nature of diagnosis Laboratory (advanced) This event
pertains to the whole country Related reports Immediate notification
(26/04/2012) Follow-up report No. 1 (15/05/2012) Outbreaks There are no new
outbreaks in this report
Epidemiology Source of the outbreak(s) or origin of infection Unknown or
inconclusive Random mutation Epidemiological comments As part of the United
States targeted bovine spongiform encephalopathy (BSE) surveillance system a
case of BSE classified as atypical was identified in a dead dairy cow that was
to be rendered. The dead animal’s carcass was placed in a secure hazardous waste
disposal site. • The cow was culled due to lameness. • The identified animal was
never presented for slaughter for human consumption, did not enter food supply
channels, and at no time presented any risk to human health. • A comprehensive
epidemiological investigation into the incident continues to be conducted.
Further epidemiological investigation of the incident has shown that: - The cow
was born on the index premises. - Two progeny have been identified – one born in
the last 2 years, was stillborn, and another, still living, was humanely
euthanized, and tested and found to be negative for BSE. - Investigation of the
feed records at the index dairy premises has found no anomalies, and audits of
all the feed suppliers to the index premises have shown them to be in compliance
with the regulations.
Control measures Measures applied Quarantine Screening No vaccination No
treatment of affected animals Measures to be applied No other measures
Future Reporting The event is continuing. Weekly follow-up reports will be
submitted.
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
###
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTERS JULY 20, 2004 USA Date: Tue, 20
Jul 2004 09:14:11 -0500 From: "Terry S. Singeltary Sr." Reply-To: Bovine
Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS
Public Health Service Food and Drug Administration
San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070
Telephone: 510/337-6700
VIA HAND DELIVERY
Our Reference No. 1000123954
June 23, 2004
Ronald M. Foster, Manager Randall C. Boyce, Manager Trevor O. Foster,
Manager George P. Foster, Manager Fresno Farming LLC P.O. Box 457 1000 Davis
Street Livingston, California
WARNING LETTER
Dear Mssrs. Foster, Boyce, Foster, and Foster:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your
medicated animal feed mill operation, Fresco Farming LLC, located in Traver,
California from April 14, 2004 through May 6, 2004, and found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal Proteins Prohibited
in Ruminant Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to
follow this rule, products you manufactured and distributed are adulterated
within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic
Act (the Act) because they were prepared, packed, or held under insanitary
conditions whereby they may have been rendered injurious to health.
Our inspection found the following violations of 21 C.F.R. 589.2000:
1. Failure to provide for measures to avoid commingling or
cross-contamination of products that contain or may contain protein derived from
mammalian tissues into animal protein or feeds that may be used for ruminants to
comply with 21 C.F.R. 589.2000(e)(1)(iii).
* Your firm uses a vacuum system to clean up spilled product in the tunnel
area. This tunnel area houses the two receiving conveyor systems and the
elevators for the two conveyor systems. When product, including ruminant meat
and bone meal, is spilled onto the floor of this area, the spilled product is
vacuumed up by the vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant meat and bone
meal. Your firm admitted that it was unaware of the vacuum system discharging
into the conveyor systems designated as free of ruminant meat and bone meal and
that this had been in place since April 2003. Your firm remedied this problem
during FDA s April/May 2004 inspection by removing the discharge hose connection
to the conveyer system that your firm had designated as free of ruminant meat
and bone meal .
* Your firm uses a dust collection system that pulls dust from systems that
receive both ruminant meat and bone meal and feed ingredients intended for
ruminants. This dust system then discharged collected product back into the two
conveyor systems via a cross connection, thereby making it likely that ruminant
meat and bone meal became commingled with ruminant feed ingredients. Your firm
admitted that it was unaware of the cross connection and that it had been in
place since April 2003. Your firm removed the cross connection during FDA s
April/May 2004 inspection.
2. Failure to maintain written procedures specifying the clean-out
procedure or other means, and specifying the procedures for separating products
that contain or may contain protein derived from mammalian tissue from all other
protein products from the time of receipt until the time of shipment, to comply
with 21 C.F.R. 589.2000(e)(1)(iv). This observation was also noted during FDA s
July/August 2003 inspection of your firm.
* There are no written procedures for separating products that contain
prohibited material from ingredients used in ruminant feeds from the time of
receipt until the time of shipment.
* The written procedure for cleaning out or flushing equipment after mixing
feeds containing prohibited material was not adequate to prevent contamination
of ruminant feed with prohibited material.
3. Failure to maintain records sufficient to track materials that contain
protein derived from mammalian tissues throughout their receipt, processing, and
distribution to comply with 21 C.F.R. 589.2000(e)(1)(i). This observation was
also noted during FDA s July/August 2003 inspection of your firm.
* Specifically, your firm has failed to develop and implement complete
written procedures to separate ruminant meat and bone meal from feed ingredients
intended for ruminants from the time of receipt until the time of distribution.
The written procedures that do exist fail to address the use of equipment common
to ruminant meat and bone meal and ruminant feed ingredients.
The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for use as animal feed,
you are responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby such violations do not recur. Failure to promptly correct these
violations may result in regulatory action without further notice, such as
seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of receiving this letter of the steps you have taken to bring your firm into
compliance with the law. Your response should include an explanation of each
step being taken to correct the violations and prevent their recurrence. If
corrective actions cannot be completed in fifteen (15) working days, state the
reason for the delay and the date by which the corrections will be completed.
Include copies of any available documentation demonstrating that corrections
have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention:
Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay Parkway, Alameda,
California 94502-7070. If you have questions regarding this letter, please
contact Ms. Kishida at (510) 337-6824.
Sincerely,
/s/
CD Moss, Acting DD for Barbara J. Cassens District Director San Francisco
District
cc:
VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED C. Michael Blasco, Feed Mill
Manager Fresno Farming LLC P.O. Box 430 Traver, California 93673
Surveillance for BSE in California
Surveillance for BSE began in 1990. California collected 560 samples in
2001 and approximately 2,000 in 2002 and in 2003. The US sampled 20,543 cattle
in 2003 - a sample size designed to detect BSE if it occurred in 1 animal per
million adult cattle with a 95% confidence rate. This sample size is more that
47 times the international standard for countries with a “low risk” of
BSE.
California is working with the USDA and the cattle industry to determine
the best way to enhance BSE surveillance and test as many “high-risk” cattle as
possible for 12-18 months. Brain samples will be collected from cattle over 30
months of age that are:
Non-ambulatory (cannot rise or cannot walk)
Showing neurological signs
Condemned, euthanized or died following signs that may be associated with
BSE
Dead from unknown cause.
In addition, a random sample of apparently healthy aged cattle will be
sampled at California slaughter facilities.
Sample Tests
There are no tests that detect BSE in live animals. Current tests look for
the abnormal prion protein in the brain. Two rapid screening tests have recently
been licensed for use in the US; Bio-Rad Laboratories rapid TeSeE® test and
Idexx HerdChek(R) BSE Antigen Test Kit.
Sensitive screening tests may give false positive results - samples
positive to these BSE screening tests will be sent for further confirmatory
testing at the national reference laboratory.
P.4.23
Transmission of atypical BSE in humanized mouse models
Liuting Qing1, Wenquan Zou1, Cristina Casalone2, Martin Groschup3, Miroslaw
Polak4, Maria Caramelli2, Pierluigi Gambetti1, Juergen Richt5, Qingzhong Kong1
1Case Western Reserve University, USA; 2Instituto Zooprofilattico Sperimentale,
Italy; 3Friedrich-Loeffler-Institut, Germany; 4National Veterinary Research
Institute, Poland; 5Kansas State University (Previously at USDA National Animal
Disease Center), USA
Background: Classical BSE is a world-wide prion disease in cattle, and the
classical BSE strain (BSE-C) has led to over 200 cases of clinical human
infection (variant CJD). Atypical BSE cases have been discovered in three
continents since 2004; they include the L-type (also named BASE), the H-type,
and the first reported case of naturally occurring BSE with mutated bovine PRNP
(termed BSE-M). The public health risks posed by atypical BSE were largely
undefined.
Objectives: To investigate these atypical BSE types in terms of their
transmissibility and phenotypes in humanized mice. Methods: Transgenic mice
expressing human PrP were inoculated with several classical (C-type) and
atypical (L-, H-, or Mtype) BSE isolates, and the transmission rate, incubation
time, characteristics and distribution of PrPSc, symptoms, and histopathology
were or will be examined and compared.
Results: Sixty percent of BASE-inoculated humanized mice became infected
with minimal spongiosis and an average incubation time of 20-22 months, whereas
only one of the C-type BSE-inoculated mice developed prion disease after more
than 2 years. Protease-resistant PrPSc in BASE-infected humanized Tg mouse
brains was biochemically different from bovine BASE or sCJD. PrPSc was also
detected in the spleen of 22% of BASE-infected humanized mice, but not in those
infected with sCJD. Secondary transmission of BASE in the humanized mice led to
a small reduction in incubation time.*** The atypical BSE-H strain is also
transmissible with distinct phenotypes in the humanized mice, but no BSE-M
transmission has been observed so far.
Discussion: Our results demonstrate that BASE is more virulent than
classical BSE, has a lymphotropic phenotype, and displays a modest transmission
barrier in our humanized mice. BSE-H is also transmissible in our humanized Tg
mice. The possibility of more than two atypical BSE strains will be discussed.
Supported by NINDS NS052319, NIA AG14359, and NIH AI 77774.
MAD COW USDA ATYPICAL L-TYPE BASE BSE, the rest of the story...
***Oral Transmission of L-type Bovine Spongiform Encephalopathy in Primate
Model
***Infectivity in skeletal muscle of BASE-infected cattle
***feedstuffs- It also suggests a similar cause or source for atypical BSE
in these countries.
***Also, a link is suspected between atypical BSE and some apparently
sporadic cases of Creutzfeldt-Jakob disease in humans.
full text ;
atypical L-type BASE BSE
Tuesday, May 1, 2012
BSE MAD COW LETTERS TO USDA (Tom Vilsack, Secretary of Agriculture) and FDA
(Magaret Hamburg, Commissioner of FDA) May 1, 2012
Wednesday, May 2, 2012
ARS FLIP FLOPS ON SRM REMOVAL FOR ATYPICAL L-TYPE BASE BSE RISK HUMAN AND
ANIMAL HEALTH
Friday, May 4, 2012
May 2, 2012: Update from APHIS Regarding a Detection of Bovine Spongiform
Encephalopathy (BSE) in the United States
Sunday, March 11, 2012
APHIS Proposes New Bovine Spongiform Encephalopathy Import Regulations in
Line with International Animal Health Standards Proposal Aims to Ensure Health
of the U.S. Beef Herd, Assist in Negotiations
Wednesday, April 4, 2012
Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine
Products APHIS-2008-0010-0008 RIN:0579-AC68
Sunday, May 6, 2012
Bovine Spongiform Encephalopathy Mad Cow Disease, BSE May 2, 2012 IOWA
State University OIE
SPONTANEOUS ??? NOT...
How the California cow got the disease remains unknown. Government
officials expressed confidence that contaminated food was not the source, saying
the animal had atypical L-type BSE, a rare variant not generally associated with
an animal consuming infected feed.
However, a BSE expert said that consumption of infected material is the
only known way that cattle get the disease under natural conditons.
“In view of what we know about BSE after almost 20 years experience,
contaminated feed has been the source of the epidemic,” said Paul Brown, a
scientist retired from the National Institute of Neurological Diseases and
Stroke.
BSE is not caused by a microbe. It is caused by the misfolding of the
so-called “prion protein” that is a normal constituent of brain and other
tissues. If a diseased version of the protein enters the brain somehow, it can
slowly cause all the normal versions to become misfolded.
It is possible the disease could arise spontaneously, though such an event
has never been recorded, Brown said.
Friday, May 11, 2012
Experimental H-type bovine spongiform encephalopathy characterized by
plaques and glial- and stellate-type prion protein deposits
In addition, the present data will support risk assessments in some
peripheral tissues derived from cattle affected with H-type BSE.
Wednesday, May 16, 2012
Independent experts should be kept from undue suspicion as well as undue
influence
IN REPLY TO ;
TSS
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.