Wednesday, May 16, 2012

OIE UPDATE BOVINE SPONGIFORM ENCEPHALOPATHY UNITED STATES OF AMERICA MAY 15, 2012

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


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-------- 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


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