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From: TSS ()
In Reply to: Re: INTERVIEW - Mad Cow DNA May Offer Clues to Latest US Case posted by TSS on June 19, 2005 at 8:43 pm:
##################### Bovine Spongiform Encephalopathy ##################### USDA SPONTANEOUS EVENTS OF PURE BSe with transmission studies FDA Statement Statement on Texas Cow With Central Nervous System Symptoms FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse. FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA. Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison). FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs. To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle. Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry. FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger. #### http://www.fda.gov/bbs/topics/news/2004/NEW01061.html Agriculture News http://www.agriculture.com/worldwide/IDS/2004-05-06T210235Z_01_N067970_RTRIDST_0_MADCOW-TEXAS.html By Richard Cowan WASHINGTON, May 6 (Reuters) - The head of the U.S. Food and Drug Administration on Thursday noted a possible link between a condemned cow in Texas and eight-year-old animal feed that was not protected against mad cow disease. The U.S. Department of Agriculture on Monday acknowledged it erred in failing to test a cow for the brain-wasting disease when it arrived at a south-central Texas slaughterhouse possibly exhibiting a central nervous system disorder. While beef from the 12-year-old cow never entered the human food supply, USDA's mistake came as the government has vowed to toughen surveillance and testing for mad cow disease. The extra surveillance is an important step toward restoring about $4 billion in beef exports that were wiped out by the discovery of mad cow disease in a Washington state animal four months ago. Acting FDA Commissioner Lester Crawford was asked by reporters whether his agency had found any problems with feed currently on the San Angelo, Texas, farm where the condemned cow lived its entire life. He responded that the farm has never been found in violation of animal feed rules, but added that the cow was so old that it would have consumed feed a long time ago that was not covered by newer regulations. "The feed that was fed to this animal would have been probably eight years ago," said Acting FDA Commissioner Lester Crawford, an expert on veterinary medicine. Prior to 1997, cattle feed was allowed to contain bits of slaughtered cattle. An outbreak of mad cow disease in Europe in the 1980s, which still plagues the European Union, led to U.S. prohibitions in 1997 on feeding cattle parts to live cattle. Experts agree the ruminant feed ban is the most important defense against mad cow disease. "The cow was 12 years old. The feed ban has only been in place for seven years," Crawford said after speaking to a consumer safety group. USDA officials on Wednesday said they hope to wrap up an internal investigation by the end of the week into why the condemned cow's carcass was rendered without being testing for mad cow disease. Mad cow disease has been linked to a human variant blamed for 140 deaths in Europe. Crawford said FDA took control of 200,000 pounds of rendered cattle meat and bone meal that could have contained parts of the condemned Texas cow because, "Now it's clear that we have BSE in this country and that allegedly the cow was exhibiting neurological signs." Asked why it was clear there was mad cow disease in the United States, Crawford said he was referring to the Washington state cow, which was born in Canada. Officials have given mixed signals on whether the USDA is broadening its probe related to the condemned Texas cow. On Wednesday, Peter Fernandez, associate administrator of USDA's Animal Plant and Health Inspection Service, said his agency was "looking into where this animal came from and any of the possibilities that it might pose a risk." However, he refused to detail the agency's activities related to the San Angelo farm and referred questions to the Texas Animal Health Commission. Officials at that state agency referred all questions to USDA on Thursday. FDA, which regulates animal feed, is expected to propose later this month its long-awaited rules to prohibit cattle blood and poultry litter from cattle feed, Crawford said. ================================ NOW, WHAT DO WE FEED OUR TEXAS COWS ??? FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT Today the Food and Drug Administration announced the results of tests FDA has determined that each animal could have consumed, at most and in It is important to note that the prohibited material was domestic in According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Despite this negligible risk, Purina Mills, Inc., is nonetheless FDA believes that Purina Mills has behaved responsibly by first This episode indicates that the multi-layered safeguard system put into FDA will continue working with USDA as well as State and local officials http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html WHAT ABOUT 2005??? ##################### Bovine Spongiform Encephalopathy ##################### Public Health Service January 12, 2005 Ref: 2005-DAL-WL-11 WARNING LETTER CERTIFIED MAIL Mr. William L. Brown, Owner Dear Mr. Brown: An inspection of your ruminant feeding operation located at 1 Feed Lot Road, Petrolia, Texas, was conducted on August 24 and September 8, 2004 by an Investigator from the Food and Drug Administration (FDA). The inspection found significant deviations from Our inspection revealed that you feed prohibited material, as defined by 21 CFR 598.2000(a), to ruminants. This prohibited material consists of human food processing waste, which is derived from corn dog manufacturing and contains hot dogs and corn dogs. Inspected meat products that have been cooked and offered for human food and further heat processed for animal feed are not prohibited material. This is more fully described in Guidance for Industry 76, which was previously provided to your firm. The human food processing waste you are using has not been further heat processed. The failure to further heat process this material causes the feed to be adulterated within the meaning of Section 402(a)(2)(C)(i) of the Federal, Food, Drug, and Cosmetic Act. During our previous inspection on January 17, 2002, copies of the BSE Guidance documents 69, 70 and 76 and 21 CFR 589.2000, the BSE regulation, were provided to and discussed with you. Failure to correct these violations may result in FDA taking regulatory action without further notice including, but not limited to, seizure and/or injunction. It is necessary for you to take action on this matter now. Please notify this office in writing within fifteen (15) working days from the date you received this letter. Your response should specifically identify the actions you are taking to correct the violations and provide specific timeframes for achieving compliance. Also, as part of your written response, you should provide information regarding the current feeding practices followed at your facility and information pertaining to the planned marketing of your animals. Your reply should be sent to Edwin Ramos, Compliance Officer, at the above stated address. If you have any questions concerning the stated matters, you may contact Mr. Ramos at 214-253-5218. Sincerely, /s/ Michael A. Chappell Dallas District Director http://www.fda.gov/foi/warning_letters/g5175d.htm TSS ######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ########## Public Health Service Dallas District Ref: 2005-DAL-WL-12 WARNING LETTER CERTIFIED MAIL Mr. Dwayne Woody, Owner Dear Mr. Woody: An inspection of your feed manufacturing operation located at 6391 Old Agnes Road, Poolville, Texas, was conducted on August 27 and September 2, 2004 by an Investigator from the Food and Drug Administration (FDA). The inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, the corn dogs containing cooked meat and other ingredients used for manufacturing ruminant feed are adulterated within the meaning of Section 402(a)(2)(C)(i) and misbranded within the meaning of Section 403(a)(1) of the Federal, Food, Drug and Cosmetic Act (the Act). The use of protein derived from mammalian tissues, as defined in 21 CFR 589.2000(a)(1), as an animal feed ingredient or in animal feeds must comply with the requirements of 21 CFR 589.2000. That regulation provides that the use of protein derived from mammalian tissues in ruminant feed is prohibited. The definition of “protein derived from mammalian tissues” excludes inspected meat products which have been cooked and offered for human food, such as the corn dogs you receive, that have been further heat processed for use in animal feed. This requirement was previously communicated to you in an April 3, 2001 letter from the Texas State Feed and Fertilizer Control Service. In the absence of the required further heat processing, such products for use in ruminant feeds are adulterated under Section 402(a)(2)(C)(i) of the Act. Our inspection revealed that whole corn dogs which contain protein derived from mammalian tissues and are sold by your firm to the [redacted] for use in ruminant feed are not subjected to further adulterated feed under Section 402(a)(2)(C)(i) of the Act. In addition, because the whole corn dogs are not subjected to further heat processing and are thus not exempt from the regulation, they must bear the caution statement, “Do not feed to cattle or other ruminants.” Our inspection revealed that they do not bear this caution statement, which causes them to be misbranded animal feed under Section 403(a)(1) of the Act. Copies of the BSE Guidance documents 69, 70 and 76 were provided to Mr. Billy J. Brooks, General Manager, and further discussed by personnel from the Texas Feed and Fertilizer Control Service. Also, you received a copy of the 21 CFR 589.2000, the BSE regulation which was again explained in more specific detail. These serious violations of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizure and/or a court injunction against further sale of protein derived from mammalian tissues for use in ruminant feed or ruminant feed containing such materials. It is necessary for you to take action on this matter now. Please notify this office in writing within fifteen (15) working days from the date you received this letter. Your response should specifically identify the actions you are taking to correct the violations that would involve the continued use of corn dogs to manufacture ruminant feed and provide specific timeframes for achieving compliance. Your reply should be sent to Edwin Ramos, Compliance Officer, at the above stated address. If you have any questions concerning the stated matters, you may contact Mr. Ramos at 214-253-5218. Sincerely, Michael A. Chappell http://www.fda.gov/foi/warning_letters/g5184d.htm TSS ######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ########## ######## Bovine Spongiform Encephalopathy ######### RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II _______________________________ PRODUCT a) Bulk whole corn. Recall # V-150-4; CODE No coding information is used. RECALLING FIRM/MANUFACTURER Fresno Farming LlC, Traver, CA, by letters on June 30, 2004. Firm REASON VOLUME OF PRODUCT IN COMMERCE DISTRIBUTION http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html DISTRIBUTION ######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ########## TSS W.H.O. Dr Maura Ricketts BSE/TSE .1 GRAM LETHAL realplayer audio Terry S. Singeltary Sr. wrote: > ##################### Bovine Spongiform Encephalopathy http://www.vegsource.com/talk/madcow/messages/93949.html 1: J Infect Dis 1980 Aug;142(2):205-8 Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates. Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC. Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation. PMID: 6997404 Transmission of human spongiform encephalopathies to experimental animals: comparison of the chimpanzee and squirrel monkey. Asher DM, Gibbs CJ Jr, Sulima MP, Bacote A, Amyx H, Gajdusek DC. Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, MD 20992. The agents of kuru and Creutzfeldt-Jakob disease have been consistently transmitted from patients with those diseases to chimpanzees and squirrel monkeys, as well as to other new-world primates, with average incubation periods of two or three years. No other animals have been found so consistently susceptible to the agents in human tissues. More rapid and convenient assays for the infectious agents would greatly facilitate research on the spongiform encephalopathies of humans. PMID: 8270119 [PubMed - indexed for MEDLINE] 1: J Med Primatol. 1976;5(4):205-9. Masters CL, Alpers MP, Gajdusek DC, Gibbs CJ Jr, Kakulas BA. The experimental host range for the slow virus infections causing subacute spongiform virus encephalopathies is enlarged in primates to include the gibbon for kuru, the pigtailed macaque for Creutzfeldt-Jakob disease, and the sooty mangabey for both diseases. The report is based on neuropathological evidence of the diseases in animals with preclinical lesions. A table lists all the species to which the subacute spongiform virus encephalopathies have been transmitted. PMID: 826636 [PubMed - indexed for MEDLINE] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=826636 1: Brain. 1975 Dec;98(4):595-612. Experimental kuru in the spider monkey. Histopathological and ultrastructural studies of the brain during early stages of incubation. Beck E, Bak IJ, Christ JF, Gajdusek DC, Gibbs CJ Jr, Hassler R. The brains of 10 spider monkeys inoculated intracerebrally with brain suspension from kuru patients have been studied histologically and ultrastructurally. The animals were killed by perfusion of fixative from four to forty-one weeks after inoculation, when healthy and free of neurological signs. Definite histopathological changes had occurred as early as four weeks after inoculation, when moderate numbers of bi-nucleated neurons were found within the limbic cortex, striatum, the hypothalamus and amongst the Purkinje cells of the cerebellum. At later stages of incubation a moderate loss of neurons in the cerebral and cerebellar cortex and a mild to moderate proliferation of fibrous astrocytes here and also in the hypothalamus were the most striking features. None of our cases showed either status spongiosus or the generalized astrocytic proliferation and hypertrophy, characteristic of fully developed experimental kuru, in any region of the brain. The principal ultrastructural abnormalities consisted of the formation of membrane-bound intracytoplasmic vacuoles, predominantly within dendrites, and of concentric laminar arrays derived from the endoplasmic reticulum. The former were seen in all regions of the brain examined and at all stages of incubation. Concentric laminar arrays were confined to the cerebellar nodulus, where they were most numerous in dendrites and neuronal perikarya four weeks after inoculation. Both changes are interpreted as an indication that the kuru agent acts upon the plasma membrane from an early stage onwards and, by stimulating its growth, leads to the formation of complex, membrane-bounded vacuoles and to hyperplasia of the endoplasmic reticulum. The formation of vacuoles is further regarded as the first sign of status spongiosus on an ultrastructural level. Attention is drawn to the great similarities between the changes observed in the present material and those described in the brains of patients dying from kuru and of primates with fully developed experimental kuru. The significance of the relatively rapid spread of the kuru agent throughout the brain is discussed in relation to the concept of "slow virus" diseases. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=814967 1: Adv Neurol. 1975;10:291-317. Familial and sporadic chronic neurological degenerative disorders transmitted from man to primates. Gajdusek DC, Gibbs CJ Jr. PMID: 125030 [PubMed - indexed for MEDLINE] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=125030 1: Intervirology. 1974;2(1):14-9. Transmission of kuru and Creutzfeldt-Jakob disease to marmoset monkeys. Peterson DA, Wolfe LG, Deinhardt F, Gajdusek DC, Gibbs CJ Jr. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=4207302 Gajdusek DC, Gibbs CJ Jr. Gajdusek DC, Rogers NG, Basnight M, Gibbs CJ Jr, Alpers M. 1: Ann N Y Acad Sci. 1969 Jul 3;162(1):529-50. Transmission experiments with kuru in chimpanzees and the isolation of latent viruses from the explanted tissues of affected animals. Gajdusek DC, Rogers NG, Basnight M, Gibbs CJ Jr, Alpers M. PMID: 5257421 [PubMed - indexed for MEDLINE] 53: Beck E, Daniel PM, Alpers M, Gajdusek DC, Gibbs CJ Jr. 1: J Neurol Neurosurg Psychiatry 1994 Jun;57(6):757-8 Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery. Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC. Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892. Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them. PMID: 8006664 [PubMed - indexed for MEDLINE] 07/11/2004 09:34 PM fdadockets@oc.fda.gov cc: regulations@aphis.usda.gov, burt.pritchett@fda.gov bcc: Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW No. 04-047-l No. 04-021ANPR No. 2004N-0264 NEW BSE SAFEGUARDS Federal Measures to Mitigate BSE Risks: Considerations for Further Action http://www.fda.gov/cvm/index/updates/bseanprm.htm Greetings FDA, USDA and APHIS et al, I would kindly like to comment on the continued delay of the regulations CWD and Scrapie have been running rampant in the USA for decades. Strong Scientific evidence discovered Congressman Henry Waxmans Letter to the Honorable Ann Veneman USA BSE RED BOOK > October 1998 > 7.2.1.7 Laboratory Coordination--The Laboratory Coordination Officer > BSE Red Book 2.1-39 > BSE Red Book 2.1-40 > 7.7.3 Rendering snip... > 7.10.11 Prevention--Suspects and animals confirmed to have BSE must not USDA/APHIS ET AL MUST GET BSE/TSE TESTING DONE CORRECTLY THE recent findings of positive 'inconclusives' that turned up negative Diagnosis: A. Laboratory where diagnosis was made: Institute of Animal Neurology, B. Diagnostic tests used: - histology; - immunohistochemistry; - ELISA (two different kits); - western blot. All tests gave positive results. Subject: WHY is the UK not going to verify the findings of BSE/TSE in tissue samples I think that having several different rapid TSE test kits (Prionics, Bio-Rad etc.) snip... FULL TEXT ; https://web01.aphis.usda.gov/regpublic.nsf/ 0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument TSS #################### https://lists.aegee.org/bse-l.html ####################
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