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From: TSS ()
June 20, 2005 June 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, here called the Ruminant Feed Ban , became effective on August 4, 1997. This is an update on FDA enforcement activities regarding the ruminant feed regulation. FDA's CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA's inspection database as of June 11, 2005. As of June 11, 2005, FDA had received over 37,000 inspection reports. The majority of these inspections (around 68%) were conducted by State officials under contract to FDA, with the remainder conducted by FDA officials. Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI). An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented. A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban. These include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds. An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions. The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive. RENDERERS These firms are the first to handle and process (i.e., render) animal proteins and to send these processed materials to feed mills and/or protein blenders for use as a feed ingredient. Number of active firms whose initial inspection has been reported to FDA – 263 Number of active firms handling materials prohibited from use in ruminant feed – 176 (67% of those active firms inspected) Of the 176 active firms handling prohibited materials, their most recent inspection revealed that: 2 firms (1.1%) were classified as OAI 8 firms (4.5%) were classified as VAI LICENSED FEED MILLS FDA licenses these feed mills to produce medicated feed products. The license is required to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time. This licensing has nothing to do with handling prohibited materials under the feed ban regulation. A medicated feed license from FDA is not required to handle materials prohibited under the Ruminant Feed Ban. Number of active firms whose initial inspection has been reported to FDA – 1,069 Number of active firms handling materials prohibited from use in ruminant feed – 411 (38% of those active firms inspected) Of the 411 active firms handling prohibited materials, their most recent inspection revealed that: 1 firm (0.2%) was classified as OAI 7 firms (1.7%) were classified as VAI FEED MILLS NOT LICENSED BY FDA These feed mills are not licensed by the FDA to produce medicated feeds. Number of active firms whose initial inspection has been reported to FDA – 5,145 Number of active firms handling materials prohibited from use in ruminant feed – 1,920 (37% of those active firms inspected) Of the 1,920 active firms handling prohibited materials, their most recent inspection revealed that: 2 firms (0.1%) were classified as OAI 27 firms (1.4%) were classified as VAI PROTEIN BLENDERS These firms blend rendered animal protein for the purpose of producing quality feed ingredients that will be used by feed mills. Number of active firms whose initial inspection has been reported to FDA -- 329 Number of active firms handling materials prohibited from use in ruminant feed – 117 (36% of those active firms inspected) Of the 117 active firms handling prohibited materials, their most recent inspection revealed that: 0 firms (0%) were classified as OAI 3 firms (2.6%) were classified as VAI RENDERERS, FEED MILLS, AND PROTEIN BLENDERS This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients. Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,550 Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 553 (8.4% of those active firms inspected) Of the 553 of active renderers, feed mills, and protein blenders processing with prohibited materials, their most recent inspection revealed that: 5 firms (0.9%) were classified as OAI 20 firms (3.6%) were classified as VAI OTHER FIRMS INSPECTED Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters. Number of active firms whose initial inspection has been reported to FDA – 12,575 Number of active firms handling materials prohibited from use in ruminant feed – 3,288 (26% of those active firms inspected) Of the 3,288 active firms handling prohibited materials, their most recent inspection revealed that: 8 firms (0.2%) were classified as OAI 90 firms (2.7%) were classified as VAI TOTAL FIRMS Note that a single firm can be reported under more than one firm category; therefore, the summation of the individual OAI/VAI firm categories will be more than the actual total number of OAI/VAI firms, as presented below. Number of active firms whose initial inspection has been reported to FDA – 15,676 Number of active firms handling materials prohibited from use in ruminant feed – 4,093 (26% of those active firms inspected) Of the 4,093 active firms handling prohibited materials, their most recent inspection revealed that: 10 firms (0.2%) were classified as OAI 98 firms (2.4%) were classified as VAI Issued by: http://www.fda.gov/cvm/bse0605.htm THOSE TRIPLE BSE MAD COW FIREWALLS are still leaking in June 2005. The 8/4/97 ruminant to ruminant feed ban was nothing more than ink on paper. Lets look at one year ago; Of the 3,444 active firms handling prohibited materials, their most recent inspection revealed that: 16 firms (0.5%) were classified as OAI 89 firms (2.6%) were classified as VAI http://www.fda.gov/cvm/bseup112304.htm BSE/TSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram THE TEXAS GONZALES/PURINA INCIDENT SHOWED THAT 5.5 GRAMS OF FOR IMMEDIATE RELEASE 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 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 Published online January 27, 2005 http://www.thelancet.com/journal/journal.isa 06/09/05 BSE Roundtable Discussion Transcript 2 Based on our scientific knowledge 3 of the disease, we have taken several key 4 steps, some of which have been in place for a 5 number of years to safeguard the health of US 6 livestock and our food supply against BSE. 7 And we are fortunate that Canada shares our 8 commitment and overall approach to dealing 9 with the disease by taking comparable and 10 effective measures consistent with our own. 11 This is especially important given that 12 historically the North American cattle 13 industry has been highly integrated. 14 In 1997, long before finding the 15 first native born case in North America, both 16 Canada and the United states implemented feed 17 regulations banning, with some exceptions, 18 the feeding of ruminant protein back to other 19 ruminants. This critical action has helped 20 prevent an outbreak similar to those seen in 21 countries where feed bans were instituted 22 only after BSE cases were identified. Expert Page 28 ~4525779.txt 23 risk analyses have repeatedly shown that if 24 BSE were introduced into the US herd, the 25 feed ban, even if not perfectly enforced, 30 1 would prevent the disease from becoming 2 established and spread in the United States. 3 Additional safeguards in place, 4 both in the United States and Canada include 5 comparable and effective import restrictions, 6 slaughter restrictions, the rendering process 7 and removal of specified risk materials from 8 the human food supply. Given these 9 safeguards and the fact that BSE can be 10 transmitted only under very specific 11 conditions and not through casual contact 12 between animals, the risk of BSE transmission 13 in the United States and Canada remains 14 extremely low. ... snip... http://www.aphis.usda.gov/lpa/issues/bse/BSE_roundtable_6_9_05.pdf Release No. 0066.05 >>> USDA assembled a team of technical experts that arrived in Canada on Jan. 24 to gather all relevant information to do an in-depth assessment on Canada's ruminant-to-ruminant feed ban and their feed ban inspection program. USDA took this additional step to ensure compliance with Canada's feed ban control measures. The feed ban has been determined to be an important BSE risk mitigation measure to protect animal health. The inspection team's report states that "Canada has a robust inspection program, that overall compliance with the feed ban is good and that the feed ban is reducing the risk of transmission of bovine spongiform encephalopathy in the Canadian cattle population." <<< http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2005/02/0066.xml HOLY MAD COW, this is like the blind leading the blind. the total lack of BSE protocol here again shows that the USDA/APHIS et al should NOT be giving any expert BSE advise to anyone. ...TSS [Overall BSE measures/firewalls] Are all SRMs properly removed? What is the procedure? How is SRM-removal and prevention of cross-contamination ensured? Feed ban: The United States claims that it has been implementing a ban on feeding mammalian proteins to ruminants since 1997, but it still is primarily a ruminant-to-ruminant feed ban. How can you prevent bovine-derived poultry feed, for example, from commingling with cattle feed? What was the rate of compliance of the U.S. feed ban in the initial stages of its implementation? What is A Maturity? What is vCJD? How many vCJD cases have been found in the United States? What about the alleged cases in New Jersey? Q6. The United States claims that it has been implementing a ban on feeding mammalian proteins to ruminants since 1997, but it still is primarily a ruminant-to-ruminant feed ban. How can you prevent bovine-derived poultry feed, for example, from commingling with cattle feed? A6. There is a scientific consensus that BSE cannot be transmitted through the use of mammalian origin meat-and-bone meal (MBM) tp swine, poultry, or other non-ruminant species. However, firms that handle or produce feed for ruminants and non-ruminants are required to have separate equipment or facilities or have an adequate cleanout process in order to prevent cross-contamination. The feed ban's restrictions on the use of mammalian protein apply only to its use in ruminant feed and not to feed for other species. Therefore, mammalian origin meat-and-bone meal (MBM) may be used in feed for swine, poultry, and other non-ruminant species. However, firms that handle material prohibited for ruminants (but allowed for non-ruminants) and also produce ruminant feed are required to have separate equipment or facilities or else have cleanout procedures adequate to prevent cross-contamination. This requirement applies to firms at all levels, from rendering to on-farm mixing. They also are required to clearly label prohibited material as not to be fed to ruminants. Guidance on preventing cross-contamination is available through FDA's Center for Veterinary Medicine. Q7. What was the rate of compliance of the U.S. feed ban in the initial stages of its implementation? A7. FDA initiated a feed ban in August 1997. Compliance rates for the first year showed higher than anticipated for a new program with 50-85 percent of the renderers and feed manufacturers in compliance with all aspects of the regulation. The majority of problems were minor, relating to noncompliance of simple documentation requirements as opposed to serious concerns such as the presence of prohibited material. As of July 2004, conditions or practices warranting regulatory sanctions had been found in less than one percent of inspected facilities. Inspection results are posted in a searchable online database. In August, 2005, the U.S. will have had an effective feed ban in place for 8 years, the time period recommended by OIE to effectively mitigate the spread or introduction of BSE within a domestic herd. Q14. A recent Government Accountability Office (GAO) report found that 19 percent of the feed industry has not been re-inspected in the past five years. How can the FDA ensure the Japanese people that U.S. cattle are not consuming meat-and-bone meal? A14. To maximize enforcement of the ruminant feed ban, FDA inspects firms (renderers, feed mills, etc.) considered to be of highest risk more frequently than low risk firms. High-risk firms are those which manufacture, or process feeds or feed ingredients containing prohibited meat-and-bone meal (which is allowed for non-ruminants). High-risk firms are inspected at least once every year to ensure their compliance with FDA requirements preventing cross contamination. Low risk firms are those that purchase feed or feed ingredients from high-risk firms, but do not further process or re-manufacture the feed or feed ingredients. For most of these firms there is no commercial handling of meat-and-bone meal since they are handling only packaged products like pet food. As a result, it would be highly unlikely that cattle would have access to any of these products. Once FDA has established through inspection that these firms do not manufacture or process feeds containing meat-and-bone meal, the frequency of re-inspection is reduced so that greater enforcement activities can be focused on the high-risk firms. The 19 percent of the feed industry cited in the GAO report consist entirely of low risk firms. snip... Q22. What is the U.S. response to the EU's classification of the U.S. as having a risk level III in its geographical bovine encephalopathy risk assessment (GBR)? A22. The U.S. has expressed its disappointment to the EU over this determination, which was based on unsubstantiated assumptions and uses worst-case scenarios without proper justification. In fact, we feel that the U.S. has learned many lessons over the past 15 years from GBR III countries with demonstrated risks (as in Europe). We used this information to develop a strong BSE control program that ensures that the risk to consumers in the U.S. is negligible. More specifically, we implemented BSE control measures such as an import ban and a feed ban long before the 1st case of BSE was discovered in Canada. As a result, despite extensive surveillance, BSE has never been disclosed in an animal born in the United States. Also the U.S. and Canada both implemented multiple BSE controls to prevent the spread of BSE in North America. That is why the U.S. has had no domestic cases of BSE except for one Canadian cow, and why Canada has had only 4 cases confined to a small geographical area. ... http://tokyo.usembassy.gov/e/p/tp-20050304-71.html#14 National Renderers Association Public Response to USDA-APHIS http://www.rendermagazine.com/news/USDA-ANPRDownersApendices.doc SCRAPIE USA UPDATE MAY 2005 SCRAPIE has increased drastically since the report i posted in March 2005, with additional case in a goat; SCRAPIE USA MONTHLY REPORT 2005 AS of March 31, 2005, there were 70 scrapie infected source flocks (Figure 3). There were 11 new infected and source flocks reported in March (Figure 4) with a total of 51 flocks reported for FY 2005 (Figure 5). The total infected and source flocks that have been released in FY 2005 are 39 (Figure 6), with 1 flock released in March. The ratio of infected and source flocks released to newly infected and source flocks for FY 2005 = 0.76 : 1. IN addition, as of March 31, 2005, 225 scrapie cases have been confirmed and reported by the National Veterinary Services Laboratories (NVSL), of which 53 were RSSS cases (Figure 7). This includes 57 newly confirmed cases in March 2005 (Figure 8). Fourteen cases of scrapie in goats have been reported since 1990 (Figure 9). The last goat cases was reported in January 2005. New infected flocks, source flocks, and flocks released or put on clean-up plans for FY 2005 are depicted in Figure 10. ... FULL TEXT ; http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.html SCRAPIE USA MAY 2005 AS OF MAY 31, 2005, there were 104 scrapie infected and source flocks (Figure 3). There were 20 new infected and source flocks reported in May (Figure 4) with a total of 104 flocks reported for FY 2005 (Figure 5). The total infected and source flocks that have been released in FY 2005 are 63 (Figure 6), with 16 flocks released in May. The ratio of infected and source flocks released to newly infected and source flocks for FY 2005 = 0.61 : 1. In addition, as of May 31, 2005, 367 scrapie cases have been confirmed and reported by the National Veterinary Services Laboratories (NVSL), of which 85 were RSSS cases (Figure 7). This includes 75 NEWLY confirmed cases in May 2005 (Figure 8). Fifteen cases of scrapie in goats have been reported since 1990 (Figure 9). The last goat case was reported in May 2005. ........ snip... http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.html CWD USA UPDATE http://www.aphis.usda.gov/vs/nahps/cwd/cwd-distribution.html Press Releases 5/9/2005: Negative Results for Chronic Wasting Disease in Captive Herd Learn More 5/4/2005: DEC Announces Sampling Results for Chronic Wasting Disease Learn More 4/29/2005: DEC Issues Emergency Regulations in Response to Discovery of Chronic Wasting Disease. Learn More 4/27/2005: Chronic Wasting Disease Found in Oneida County Deer. Learn More. 4/21/2005: DEC Releases Results of Tests for Chronic Wasting Disease. Learn More. 4/13/2005: DEC to Test For Chronic Wasting Disease in Hamilton County. Learn More. 4/8/2005: Chronic Wasting Disease Update: Test Results Reveal Three Additional Positives From Index Herd. Learn More. 4/5/2005: Chronic Wasting Disease Update. Learn More. 4/2/2005: Second Case of CWD Found in Oneida County Deer. Learn More. 3/31/2005: Positive Case of CWD Found in Oneida County Deer. Learn More. Transcript from March 31 Press Conference Regarding First Case of CWD in NewYork State If you have difficulty opening the PDF files, please contact the Department of Agriculture & Markets. http://www.agmkt.state.ny.us/AI/cwd.html TME USA UPDATE Transmissible Mink Encephalopathy February 2002 Transmissible mink encephalopathy (TME) is a rare illness that affects the central nervous system of ranch-raised mink. It was first detected in the United States in 1947. Since then, TME outbreaks have been reported in numerous locations worldwide, including the United States, Canada, Finland, Germany, and the republics of the former Soviet Union. Related Diseases Clinical Signs Diagnosis The 1985 Stetsonville Outbreak Evidence That Transmissible Mink Encephalopathy R.F. Marsh* and G.R. Hartsough •Department of Veterinary Science, University of Wisconsin-Madison, Madison, ABSTRACT INTRODUCTION Transmissible mink encephalopathy (TME) was first reported in 1965 by Hartsough OBSERVATIONS AND RESULTS A New Incidence of TME. In April of 1985, a mink rancher in Stetsonville, Wisconsin Experimental Transmission. The clinical diagnosis of TME was confirmed by DISCUSSION ACKNOWLEDGEMENTS REFERENCES MARSH http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf Title: Transmission of Transmissible Mink Encephalopathy (Tme) to Raccoons (Procyon Lotor) by Intracerebral Inoculation Authors Hamir, Amirali Interpretive Summary: To determine the transmissibility of transmissible mink encephalopathy (TME) agent to raccoons and to provide information about clinical course, lesions and suitability of currently used diagnostic tests for detection of TSEs in raccoons, 4 raccoon kits were inoculated in the brain with a brain suspension from mink experimentally infected with TME. One uninoculated raccoon kit served as a control. All 4 animals in the TME-inoculated group became sick and were euthanized between 21 and 23 weeks post inoculations (PI). Necropsy examinations revealed no gross lesions. However, laboratory tests were positive for the disease (spongiform encephalopathy). These findings further confirm that TME is transmissible to raccoons and that tests currently used for transmissible spongiform encephalopathy (TSE) in livestock detects the disease (prion protein) in raccoon tissues. According to previously published data, the incubation period of sheep scrapie in raccoons is 2 years, whereas chronic wasting disease (CWD) had not shown transmission after 3 years of observation. Further studies, such as the incubation periods of bovine spongiform encephalopathy (BSE, mad cow disease) and other TSE isolates in raccoons are needed before the raccoon model can be recommended for differentiation of TSE agents. IMPACT: Since incubation periods for the 3 US TSEs (scrapie, TME and CWD) in raccoons appear to be markedly different, it may be possible to use raccoons for differentiating unknown TSE agents. Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION] http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Comment Number: EC -10 Accepted - Volume 2 PART 2 Statement By Agriculture Secretary Mike Johanns Regarding The Passage Of S.J.Res. 4 By The United States Senate "I am very disappointed in today's vote by the United States Senate to disapprove the rule submitted by the U.S. Department of Agriculture to establish minimal risk regions and resume trade in Canadian beef and cattle under 30 months of age. "Today's action undermines the U.S. efforts to promote science-based regulations, complicates U.S. negotiations to reopen foreign markets to U.S. beef and would perpetuate the economic disruption of the beef and cattle industry. "USDA remains confident that the requirements of the minimal-risk rule, in combination with the animal and public health measures already in place in the United States and Canada, provide the utmost protection to both U.S. consumers and livestock. We also remain fully confident in the underlying risk assessment, developed in accordance with the OIE guidelines, which determined Canada to be a minimal risk region. "I will now work with the U.S. House of Representatives to prevent passage of this resolution, which is strongly opposed by the Bush Administration, and continue our aggressive efforts to reopen international markets to U.S. beef." THIS MMR POLICY THAT JOHANNS AND GW HAVE SHOVED DOWN THE THROAT OF MILLIONS, well, in doing so they also have shoved TSEs down the throat of millions and millions have needlessly become exposed. ALL the OIE did in approving this was give the green light for the legal trading of all strains of TSEs globally. IT was an assinine move on all parties involved, it was a move based on nothing more than greed (commodities and futures), there was no science involved. with the many strains of TSE in North America in cattle, sheep, goats, deer, elk, mink, humans, we have a very unique and dangerous situation with all these different strains of TSEs being rendered and fed back to humans and animals for human consumption. for this administration to continue to base it's BSE/TSE mad cow protocols and policy solely on commodities and futures will continue to further expose this deadly agent needlessly to millions of animals and humans, thus the accumulation will continue, the agent will amplify and spread in feed, the hospital surgical arena, tissue and blood, cosmetics, supplements, in short a multitude of proven routes and sources. Johanns statement about BSE mad cow disease and walking across the street to the store to buy beef, and the chances of being run over by a car greater, than dying from beef, might hold true for some. there are many out there though, this did NOT hold true to. course, the sporadic CJD does not count, kinda like that 3 postive test they did not announce on the Texas inconclusive did not count. but science and transmission studies speak for themselves; Medical Sciences Cristina Casalone *, Gianluigi Zanusso , Pierluigi Acutis *, Sergio Ferrari , Lorenzo Capucci , Fabrizio Tagliavini ¶, Salvatore Monaco ||, and Maria Caramelli * *Centro di Referenza Nazionale per le Encefalopatie Animali, Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d'Aosta, Via Bologna, 148, 10195 Turin, Italy; Department of Neurological and Visual Science, Section of Clinical Neurology, Policlinico G.B. Rossi, Piazzale L.A. Scuro, 10, 37134 Verona, Italy; Istituto Zooprofilattico Sperimentale della Lombardia ed Emilia Romagna, Via Bianchi, 9, 25124 Brescia, Italy; and ¶Istituto Nazionale Neurologico "Carlo Besta," Via Celoria 11, 20133 Milan, Italy Edited by Stanley B. Prusiner, University of California, San Francisco, CA, and approved December 23, 2003 (received for review September 9, 2003) Transmissible spongiform encephalopathies (TSEs), or prion diseases, are mammalian neurodegenerative disorders characterized by a posttranslational conversion and brain accumulation of an insoluble, protease-resistant isoform (PrPSc) of the host-encoded cellular prion protein (PrPC). Human and animal TSE agents exist as different phenotypes that can be biochemically differentiated on the basis of the molecular mass of the protease-resistant PrPSc fragments and the degree of glycosylation. Epidemiological, molecular, and transmission studies strongly suggest that the single strain of agent responsible for bovine spongiform encephalopathy (BSE) has infected humans, causing variant Creutzfeldt-Jakob disease. The unprecedented biological properties of the BSE agent, which circumvents the so-called "species barrier" between cattle and humans and adapts to different mammalian species, has raised considerable concern for human health. To date, it is unknown whether more than one strain might be responsible for cattle TSE or whether the BSE agent undergoes phenotypic variation after natural transmission. Here we provide evidence of a second cattle TSE. The disorder was pathologically characterized by the presence of PrP-immunopositive amyloid plaques, as opposed to the lack of amyloid deposition in typical BSE cases, and by a different pattern of regional distribution and topology of brain PrPSc accumulation. In addition, Western blot analysis showed a PrPSc type with predominance of the low molecular mass glycoform and a protease-resistant fragment of lower molecular mass than BSE-PrPSc. Strikingly, the molecular signature of this previously undescribed bovine PrPSc was similar to that encountered in a distinct subtype of sporadic Creutzfeldt-Jakob disease. C.C. and G.Z. contributed equally to this work. ||To whom correspondence should be addressed. E-mail: salvatore.monaco@mail.univr.it . www.pnas.org/cgi/doi/10.1073/pnas.0305777101 Characterization of two distinct prion strains http://vir.sgmjournals.org/cgi/content/abstract/85/8/2471 THE findings from Corinne Ida Lasmézas*, [dagger] , Jean-Guy Fournier*, Hermann Boe*, Domíníque Marcé*, François Lamoury*, Nicolas Kopp [Dagger ] , Jean-Jacques Hauw§, James Ironside¶, Moira Bruce [||] , Dominique Dormont*, and Jean-Philippe Deslys* et al, that The agent responsible http://www.pnas.org/cgi/content/full/041490898v1 IN light of Asante/Collinge et al findings that BSE transmission to the -------- Original Message -------- Subject: re-BSE prions propagate as either variant CJD-like or sporadic CJD Date: Thu, 28 Nov 2002 10:23:43 -0000 From: "Asante, Emmanuel A" To: Dear Terry, I have been asked by Professor Collinge to respond to your request. I am a Senior Scientist in the MRC Prion Unit and the lead author on the paper. I have attached a pdf copy of the paper for your attention. Thank you for your interest in the paper. In respect of your first question, the simple answer is, yes. As you will find in the paper, we have managed to associate the alternate phenotype to type 2 PrPSc, the commonest sporadic CJD. It is too early to be able to claim any further sub-classification in respect of Heidenhain variant CJD or Vicky Rimmer's version. It will take further studies, which are on-going, to establish if there are sub-types to our initial finding which we are now reporting. The main point of the paper is that, as well as leading to the expected new variant CJD phenotype, BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc. I hope reading the paper will enlighten you more on the subject. If I can be of any further assistance please to not hesitate to ask. Best wishes. Emmanuel Asante <> ____________________________________ Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics Dept. Imperial College School of Medicine (St. Mary's) Norfolk Place, LONDON W2 1PG Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email: e.asante@ic.ac.uk (until 9/12/02) New e-mail: e.asante@prion.ucl.ac.uk (active from now) ____________________________________ snip... full text ; http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm 1: J Infect Dis 1980 Aug;142(2):205-8 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 EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Report Summary 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. 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 snip...end full text ; http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf http://www.bseinquiry.gov.uk/report/volume2/chaptea3.htm#820543 =========================== Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 http://vegancowboy.org/TSS-part1of8.htm Moms death from hvCJD (Heidenhain Variant Creutzfeldt Jakob Disease) http://www.vegsource.com/talk/madcow/messages/7252.html 'MOMS AUTOPSY REPORT' http://www.vegsource.com/talk/madcow/messages/7548.html P.O. BOX 42 Bacliff, Texas USA 77518
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