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4/03/2006 This is my very first visitor response aside from some goofy recipies posted over on the recipe page. This reader seems to object to the idea that Mad Cow Disease is slowly going away. In response I say the I still agree that Mad Cow Disease is becoming less of a worry, but all kinds of other transmissible spongiform encephalopathies (TSEs, also known as prion diseases) are popping up in many animals including sheep, deer, and even felines! RE: BSE is on the Wane
Greetings,
Below is a whole mess of references posted by Terry. I am not going to make an effort to sort this out or formate the text so please go through it at your leisure. There are some legible paragraphs in the middle and towards the end, the rest are links are references. Thank you Terry. Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”): Current and Proposed Safeguards Updated October 13, 2005 Geoffrey S. Becker Specialist in Agricultural Policy Resources, Science and Industry Division Sarah A. Lister Specialist in Public Health and Epidemiology Domestic Social Policy Division SNIP... http://www.ncseonline.org/NLE/CRSreports/05oct/RL32199.pdf SUPPRESSED peer review of Harvard study October 31, 2002 http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT July 1, 2005 through September 30, 2005 snip... Administrative Actions Pending or Taken at Small HACCP Plants [includes actions initiated in prior quarters] snip... DESERET MEAT 04852 M SPANISH FORK, UT 07/27/05 08/01/05 X X On 7/27/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3. snip... Administrative Actions Pending or Taken at Small HACCP Plants [includes actions initiated in prior quarters] snip... MONTEBELLO MEAT PROCESSING, INC 19075 M19075 P MANATI, PR 08/01/05 08/18/05 X X X 09/26/05 On 8/1/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4. snip... Table 7. Administrative Actions: Very Small HACCP Plants (7/01/05 to 9/30/05) snip... A.J. CEKAK\'S MEAT MARKET 09/01/05 09/20/05 On 9/1/05, an enforcement action 21562 M concerning failure to meet regulatory ORD, NE requirements for Escherichia coli X X X Biotype 1 (E. coli) and Bovine Spongiform Encephalopathy/Specified Risk Material was taken in accordance with 9 CFR Part 500.4. snip... Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters] snip... BROWN\'S PROCESSING 13100 M13100 P ELSBERRY, MO 08/08/05 08/16/05 X X X On 8/8/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4. snip... Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters] snip... FIVE STAR PACK INC. 08725 M08725 P GOLDEN CITY, MO 09/01/05 09/09/05 X X On 9/1/05, an enforcement action concerning failure to meet regulatory requirements for Escherichia coli Biotype 1 (E. coli) and Bovine Spongiform Encephalopathy/Specified Risk Material was taken in accordance with 9 CFR Part 500.4. snip... Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters] snip... H AND P MEATS 21352 M SOUTH PITTSBURG, TN 07/28/05 08/08/05 08/17/05 08/19/05 X X On 8/17/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3. snip... HOPKINS PACKING COMPANY 11069 M BLACKFOOT, ID 07/28/05 08/01/05 X X On 7/28/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3. snip... Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters] snip... NORTHWEST PREMIUM MEATS LLC 11032 M11032 P NAMPA, ID 07/26/05 07/29/05 X X On 7/26/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3. snip... PARADISE LOCKER MEATS 31865 M31865 P TRIMBLE, MO 09/21/05 X X On 9/21/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4. PARAGON SPRAY DRYING, LLC 31792 M31792 P WAUKON, IA 09/06/05 09/12/05 X X X On 9/6/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4. snip... Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters] snip... RANDALL MEAT COMPANY 10669 M HOT SPRINGS, AR 07/01/05 07/28/05 X X X On 7/1/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4. snip... Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters] snip... 08/04/05 08/19/05 On 8/4/05, an enforcement action 01046 M01046 P concerning Bovine SpongiformKANSAS CITY, MO X X Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4. Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters] snip... THE MEAT SHOP 08/18/05 09/06/05 09/09/05 On 9/6/05, a suspension action 31561 M concerning Bovine SpongiformBENSON, VT Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3. XX X X X THEURER\'S QUALITY MEATS, 07/27/05 07/29/05 On 7/27/05, a suspension action INC concerning Bovine Spongiform31647 M31647 P Encephalopathy and Specified Risk X X LEWISTON, UT Material was taken in accordance with 9 CFR Part 500.3. TOOELE VALLEY MEATS 07/25/05 08/01/05 On 7/25/05, a suspension action 20594 M20594 Pconcerning Bovine Spongiform GRANTSVILLE, UT X X Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3. snip... 52 pages http://www.fsis.usda.gov/PDF/QER_Q4_FY2005.pdf FOR IMMEDIATE RELEASE Contact: Kate Cyrul Friday, February 3, 2006 (202) 225-3661 DeLauro Questions APHIS Officials over Retesting of Infected Cow – IG Report finds agency officials overruled advice of field scientists – WASHINGTON, D.C. – Congresswoman Rosa L. DeLauro (Conn.-3) today questioned the reasoning of officials at the Animal and Plant Health Inspection Service (APHIS) that overruled the advice of field scientists on the retesting of a domestic cow found to have the bovine spongiform encephalopathy (BSE) disease. After the USDA announced that the first case of BSE was identified in a native-born cow last June, officials at APHIS said no further testing of the animal was needed. The USDA’s inspector general, however, determined the testing used proved inconclusive results and said that a sample from the cow should be sent for further testing. DeLauro is ranking member of the House Appropriations Agriculture subcommittee, which has jurisdiction and oversight responsibilities of USDA and FDA. “I am concerned that the APHIS officials that reviewed these results seemed to make decisions based not on science, but on the economic ramifications a positive BSE finding in a domestic born animal could have on the U.S. economy,” said DeLauro. “When consumer safety is in question, APHIS should not be forced into additional testing of an inconclusive sample by its inspector general. “While we are glad that this cow did not enter the human food supply, APHIS officials had a responsibility to further examine this sample that even our “gold standard” test proved inconclusive. By refusing to send samples for further testing, APHIS could have jeopardized consumer health and safety and put the industry at a disadvantage, drawing into question the safety of our beef. “Today I am requesting that APHIS disclose which officials made this decision and further explain their reasoning for not voluntarily testing this inconclusive sample further.” ### www.house.gov/delauro http://www.house.gov/delauro/press/2006/February/APHIS_retesting_2_3_06.html Audit Report Animal and Plant Health Inspection Service Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II and Food Safety and Inspection Service Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III UNITED STATES DEPARTMENT OF AGRICULTURE OFFICE OF INSPECTOR GENERAL Washington, D.C. 20250 January 25, 2006 REPLY TO ATTN OF: 50601-10-KC TO: W. Ron DeHaven Administrator Animal and Plant Health Inspection Service Barbara Masters Administrator Food Safety and Inspection Service ATTN: William J. Hudnall Deputy Administrator Marketing Regulatory Program Business Services William C. Smith Assistant Administrator Office of Program Evaluation, Enforcement, and Review FROM: Robert W. Young /s/ Assistant Inspector General for Audit SUBJECT: Animal and Plant Health Inspection Service - Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and Food Safety and Inspection Service - Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III This report presents the results of our audit of the enhanced BSE surveillance program and controls over specified risk materials and advanced meat recovery products. Your written response to the official draft report, dated January 20, 2006, is included as exhibit G with excerpts of the response and the Office of Inspector General’s (OIG) position incorporated into the Findings and Recommendations section of the report, where applicable. We accept the management decisions for all recommendations. Please follow your agency’s internal procedures in forwarding documentation for final action to the Office of the Chief Financial Officer (OCFO). We are providing a separate memorandum to the agencies and OCFO that provides specific information on the actions to be completed to achieve final action. We appreciate your timely response and the cooperation and assistance provided to our staff during the audit USDA/OIG-A/50601-10-KC/ Page i Executive Summary Animal and Plant Health Inspection Service - Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and Food Safety and Inspection Service - Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III Results in Brief This report evaluates elements of the interlocking safeguards in place to protect United States (U.S.) beef from Bovine Spongiform Encephalopathy, widely known as BSE or \"mad cow disease.\" Since 1990, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), has led a multi-agency effort to monitor and prevent BSE from entering the food supply. After discovering a BSE-positive cow in December 2003, APHIS expanded its BSE surveillance program. To further protect the food supply, USDA banned materials identified as being at risk of carrying BSE (specified risk materials (SRM)), such as central nervous system tissue. As part of this effort, USDA’s Food Safety and Inspection Service (FSIS) required beef slaughter and processing facilities to incorporate controls for handling such materials into their operational plans. Onsite FSIS inspectors also inspect cattle for clinical signs in order to prevent diseased animals from being slaughtered for human consumption. To evaluate the effectiveness of the safeguards, we assessed APHIS’ implementation of the expanded surveillance program, as well as FSIS’ controls to prevent banned SRMs from entering the food supply. In June 2004, APHIS implemented its expanded surveillance program; participation by industry in this surveillance program is voluntary. As of May 2005, over 350,000 animals were sampled and tested for BSE. To date, two animals tested positive for BSE; one tested positive after implementation of the expanded surveillance program. USDA made significant efforts to implement the expanded BSE surveillance program. Much needed to be done in a short period of time to establish the necessary processes, controls, infrastructure, and networks to assist in this effort. In addition, extensive outreach and coordination was undertaken with other Federal, State, and local entities, private industry, and laboratory and veterinary networks. This report provides an assessment as to the progress USDA made in expanding its surveillance effort and the effectiveness of its controls and processes. This report also discusses the limitations of its program and data in assessing the prevalence of BSE in the U.S. herd. snip... 40 ELISA test procedures require two additional (duplicate) tests if the initial test is reactive, before final interpretation. If either of the duplicate tests is reactive, the test is deemed inconclusive. 41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain Samples and Report Results for BSE Surveillance Standard Operating Procedure (SOP), dated October 26, 2004. 42 The NVSL conducted an ELISA test on the original material tested at the contract laboratory and on two new cuts from the sample tissue. 43 A visual examination of brain tissue by a microscope. 44 A localized pathological change in a bodily organ or tissue. SNIP... PLEASE SEE FLAMING EVIDENCE THAT THE USDA ET AL COVERED UP MAD COW DISEASE IN TEXAS ; PAGE 43; Section 2. Testing Protocols and Quality Assurance Controls snip... FULL TEXT 130 PAGES http://www.usda.gov/oig/webdocs/50601-10-KC.pdf [GAO-05-101 ] Mad Cow Disease: FDA\'s Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filen ame=d05101.txt&directory=/diskb/wais/data/gao [2] [GAO-05-101 ] Mad Cow Disease: FDA\'s Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filen ame=d05101.txt&directory=/diskb/wais/data/gao Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17, 2006 Date: March 10, 2006 at 5:23 pm PST Marie A. Vodicka, PhD Assistant Vice President Biologics & Blotechnology Scientlflc & Regulatory Affairs SCIENCE & REG AFFAIRS Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rrn . 1061 Rackville, MD 20862 Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket No. 2002N-0273 February 14, 2006 Dear Sir or Madam : The Pharmaceutical Research and Manufacturers of America (PhRMA) is providing comment to the proposed rules issued. ...... snip... http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed PAUL BROWN Date: January 20, 2006 at 9:31 am PST December 20,2005 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed Dear Sir or Madame: As scientists and Irecognized experts who have worked in the field of TSEs for decades, we are deeply concerned by the recent discoveries of indigenous BSE infected cattle in North America and appreciate the opportunity to submit comments to this very......... snip... Given that BSE can be transmitted to cattle via an oral route with just .OO1 gram of infected tissue, it may not take much infectivity to contaminate feed and keep the disease recycling. ........ http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf December 19, 2005 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed Dear Sir or Madame: The McDonald’s Corporation buys more beef than any other restaurant in the United States. It is essential for our customers and our company that the beef has the highest level of safety. Concerning BSE, ........... snip....... http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273_emc-000134-02.pdf THE SEVEN SCIENTIST REPORT *** http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle 03-025IFA 03-025IFA-2 Terry S. Singeltary http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf Research Project: Study of Atypical Bse Location: Virus and Prion Diseases of Livestock Project Number: 3625-32000-073-07 Project Type: Specific C/A Start Date: Sep 15, 2004 End Date: Sep 14, 2007 Objective: The objective of this cooperative research project with Dr. Maria Caramelli from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct comparative studies with the U.S. bovine spongiform encephalopathy (BSE) isolate and the atypical BSE isolates identified in Italy. The studies will cover the following areas: 1. Evaluation of present diagnostics tools used in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison of the U.S. BSE isolate and other typical BSE isolates with atypical BSE cases. 3. Studies on transmissibility and tissue distribution of atypical BSE isolates in cattle and other species. Approach: This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate. Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal. http://www.ars.usda.gov/research/projects/projects.htm?accn_no=408490 Research Project: Study of Atypical Bse Location: Virus and Prion Diseases of Livestock 2005 Annual Report This report serves to document research conducted under a specific cooperative agreement between ARS and the Italian Reference Centre for Animal TSE (CEA) at the Istituto Zooprofilattico Sperimentale, Turin, Italy. Additional details of research can be found in then report for the parent project 3625-32000-073-00D, Transmission, Differentiation, and Pathobiology of Transmissible Spongiform Encephalopathies. The aim of the cooperative research project conducted by the CEA and ARS is to compare the U.S. bovine spongiform encephalopathy (BSE) isolate and the bovine amyloidotic spongiform encephalopathy isolates (BASE) identified in Italy. The first objective was to determine whether diagnostic methods routinely used by USDA are able to identify the Italian BASE cases. For this purpose, CEA received the immunohistochemistry (IHC) protocol developed by APHIS-USDA. The IHC protocol was reproduced and standardized in the CEA laboratory and will be applied to the Italian BSE and BASE cases. Furthermore, fixed brainstem sections and frozen brainstem material from Italian BSE and BASE cases will be sent to ARS for analysis using USDA IHC and Western blot (WB) methods. These studies will enable us to determine whether the present diagnostic tools (IHC and WB) employed at the USDA will be able to detect the Italian BASE cases and also enable us to compare Italian BSE and BASE with the U.S. BSE cases. http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490&showpars=t rue&fy=2005 BASE in cattle in Italy of Identification of a second bovine amyloidotic spongiform encephalopathy: Molecular similarities with sporadic Creutzfeldt-Jakob disease http://www.pnas.org/cgi/content/abstract/0305777101v1 now ponder this; Information obtained from Dr Wrathall\'s notes of a meeting of the U.S. Animal Health Association at Little Rock, Arkansas Nov. 1988. 33 end...TSS >> Differences in tissue distribution could require new regulations >> regarding specific risk material (SRM) removal. snip...end full text 33 PAGES ; http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf It was, however, performed in the USA in 1979, when it was shown that cattle inoculated with the scrapie agent endemic in the flock of Suffolk sheep at the United States Department of Agriculture in Mission, Texas, developed a TSE quite unlike BSE. 32 The findings of the initial transmission, though not of the clinical or neurohistological examination, were communicated in October 1988 to Dr Watson, Director of the CVL, following a visit by Dr Wrathall, one of the project leaders in the Pathology Department of the CVL, to the United States Department of Agriculture. 33 The results were not published at this point, since the attempted transmission to mice from the experimental cow brain had been inconclusive. The results of the clinical and histological differences between scrapie-affected sheep and cattle were published in 1995. Similar studies in which cattle were inoculated intracerebrally with scrapie inocula derived from a number of scrapie-affected sheep of different breeds and from different States, were carried out at the US National Animal Disease Centre. 34 The results, published in 1994, showed that this source of scrapie agent, though pathogenic for cattle, did not produce the same clinical signs of brain lesions characteristic of BSE. http://www.bseinquiry.gov.uk/ 1: J Infect Dis. 1994 Apr;169(4):814-20. Intracerebral transmission of scrapie to cattle. Cutlip RC, Miller JM, Race RE, Jenny AL, Katz JB, Lehmkuhl HD, DeBey BM, Robinson MM. USDA, Agriculture Research Service, National Animal Disease Center, Ames, IA 50010. To determine if sheep scrapie agent(s) in the United States would induce a disease in cattle resembling bovine spongiform encephalopathy, 18 newborn calves were inoculated intracerebrally with a pooled suspension of brain from 9 sheep with scrapie. Half of the calves were euthanatized 1 year after inoculation. All calves kept longer than 1 year became severely lethargic and demonstrated clinical signs of motor neuron dysfunction that were manifest as progressive stiffness, posterior paresis, general weakness, and permanent recumbency. The incubation period was 14-18 months, and the clinical course was 1-5 months. The brain from each calf was examined for lesions and for protease-resistant prion protein. Lesions were subtle, but a disease-specific isoform of the prion protein was present in the brain of all calves. Neither signs nor lesions were characteristic of those for bovine spongiform encephalopathy. MeSH Terms: Animals Brain/microbiology* Brain/pathology Cattle Cattle Diseases/etiology* Cattle Diseases/pathology Encephalopathy, Bovine Spongiform/etiology* Encephalopathy, Bovine Spongiform/pathology Immunoblotting/veterinary Immunohistochemistry Male Motor Neurons/physiology Prions/analysis Scrapie/pathology Scrapie/transmission* Sheep Sleep Stages Time Factors Substances: Prions http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8 133096&dopt=Citation Intracerebral transmission of scrapie to cattle FULL TEXT PDF; SNIP... Discussion WE conclude that American sources of sheep scrapie are transmissible to cattle by direct intracerebral inoculation but the disease induced is NOT identical to BSE as seen in the United Kingdom. While there were similarities in clinical signs between this experimental disease and BSE, there was no evidence of aggressiveness, hyperexcitability, hyperesthesia (tactile or auditory), or hyperemetria of limbs as has been reported for BSE (9). Neither were there extensive neurologic lesions, which are primary for BSE, such as severe vacuolation of neurons and neuropil or neuronal necrosis and gliosis. Although some vacuolation of neuropil, chromotolysis in neurons, and gliosis were seen in the brains of some affected calves, these were industinguishable from those of controls. Vacuolated neurons in the red nucleus of both challenged and normal calves were considered normal for the bovines as previously described (50). PrP-res was found in ALL CHALLENGED CALVES REGARDLESS OF CLINCIAL SIGNS, and the amount of PrP-res positively related to the length of the incubation. ... snip... WE also conclude from these studies that scrapie in cattle MIGHT NOT BE RECOGNIZED BY ROUTINE HISTOPATHOLOGICAL EXAMINATION OF THE BRAIN AND SUGGEST THAT DETECTION OF PrP-res by immunohistochemistry or immunoblotting is necessary to make a definitive diagnosis. THUS, undiagnosed scrapie infection could contribute to the \'\'DOWNER-COW\'\' syndrome and could be responsible for some outbreaks of transmissible mink encephalopathy proposed by Burger and Hartsough ( and Marsh and harsough (52). ... snip... Multiple sources of sheep affected with scrapie and two breeds of cattle from several sources were used inthe current study in an effort to avoid a single strain of either agent or host. Preliminary results from mouse inoculations indicate multiple strains of the agent were present in the pooled inoculum (unpublished data). ... Transmission of the sheep scrapie to cattle was attempted in 1979 by using intracerebral, intramuscular, subcutaneous, and oral routes of inoculation of 5, 8- to 11-month old cattlw with a homologous mixture of brain from 1 affected sheep (61, 62). ONE of the 5 cattle develped neurologic signs 48 months after inoculation. Signs were disorientation, incoordination, a stiff-legged stilted gait, progressive difficulty in rising, and finally in terminal recumbency. The clinical course was 2.5 months. TWO of the 5 cattle similarly inoculated with brain tissue from a goat with scrapie exhibited similar signs 27 and 36 months after incoluation. Clinical courses were 43 an 44 days. Brain lesions of mild gliosis and vacuolation and mouse inoculation data were insufficient to confirm a diagnosis of scrapie. This work remained controversial until recent examination of the brains detected PrP-res in all 3 cattle with neurologic disease but in none of the unaffected cattle (62). Results of these studies are similar to ours and underscore the necessity of methods other than histopathology to diagnose scrapie infection in cattle. We believe that immunologic techniques for detecting PrP-res currently provide the most sensitive and reliable way to make a definitive diagnosis... http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf Visit to USA ... info on BSE and Scrapie http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf http://www.ngpc.state.ne.us/cgi-bin/ultimatebb.cgi?ubb=get_topic;f=12;t=000385 12/10/76 AGRICULTURAL RESEARCH COUNCIL REPORT OF THE ADVISORY COMMITTE ON SCRAPIE Office Note CHAIRMAN: PROFESSOR PETER WILDY snip... A The Present Position with respect to Scrapie A] The Problem Scrapie is a natural disease of sheep and goats. It is a slow and inexorably progressive degenerative disorder of the nervous system and it ia fatal. It is enzootic in the United Kingdom but not in all countries. The field problem has been reviewed by a MAFF working group (ARC 35/77). It is difficult to assess the incidence in Britain for a variety of reasons but the disease causes serious financial loss; it is estimated that it cost Swaledale breeders alone $l.7 M during the five years 1971-1975. A further inestimable loss arises from the closure of certain export markets, in particular those of the United States, to British sheep. It is clear that scrapie in sheep is important commercially and for that reason alone effective measures to control it should be devised as quickly as possible. Recently the question has again been brought up as to whether scrapie is transmissible to man. This has followed reports that the disease has been transmitted to primates. One particularly lurid speculation (Gajdusek 1977) conjectures that the agents of scrapie, kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of mink are varieties of a single \"virus\". The U.S. Department of Agriculture concluded that it could \"no longer justify or permit scrapie-blood line and scrapie-exposed sheep and goats to be processed for human or animal food at slaughter or rendering plants\" (ARC 84/77)\" The problem is emphasised by the finding that some strains of scrapie produce lesions identical to the once which characterise the human dementias\" Whether true or not. the hypothesis that these agents might be transmissible to man raises two considerations. First, the safety of laboratory personnel requires prompt attention. Second, action such as the \"scorched meat\" policy of USDA makes the solution of the acrapie problem urgent if the sheep industry is not to suffer grievously. snip... 76/10.12/4.6 http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf THE infamous USA SPORADIC CJDs, something to ponder; IF the USA TSE in cattle does not look like UK BSE, why would the USA human TSE look like UK nvCJD??? now, please look at not only the sporadic, but the \'unknown\'? USA notice steady increase, but also notice in 2005, # 7 the 38 pendings cases through Oct. and #8 includes 53 type pending, 1 type unknown. if you look at 2003 there were 3 type unknown. wonder if they were the same or different than the unknown in 2005? considering the soup that has been brewing over here in the USA for years via the rendering of BSE and atypical TSE in cattle, CWD, Scrapie, a few TME cases (not too much due to scent gland, but there were a few rendered, but all this, and you have one hell of a recipe for a new strains of TSE in humans. then who knows what \'friendly fire\' cases would look like from this soup via secondary transmission via medical/surgical/dental arena. ...TSS National Prion Disease Pathology Surveillance Center case exams... http://www.cjdsurveillance.com/resources-casereport.html Summary of the Scientific Report The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003. The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties. A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries. EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases. Publication date: 20 August 2004 http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_it.html http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02 _usa_report_summary_en1.pdf http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02 _usa_report_v2_en1.pdf ##################### Bovine Spongiform Encephalopathy ##################### Subject: REPORT OF THE COMMITTEE ON SCRAPIE November 9, 2005 USAHA Date: February 12, 2006 at 1:03 pm PST REPORT OF THE COMMITTEE ON SCRAPIE Chair: Dr. Jim Logan, Cheyenne, WY Vice Chair: Dr. Joe D. Ross, Sonora, TX Dr. Deborah L. Brennan, MS; Dr. Beth Carlson, ND; Dr. John R. Clifford, DC; Dr. Thomas F. Conner, OH; Dr. Walter E. Cook, WY; Dr. Wayne E. Cunningham, CO; Dr. Jerry W. Diemer, TX; Dr. Anita J. Edmondson, CA; Dr. Dee Ellis, TX; Dr. Lisa A. Ferguson, MD; Dr. Keith R. Forbes, NY; Dr. R. David Glauer, OH; Dr. James R. Grady, CO; Dr. William L. Hartmann, MN; Dr. Carolyn Inch, CAN; Dr. Susan J. Keller, ND; Dr. Allen M. Knowles, TN; Dr. Thomas F. Linfield, MT; Dr. Michael R. Marshall, UT; Dr. Cheryl A. Miller, In; Dr. Brian V. Noland, CO; Dr. Charles Palmer, CA; Dr. Kristine R. Petrini, MN; Mr. Stan Potratz, IA; Mr. Paul E. Rodgers, CO; Dr. Joan D. Rowe, CA; Dr. Pamela L. Smith, IA; Dr. Diane L. Sutton, MD; Dr. Lynn Anne Tesar, SD; Dr. Delwin D. Wilmot, NE; Dr. Nora E. Wineland, CO; Dr. Cindy B. Wolf, MN. The Committee met on November 9, 2005, from 8:00am until 11:55am, Hershey Lodge and Convention Center, Hershey, Pennsylvania. The meeting was called to order by Dr. Jim Logan, chair, with vice chairman Dr. Joe D. Ross attending. There were 74 people in attendance. The Scrapie Program Update was provided by Dr. Diane Sutton, National Scrapie Program Coordinator, United States Department of Agriculture (USDA), Animal and Plant Health Inspection Services (APHIS), Veterinary Services (VS). The complete text of the Status Report is included in these Proceedings. Dr. Patricia Meinhardt, USDA-APHIS-VS-National Veterinary Services Laboratory (NVSL) gave the Update on Genotyping Labs and Discrepancies in Results. NVSL conducts investigations into discrepancies on genotype testing results associated with the Scrapie Eradication Program. It is the policy of the Program to conduct a second genotype test at a second laboratory on certain individual animals. Occasionally, there are discrepancies in those results. The NVSL conducts follow-up on these situations through additional testing on additional samples from the field and archive samples from the testing laboratories. For the period of time from January 1, 2005, until October 15, 2005, there were 23 instances of discrepancies in results from 35 flocks. Of those 23 instances, 14 were caused by laboratory error (paperwork or sample mix-up), 3 results from field error, 5 were not completely resolved, and 1 originated from the use of a non-approved laboratory for the first test. As a result of inconsistencies, one laboratory’s certification was revoked by APHIS-VS. To reduce/eliminate these problems, the Program has placed additional quality requirements on the testing laboratories: additional review of final reports, additional coding systems for testing operations, strict follow-up and reports to NVSL on corrective actions, dual data entry systems, and more frequent inspections. The Agricultural Research Services (ARS) Scrapie Research Update was given by Janet Alverson, USDA- ARS. Dr. Alverson reported on the effect of multiple births and fetal position within the uterus on PrP-Sc accumulation in fetal cotyledons. Fetal cotyledons of fetuses with resistant genotypes can accumulate PrP-Sc when positioned next to a fetus of susceptible genotype with cotyledons positive for PrP-Sc accumulation. Scrapie Surveillance Evaluation Working Group Update was presented by Tracey Lynn, Epidemiologist with the National Surveillance Unit, Center for Epidemiology and Animal Health (CEAH). The presentation provided a background on evaluation, a quick review of analyses completed to date by the scrapie surveillance evaluation working group, and some of the preliminary findings. The process of surveillance system evaluation is undertaken to assist a disease control program with identifying possible improvements to their surveillance system, and includes an assessment of the overall utility of the system, identification of potential gaps in coverage, and an evaluation of the overall performance of the system. The scrapie surveillance evaluation working group reviewed the structure and processes of the scrapie surveillance program, as well as various quality and effectiveness measures. Overall, 98-99% of surveillance samples come from the Regulatory Scrapie Surveillance System (RSSS), so the RSSS system has been the primary focus of the evaluation process. The working group developed a flow chart indicating the flow of sheep through RSSS, which identified potential gaps in surveillance coverage, including custom kill plants and sheep being exported to Mexico. Spatial analyses can assist in identifying areas with high density sheep populations with lower levels of RSSS sampling. Identification compliance is being evaluated by reviewing reports from slaughter plants on the proportion of animals with appropriate identification. Additional analyses remain, including defining the most appropriate economic analyses, and comparing the surveillance system with developing surveillance standards. The working group hopes to have a draft written report for review by the end of the year. Giving the Update on Scrapie Diagnostics and Susceptibility was Katherine O’Roarke, Research Microbiologist, USDA-ARS. \"What’s New in Scrapie\" -- Biopsy sampling of the third eyelid or tonsillar lymphoid tissue is a useful live animal test for scrapie. The biopsy sample is examined for accumulation of the abnormal prion protein using immunohistochemistry. A joint project conducted by the Veterinary Laboratory Agencies and the Moredun Institute in the United Kingdom has developed an alternative technique in which tissue is collected from the narrow band of lymphoid tissue near the rectal-anal junction. The morphology of the lymphoid follicles is similar in the tonsil, retropharyngeal lymph nodes, third eyelid, and rectal-anal mucosal tissue. A report on more than 300 sheep in the United Kingdom (UK), prepared by Drs. Lorenzo Gonzalez and Jeffrey Martin, will describe the sensitivity, specificity, and optimal collection interval for this technique in a variety of breeds of British sheep. ARS has done a preliminary evaluation of the technique in US sheep. Samples of third eyelid and rectal-mucosal tissue were collected from 56 sheep. Forty-two (42) sheep had negative biopsies at both sites; most of these sheep have been necropsied and no PrP-d was found in retropharyngeal lymph node or tonsil, showing good agreement with the antemortem biopsies. Fourteen (14) sheep had positive rectal biopsy samples; of those, only 12 had positive eyelid biopsies. These sheep will be monitored for disease development. However, the protocol is identical for all samples and it is probable that these sheep represent false negative third eyelid results. Abstracts of reports on the UK studies indicate that sensitivity of the test was 70% in the UK; similar large scale testing on US sheep is necessary. The biopsy tissue is somewhat difficult to handle in the tissue processing laboratory and adaptation to an ELISA format may improve test performance. Alexia McKnight, Assistant Professor of Radiology, University of Pennsylvania, reviewed magnetic resonance imaging (MRI) diagnostics before the committee. A synopsis containing references is attached at the end of this report. Dr. McKnight asked the question, \"could MRI be a cost-effective screening test, estimated at $25-30 each with results immediately available.\" The committee feels that it is not practical as compared to other alternatives currently available. However, the committee expressed interest in future reference to this technology. Dr. Diane Sutton lead the Uniform Methods and Rules (UM&R) and Regulatory Issues Discussion. Several modifications to the UM&R were discussed. Eight issues were identified and communicated to the APHIS scrapie program coordinator. The committee acknowledged that APHIS and the industry is adequately addressing the year-to-year industry concerns. Dr. Kris Petrini representing the North Central United States Animal Health Association District presented five recommendations to the Committee. During the discussions regarding these recommendations it was evident that all five issues had been addressed during the year at this Committee meeting. The Committee approved a recommendation that USDA-APHIS-VS continue to provide indemnity funds for animals that have been designated for testing in Flocks Under Investigation as an alternative to third eyelid testing after consultation with the designated Scrapie Epidemiologist (DSE) and the Regional Area Epidemiologist (RAE). The 2004 Resolutions along with their responses were reviewed by the Committee. A Resolution concerning premises registration and identification was approved by the Committee and forwarded to the Committee on Nominations and Resolutions. Committee on Scrapie Status Report-Fiscal Year 2005: Cooperative State-Federal Scrapie Eradication Program Submitted by Diane Sutton, DVM and Gary Ross, DVM National Center for Animal Health Programs, APHIS, USDA In Fiscal Year 2005 the Scrapie Eradication Program focused on: (1) utilization of a genetic based approach to flock clean-up plans; (2) cleaning up infected and source flocks; (3) tracing and testing exposed animals and flocks; (4) expansion of regulatory slaughter surveillance (RSSS); (5) conducting considtent state reviews, (6) producer education; (7) upgrading of the Scrapie National Generic Database and (8) publishing the updated Scrapie Eradication Uniform Methods and Rules (UM&R). The current Scrapie Eradication UM&R is posted at http://www.aphis.usda.gov/vs/nahps/scrapie/umr-scrapie-erad.pdf. Consistent State Reviews States must meet the requirements in 9 CFR 79.6 in order to move sheep and goats in interstate commerce with minimal restrictions. Twenty seven states have enacted the required identification rules, the remaining states have submitted a work plan that describes the steps that will be taken to comply and provided a timeline for completing significant milestones. USDA is conducting onsite scrapie program consistent state reviews and has completed reviews in 12 states. States must be in full compliance by the end of their current rule making cycle. States not in full compliance at that time will be removed from the consistent state list. Removal from the list would create a significant impact on the interstate movement of sheep and goats from those States. Scrapie Flock Certification Program As of September 30, 2005, there were 1,961 flocks participating in the Scrapie Flock Certification Program (SFCP). Of these flocks 188 were certified flocks, 1,770 were complete monitored flocks, and 3 were selective monitored flocks (figure 2). There were 209 flocks newly enrolled and 53 newly certified (13 with status dates in FY 2005 and 40 with status dates in previous years) in FY 2005 (figure 3). Infected and Source Flocks As of September 30, 2005, there were 105 scrapie infected and source flocks. There were a total of 165** new infected and source flocks reported for FY 2005. The total infected and source flocks that have been released in FY 2005 was 128. The ratio of infected and source flocks cleaned up or placed on clean up plans vs. new infected and source flocks discovered in FY 2005 was 1.03 : 1*. In addition 622 scrapie cases were confirmed and reported by the National Veterinary Services Laboratories (NVSL) in FY 2005, of which 130 were RSSS cases. Fifteen cases of scrapie in goats have been reported since 1990. The last goat case was reported in May 2005. Approximately 5,626 animals were indemnified comprised of 49% non-registered sheep, 45% registered sheep, 1.4% non-registered goats and 4.6% registered goats. Regulatory Scrapie Slaughter Surveillance (RSSS) RSSS was designed to utilize the findings of the Center for Epidemiology and Animal Health (CEAH) Scrapie: Ovine Slaughter Surveillance (SOSS) study. The results of SOSS can be found at http://www.aphis.usda.gov/vs/ceah/cahm/Sheep/sheep.htm . RSSS started April 1, 2003. It is a targeted slaughter surveillance program which is designed to identify infected flocks for clean-up. During FY 2005 collections increased by 32% overall and by 90% for black and mottled faced sheep improving overall program effectiveness and efficiency as demonstrated by the 26% decrease in percent positive black faced sheep compared to FY 2004. Samples have been collected from 62,864 sheep since April 1, 2003, of which results have been reported for 59,105 of which 209 were confirmed positive. During FY 2005, 33,137 samples were collected from 81 plants. There have been 130 NVSL confirmed positive cases (30 collected in FY 2004 and confirmed in FY 2005 and 100 collected and confirmed in FY 2005) in FY 2005. Face colors of these positives were 114 black, 14 mottled, 1 white and 1 unknown. The percent positive by face color is shown in the chart below. Scrapie Testing In FY 2005, 35,845 animals have been tested for scrapie: 30,192 RSSS; 4,742 regulatory field cases; 772 regulatory third eyelid biopsies; 10 third eyelid validations; and 129 necropsy validations (chart 9). Animal ID As of October 04, 2005, 103,580 sheep and goat premises have been assigned identification numbers in the Scrapie National Generic Database. Official eartags have been issued to 73,807 of these premises. *This number based on an adjusted 12 month interval to accommodate the 60 day period for setting up flock plans. http://www.usaha.org/committees/reports/2005/report-scr-2005.pdf Greetings, >>>For the period of time from January 1, 2005, until October 15, 2005, there were 23 instances of discrepancies in results from 35 flocks. Of those 23 instances, 14 were caused by laboratory error (paperwork or sample mix-up), 3 results from field error, 5 were not completely resolved, and 1 originated from the use of a non-approved laboratory for the first test. As a result of inconsistencies, one laboratory’s certification was revoked by APHIS-VS. <<< i find this very very disturbing? why so many discrepancies in 2005? reminds me of the BSE june 2004 'enhanced' surveillance protocols that were bungled time and time again. in essense, they have know idea of the true scrapie, bse, and or cwd count in the USA. don't want to know either. reminds me of the import protocols they flagrantly ignored; In May (5/20/2003) of this year a single cow was diagnosed with BSE in Canada. This cow was of beef cattle breeding on a commercial cow-calf operation in northern Alberta. This case was picked up by the Canadian targeted surveillance program. At that date the U.S. imposed import restrictions on live ruminants and most ruminant products from Canada and was published in Federal Register, May 29, 2003. On August 8, 2003, there was a lift of restrictions to allow imports of `low-risk\' products, such as Hunter harvest wild ruminant _ immediately and the ability to accept import permit applications for others. The \"Low-risk\" decision was based on information from Canadian authorities on their investigation, scientific background on tissue infectivity and pathogenesis and international standards. The \"Low-risk\" products announcement on August 8, consisted of finished pet chews _ bone, ligaments, hides, hooves; bovine liver; veal (include carcasses) from animals 36 weeks of age or less; boneless sheep/goat meat from animals 12 months of age or less; boneless bovine meat from animals 30 months of age or less; cervine meat. ... http://usaha.org/committees/reports/reports03/r03imex.html and in 2005 we also found that ; The 11th BSE case in Japan PrPSc was also detected in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve). ... we also know that ; Results PrPSc was present in the brain tissue of all patients. In addition, we found PrPSc in 10 of 28 spleen specimens and in 8 of 32 skeletal-muscle samples. Three patients had PrPSc in both spleen and muscle specimens. Patients with extraneural PrPSc had a significantly longer duration of disease and were more likely to have uncommon molecular variants of sporadic Creutzfeldt–Jakob disease than were patients without extraneural PrPSc. and we now know that ; Prions in Skeletal Muscles of Deer with Chronic Wasting Disease www.sciencexpress.org / 26 January 2006 / Page 1 / 10.1126/science.1122864 we have known that prions were in skeletal muscle ; http://europa.eu.int/comm/food/fs/sc/ssc/out254_en.pdf http://www.bseinquiry.gov.uk/files/yb/1990/01/19009001.pdf http://www.pnas.org/cgi/content/full/99/6/3812?maxtoshow=&HITS=10&hits=10&RESULT FORMAT=&author1=prusiner&author2=prusiner&titleabstract=prions+meat+tissue+mice& fulltext=prions+meat+tissue+mice&searchid=1050249844061_1953&stored_search=&FIRS TINDEX=0&fdate=1/1/2002 Extraneural Pathologic Prion Protein in Sporadic Creutzfeldt–Jakob Disease Markus Glatzel, M.D., Eugenio Abela, Manuela Maissen, M.S., and Adriano Aguzzi, M.D., Ph.D. http://content.nejm.org/cgi/content/short/349/19/1812?query=TOCTHESE TSS #################### https://lists.aegee.org/bse-l.html #################### National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC) Testing Summary The BSE enhanced surveillance program involves the use of a rapid screening test, followed by confirmatory testing for any samples that come back \"inconclusive.\" The weekly summary below captures all rapid tests conducted as part of the enhanced surveillance effort. It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. ... http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html I don\'t believe them anymore, and i am not the only one. ...TSS IT was said long ago, and they damn well meant it, it\'s been proven now ; 3. Prof. A. Robertson gave a brief account of BSE. The US approach was to accord it a _very low profile indeed_. Dr. A Thiermann showed the picture in the \'\'Independent\'\' with cattle being incinerated and thought this was a fanatical incident to be _avoided_ in the US _at all costs_... snip... http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf Dr. Detwiler tried to tell them in 2003, before she was sent out to pasture by the Bush Administration, but Bush wanted to cover up mad cow disease; USDA 2003 We have to be careful that we don\'t get so set in the way we do things that we forget to look for different emerging variations of disease. We\'ve gotten away from collecting the whole brain in our systems. We\'re using the brain stem and we\'re looking in only one area. In Norway, they were doing a project and looking at cases of Scrapie, and they found this where they did not find lesions or PRP in the area of the obex. They found it in the cerebellum and the cerebrum. It\'s a good lesson for us. Ames had to go back and change the procedure for looking at Scrapie samples. In the USDA, we had routinely looked at all the sections of the brain, and then we got away from it. They\'ve recently gone back. Dr. Keller: Tissues are routinely tested, based on which tissue provides an \'official\' test result as recognized by APHIS . Dr. Detwiler: That\'s on the slaughter. But on the clinical cases, aren\'t they still asking for the brain? But even on the slaughter, they\'re looking only at the brainstem. We may be missing certain things if we confine ourselves to one area. snip............. Dr. Detwiler: It seems a good idea, but I\'m not aware of it. Another important thing to get across to the public is that the negatives do not guarantee absence of infectivity. The animal could be early in the disease and the incubation period. Even sample collection is so important. If you\'re not collecting the right area of the brain in sheep, or if collecting lymphoreticular tissue, and you don\'t get a good biopsy, you could miss the area with the PRP in it and come up with a negative test. There\'s a new, unusual form of Scrapie that\'s been detected in Norway. We have to be careful that we don\'t get so set in the way we do things that we forget to look for different emerging variations of disease. We\'ve gotten away from collecting the whole brain in our systems. We\'re using the brain stem and we\'re looking in only one area. In Norway, they were doing a project and looking at cases of Scrapie, and they found this where they did not find lesions or PRP in the area of the obex. They found it in the cerebellum and the cerebrum. It\'s a good lesson for us. Ames had to go back and change the procedure for looking at Scrapie samples. In the USDA, we had routinely looked at all the sections of the brain, and then we got away from it. They\'ve recently gone back. Dr. Keller: Tissues are routinely tested, based on which tissue provides an \'official\' test result as recognized by APHIS . Dr. Detwiler: That\'s on the slaughter. But on the clinical cases, aren\'t they still asking for the brain? But even on the slaughter, they\'re looking only at the brainstem. We may be missing certain things if we confine ourselves to one area. snip... FULL TEXT; Completely Edited Version PRION ROUNDTABLE Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado AND THE REST IS HISTORY, BSE MRR, the legal trading of all strains of TSE globally; Questions and Answers for Minimal- Risk (Canada) Rule Q. What does the final rule on bovine spongiform encephalopathy (BSE) and minimal-risk regions change? A. The rule amends regulations regarding the importation of ruminants and ruminant products and byproducts. It establishes a set of conditions whereby a country can be recognized as presenting minimal risk of introducing BSE into the United States. The new rule will continue to protect the United States from the introduction of BSE, while removing unnecessary prohibitions on the importation of certain commodities from minimal-risk regions. Q. What is a minimal-risk region? A. A minimal-risk region must meet the standards described in the rule and includes • A region in which BSE-infected animals have been diagnosed but sufficient regulatory measures have been put in place that would make the introduction of BSE into the United States unlikely; or • A region that has taken effective regulatory measures to prevent BSE, has never detected the disease, but cannot be considered BSE-free. A minimal-risk region must have had in place, prior to the detection of BSE, risk-mitigation measures —such as import restrictions, a ruminant-toruminant feed ban, and surveillance—adequate to prevent widespread establishment of the disease. The region also should conduct epidemiologic investigations and risk assessments when cases are identified and impose additional risk-mitigation measures as necessary. Q. Has any country met the conditions and been listed as a minimal-risk region? A. Canada has provided information for an evaluation and has been determined to meet the conditions of a minimal-risk region. The U.S. Department of Agriculture (USDA) conducted a thorough, scientific assessment to evaluate the risk of resuming the importation of Canadian ruminants and ruminant products in view of the two BSE cases of Canadian origin. This risk assessment included careful consideration of the risk-mitigation measures Canada has in place, the risk-mitigation measures in the United States, and also the risk-mitigation measures imposed in this final rule. The assessment confirms that allowing the importation of certain Canadian ruminants and ruminant products under the conditions imposed by the rule will continue to protect against introduction of BSE into the United States. Q. What types of mitigation measures does Canada have in place to qualify as a minimal-risk region? A. The minimal-risk standards that Canada has met include • Import restrictions sufficient to minimize exposure to BSE: Since 1990, Canada has maintained stringent import restrictions, preventing the entry of live ruminants and ruminant products, including rendered protein products, from countries that have found BSE in native cattle or that are considered to be at significant risk for BSE. • Surveillance for BSE at levels that meet or exceed international guidelines: Canada has conducted active surveillance for BSE since 1992 and exceeded the level recommended in international guidelines for at least the past 7 years. • Ruminant-to-ruminant feed ban in place and effectively enforced: Canada has had a ban on the feeding of ruminant proteins to ruminants since August 1997, with compliance monitored through routine inspections. • Appropriate epidemiologic investigations, risk assessments, and risk-mitigation measures imposed as necessary: Canada has conducted extensive investigations in response to any BSE finding and has taken additional mitigation measures in response. These risk-mitigation measures include, among others, prohibiting specified risk materials in human food. Q. Why is Canada in a different category from other countries where BSE has been discovered? A. USDA has determined through a scientific risk assessment that the risk presented by opening the borders to certain Canadian ruminants and ruminant products is minimal. We have used international recommendations—as defined by the World Organisation for Animal Health (OIE)—as a reference in developing these regulations. The OIE recom- Factsheet July 2005 Veterinary Services APHIS mendation, based on current scientific understanding, recognizes that there are different levels of risk in countries or regions, and provides guidelines for trade according to these levels of risk. Canada has had a stringent set of risk-mitigation measures in place for several years prior to the diagnosis of a case of BSE. Thus, the first case doesn’t represent the front edge of a rapidly increasing outbreak situation. It represents a limited exposure that occurred years ago that has not continued to circulate or amplify. This creates a very different risk scenario as compared to a country that diagnoses the first case of BSE and then begins to institute risk-management measures. In this latter scenario, the disease would have continued to amplify, and the first case may have indicated the beginning of a significant outbreak curve. Other countries may seek minimal-risk status if they meet the necessary conditions. USDA will determine the eligibility of future countries in the same manner it used with Canada-risk analysis and appropriate rulemaking procedures. Q. What types of products will be eligible for importation from Canada? A. The commodities that will be allowed to be imported from Canada under specified conditions under this final rule can be summarized as • Bovines for feeding or immediate slaughter, as long as they are slaughtered at less than 30 months; • Sheep and goats (ovines and caprines) for feeding or immediate slaughter, as long as they are slaughtered at less than 12 months of age; • Meat from bovines, ovines, caprines, and cervids (deer, elk, caribou, moose, and reindeer); and • Certain other products and byproducts, including bovine livers and tongues, gelatin, and tallow. USDA is also specifying that there are no import restrictions due to BSE for live cervids or camelids (i.e., llamas, alpacas, guanacos, and vicunas) from a BSE minimal-risk region. Q. When will cattle start crossing the border from Canada? A. The rule is effective immediately–July 15, 2005– due to the order from the Circuit Court, and the live animals and products addressed in the rule are eligible for importation as of that date. However, to ensure appropriate certification procedures and policies are in place, USDA does not expect any movement to occur until Monday, July 18, 2005. Q. Under the new rule, can live ruminants from Canada enter the United States through any port? A. The final rule requires that live ruminants from Canada enter the United States through specified ports-of-entry. These 20 entry points have the facilities available to ensure the requirements of the final rule are being met: Eastport, ID; Houlton, and Jackman, ME; Detroit, Port Huron, and Sault Ste. Marie, MI; Baudette, MN; Opheim, Raymond, and Sweetgrass, MT; Alexandria Bay, Buffalo, and Champlain, NY; Dunseith, Pembina, and Portal, ND; Derby Line and Highgate Springs, VT; Oroville and Sumas, WA. Q. Can ruminant products come through the same entry ports as live ruminants? A. No, all ruminant products entering the United States from Canada must, if arriving at a land border port, arrive at one of the following ports: Eastport, ID; Calais and Houlton, ME; Detroit (Ambassador Bridge), Port Huron, and Sault St. Marie, MI; International Falls, MN; Raymond, Roosville, and Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston Bridge and Peace Bridge), and Champlain, NY; Pembina and Portal, ND; Derby Line and Highgate Springs, VT; and Blaine (Pacific Highway and Cargo Ops), Lynden, Oroville, and Sumas (Cargo), WA. Q. Will feeder cattle and feeder sheep and goats imported from minimal-risk regions require identification before they cross the border? A. Yes. Feeder cattle must be permanently marked with a brand to identify the BSE minimal-risk region of origin before entering the United States. Feeder cattle exported from Canada must be branded with \"C/\\N\" and feeder sheep and goats from Canada will be branded with \"C.\" In addition, all feeder cattle and feeder sheep and goats imported from minimal-risk regions must be individually identified by an official eartag of the country of origin. The eartag must be applied before the animal’s arrival at the port-of-entry into the United States, meet U.S. eartag standards, and be traceable to the animal’s premises of origin. No person may alter, deface, remove, or otherwise tamper with the individual identification while the animal is in the United States or moving through the United States. Q. Will Canadian products be labeled with their country of origin? A. All Canadian ruminant products and byproducts will need to have the proper import documentation when they cross the border into the United States. However, these products won’t be labeled with their country of origin when they reach the consumer. It is important to remember that imported meat products are subject to the same stringent food safety standards as domestic products. Foreign countries must undergo a stringent review process before they become eligible to export meat, poultry, or egg products to the United States. The 2002 Farm Bill provided for country-of-origin labeling for beef, lamb, pork, fish, perishable agricultural commodities, and peanuts. However, Public Law 108–199 (the FY 2004 Consolidated Appropriations Act) delayed the implementation of mandatory country of origin labeling (COOL) for all covered commodities, except wild and farm-raised fish and shellfish, until September 30, 2006. When mandatory COOL goes into effect for beef, it will apply to all appropriate Canadian ruminant products and byproducts. Q. What safeguarding measures does the rule require for the importation of live Canadian cattle for immediate slaughter? A. Canadian cattle imported for immediate slaughter must be less than 30 months of age when imported. They must be accompanied by a health certificate, attesting to their age and relating to animal identification, origin, destination, and responsible parties. Cattle for immediate slaughter must move directly as a group from the port of entry to a recognized slaughtering establishment in sealed containers. They must be slaughtered as a group, and all appropriate specified risk materials as defined by USDA’s Food Safety and Inspection Service (FSIS) must be removed. Q: What happens if a bovine animal over 30 months of age enters the United States from Canada? A: USDA thinks such a scenario is very unlikely due to the fact that each animal presented at slaughter comes in under sealed containers and with a veterinary health certificate attesting to the age and health condition of the animal. If the animal is determined to be over 30 months of age, it will be properly disposed of and will not enter the human or animal food chains. As noted in the March 2004 notice reopening the comment period on the proposed minimal-risk region rule, APHIS is currently evaluating the appropriate approach regarding live cattle 30 months of age and older and intends to address that issue in a separate rulemaking proceeding in the Federal Register. Q. Will Canadian cattle be tested for BSE in the United States? A. BSE testing in the United States is conducted for animal health surveillance purposes. The current enhanced surveillance program focuses on obtaining samples from the targeted population of cattle where the disease is most likely to be found—in adult animals that have some type of clinical abnormality that could be consistent with BSE. Because of the nature of the disease and limitations of current BSE testing technology, testing clinically normal animals does not provide any significantly meaningful information for surveillance purposes. In addition, the BSE test cannot be considered a food safety test. If any Canadian cattle fit our targeted population as described, they will be subject to sampling under the enhanced BSE surveillance program. This would include any cattle condemned by FSIS at antemortem examination. Q. If Canada discovers additional cases of BSE, will the border be closed again? A. Should another case of BSE be discovered, any actions taken by USDA will depend on the facts and circumstances of the situation, an analysis of these facts and circumstances, and Canada’s subsequent response to the detection. Q. How will the amended regulations affect transshipment of domestic ruminants and ruminant products through Canada to Alaska? A. This regulation will not affect the transshipment of domestic ruminants and ruminant products through Canada to Alaska. Earlier this year, the Canadian Food Inspection Agency (CFIA) began allowing the temporary entry of live cattle under conditions that included the USDA’s assurance that the animals would return to the United States. Accordingly, all BSE-based restrictions that prohibited the transshipment of ruminant livestock from the lower 48 States to Alaska via Canada were lifted. However, CFIA’s regulations pertaining to the humane transport of livestock continue to preclude the transshipment of livestock by land via Canada. Q. What process did USDA use to amend these regulations? A. USDA amended the regulations through the Federal rulemaking process. USDA first proposed changes to its regulations regarding establishing minimal-risk regions and conditions for safely importing certain live ruminants and ruminant products from such regions on November 4, 2003, and the comment period was still under way when the United States announced its first case of BSE on December 23, 2003, in a cow imported from Canada. To allow additional time for commenters to evaluate the proposal in the context of the first U.S. finding of the disease, USDA reopened the comment period and accepted comments until April 7, 2004. Q. Is USDA confident that the final rule will continue to safeguard U.S. public and animal health? A. USDA conducted a thorough, scientific assessment of the risk of certain types of Canadian ruminants and ruminant products introducing BSE into Safeguarding American Agriculture Animal and Plant Health Inspection Service • United States Department of Agriculture • the United States. This risk assessment included consideration of the risk-mitigation measures Canada has in place, the risk-mitigation measures in the United States, and also the risk-mitigation measures imposed in this final rule. USDA determined that allowing the importation of Canadian ruminants and ruminant products under the conditions imposed by the rule will continue to protect against the introduction of BSE into the United States and protect human and animal health. Q. Is USDA working with any other agencies to implement these regulations? How will USDA implement this rule? A. USDA’s Animal and Plant Health Inspection Service (APHIS) is finalizing preparations to implement the rule and will have these in place by Monday, July 18, 2005. APHIS and FSIS have worked closely together throughout the rulemaking process and have agreed on certification language for ruminant products and prepared importer information. These will be posted to the APHIS Web site on July 15, 2005. Stakeholders can find out more about importing animal products by going to gov/lpa/issues/bse/trade/Dear_Product_importer. pdf>. USDA has also coordinated these regulations with the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration. In addition, APHIS will be working closely with the U.S. Department of Homeland Security’s Customs and Border Protection to ensure that the regulations and policies are clear to those performing inspections at the border. Q. Will other countries be categorized as minimalrisk regions in the future? A. Other countries that meet the conditions necessary to be recognized as a minimal-risk region will be considered in the future. The designation of any future countries as minimal risk will be accomplished in the same manner as Canada—through risk analysis and appropriate rulemaking. Q. What is the risk of allowing cattle to enter from Canada? A. The risk of BSE being introduced and spread through cattle imported under the provisions of this rule is absolutely minimal. The risk analysis conducted demonstrates that Canada has taken appropriate risk mitigation measures and that the possible prevalence of BSE circulating in Canada is extremely low. The risk of introduction is further lessened by the specific import restrictions imposed on animals and animal products imported under this rule. In addition to these measures, there are measures in place in the United States, such as the ruminant-to-ruminant feed ban, that prevent the disease from spreading into the U.S. domestic cattle population in the highly unlikely even that it is introduced. The risk is further mitigated by five interlocking, overlapping, and sequential risk barriers applied at critical control points. For an infected Canadian animal to transmit infection to a U.S. cow, five barriers must be crossed: (1) U.S. import restrictions; (2) slaughter controls; (3) rendering inactivation; (4) feed manufacturing controls; and (5) dose limitations. Since the risk of infectivity circulating in Canada is already minimal, each of these barriers will further reduce that risk, leading to a very small residual risk. Q. Where can the public view a copy of the final rule? A. The final rule is available online at aphis.usda.gov/lpa/issues/bse/bse.html>. Q. Where can the public view a copy of the risk assessment? A. The risk assessment is available online at www.aphis.usda.gov/lpa/issues/bse/bse.html>. The U.S.Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA’s TARGET Center at (202) 720–2600 (voice and TDD). To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326–W, Whitten Building, 14th and Independence Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964 (voice and TDD). USDA is an equal opportunity provider and employer. http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/faq_ahbse_minrisk.pdf no sound science here, just more BSe. nothing but commodities and futures, and apparently, the FOA and the OIE are in FULL support of this. ...TSS WHY the increase in sporadic CJD in the USA, and please notice the \'unknown\' strains showing up; USA notice steady increase, but also notice in 2005, # 7 the 38 pendings cases through Oct. and #8 includes 53 type pending, 1 type unknown. if you look at 2003 there were 3 type unknown. wonder if they were the same or different than the unknown in 2005? considering the soup that has been brewing over here in the USA for years via the rendering of BSE and atypical TSE in cattle, CWD, Scrapie, a few TME cases (not too much due to scent gland, but there were a few rendered, but all this, and you have one hell of a recipe for a new strains of TSE in humans. then who knows what \'friendly fire\' cases would look like from this soup via secondary transmission via medical/surgical/dental arena. ...TSS National Prion Disease Pathology Surveillance Center case exams... http://www.cjdsurveillance.com/resources-casereport.html http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf Visit to USA ... info on BSE and Scrapie http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf http://www.ngpc.state.ne.us/cgi-bin/ultimatebb.cgi?ubb=get_topic;f=12;t=000385 CWD http://www.ngpc.state.ne.us/cgi-bin/ultimatebb.cgi?ubb=forum&f=12&DaysPrune=1000 &submit=Go TSS |
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