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From: TSS ()
news@ens-news.com christopher.matthews@fao.org Greetings, Amid the current international alarm over avian flu, it is good news that the battle against another worrying disease is being won. In 2005, just 474 animals died of BSE around the world, compared with 878 in 2004 and 1646 in 2003, and against a peak of several tens of thousands in 1992, according to figures collected by the Paris-based World Animal Health Organization (OIE), with which FAO works closely. Only five human deaths resulting from variant Creutzfeldt-Jakob Disease (vCJD), believed to be the human form of BSE, were reported worldwide in 2005. All of them were in the United Kingdom – the country most affected by the disease – where nine deaths were registered in 2004 and 18 in 2003. ... 'Mad Cow Disease Dying Out Worldwide' Thank you, I am sincerely, “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 http://www.ncseonline.org/NLE/CRSreports/05oct/RL32199.pdf SUPPRESSED peer review of Harvard study October 31, 2002 UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Table 7. Administrative Actions: Very Small HACCP Plants (7/01/05 to 21562 M concerning failure to meet regulatory ORD, NE requirements for Escherichia PARAGON SPRAY DRYING, LLC 31792 M31792 P WAUKON, IA 08/19/05 On 8/4/05, an enforcement action 01046 M01046 P concerning Bovine SpongiformKANSAS 09/09/05 On 9/6/05, a suspension action 31561 M concerning Bovine SpongiformBENSON, On 7/27/05, a suspension action INC concerning Bovine Spongiform31647 M31647 LEWISTON, UT Material was taken in accordance with 9 CFR Part 500.3. On 7/25/05, a suspension action 20594 M20594 Pconcerning Bovine Spongiform GRANTSVILLE, UT X X Encephalopathy and Specified Risk Material was taken in FOR IMMEDIATE RELEASE Contact: Kate Cyrul – IG Report finds agency officials overruled advice of field scientists – WASHINGTON, D.C. – Congresswoman Rosa L. DeLauro (Conn.-3) today questioned DeLauro is ranking member of the House Appropriations Agriculture “I am concerned that the APHIS officials that reviewed these results seemed “While we are glad that this cow did not enter the human food supply, APHIS “Today I am requesting that APHIS disclose which officials made this ### http://www.house.gov/delauro/press/2006/February/APHIS_retesting_2_3_06.html Executive Summary Animal and Plant Health Inspection Service - Bovine Spongiform Results in Brief This report evaluates elements of the interlocking In June 2004, APHIS implemented its expanded surveillance program; USDA made significant efforts to implement the expanded BSE surveillance 41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain 42 The NVSL conducted an ELISA test on the original material tested at the 43 A visual examination of brain tissue by a microscope. 44 A localized pathological change in a bodily organ or tissue. SNIP... [GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has [2] [GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filename=d05101.txt&directory=/diskb/wais/data/gao 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 No. 2002N-0273 February 14, 2006 Dear Sir or Madam : The Pharmaceutical Research and Manufacturers of America (PhRMA) is comment to the proposed rules issued. ...... Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances 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 decades, we are deeply concerned by the recent discoveries of indigenous BSE cattle in North America and appreciate the opportunity to submit comments to oral route with just .OO1 gram of infected tissue, it may not take much contaminate feed and keep the disease recycling. ........ 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 essential for our customers and our company that the beef has the highest Concerning BSE, ........... 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 03-025IFA Research Project: Study of Atypical Bse Project Number: 3625-32000-073-07 Approach: 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 http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490&showpars=true&fy=2005 BASE in cattle in Italy of Identification of a Creutzfeldt-Jakob disease 33 end...TSS full text 33 PAGES ; http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf http://www.bseinquiry.gov.uk/ 1: J Infect Dis. 1994 Apr;169(4):814-20. 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: Substances: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8133096&dopt=Citation SNIP... http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf snip... A The Present Position with respect to Scrapie Scrapie is a natural disease of sheep and goats. It is a slow The field problem has been reviewed by a MAFF working group It is clear that scrapie in sheep is important commercially and Recently the question has again been brought up as to whether Whether true or not. the hypothesis that these agents might be 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; now, please look at not only the sporadic, but the 'unknown'? USA 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 http://www.cjdsurveillance.com/resources-casereport.html 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 ##################### Bovine Spongiform Encephalopathy ##################### 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, 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. ... PrPSc was also detected in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve). ... 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. #################### 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 ; snip... We have to be careful that we don't get so set in the way we do things that Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't Dr. Keller: Tissues are routinely tested, based on which tissue provides an Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't 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. WHY the increase in sporadic CJD in the USA, and please notice the 'unknown' strains showing up; USA 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 http://www.cjdsurveillance.com/resources-casereport.html http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf CWD http://www.ngpc.state.ne.us/cgi-bin/ultimatebb.cgi?ubb=forum&f=12&DaysPrune=1000&submit=Go TSS
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