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From: TSS ()
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC 08-07 2/2/2007 FSIS NOTICE SAMPLE COLLECTION FROM CATTLE UNDER THE BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) ONGOING SURVEILLANCE PROGRAM I. PURPOSE This notice provides the Food Safety and Inspection Service (FSIS) inspection program personnel with instructions regarding the collection of brain samples for the Animal and Plant Health Inspection Service’s (APHIS) Bovine Spongiform Encephalopathy (BSE) ongoing surveillance plan. This notice cancels FSIS Notice 51-06, Sample Collection from Cattle under the Bovine Spongiform Encephalopathy (BSE) Ongoing Surveillance Program, and FSIS Notice 52-06, Temporary Suspension of Provision in the Bovine Spongiform Encephalopathy (BSE) Ongoing Surveillance Program. FSIS has incorporated the pertinent information from the cancelled notices into this notice. This revised notice is a result of changes APHIS has made to its surveillance plan. II. DEFINITION OF NEW COLLECTION PROCEDURES A. Approved Alternative Off-Site Sample Collection 1. APHIS will provide for the collection of brain (obex) samples from an allocated number of cattle 30 months and older condemned for any reason on ante-mortem inspection, and from cattle of any age displaying Central Nervous System (CNS) symptoms, at federally-inspected slaughter establishments that have agreements with APHIS under the approved alternative off-site sample collection program. b. disposition information (i.e., the reason for condemnation under 9 CFR Part 309). DISTRIBUTION: Inspection Offices; NOTICE EXPIRES: 3/1/08 OPI: OPPED T/A Inspectors; TSC; Import Offices B. Brain Sample Collection of Cattle Displaying CNS Symptoms 1. At Federally-inspected establishments not under the approved alternative off-site sample collection program, FSIS Public Health Veterinarians (PHVs): a. will collect appropriate BSE samples from cattle of all ages that display CNS symptoms, or III. FSIS PERSONNEL RESPONSIBILITIES 2. if not, whether: a. FSIS is to collect brain samples from cattle displaying CNS symptoms (paragraph II. B. 1.a.); or FSIS NOTICE 08-07 D. If the establishment plans to work with APHIS to begin off-site sampling, the FSIS PHV is to update the MOI as to whether an agreement was reached and in general, what the agreement was. E. The FSIS PHV is to maintain a copy of the memorandum of interview in the official government file, provide a copy to the plant management, and electronically mail a copy to the APHIS AVIC as changes occur. IV. FSIS RESPONSIBILITIES RELATED TO APPROVED ALTERNATIVE OFFSITE SAMPLE COLLECTION V. FSIS SAMPLE COLLECTION FOR CATTLE DISPLAYING CNS SYMPTOMS A. If the establishment does not have an agreement with APHIS for off-site sampling of cattle with CNS symptoms, the FSIS PHV will collect the brain samples from cattle showing signs of CNS symptoms. The FSIS PHV is to make all final disposition decisions regarding whether to condemn cattle in accordance with 9 CFR part 309. NOTE: FSIS PHVs can also find information regarding BSE sampling (e.g., forms, sampling supply information) at: Public Folders/All Public Folders/OFO/Technical Service Center/BSE Training Info 3 B. The FSIS PHV, or the establishment under the supervision of the FSIS PHV, should promptly remove the head in order to collect the brain sample. If the establishment does not arrange to remove the head, the FSIS PHV may need to collect the brain sample as a priority over other ante-mortem or post-mortem procedures. C. The FSIS PHV should collect the brain sample either in the inedible area of the establishment or in another area set aside for such collection to prevent the creation of an insanitary condition. Establishment personnel and FSIS inspection program personnel are to take proper sanitary measures before returning to edible areas of the establishment after brain sample collection, in accordance with 9 CFR 416.5. D. In situations where the FSIS PHV has missed the last FedEx pick-up for the day, or the FSIS PHV collected the sample on a day when FedEx does not pick up, the PHV is to refrigerate the samples until the next available FedEx pick-up day. Remember, the sample is not to pass through or to be stored in areas of the establishment where the establishment produces edible product. The FSIS PHV is to maintain the sample’s chain-of-custody. E. The FSIS PHV is to verify the collection, documentation, and control of all animal identification associated with cattle condemned during ante-mortem inspection that are to be sampled by FSIS. The FSIS PHV is to attach the "U. S. Condemned" tag to cattle condemned during ante-mortem inspection in accordance with 9 CFR 309.13. This documentation will facilitate traceback in the event that the sample result is positive for BSE. The documentation should include records in accordance with 9 CFR 320.1. F. The FSIS PHV is to verify that the presence of condemned cattle or parts does not create insanitary conditions (9 CFR part 416). The establishment is responsible for the disposal of the condemned cattle in accordance with 9 CFR part 314. The FSIS PHV also is to verify that the establishment maintains records regarding the disposal of the condemned cattle in accordance with 9 CFR 320.1. G. Inspection program personnel may inform the establishment that it may choose to hold the carcass and parts until testing results are available. If the establishment chooses to dispose of any carcass or parts before it receives test results, inspection program personnel are to advise the establishment that it must dispose of the carcass in one of the following ways: 1. render it at a facility for non-animal feed use (e.g., biofuel or cement); 1. For locations without high-speed internet connections, the FSIS PHV is to forward the completed BSE Surveillance Information System (BSE-SIS) sample 4 FSIS NOTICE 08-07 collection sheets to the APHIS,VS office by FAX or by e-mail. The follow site lists the VS office FAX numbers and e-mail where available: http://www.aphis.usda.gov/vs/area_offices.htm The APHIS AVIC in each area office may assist with sample delivery verification and troubleshooting. The FSIS PHV can get copies of BSE-SIS forms by contacting the local APHIS office. 2. The FSIS PHV is to enter the relevant information into the BSE-SIS at locations with high-speed connections and proceed as instructed in the training materials. FSIS PHVs may get the training from AgLearn or may contact the District Office if they need a copy of the BSE Surveillance Information System (BSE-SIS) training CD and for assistance in getting permission to have access to BSE-SIS. VI. TEST RESULTS FOR FSIS SAMPLING FROM CATTLE SHOWING CNS SYMPTOMS The FSIS PHV will receive, by e-mail, a report from the AVIC on the BSE test results. The AVIC will also send copies of the results to the District Office. 1. If the test is negative (reported as "not detected"), any carcasses and parts the establishment has held may be released for rendering or other disposal in accordance with 9 CFR 314. After sampling cattle showing signs of CNS symptoms, the FSIS PHV (or designee) is to enter the relevant information for each sample into eADRS. 1. The FSIS PHV (or designee) is to enter each ante-mortem condemned animal in eADRS under the applicable pathological condition. 5 animals sampled and the applicable "U.S. Condemned" Z-tag number for each sampled animal. 4. After entering the relevant information, the FSIS PHV is to click the "Save" button and proceed to the next disease condition. For additional information on entering BSE sample information, refer to Section 7 of the eADRS User Guide. VIII. RABIES In a rare situation, such as when an animal is condemned by the FSIS PHV on antemortem for rabies, the FSIS PHV should contact their District Office, who will advise APHIS. In these cases, APHIS will see that the animal is tested for rabies. APHIS will work with the laboratory to get appropriate samples forwarded for BSE surveillance from rabies negative animals. Rabies vaccination of FSIS collectors is still highly recommended. The voluntary rabies vaccination program details are covered in FSIS Notice 29-04, Questions and Answers for FSIS Notice 28-04 Regarding Ante-Mortem Condemned Cattle. Refer questions to the Technical Assistance and Correlation Division, Technical Service Center, at 1-800-233-3935. Assistant Administrator Office of Policy, Program, and Employee Development 6 http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/08-07.pdf FOR IMMEDIATE RELEASE Statement on Texas Cow With Central Nervous System Symptoms FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse. FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA. Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison). FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs. To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle. Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry. FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger. #### http://www.fda.gov/bbs/topics/news/2004/NEW01061.html [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf THE SEVEN SCIENTIST REPORT *** http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf SEROLOGICALS CORPORATION http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf Embassy of Japan 03-025IF 03-025IF-631 Linda A. Detwiler [PDF] 03-025IFA 03-025IFA-6 Jason Frost [PDF] http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf 18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7 64. A member noted that at the recent Neuroprion meeting, a study was Other work presented suggested that BSE and bovine amyloidotic spongiform http://www.seac.gov.uk/minutes/95.pdf Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain ***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than There is a growing number of human CJD cases, and they were presented last He estimates that it may be up to 14 or 15 persons which display selectively THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ; The second case, which was detected last year in a Texas cow and which USDA These two cases (the latest was detected in an Alabama cow) present a "The fact the Texas cow showed up fairly clearly implied the existence of Brown, who is preparing a scientific paper based on the latest two mad cow USDA officials finally retested the cow and confirmed it was infected seven "Everything they did on the Texas cow makes everything USDA did before 2005 CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ... PAUL BROWN COMMENT TO ME ON THIS ISSUE Tuesday, September 12, 2006 11:10 AM SOMETHING TO CHEW ON BMJ http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2 BMJ http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1 BY Philip Yam Answering critics like Terry Singeltary, who feels that the U.S. under- http://www.thepathologicalprotein.com/ INTRODUCTION http://www.thepathologicalprotein.com/_wsn/page3.html Yam Philip Yam News Editor Scientific American www.sciam.com Singeltary, Sr et al. JAMA.2001; 285: 733-734. http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc? Tracking spongiform encephalopathies in North America THE LANCET Infectious Diseases Vol 3 August 2003 http://www.thelancet.com/journals/laninf/article/PIIS1473309903007151/fulltext http://download.thelancet.com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf
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