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##################### Bovine Spongiform Encephalopathy ##################### Media/Press Results Of BSE Test Announced AUSTIN – The Texas Department of Agriculture reported today that DNA has confirmed the 12-year-old cow testing positive for Bovine Spongiform Encephalopathy – commonly known as mad cow disease – was from a Texas herd. The cow, which was originally tested and sampled in November 2004, was blocked and removed from the human food supply last year at the time of testing. “Texas cattle producers are committed to ensuring that the nation’s beef supply remains safe for all consumers both here and abroad,” Agriculture Commissioner Susan Combs said. “It is important to remember that this animal was banned from the food or feed chain and that long-standing safeguards have been in place to protect public health.” Because the animal was unable to walk, it was removed from the food supply and was processed at a facility that handles animals unsuitable for human consumption. The carcass was incinerated. The infected cow was born before the industry’s ban on feeding ruminant-derived protein to cattle. “Because of progressive steps taken by the U.S. cattle industry and the government and the strong firewalls in place, the American beef supply remains safe. For more than two decades, the government and industry have taken precautions to protect the public health,” Combs said. “Following the discovery of a Canadian-born cow with BSE in Washington state in December 2003, additional safeguards were added.” In 2003, USDA banned from the human food supply any cattle that are unable to walk or show signs of possible neurological disease. In addition, USDA mandates that material that would most likely carry the BSE agent, such as the brain and spinal cord, be removed from the food supply. “Last year I met with British veterinarians, researchers and cattle producers in the United Kingdom to learn how the United Kingdom had handled its outbreak of BSE. Their system had clearly been inadequate. This is not the case in the United States,” Combs said. “We have had a nearly 20-year plan with effective safeguards. “Our strong vigilance should assure consumers that the United States has the safest beef supply in the world,” Combs said. Texas is the leading cattle state in the nation with 13.8 million head or 15 percent of the total U.S. cattle inventory. In 2004, cattle added $8 billion to the Texas agricultural economy with a total economic impact of $14 billion on the state’s economy. Return to Media/Press Index Send Questions and Comments to: contact@agr.state.tx.us http://www.agr.state.tx.us/media/press_releases/0605/com_062905.htm AUSTIN – Gov. Rick Perry issued the following statement today on the announcement by the U.S. Department of Agriculture that a cow recently tested for Bovine Spongiform Encephalopathy – commonly known as mad cow disease – is from a Texas herd. “I want to urge calm and reassure the public that they can have the highest confidence in our beef supply, and the safeguards we have in place to protect the public from the spread of BSE. There is not, nor has there ever been, a known instance of BSE contaminating the food supply in Texas or anywhere else in the United States. The animal in question was not processed into food or any other product. Texans can be sure that the beef they buy at their local supermarkets or restaurants is as safe today as it was yesterday, and I encourage Texans to continue to enjoy Texas beef products.” how in the hell can beef be safe in Texas after getting caught lying about a Second MAD COW in TEXAS. they did not render that stumbling and staggering cow that showed all signs of BSE without any test at all for nothing. i wish Govern Perry would show me his mad cow crystal ball. we still feed cattle to cattle in TEXAS in 2005 for pete's sake. another mad cow official that is married to the industry. in fact, we feed a single cow 5.5 grams of ruminant feed in Texas, this is _documented_, probably more than that. some things to ponder? TEXAS MAD COW FEED INCIDENT ; FOR IMMEDIATE RELEASE FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT Today the Food and Drug Administration announced the results of tests FDA has determined that each animal could have consumed, at most and in It is important to note that the prohibited material was domestic in According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Despite this negligible risk, Purina Mills, Inc., is nonetheless FDA believes that Purina Mills has behaved responsibly by first This episode indicates that the multi-layered safeguard system put into FDA will continue working with USDA as well as State and local officials http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html 24. Februar 2001 USA Loch in der Mauer Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind lax. snip... "Löcher wie in einem Schweizer Käse" hat auch Terry Singeltary im Von der Fachwelt wurde Singeltary lange als versponnener Außenseiter snip... http://www.spiegel.de/spiegel/0,1518,119306,00.html BSE/TSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys Published online January 27, 2005 http://www.thelancet.com/journal/journal.isa =================================== #1 TEJAS MAD COW THAT WAS NOT TESTED AT ALL! FDA Statement 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. OOPS!..........TSS http://www.fda.gov/bbs/topics/news/2004/NEW01061.html TEJAS BSE COW (3rd inconclusive THAT TURNED UP POSITIVE FOR THE 4TH TIME SOME 7+ MONTHS LATER) 11/18/2004 APHIS Statement Regarding Third Inconclusive BSE Test Release No. 0508.04 "The Nov. 18 sample is the first that has tested inconclusive under an APHIS protocol announced in August that calls for public reporting of screening results only after two reactive screens. NVSL used the immunohistochemistry (IHC) test, an internationally-recognized gold standard test for BSE, and received a negative result on Nov. 22. Because the Nov. 18 screening test results were reactive in both the first and second screens, NVSL scientists made the recommendation to run the IHC test a second time. On Nov. 23 they reported the second IHC test was negative. Negative results from both IHC tests make us confident that the animal in question is indeed negative for BSE. "APHIS began an enhanced surveillance program on June 1 and to date has tested over 121,000 samples for BSE. Screening tests are designed to be extremely sensitive and false positives are not unexpected. APHIS has reported three inconclusives including the Nov. 18 sample and all have tested negative on confirmatory testing." http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2004/11/0508.xml Dallas District Ref: 2005-DAL-WL-12 WARNING LETTER CERTIFIED MAIL Mr. Dwayne Woody, Owner Dear Mr. Woody: An inspection of your feed manufacturing operation located at 6391 Old The use of protein derived from mammalian tissues, as defined in 21 CFR Our inspection revealed that whole corn dogs which contain protein In addition, because the whole corn dogs are not subjected to further Copies of the BSE Guidance documents 69, 70 and 76 were provided to Mr. It is necessary for you to take action on this matter now. Please notify Sincerely, Michael A. Chappell http://www.fda.gov/foi/warning_letters/g5184d.htm January 12, 2005 Ref: 2005-DAL-WL-11 WARNING LETTER CERTIFIED MAIL Mr. William L. Brown, Owner Dear Mr. Brown: An inspection of your ruminant feeding operation located at 1 Feed Lot Our inspection revealed that you feed prohibited material, as defined by During our previous inspection on January 17, 2002, copies of the BSE Failure to correct these violations may result in FDA taking regulatory It is necessary for you to take action on this matter now. Please notify Sincerely, /s/ Michael A. Chappell Dallas District Director http://www.fda.gov/foi/warning_letters/g5175d.htm August 10th, 2004, 04:26 PM Dallas District Ref: 2004-DAL-WL-18 WARNING LETTER CERTIFIED MAIL Mr. Patrick ORay, CEO & President Dear Mr. ORay: An inspection of your food manufacturing facility located at 601 E. 3rd Our inspection revealed that your firm sells its reduction stream waste At the close of the inspection, a list of inspectional observations (FDA Products that contain protein derived from mammalian tissues and that Because your manufacturing stream waste did not bear this cautionary You should know that this serious violation of the law may result in FDA We are in receipt of a letter from Mr. Anthony E. ROCZ, Plant Manager, snip... http://www.fda.gov/foi/warning_letters/g4898d.htm Public Health Service Dallas District Ref: 2004-DAL-WL-17 WARNING LETTER CERTIFIED MAIL Mr. Jack Chapman, Owner Dear Mr. Chapman: An inspection of your ruminant feeding operation located at 11071 CR Our inspection revealed that you feed prohibited material, as defined by At the close of the inspection, copies of the BSE Guidance documents 69, snip... http://www.fda.gov/foi/warning_letters/g4899d.htm Food and Drug Administration Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4896 February 12, 2002 CERTIFIED MAIL RETURN RECEIPT REQUESTED In reply refer to Warning Letter SEA 02-29 WARNING LETTER John Tyson, Chairman of the Board and CEO Tyson Foods 3 70 1 Johnson Road Springdale, Arkansas 72762 Dear Mr. Tyson: An inspection of your rendering operation, IBP, Inc., located at Dodd Road, Wallula, Washington, conducted by a Washington State Department of Agriculture Investigator, on January 8, 2002, under contract with the Food and Drug Administration (FDA), found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and/or distributed by this facility to be misbranded within the meaning of Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act). Our investigation found a failure to label your organ slurry product with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants". The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser. The above is not intended to be an all-inclusive list of deviations from the regulations, As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA’s Small Entity Compliance Guide to assist you with complying with the regulation. You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. You should notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made. Please send your reply to the Food and Drug Administration, Attention; Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Williamson at (425) 483-4976. Sincerely, Charles M. Breen District Director http://www.fda.gov/foi/warning_letters/g3091d.htm wonder if any of these cattle got into the feed/food chain for human and animal consumption ? NEWS RELEASE Texas Animal Health Commission Box 12966 • Austin, Texas 78711 • (800) 550-8242 • FAX (512) 719-0719 Linda L. Logan, D.V.M., Ph.D. • Executive Director For info: Carla Everett, information officer, at 1-800-550-8242, ext. 710, or ceverett@tahc.state.tx.us For Immediate Release – April 30, 2001 Sixteen German-Imported Cattle Tested for BSE, All Negative The National Veterinary Services Laboratory (NVSL) in Ames, Iowa, has reported there was no evidence of bovine spongiform encephalopathy (BSE) in brain tissue collected from 16 German-imported cattle euthanized at Texas A&M University in early April. The animals were imported from Germany to Texas in l996, before BSE was diagnosed in that country. In l997, BSE was detected in Belgium, and the U.S. Department of Agriculture (USDA) authorities determined that contaminated feed was being moved throughout the European Union. The agency then prohibited the importation of cattle and meat products from the EU. As a safety precaution, the German-imported cattle in Texas had been restricted to their premises since March 1997. The animals were transported to Texas A&M University in early April, where a veterinary team, headed by USDA's Dr. Gary Svetlik, euthanized the animals and collected brain tissue for testing from each animal. The animal carcasses were incinerated and did not enter the food chain. One Texas producer imported four head of the German animals. He sold one animal for diagnostic purposes and agreed to sell another for testing in about 45 days, but does not want to sell the remaining two animals. The remaining animals are under restriction and surveillance by a USDA field veterinarian. The owner also is instructed to report any health problems so the animals can be re-examined immediately. ---30--- http://www.tahc.state.tx.us/news/pr/2001/2001Apr_german_bse.pdf http://www.upi.com/view.cfm?StoryID=20040504-012834-2365r http://www.upi.com/view.cfm?StoryID=20040511-015527-4917r http://washingtontimes.com/upi-breaking/20040505-064316-1509r.htm Published 5/14/2004 11:06 AM WASHINGTON, May 14 (UPI) -- The U.S. Department of Agriculture did not test any cows for mad cow disease in the past seven months at the same Texas facility where federal testing policies for the deadly disorder were violated last month, United Press International has learned. http://www.upi.com/view.cfm?StoryID=20040513-065401-5285r USDA Ordered that Suspected Mad Cow in Texas Not Be Tested. USDA's San Angelo vets and techs ordered not to test suspect cow by Daniel Yovich on 5/5/04 for Meatingplace.com One government source and another within the industry, both of whom say they What USDA has confirmed is that the agency's standard operating procedures As a condemned cow, there was never any chance that the meat from the animal USDA spokesman Ed Loyd said the agency was conducting an investigation into What is clear, in the mind of the two sources who spoke to Meatingplace.com "Everybody expected a test, and then the word came that there wasn't going i find it odd that there are no ruminant feed ban violation warning letters documented Menu Foods, Inc. http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=A CVM Reports BSE Inspection Figures as of March 5 2005 Approximately 70 percent of the inspections were conducted by State officials under contract to FDA, with the remainder conducted by FDA officials. Inspections conducted by State and FDA investigators are classified to reflect the compliance status at the time of the inspection, based upon whether objectionable conditions were documented. Based on the conditions found, inspection results are recorded in one of three classifications: • OAI (Official Action Indicated) when inspectors find significant objectionable conditions or practices and believe that regulatory sanctions are warranted to address the establishment’s lack of compliance with the regulation. An example of an OAI classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspectors will promptly re-inspect facilities classified OAI after regulatory sanctions have been applied to determine whether the corrective actions are adequate to address the objectionable conditions. • VAI (Voluntary Action Indicated) when inspectors find objectionable conditions or practices that do not meet the threshold of regulatory significance, but warrant an advisory to inform the establishment that inspectors found conditions or practices that should be voluntarily corrected. VAI violations are typically technical violations of the 1997 BSE Feed Rule. These violations include minor recordkeeping lapses or conditions involving non-ruminant feeds. • NAI (No Action Indicated) when inspectors find no objectionable conditions or practices or, if they find objectionable conditions, those conditions are of a minor nature and do not justify further actions. (Note: The following figures are as of March 5.) Renderers These firms are the first to handle and process (i.e., render) animal proteins. After they process the material, they send it to feed mills and/or protein blenders for use as a feed ingredient. • Number of active firms whose initial inspection has been reported to FDA – 255 • Number of active firms handling materials prohibited from use in ruminant feed – 169 (66 percent of those active firms inspected) Of those 169 firms: v 1 (0.6 percent) was classified as OAI v 6 (3.5 percent) were classified as VAI Licensed feed mills • In the inspection report database, FDA lists medicated feed licensed feed mills separately from non-licensed feed mills. But the licensing has nothing to do with handling prohibited materials under the feed ban regulation. FDA requires feed mills to have medicated feed licenses to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time, to produce certain medicated feed products. • Number of active firms whose initial inspection has been reported to FDA – 1,066 • Number of active firms handling materials prohibited from use in ruminant feed – 402 (38 percent of those active firms inspected) Of those 402 firms: v 1 (0.2 percent) was classified as OAI v 9 (2.2 percent) were classified as VAI Feed Mills Not Licensed by FDA These feed mills are not licensed by the FDA to produce medicated feeds. • Number of active firms whose initial inspection has been reported to FDA – 5,133 • Number of active firms handling materials prohibited from use in ruminant feed – 1,785 (35 percent of those active firms inspected) Of those 1,785 firms: v 4 (0.2 percent) were classified as OAI v 30 (1.7 percent) were classified as VAI Protein blenders These firms blend rendered animal protein for the purpose of producing feed ingredients used by feed mills. • Number of active firms whose initial inspection has been reported to FDA – 302 • Number of active firms handling materials prohibited from use in ruminant feed – 86 (28 percent of those active firms inspected) Of those 86 firms: v 0 were classified as OAI v 3 (3.5 percent) were classified as VAI Renderers, feed mills, protein blenders This category includes any firm that is represented by any of the above four categories, but includes only those firms that manufacture, process or blend animal feed or feed ingredients using prohibited materials. • Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,526 • Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 568 (8.7 percent of those active firms inspected) Of those 568 firms: v 6 (1.1 percent) were classified as OAI v 22 (3.9 percent) were classified as VAI Other firms inspected Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers and animal feed transporters. • Number of active firms whose initial inspection has been reported to FDA – 12,009 • Number of active firms handling materials prohibited from use in ruminant feed – 3,001 (30 percent of those active firms inspected) Of those 3,001 firms: v 11 (0.4 percent) were classified as OAI v 89 (3.0 percent) were classified as VAI Total Firms • Number of active firms whose initial inspection has been reported to FDA – 15,249 • Number of active firms handling materials prohibited from use in ruminant feed – 3,804 (25 percent of those active firms inspected) Of those 3,804 firms: v 13 (0.3 percent) were classified as OAI v 95 (2.5 percent) were classified as VAI (Note: A single firm that has more than one function can be listed in different industry segments, which also means that the total may be less than a combination of all the segments.) • David L. and Nancy E. Huebner, Owners, Huebner Farm, Columbus, WI • Daniel W. Thuemmel, President, Thuemmel Dairy, Inc., Port Austin, MI • Jay L. DeJong, Owner, Rhody Dairy, Sumas, WA The above violations involved penicillin, gentamicin, and flunixin in dairy cows. Warning Letters were issued to Roger Nutsch, Partner, U R Farms, Jerome, ID; Daniel W. Nolan, Owner, Nolan Livestock, Bonduel, WI; and Laurens A.T.M. Schilderink, President, Spandet Dairy, Inc., Hart, TX, because investigations found they were offering animals for slaughter that contained illegal tissue residues. The investigations further revealed deviations from rules for Extralabel Drug Use in Animals. The extralabel use of approved animal drugs by veterinarians is allowed by law, provided that the regulations contained in 21 CFR Part 530 are followed. Extralabel use of an approved animal drug that is not in compliance with the regulations renders the drug unsafe under Section 512 and thus adulterated under Section 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act.). A Warning Letter was issued to -Joseph A. Gingerich, Co-Owner, Prime Veal Feed, Ltd., Kensington, OH, for selling and dispensing veterinary prescription drug products without a lawful order from a licensed veterinarian, which caused the products to be misbranded within the meaning of Section 503(f)(1)(C) of the Act. Examples of veterinary prescription drugs dispensed without the order from a licensed veterinarian include Banamine (flunixin meglumine), Micotil (tilmicosin), and Nuflor (florfenicol). In addition, these prescription veterinary drugs were misbranded within the meaning of 502(f)(1) of the Act because they did not bear adequate directions for use, and they do not fall into an exception to that requirement. FDA has defined “adequate directions for use” as “directions under which the layman can use a drug safely and for the purposes for which it is intended.” Inspection also revealed the firm dispensed Flunixin Meglumine Injection bearing a Dexamethasone label and Selenium-Vitamin E Injection (Mu-Se) bearing an Amoxicillin label. These drugs are misbranded under section 502(a) of the Act, because labeling is false or misleading, and 502(i)(3), in that they were offered for sale under the name of another drug. In addition, the inspection found the dispensing of human prescription drugs, such as Sulfamethoxazole and Trimethoprim tablets, Cephalexin capsules, and Amoxicillin capsules, for extralabel use in animals. A Warning Letter was issued to Alan O. Bostick, President, Sunshine Mills, Inc., Red Bay, AL, because inspection at his feed manufacturing facility in Tupelo, MS, revealed significant deviations from the requirements sent forth in Title 21, Code of Federal Regulations (CFR), Part 589.2000 – Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of bovine spongiform encephalopathy. The inspection indicated the manufacturing of products containing beef meat and bone meal that require the cautionary statement, “Do not feed to cattle or other ruminants,” and the firm failed to label the products with this statement. Specifically, the products that contained protein derived from mammalian tissues, but lacked the required statement included “Happy Fishman” and “Premier” catfish feeds. A Warning Letter was issued to -William B. Parrish, Chairman of the Board, Parrish & Heimbecker, Limited, Winnipeg, Manitoba, Canada, because inspection of his feed mill operation, Conway Feed, Inc., located in Conway, WA, found significant deviations from the requirements set forth in 21 CFR 589.2000. The investigation found that because the operation failed to adequately inspect the label of a raw material, an ingredient with the cautionary statement “Do not feed to cattle or other ruminants” was used in the manufacture of the finished product Game Bird Crum/Pellet. This final product did not display the cautionary statement that is required because this fish meal may contain prohibited animal proteins. Any product produced from the fish meal must also have the cautionary label. The investigation also revealed that the label of the Game Bird Crum/Pellet feed did not list fish meal as an ingredient. According to the information collected during the inspection fish meal is routinely added to this ration. Pursuant to 21 CFR 501.4(a), all ingredients required to be listed on the label in descending order of predominance by weight. Correction The November/December 2004 issue of FDA Veterinarian incorrectly listed in the Regulatory Activities section the location of Lake Country Veterinary Service, P.S. It is in Albany, MN http://www.fda.gov/cvm/January2005.htm#5168 July/August 2004 BSE INSPECTION UPDATE FDA Reports Latest BSE Inspection Figures As of July 17, the Food and Drug Administration (FDA) had received more than 31,000 reports of inspections done under the ruminant feed rule designed to prevent the establishment and spread of bovine spongiform encephalopathy (BSE) in the United States. Approximately 70 percent of the inspections were conducted by State of- fi cials under contract to FDA, with the remainder conducted by FDA offi cials. Inspections conducted by State and FDA investigators are classifi ed to refl ect the compliance status at the time of the inspection, based upon whether objectionable conditions were documented. Based on the conditions found, inspection results are recorded in one of three classifi cations: • OAI (Offi cial Action Indicated) when inspectors fi nd signifi cant objectionable conditions or practices and believe that regulatory sanctions are warranted to address the establishment’s lack of compliance with the regulation. An example of an OAI classifi cation would be fi ndings of manufacturing procedures insuffi cient to ensure that ruminant feed is not contaminated with prohibited material. Inspectors will promptly re-inspect facilities classifi ed OAI after regulatory sanctions have been applied to determine whether the corrective actions are adequate to address the objectionable conditions. • VAI (Voluntary Action Indicated) when inspectors fi nd objectionable conditions or practices that do not meet the threshold of regulatory signifi cance, but warrant an advisory to inform the establishment that inspectors found conditions or practices that should be voluntarily (Continued, next page) FDA VETERINARIAN JULY/AUGUST 2004 7 corrected. VAI violations are typically technical violations of the 1997 BSE Feed Rule. These violations include minor recordkeeping lapses or conditions involving non-ruminant feeds. • NAI (No Action Indicated) when inspectors fi nd no objectionable conditions or practices or, if they fi nd objectionable conditions, those conditions are of a minor nature and do not justify further actions. (Note: The following fi gures are as of July 17.) Renderers These fi rms are the fi rst to handle and process (i.e., render) animal proteins. After they process the material, they send it to feed mills and/or protein blenders for use as a feed ingredient. • Number of active fi rms whose initial inspection has been reported to FDA – 244 • Number of active fi rms handling materials prohibited from use in ruminant feed – 161 (66 percent of those active fi rms inspected) • Of those 161 fi rms: . 0 were classifi ed as OAI . 4 (2.5 percent) were classifi ed as VAI Licensed feed mills In the inspection report database, FDA lists medicated feed licensed feed mills separately from non-licensed feed mills. But the licensing has nothing to do with handling prohibited materials under the feed ban regulation. FDA requires feed mills to have medicated feed licenses to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time, to produce certain medicated feed products. • Number of active fi rms whose initial inspection has been reported to FDA – 1,081 • Number of active fi rms handling materials prohibited from use in FDA Reports Latest BSE Inspection Figures (Continued) ruminant feed – 367 (34 percent of those active fi rms inspected) • Of those 367 fi rms: . 3 (0.8 percent) were classifi ed as OAI . 5 (1.4 percent) were classifi ed as VAI Feed Mills Not Licensed by FDA These feed mills are not licensed by the FDA to produce medicated feeds. • Number of active fi rms whose initial inspection has been reported to FDA – 5,059 • Number of active fi rms handling materials prohibited from use in ruminant feed – 1,358 (27 percent of those active fi rms inspected) • Of those 1,358 fi rms: . 6 (0.4 percent) were classifi ed as OAI . 36 (2.7 percent) were classifi ed as VAI Protein blenders These fi rms blend rendered animal protein to produce feed ingredients used by feed mills. • Number of active fi rms whose initial inspection has been reported to FDA – 267 • Number of active fi rms handling materials prohibited from use in ruminant feed – 67 (25 percent of those active fi rms inspected) • Of those 67 fi rms: . 1 (1.5 percent) was classifi ed as OAI . 2 (3.0 percent) were classifi ed as VAI Renderers, feed mills, protein blenders This category includes any fi rm that is represented by any of the above four categories, but includes only those fi rms that manufacture, process or blend animal feed or feed ingredients using prohibited materials. • Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,452 • Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 556 (8.6 percent of those active fi rms inspected) • Of those 556 fi rms: . 8 (1.4 percent) were classifi ed as OAI . 19 (3.4 percent) were classifi ed as VAI Other fi rms inspected Examples of such fi rms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers and animal feed transporters. • Number of active fi rms whose initial inspection has been reported to FDA – 10,915 • Number of active fi rms handling materials prohibited from use in ruminant feed – 2,205 (20 percent of those active fi rms inspected) • Of those 2,205 fi rms: . 16 (0.7 percent) were classifi ed as OAI . 76 (3.4 percent) were classifi ed as VAI Total Firms • Number of active fi rms whose initial inspection has been reported to FDA – 14,355 • Number of active fi rms handling materials prohibited from use in ruminant feed – 2,901 (20 percent of those active fi rms inspected) • Of those 2,901 fi rms: . 17 (0.6 percent) were classifi ed as OAI . 86 (3.0 percent) were classifi ed as VAI (Note: A single fi rm that has more than one function can be listed in different industry segments, which also means that the total may be less than a combination of all the segments.) http://www.fda.gov/cvm/Documents/JulAug04.pdf USING RISK-BASED MANAGEMENT PRACTICES b.. FDA and state investigators specifically inspected a high-interest subset of 645 firms as part of our annual BSE performance goal feed inspections obligation. This subset represented 100 percent of all known renderers and feed mills processing products containing prohibited material; c.. In July 2004, co-published with USDA an advanced notice of proposed rulemaking (ANPRM) requesting comments and scientific information on several additional regulatory measures that would strengthen the feed regulation; d.. Developed a real-time Polymerase Chain Reaction (PCR) based method capable of detecting cattle, swine, sheep, goats, horses, or deer material along with poultry, goose, and turkey for use in analyzing samples of animal feeds and feed ingredients in support of the animal protein prohibition; e.. Evaluated two commercially available diagnostic test marketed to detect mammalian proteins in animal feed and feed ingredients; f.. Issued 10 Warning Letters for animal proteins prohibited in ruminant feed, and 15 class II recalls involving 15 firms and 25 products in response to violations of the BSE rule; g.. Issued assignments for collection of 600 samples from domestic animal feeds, 300 samples of animal feeds imported from countries not considered at risk for BSE, and 300 samples of animal feeds imported from countries considered at risk for BSE for subsequent feed analysis to determine possible non-compliance with the ruminant feed ban regulation and the import alert prohibiting importation of feeds containing animal tissues; h.. Provided separate formal ruminant feed ban inspection training seminars to feed safety officials in the states of Montana, Washington, Oregon, New York, Wisconsin, Oklahoma, and Idaho; i.. Participated in BSE working groups at three separate meetings of the Association of American Feed Control Officials; j.. Provided staffing to the FDA and USDA/APHIS emergency operation centers, tracking the distribution and disposition of suspect material, communicating with state authorities, and overseeing the final disposition of destruction of suspect material after discovery of a BSE-infected cow in the U.S.; and, k.. Issued Guidance for Industry (GFI #174) for the disposition of material from BSE positive cattle in animal feed. http://www.fda.gov/cvm/CVMAccomp.htm MAD COW FEED BAN VIOLATIONS 2003 Consent Decree of Permanent Injunction Filed Against X-Cel Feeds, Inc. Based on Violations of 1997 Animal Feed Rule On July 11, 2003, FDA announced the filing of a Consent Decree of Permanent Injunction against X-Cel, Feeds Inc., and individual officers based on violations of the Food, Drug, and Cosmetic Act. In the Consent Decree, the Firm and officers admitted liability for introducing adulterated and misbranded animal feeds into interstate commerce and agreed to implement measures to correct the violations under FDA’s supervision. “No case of BSE has ever been documented in the U.S., despite aggressive surveillance, said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “FDA’s animal feed regulations provide a firewall against BSE, and we are committed to strictly enforcing the rules that protect Americans from this disease.” The Department of Justice, Civil Division, Office of Consumer Litigation and the United States Attorney’s Office of the Western District of Washington filed the Consent Decree in the United States District Court of the Western District in Tacoma, Washington. It permanently enjoins X-Cel from manufacturing animal feeds in violation of the Food, Drug, and Cosmetic Act and requires the firm, its officers, and employees to take specific steps to avoid future violations including, implementing clean-out procedures, obtaining protein supplier certifications and implementing standard operating procedures for compliance until it satisfies FDA that it has corrected its problems. FDA’s animal feed regulations protect the United States from the potential threat of BSE by prohibiting the use of certain proteins derived from mammalian tissue in the feed for cattle and other ruminant animals. In addition, FDA and the State regulatory agencies have increased the number of inspections of renderers, animal feed manufacturers, and other firms responsible for keeping prohibited mammalian protein out of cattle and other ruminant feed. U.S. industry compliance with the 1997 Animal Feed Rule currently exceeds 99 percent. snip... Draft Guidance on Use of Material From Deer and Elk in Animal Feed; CVM Updates on Deer and Elk Withdrawn??? FDA has announced the availability of a draft guidance for industry entitled “Use of Material from Deer and Elk in Animal Feed.” This draft guidance document (GFI #158), when finalized, will describe FDA’s current thinking regarding the use in animal feed of material from deer and elk that are positive for Chronic Wasting Disease (CWD) or that are at high risk for CWD. CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the cervidae animal family (cervids). Only deer and elk are known to be susceptible to CWD by natural transmission. The disease has been found in farmed and wild mule deer, white-tailed deer, North American elk, and farmed black-tailed deer. CWD belongs to a family of animal and human diseases called transmissible spongiform encephalopathies (TSEs). TSEs are very rare, but are always fatal. This draft Level 1 guidance, when finalized, will represent the Agency’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations. Draft guidance #158 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the draft guidance may be obtained from the FDA Veterinarian. http://www.fda.gov/cvm/Jul_Aug03.htm#2108 http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm 2003D-0186 practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions. The results to date are reported here both by "segment of industry" and "in total". NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive. Renderers These firms are the first to handle and process (i.e., render) animal proteins and to send these processed materials to feed mills and or protein blenders for use as a feed ingredient. • Number of active firms whose initial inspection has been reported to FDA – 234 • Number of active firms handling materials prohibited from use in ruminant feed – 157 (67% of those active firms inspected.) • Of the 157 active firms handling prohibited materials, their most recent inspection revealed that: . 0 firms (0%) were classified as OAI. . 7 firms (4.5%) were classified as VAI. Liscensed Feed Mills FDA licenses these feed mills to produce medicated feed products. The license is required to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time. This licensing has nothing to do with handling prohibited materials under the feed ban regulation. A medicated feed license from FDA is not required to handle materials prohibited under 21 CFR 589.2000. • Number of active firms whose initial inspection has been reported to FDA – 1,110 • Number of active firms handling materials prohibited from use in ruminant feed – 300 (27% of those active firms inspected.) • Of the 300 active firms handling prohibited materials, their most recent inspection revealed that: . 2 firms (0.7%) were classified as OAI. . 15 firms (5.0%) were classified as VAI. Feed Mills Not Licensed by FDA These feed mills are not licensed by the FDA to produce medicated feeds. • Number of active firms whose initial inspection has been reported to FDA – 5,084 • Number of active firms handling materials prohibited from use in ruminant feed – 579 (11% of those active firms inspected.) • Of the 579 active firms handling prohibited materials, their most recent inspection revealed that: . 2 firms (0.3%) were classified as OAI. . 98 firms (17%) were classified as VAI. Protein Blenders These firms blend rendered animal protein for the purpose of producing a quality feed ingredients that will be used by feed mills. • Number of active firms whose initial inspection has been reported to FDA – 220 • Number of active firms handling materials prohibited from use in ruminant feed – 62 (28% of those active firms inspected.) • Of the 62 active firms handling prohibited materials, their most recent inspection revealed that: . 0 firms (0%) were classified as OAI. . 4 firms (6.5%) were classified as VAI. Other Firms Inspected Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters. • Number of active firms whose initial inspection has been reported to FDA – 6,905 • Number of active firms handling materials prohibited from use in ruminant feed – 1,053 (15% of those active firms inspected) • Of the 1,053 active firms handling prohibited materials, their most recent inspection revealed that: . 3 firms (0.3%) were classified as OAI. . 137 firms (13%) were classified as VAI. Total Firms Note that a single firm can be reported under more than one firm category; therefore, the summation of the individual OAI/VAI firm categories will be more than the actual total number of OAI/VAI firms, as presented below. • Number of active firms whose initial inspection has been reported to FDA – 11,375 • Number of active firms handling materials prohibited from use in ruminant feed – 1,664 (15% of those active firms inspected) • Of the 1,664 active firms handling prohibited materials, their most recent inspection revealed that: . 6 firms (0.4%) were classified as OAI. . 171 firms (10%) were classified as VAI. Ruminant Feed (BSE) Enforcement Activities (Continued) FDA VETERINARIAN SEPTEMBER/OCTOBER 2003 17 http://www.fda.gov/cvm/Documents/Sep-Oct03.pdf To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997. To date, active monitoring by the U.S. Department of Agriculture (USDA) has found no cases of bovine spongiform encephalopathy (BSE) in U.S. cattle. This is an update on FDA enforcement activities regarding the ruminant feed (BSE) regulation. FDA's enforcement plan for the ruminant feed regulation includes education, as well as inspections, with FDA taking compliance actions for intentional or repeated non-compliance. FDA's Center for Veterinary Medicine (CVM) has assembled data from the inspections that have been conducted AND whose final inspection report has been submitted to CVM (i.e., "inspected/reported") as of March 11, 2002. There is a lag time between the completion of an inspection and the submission of a final inspection report to CVM. This lag period includes the time required to conduct quality assurance on the report and to evaluate the findings before a final report is submitted. As of March 11, CVM had received inspection reports covering inspections (both initial inspections and re-inspections) of 10,458 different firms. The majority of these inspections (around 80%) were conducted by State officials under contract to FDA and the remainder by FDA officials. Various segments of the feed industry had different levels of compliance with this feed ban regulation. The results to date are reported here both by "segment of industry" and "in total". RENDERERS (These firms are the first to handle rendered protein and send materials to feed mills and ruminant feeders.) a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 239 b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 171 (72% of those firms inspected/reported). c.. Of the 171 renderers handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): FDA LICENSED FEED MILLS (FDA licenses these mills to produce medicated feed products. This licensing has nothing to do with handling prohibited materials under the feed ban rule: 21 CFR 589.2000. A license from FDA is not required to handle materials prohibited under 21 CFR 589.2000.) a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 1,203 b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 370 (31% of those firms inspected/reported) c.. Of the 370 licensed feed mills handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): FEED MILLS NOT LICENSED BY FDA a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 4,867 b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 1,224 (25% of those firms inspected/reported) c.. Of the 1,224 feed mills not licensed by FDA handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): OTHER FIRMS INSPECTED (Examples of such firms include: ruminant feeders, on-farm mixers, protein blenders, and distributors.) a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 4,710 b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 565 (12% of those firms inspected/reported) c.. Of the 565 such firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): TOTALS (as of March 11, 2002) a.. NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM - 10,458 b.. NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT FEED - 2,153 (21% of those firms inspected/reported) c.. Of the 2,153 firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): RE-INSPECTIONS When firms are found to be out of compliance with the feed ban rule, FDA lists them for a re-inspection. As of March 11, 2002, reports of 2,185 re-inspections have been submitted to CVM. On re-inspection of these 2,185 firms, 32 (1%) were found still to be out of compliance with this rule. Firms previously found to be not in compliance have corrected problems through a variety of ways, including further training of employees about the rule, developing systems to prevent co-mingling, re-labeling their products properly, and adhering to record keeping regulations. Other firms have achieved compliance by eliminating prohibited materials from their operations. DATABASE CHANGE After March 11, 2002, FDA discontinued the database that was used to compile these numbers. The Agency is starting a new database on April 15, 2002, and future updates on BSE enforcement will draw from it. http://www.fda.gov/cvm/May_June02.htm#2276 2001 MAD COW FEED VIOLATION REPORT To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997. To date, active monitoring by the U.S. Department of Agriculture (USDA) has found no cases of bovine spongiform encephalopathy (BSE) in U.S. cattle. This is an update on FDA enforcement activities regarding the ruminant feed (BSE) regulation. FDA previously provided information on this issue in three CVM UPDATEs, most recently one on July 6, 2001. FDA's enforcement plan for the ruminant feed regulation includes education, as well as inspections, with FDA taking compliance actions for intentional or repeated non-compliance. As part of the enforcement plan, an initial inspection assignment was issued to all FDA District Offices in 1998 to conduct inspections of 100% of all renderers and known feed mills to determine compliance. Additional assignments have been issued to FDA District Offices regarding (1) further initial inspections of previously unknown firms potentially handling materials prohibited in ruminant feed and (2) re-inspections of firms found on initial inspection to be out of compliance with this regulation. FDA's Center for Veterinary Medicine (CVM) has assembled data from the inspections that have been conducted AND whose final inspection report has been submitted to CVM (i.e., "inspected/reported") as of October 26, 2001. There is a lag time between the completion of an inspection and the submission of a final inspection report to CVM. This lag period includes the time required to conduct quality assurance on the report and to evaluate the findings before a final report is submitted. As of October 26, 2001, CVM had received inspection reports covering inspections (both initial inspections and re-inspections) of 10,018 different firms. The majority of these inspections (around 80%) were conducted by State officials under contract to FDA and the remainder by FDA officials. Various segments of the feed industry had different levels of compliance with this feed ban regulation. The results to date are reported here both by "segment of industry" and "in total". RENDERERS (These firms are the first to handle rendered protein and send materials to feed mills and ruminant feeders.) a.. Estimated number of rendering firms in the U.S. — 264 b.. Number of firms that have received an initial inspection — 264 c.. Number of firms whose initial inspection has been reported to CVM — 232 d.. Number of firms handling materials prohibited for use in ruminant feed — 174 (75% of those firms inspected/reported). e.. Of the 174 renderers handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): a.. 8 (5%) had products that were not labeled as required b.. 6 (3%) did not have adequate systems to prevent co-mingling c.. 2 (1%) did not adequately follow record keeping regulations d.. 13 (7%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule) FDA LICENSED FEED MILLS (FDA licenses these mills to produce medicated feed products. This licensing has nothing to do with handling prohibited materials under the feed ban rule: 21 CFR 589.2000. A license from FDA is not required to handle materials prohibited under 21 CFR 589.2000.) a.. Number of FDA licensed feed mills in the U.S. as of October 26, 2001 — 1,231 b.. Number of firms that have received an initial inspection —1,240 c.. Number of firms whose initial inspection has been reported to CVM — 1,181 d.. Number of firms handling materials prohibited for use in ruminant feed — 406 (34% of those firms inspected/reported) e.. Of the 406 licensed feed mills handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): a.. 24 (6%) had products that were not labeled as required b.. 25 (6%) did not have adequate systems to prevent co-mingling c.. 3 (1%) did not adequately follow record keeping regulations d.. 42 (10%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule) FEED MILLS NOT LICENSED BY FDA (FDA does not know the total number of these feed mills because they are not required to be licensed by FDA.) a.. Estimated number of feed mills not licensed by FDA in the U.S. — 6,000-8,000 b.. Number of firms whose initial inspection has been reported to CVM — 4,835 c.. Number of firms handling materials prohibited for use in ruminant feed —1,439 (30% of those firms inspected/reported d.. Of the 1,439 feed mills not licensed by FDA handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): a.. 133 (9%) had products that were not labeled as required b.. 78 (5%) did not have adequate systems to prevent co-mingling c.. 82 (6%) did not adequately follow record keeping regulations d.. 228 (16%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule OTHER FIRMS INSPECTED (Examples of such firms include: ruminant feeders, on-farm mixers, protein blenders, and distributors.) a.. Estimated number of such firms in the U.S. — unknown b.. Number of firms whose initial inspection has been reported to CVM — 4,237 c.. Number of firms handling materials prohibited for use in ruminant feed — 629 (15% of those firms inspected/reported) d.. Of the 629 such firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): a.. 56 (9%) had products that were not labeled as required b.. 21 (3%) did not have adequate systems to prevent co-mingling c.. 27 (4%) did not adequately follow record keeping regulations d.. 81 (13%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule) TOTALS (as of October 26, 2001) a.. Number of firms whose initial inspection has been reported to CVM — 10,018 b.. Number of firms handling materials prohibited for use in ruminant feed — 2,501 (25% of those firms inspected/reported) c.. Of the 2,501 firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): a.. 204 (8%) had products that were not labeled as required b.. 116 (5%) did not have adequate systems to prevent co-mingling c.. 106 (4%) did not adequately follow record keeping regulations d.. 333 (13%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule. These 333 firms will be re-inspected in the near future.) RE-INSPECTIONS When firms are found to be out of compliance with the feed ban rule, FDA lists them for a re-inspection. As of October 26, 2001, reports of 1,719 re-inspections have been submitted to CVM. On re-inspection of these 1,719 firms, 108 (6%) were found still to be out of compliance with this rule. Firms previously found to be not in compliance have corrected problems through a variety of ways, including further training of employees about the rule, developing systems to prevent co-mingling, re-labeling their products properly, and adhering to record keeping regulations. Other firms have achieved compliance by eliminating prohibited materials from their operations. http://www.fda.gov/cvm/nov_dec01.htm#2358 2000 MAD COW PROTEIN DETECTION November/December 2000 FDA Veterinarian CVM sponsored a session at the International Workshop on Diagnostics of Transmissible Spongiform Encephalopathies (TSEs) devoted to its efforts to develop methods for detecting prohibited protein in animal feed. The workshop, sponsored by FDA and the National Institutes of Health (NIH), was held September 20 – 22, 2000, at the NIH campus in Bethesda, MD. CVM Director Dr. Stephen Sundlof opened the session, followed by remarks from session co-chairs Dr. Dan McChesney and Dr. Avraham Rasooly. Other sessions at the workshop focused on the latest developments in antemortem and postmortem diagnostic tests to detect TSEs in man and other animals. In seeking diagnostic tools to enforce the mammalian-to-ruminant feed ban, CVM drew on the BSE experience of Europeans by inviting speakers from the United Kingdom (UK), Switzerland, and Italy to discuss their tests and other efforts to control the spread of TSEs through animal feed. Among many distinguished presenters, Dr. Mike Ansfield, Ministry of Agriculture Fisheries and Food, UK, talked about the challenges, both CVM CONTINUES WORK ON METHODS TO DETECT PROHIBITED PROTEIN by Burt Pritchett, D.V.M., and Dragan Momcilovic, D.V.M. scientific and regulatory, in enforcing the UK feed ban, which is similar to the U.S. feed ban. Dr. Lucas Perler, Swiss Veterinary Authority, Switzerland, gave an overview of the BSE situation in Europe, with emphasis on the highly regarded and highly effective active surveillance program employed by the Swiss to detect BSE in their cattle population. France has already begun using a similar surveillance program and other European countries are considering adopting it. Dr. David Taylor, Sedecon 2000, UK, elaborated on safety of meat and (Continued, next page) 17 bone meal. Dr. Christoph von Holst, European Union, Joint Research Center, Italy, specified the validation criteria for methods for detection of prohibited ingredients in feed. Dr. Don Franco, National Renderers Association, elaborated on steps and measures that his association performs in order to maintain the safety of the U.S. meat and bone meal, while Dr. James Makowski presented feed microscopy as a means for detection of prohibited material. Dr. Mike Myers, CVM, talked about FDA’s validation of a method that is based on use of polymerase chain reaction (PCR). Dr. Dragan Momcilovic, CVM, gave an overview on other methods for detection of prohibited materials in ruminant feed and elaborated on the potential for their improvement in the future. Methods currently in use to detect proteins in feed are inadequate for reliably determining whether a sample of animal feed complies with the existing regulation. Development of new methods for that purpose is an important task that faces not only FDA but also our European counterparts. Dr. Pritchett is a Biologist with CVM’s Feed Safety Team in the Division of Animal Feeds. Dr. Momcilovic is a Medicated Feed Specialist with CVM’s Medicated Feeds Team in the Division of Animal Feeds. . . . WORK ON METHODS TO DETECT PROHIBITED PROTEIN (Continued) http://www.fda.gov/cvm/Documents/november.PDF FDA Statement on USDA BSE Positive Test Results #### http://www.fda.gov/bbs/topics/NEWS/2005/NEW01193.html TSS #################### https://lists.aegee.org/bse-l.html ####################
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