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BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 - 2006 compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE' 30936 Federal Register / Vol. 62, No. 108 / Thursday, June 5, 1997 / Rules and Regulations 21 CFR Part 589 Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Final Rule http://www.fda.gov/cvm/Images/6597bse.pdf BSE/Ruminant Feed Ban Inspections FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL http://www.fda.gov/ohrms/dockets/98fr/03d-0498-gdl0001.pdf 1999 - 2000 CVM BSE CVM Update BSE FEED REGULATION TEAM TO RECEIVE VICE PRESIDENTIAL AWARD On May 14, the Food and Drug Administration (FDA)/Association of American Feed Control Officials (AAFCO) Bovine Spongiform Encephalopathy Feed Regulation Team will be honored with Vice President Al Gore's Hammer Award. The BSE Feed Regulation Team is comprised of employees from FDA's Center for Veterinary Medicine (CVM) and Office of Regulatory Affairs (ORA), and AAFCO, an organization that includes officials from all States and the Federal government who are responsible for enforcing the laws regulating the production, labeling, distribution, and/or sale of animal feeds. The Award will be presented by Yetta Lyle who will be representing the Vice President's National Partnership for Reinventing Government at CVM's 1999 Honor Awards Ceremony. The Awards ceremony will be held from 9:30 - 11:30 a.m., at the Gaithersburg Hilton Hotel, Grand Ballroom, 620 Perry Parkway, in Gaithersburg, MD. The 17 team members who spearheaded the effort will be honored. The award citation reads, "For making a significant contribution to reducing the possibility of bovine spongiform encephalopathy (BSE, or 'mad cow disease') becoming established and spread in the U.S." The Team used an innovative education-oriented partnership program to enforce a FDA regulation designed to control BSE. Compliance rates for the first inspections of all but one industry segment equaled or exceeded 75 percent. Compliance rates at follow-up inspections should approach the goal of 100 percent compliance, based on the enforcement strategy developed and updated jointly by the partners. Independent research has shown that major industry adjustments have been made to facilitate compliance with the regulations. FDA and State inspectors have conducted an unprecedented number of education-oriented inspections; a reinvented approach to doing inspections that has resulted in 70 percent savings in the cost of inspections, amounting to $1.3 million in Fiscal Year 1999. The Hammer Award is the down-to-earth symbol of the National Partnership for Reinventing Government, a five-year old, major initiative to make the government work better for less. The program honors Federal employees and their partners who have joined forces to streamline procedures, put consumers first, and help build a better and more cost-effective government. In addition to a plain carpenter's hammer, the award includes a ribbon and the Vice President's note of appreciation, all set in an aluminum frame. Also, every Team member will receive a personal certificate of appreciation with Al Gore's signature and a lapel hammer pin. -------------------------------------------------------------------------------- Issued by: http://www.fda.gov/cvm/CVM_Updates/HAMMERUP.html PRODUCT http://www.fda.gov/bbs/topics/ENFORCE/ENF00623.html 2001 October 30, 2001 RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES October 10, 2001 FDA HOLDING PUBLIC HEARING ON RUMINANT FEED (BSE) RULES The Food and Drug Administration (FDA) is holding a public hearing to solicit information and views on its present animal feeding regulation "Animal Proteins Prohibited in Ruminant Feed" -- Code of Federal Regulations, Title 21, Part 589.2000. The purpose of the rule is to help prevent the establishment and amplification of bovine spongiform encephalopathy (BSE) in U.S. cattle herds through feed and thereby help minimize any risks from BSE to animal or human health. FDA recognizes that new information has emerged on BSE and variant Creutzfeldt-Jakob Disease (vCJD) since the rule went into effect in 1997. Therefore, FDA is requesting information and views from individuals and organizations on the present rule and whether changes in the rule or other additional measures are necessary. The Agency is particularly interested in soliciting comments and views from individuals, industry, consumer groups, health professionals, and researchers with expertise in BSE and related animal and human diseases. ...snip http://www.fda.gov/cvm/CVM_Updates/part15.htm September 25, 2001 BSE INSPECTION CHECKLIST AVAILABLE ON THE CVM INTERNET HOME PAGE http://www.fda.gov/cvm/CVM_Updates/bsecheck.htm CVM Update RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES CVM Update RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES http://www.fda.gov/cvm/CVM_Updates/bsemar3.htm CVM Update UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES http://www.fda.gov/cvm/CVM_Updates/bseup.htm RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II_______________________ RECALL NUMBER, PRODUCT AND CODE: Non-Ruminant Custom Mix Feeds: RECALL NUMBER, PRODUCT AND CODE: END OF ENFORCEMENT REPORT FOR August 29, 2001. #### http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00708.html http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00703.html END OF ENFORCEMENT REPORT FOR July 04, 2001. PODUCT: RUMINANT FEED PRODUCTS: RECALL NO. PRODUCT NO. PRODUCT NAME V-195-1 40150 B. 30% Calf Pellet NON-RUMINANT FEED PRODUCTS: V-250-1 10150 B. Miracle Starter http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00696.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00694.html RECALLS AND FIELD CORRECTIONS: VETERINARY MEDS -- CLASS II PRODUCT: http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00690.html RECALLS AND FIELD CORRECTIONS: VETENIARY MED -- CLASS II PRODUCT: http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00688.html 2002 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 noncompliance. 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 in- RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES http://www.fda.gov/cvm/Documents/MayJune.pdf July/August 2002 The following individuals/firms received warning letters for violations related to 21 CFR Part 589.2000 – Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and REGULATORY ACTIVITIES by Karen A. Kandra amplification of Bovine Spongiform Encephalopathy (BSE): • Jeffrey T. Buck, Owner, All American Feed & Tractor, Sandpoint, ID • Kenneth M. Van Dyke, President, Van Dyke Grain Elevators, Inc., North Plains, OR • Philip C. Anderson, General Manager, Darling International, Inc., Tacoma, WA Violations included failure to maintain sufficient records and written procedures to prevent cross-contamination; failure to keep written procedures for cleaning out or flushing equipment after mixing feeds containing prohibited material; failure to provide written procedures for separating products that contain or may contain prohibited material from ingredients used in ruminant feeds, from the time of receipt until the time of shipment; and, failure to label meat and bone meal with the required cautionary statement “Do Not Feed to Cattle or Other Ruminants.” snip... http://www.fda.gov/cvm/Documents/JulyAugust.pdf November 12, 2002 MATERIAL FROM CWD-POSITIVE ANIMALS SHOULD NOT BE USED FOR ANIMAL FEED This CVM Update has been _withdrawn_ by Draft Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed | doc| | pdf |, May 14, 2003 See CVM Update Draft Guidance on Use of Material from Deer and Elk in Animal Feed Available for Comment; CVM Updates on Deer and Elk in Animal Feed Withdrawn. -------------------------------------------------------------------------------- http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm Clarification of FDA Position on Use In Animal Feed of Material From Certain Free Range Deer and Elk This CVM Update has been withdrawn by Draft Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed | doc| | pdf |, May 14, 2003. See CVM Update Draft Guidance on Use of Material from Deer and Elk in Animal Feed Available for Comment; CVM Updates on Deer and Elk in Animal Feed Withdrawn. http://www.fda.gov/cvm/CVM_Updates/CWDNOV21.htm CONTAINS NON-BINDING RECOMMENDATIONS 158 Guidance for Industry Use of Material from Deer and Elk in Animal Feed Comments and suggestions regarding this guidance should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet site, select "[03D-0186][Use of Material from Deer and Elk in Animal Feed]" and follow the directions. All written comments should be identified with Docket No. 03D-0186. For questions regarding this guidance, contact Burt Pritchett, Center for Veterinary Medicine (HFV- 222), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0177. E-mail: bpritche@cvm.fda.gov Additional copies of this guidance document may be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at http://www.fda.gov/cvm. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine September 15, 2003 CONTAINS NON-BINDING RECOMMENDATIONS 1 158 Guidance for Industry1 Use of Material from Deer and Elk in Animal Feed I. Introduction FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required. Under FDA’s BSE feed regulation (21 CFR 589.2000) most material from deer and elk is prohibited for use in feed for ruminant animals. This guidance document describes FDA’s recommendations regarding the use in all animal feed of all material from deer and elk that are positive for Chronic Wasting Disease (CWD) or are considered at high risk for CWD. The potential risks from CWD to humans or non-cervid animals such as poultry and swine are not well understood. However, because of recent recognition that CWD is spreading rapidly in white-tailed deer, and because CWD’s route of transmission is poorly understood, FDA is making recommendations regarding the use in animal feed of rendered materials from deer and elk that are CWD-positive or that are at high risk for CWD. II. Background CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the animal family cervidae (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 in farmed black-tailed deer. CWD belongs to a family of animal and human diseases called transmissible spongiform encephalopathies 1 This guidance has been prepared by the Division of Animal Feeds in the Center for Veterinary Medicine (CVM) at the Food and Drug Administration. This guidance represents the Food and Drug Administration’s current thinking on the use of material from deer and elk in animal feed. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of applicable statutes or regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. CONTAINS NON-BINDING RECOMMENDATIONS 2 (TSEs). These include bovine spongiform encephalopathy (BSE or “mad cow” disease) in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jakob diseases (CJD and vCJD) in humans. There is no known treatment for these diseases, and there is no vaccine to prevent them. In addition, although validated postmortem diagnostic tests are available, there are no validated diagnostic tests for CWD that can be used to test for the disease in live animals. III. Use in animal feed of material from CWD-positive deer and elk Material from CWD-positive animals may not be used in any animal feed or feed ingredients. Pursuant to Sec. 402(a)(5) of the Federal Food, Drug, and Cosmetic Act, animal feed and feed ingredients containing material from a CWD-positive animal would be considered adulterated. FDA recommends that any such adulterated feed or feed ingredients be recalled or otherwise removed from the marketplace. IV. Use in animal feed of material from deer and elk considered at high risk for CWD Deer and elk considered at high risk for CWD include: (1) animals from areas declared by State officials to be endemic for CWD and/or to be CWD eradication zones; and (2) deer and elk that at some time during the 60-month period immediately before the time of slaughter were in a captive herd that contained a CWD-positive animal. FDA recommends that materials from deer and elk considered at high risk for CWD no longer be entered into the animal feed system. Under present circumstances, FDA is not recommending that feed made from deer and elk from a non-endemic area be recalled if a State later declares the area endemic for CWD or a CWD eradication zone. In addition, at this time, FDA is not recommending that feed made from deer and elk believed to be from a captive herd that contained no CWD-positive animals be recalled if that herd is subsequently found to contain a CWD-positive animal. V. Use in animal feed of material from deer and elk NOT considered at high risk for CWD FDA continues to consider materials from deer and elk NOT considered at high risk for CWD to be acceptable for use in NON-RUMINANT animal feeds in accordance with current agency regulations, 21 CFR 589.2000. Deer and elk not considered at high risk include: (1) deer and elk from areas not declared by State officials to be endemic for CWD and/or to be CWD eradication zones; and (2) deer and elk that were not at some time during the 60-month period immediately before the time of slaughter in a captive herd that contained a CWD-positive animal. ...snip ; http://www.fda.gov/cvm/Guidance/guide158.pdf RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES http://www.fda.gov/cvm/CVM_Updates/bseap02.htm RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II http://www.fda.gov/bbs/topics/enforce/2002/ENF00765.html RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II #### http://www.fda.gov/bbs/topics/enforce/2002/ENF00764.html RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II_______________________ #### http://www.fda.gov/bbs/topics/enforce/2002/ENF00756.html RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II #### http://www.fda.gov/bbs/topics/enforce/2002/ENF00746.html PRODUCT PRODUCT Bovine Spongiform Encephalopathy (BSE), commonly called “Mad Cow Disease” is the name for a slowly progressive, degenerative, fatal disease affecting the central nervous system of adult cattle. Since 1990, the U.S. Department of Agriculture (USDA) has conducted aggressive surveillance of the highest risk cattle going to slaughter in the United States, in which 10,000- 20,000 animals per year have been tested. To date, the only cow that has been found to be affected with BSE was the one diagnosed with BSE in December 2003. The exact cause of BSE is not known but it is generally accepted by the scientific community that infectious forms of a type of protein, prions, normally found in animals cause BSE. In cattle with BSE, these abnormal prions initially occur in the small intestines and tonsils, and are found in central nervous tissues, such as the brain and spinal cord, and other tissues of infected animals experiencing later stages of the disease. CVM and Ruminant Feed (BSE) Inspections To prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) through animal 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, 21 CFR Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997(here called the BSE/Ruminant Feed regulation.) Inspections of renderers, feed mills, ruminant feeders, protein blenders, pet food manufacturers, pet food salvagers, animal feed distributors and transporters, ruminant feeders, and others have been conducted to determine compliance with the BSE/Ruminant Feed regulations. USDA Reports Cow Tested Positive for BSE – FDA Sends Investigators FDA’s primary responsibility related to this investigation involved animal feed, which most experts believe is the main way in which BSE is amplified throughout cattle herds. BSE does not spread naturally from adult cow to adult cow. FDA worked closely with USDA and state officials in this intense investigation. FDA’s “animal feed” rule, in place since 1997, is designed to prevent the spread of BSE further throughout cattle herds. This regulation prohibits the feeding of most mammalian protein to ruminant animals such as cows, sheep and goats - the route of disease transmission that led to the epidemic of BSE in the United Kingdom, beginning in the 1980’s. A study published in 2001 by the HarvardCenterfor Risk Analysis identified FDA’s animal feed rule as one of the primary safeguards against the amplification of BSE in the U.S.cattle herd if a case were ever to occur in the U.S. FDA has vigorously enforced this rule. More than 99 percent of these facilities are currently in compliance with the provisions of this rule to protect the U.S.food supply and its cattle from the agent that causes BSE. This one case of BSE does not mean that the U.S.food supply is any less safe today than it was yesterday. Concerning the safety of milk, the scientific data indicate that milk from BSE cows does not transmit BSE. National and international public health organizations have consistently stated that milk and milk products are safe regardless of whether the country producing them has had cases of BSE. On December 27, 2003, FDA announced that its investigators and inspectors from the states of Washington and Oregon had located all of the potentially-infectious product rendered from the one cow that tested positive for BSE in Washington State. The rendering plants that processed all the non-edible material from the BSE cow placed a voluntary hold on all of the potentially-infectious product, none of which left the control of the companies and entered commercial distribution. The firms, located in Washington State and Oregon, assisted and cooperated fully with FDA’s investigation. FDA Emergency Operations Center The FDA Emergency Operations Center (EOC), a branch of the OCM, is the single point of coordination for the FDA's response to any BSE emergency. The FDA EOC is the physical facility that serves as the central point for the Agency's response activity. During a BSE emergency, the FDA EOC will coordinate and report on all response activity and interagency communication. The FDA EOC monitors BSE emergencies; triages complaints and alerts; issues assignments to the field; coordinates responses; and communicates with other federal, state, and local agencies as they request technical and material support from the FDA. The FDA EOC maintains contact with the Department of Health and Human Services (HHS) Secretary's Command Center (SCC), CDC EOC, USDA/FSIS Office of Food Security and Emergency Preparedness, and other EOCs, as appropriate. The FDA EOC will continue to direct and monitor all FDA response activities throughout the life cycle of an emergency. New Measures to Prevent BSE Several new public health measures will be implemented by FDA to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S.cattle. The existing multiple firewalls, developed by both the U.S.Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the U.S.cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23. The new safeguards are science-based and further bolster these already effective safeguards. Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates. FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule. To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication. The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics: Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.) This interim final rule will implement four specific changes in FDA's present animal feed rule. The rule: Will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE. UPDATE: The FDA also notes that in response to finding a BSE positive cow in Washington state on December 23, it inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule. To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible. FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of the USpublic health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE. Warning Letters Issued for Violations of BSE Regulations On May 6, 2003, the FDA’s Minneapolis District Office issued a Warning Letter to the President of Barr Animal Foods, Greenwood, Wisconsin. The FDA conducted an inspection of the firm on April 8, 2003. The inspection disclosed that the firm was not labeling their 50 pound blocks of frozen beef and bulk loads of beef bone chips and rendering waste, intended for animal feed with the required cautionary statement. On August 25, 2003, the FDA’s Chicago District Office issued a Warning Letter to the president of Lincoln Land Livestock Co., Inc., Mascoutah, Illinois. On April 14 - 15, 2003, FDA conducted inspection of the animal feed handling facility. The investigator found that products that contained or may contain prohibited material failed to bear the caution statement, “Do not feed to cattle or other ruminants.” The inspection also disclosed that the firm did not maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. On November 7, 2002, the FDA’s Dallas District Office issued a Warning Letter to the President and Manager of Sunnymead Ranch, Inc., Idalou, Texas. An FDA inspection of this feed mill found significant deviations from 21 CFR 589.2000. FDA’s inspection revealed that the firm manufactures feed for sheep, that may contain residues of prohibited material. The sheep feed is mixed in the same equipment that is used for mixing chicken feed containing bovine meat and bone meal. In addition, the firm failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissue to animal protein or feeds that may be used for ruminants. The Warning Letter cautioned, “As a feed manufacturer and ruminant feeder of sheep intended for slaughter as food, you are responsible for ensuring that your operations are in full compliance with the law.” On May 22, 2003, the FDA’s New Orleans District Office issued a Warning Letter to the Manager and Owner of Millstone Agri Distributors, Maryville, Tennessee. An FDA inspection of the firm on February 13, 2003, found significant deviations from the requirements of Title 21, Code of Federal Regulations (21 CFR), Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. FDA’s investigation found the following violations of 21 CFR 589.2000: Failure to separate the receipt, processing, and storage of products containing prohibited material from products not containing prohibited material; 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 Federal Food, Drug, and Cosmetic Act. http://www.fda.gov/ora/about/enf_story/archive/2003/ch5/cvm1.htm CVM Update Update On Ruminant Feed (BSE) Enforcement Activities http://www.fda.gov/bbs/topics/enforce/2003/ENF00796.html _____________________________ END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 2003 ### http://www.fda.gov/bbs/topics/enforce/2003/ENF00781.html END OF ENFORCEMENT REPORT FOR APRIL 23, 2003 ### http://www.fda.gov/bbs/topics/enforce/2003/ENF00792.html _______________________________ http://www.fda.gov/bbs/topics/enforce/2003/ENF00816.html RECALLING FIRM/MANUFACTURER http://www.fda.gov/bbs/topics/enforce/2003/ENF00828.html SELECTED FY 2004 ACCOMPLISHMENTS USING RISK-BASED MANAGEMENT PRACTICES Bovine Spongiform Encephalopathy (BSE) • For fiscal year 2004, inspected over 6,806 renderers, feed mills, and other firms, including on-farm mixers and ruminant feeders, to determine compliance with the BSE feed regulations. At the end of the FY 2004, 17 firms were classified as being out of compliance at the time of their last inspection. Re-inspections of these facilities determined to be out of compliance with the BSE regulation are still ongoing; • 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; • 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; 230 • 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; • Evaluated two commercially available diagnostic test marketed to detect mammalian proteins in animal feed and feed ingredients; • 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; snip...full text ; http://www.fda.gov/oc/oms/ofm/budget/2006/PDFs/Summary/Pages226thru251.pdf http://www.fda.gov/cvm/CVMAccomp.htm CVM Update November 2004 Update on Ruminant Feed (BSE) Enforcement Activities July 2004 Update on Ruminant Feed (BSE) Enforcement Activities http://www.fda.gov/cvm/CVM_Updates/bse72004up.htm FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight http://www.fda.gov/oc/oms/ofm/budget/2007/HTML/4AnimalDrugs.htm FDA and USDA Request Comments and Scientific Information on Possible New BSE Safeguards removing specified risk materials (SRMs) from all animal feed, including pet food, in order to control the risks of cross contamination throughout feed manufacture and distribution and on the farm due to misfeeding; requiring dedicated equipment or facilities for handling and storing feed and ingredients during manufacturing and transportation, to prevent cross contamination; prohibiting the use of all mammalian and poultry protein in ruminant feed, to prevent cross contamination; and prohibiting materials from non-ambulatory disabled cattle and dead stock from use in all animal feed. FDA has tentatively concluded that it should propose to remove SRMs from all animal feed and is currently working on a proposal to accomplish this goal. Comments on the issues raised by FDA in the ANPRM are due to FDA 30 days after they publish in the Federal Register. FDA’s 1997 ruminant feed rule has been a critical safeguard to stop the spread of BSE through the U.S. cattle population by prohibiting the feeding of most mammalian protein to cattle and other ruminant animals. After a BSE-positive cow was detected in late December 2003, FDA announced its plans to publish interim final rules on BSE that would take effect immediately upon publication. For animal feed, FDA stated that the rule would eliminate the present exemption in the ruminant feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source, ban the use of "poultry litter" as a feed ingredient for ruminant animals, and ban the use of "plate waste" as a feed ingredient for ruminants. In addition, FDA said that to further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed, the rule would require equipment, facilities, or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. On February 4, 2004 , shortly after FDA announced its plans to publish interim final rules on BSE, an International Review Team (IRT) convened by USDA issued a report and additional actions to protect the public against BSE. The proposed actions were significantly different from those FDA announced in late January. Some of those proposals would make some of FDA’s actions unnecessary. Rather than publishing a regulation that would take effect automatically, USDA and FDA are soliciting public comment on the IRT’s suggestions, as well as other measures designed to protect North America against BSE. By seeking comment on the IRT’s recommendations, the agencies hope to put into effect the most comprehensive, science-based improvements possible. http://www.fda.gov/cvm/CVM_Updates/bseanprm.htm CVM Update April 2004 Update on Ruminant Feed (BSE) Enforcement Activities http://www.fda.gov/cvm/CVM_Updates/bse42004.htm CVM Update Update on Ruminant Feed (BSE) Enforcement Activities http://www.fda.gov/cvm/CVM_Updates/BSE0206up.htm RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE-CLASS II _______________________________ END OF ENFORCEMENT REPORT FOR January 14, 2004 ### http://www.fda.gov/bbs/topics/enforce/2004/ENF00830.html PRODUCT _______________________________ END OF ENFORCEMENT REPORT FOR MARCH 24, 2004 ### http://www.fda.gov/bbs/topics/enforce/2004/ENF00840.html PRODUCT > END OF ENFORCEMENT REPORT FOR APRIL 7, 2004 ### http://www.fda.gov/bbs/topics/enforce/2004/ENF00842.html PRODUCT PRODUCT http://www.fda.gov/bbs/topics/enforce/2004/ENF00843.html _______________________________ END OF ENFORCEMENT REPORT FOR APRIL 28, 2004 ### http://www.fda.gov/bbs/topics/enforce/2004/ENF00845.html PRODUCT http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html _______________________________ PRODUCT http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II _______________________________ _______________________________ END OF ENFORCEMENT REPORT FOR October 20, 2004 ### http://www.fda.gov/bbs/topics/enforce/2004/ENF00870.html RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II http://www.fda.gov/bbs/topics/enforce/2004/ENF00880.html 2005 VM Update November 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE http://www.fda.gov/cvm/CVM_Updates/BSE1105.htm CVM Update June 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE http://www.fda.gov/cvm/CVM_Updates/bse0605.htm CVM Update March 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE http://www.fda.gov/cvm/CVM_Updates/BSE0305.htm PRODUCT http://www.fda.gov/bbs/topics/enforce/2005/ENF00925.html RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II END OF ENFORCEMENT REPORT FOR SEPTEMBER 28, 2005 ### http://www.fda.gov/bbs/topics/enforce/2005/ENF00919.html 2006 CVM Update April 2006 Update on Feed Enforcement Activities to Limit the Spread of BSE http://www.fda.gov/cvm/CVM_Updates/BSE0506.htm Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006 New Orleans District Telephone: 615-781-5380 May 17, 2006 WARNING LETTER NO. 2006-NOL-06 FEDERAL EXPRESS Mr. William Shirley, Jr., Owner Dear Mr. Shirley: On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act). Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because: You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants. As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act. This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice. You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 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 corrections have been made. Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103. Sincerely, /S Carol S. Sanchez MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE END OF ENFORCEMENT REPORT FOR July 12, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs ### ### ### 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 100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg Primate (oral route)* 1/2 (50%) Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%) RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%) PrPres biochemical detection The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal. Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula http://www.thelancet.com/journal/journal.isa also have shared Mr Bradley’s surprise at the results because all the dose levels right down to 1 gram triggered infection. 2 6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate" experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley’s surprise at the results because all the dose levels right down to 1 gram triggered infection. Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts [BBC radio 4 FARM news] http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm 2) Infectious dose: To cattle: 1 gram of infected brain material (by oral ingestion) P.O. Box 42 Bacliff, Texas USA 77518 03-025IFA From: Terry S. Singeltary Sr. [flounder9@verizon.net] Sent: Thursday, September 08, 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle Greetings FSIS, I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ; SUB CLINICAL PRION INFECTION MRC-43-00 Issued: Monday, 28 August 2000 NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH FINDINGS RELEVANT TO CJD AND BSE P.O. Box 42 Bacliff, Texas USA 77518 9/13/2005 http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf V. Wiles , E. A. Grove , K. B. Ekelman , CVM, FDA, Rockville, MD Methods: We reviewed records for 203 firm-initiated recalls of animal drug and feed products from fiscal years 2000 to 2005 to identify the types of errors associated with recalled animal drug and feed products and to determine which recalled products and errors were associated with the highest levels of health hazards. The relative level of health hazard attributed to each recalled product by FDA is reflected in an assigned recall classification number (i.e., I, II, or III). Results: Of the 203 firm-initiated recalls of animal drug and feed products from fiscal years 2000 through 2005, 103 (approximately 51%) were for non-medicated feeds, 33 (approximately 16%) were for medicated feeds, and 64 (approximately 32%) were for animal drugs. For recalls of non-medicated feeds, 18% were classified as posing a high level of health hazard (recall classification I) and 76% were classified as posing a moderate health hazard (recall classification II). For recalls of medicated feeds, 13% were classified as posing a high level of health hazard and 53% were classified as posing a moderate level of health hazard. For recalls of animal drugs, 5% were classified as posing a high level of health hazard and 42% were classified as posing a moderate level of health hazard. The most common errors identified for recalls of non-medicated feeds were those related to the BSE rule. The most common errors identified for recalls of medicated feeds were incorrect levels of drugs in feeds or feeding medicated feeds to species or ages for which the drugs in the feeds were not approved. Other errors associated with recalls of non-medicated and medicated feeds included chemical or microbiological contamination, labeling errors, and general manufacturing errors. The most common errors associated with recalls of animal drugs were due to concerns about the drugs’ stability, sterility and labeling. Conclusions: CVM is using information from the analysis of the animal feed and drug products associated with 203 firm-initiated recalls from fiscal years 2000 through 2005 to help rank the relative risks from the products, manufacturing processes and facilities. Category: I. Risk Management, Risk Assessment,and Risk Communication for Medical Products and Foods http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/search/preview.cfm?abstract_id=838&backto=category BAB = BORN AFTER BAN BARB = BORN AFTER RUMINANT BAN MAMB = BORN AFTER MAMMALIAN BAN http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/200503canada/fig3desce.html NEW TSE TERM FOR FDA = BAWB I.E. 'BORN AFTER WHAT BAN' ;-(TSS)
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