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From: TSS ()
In Reply to: Docket: 2003N-0312 - Animal Feed Safety System; ... Request for Comments posted by TSS on August 3, 2006 at 1:06 pm:
BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 - 2006 compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE' 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 FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL http://www.fda.gov/ohrms/dockets/98fr/03d-0498-gdl0001.pdf 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: 2001 RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES 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_______________________ Non-Ruminant Custom Mix Feeds: END OF ENFORCEMENT REPORT FOR October 10, http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00714.html #### RECALL NUMBER, PRODUCT AND CODE: RECALL NUMBER, PRODUCT AND CODE: RECALL NUMBER, PRODUCT AND CODE: END OF ENFORCEMENT REPORT FOR July 04, 2001. RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS IIPRODUCT & CODES: 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/ENF00688.html 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 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.” 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. EMC 1 http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm CVM Update 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. 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 ; 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/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 2003 AS at August 8, 2006, the following rules to further enhance safety from feed containing mad cow ingredients were never implemented, just more lies and broken promises to cater to the industry. ... 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. CVM Update Update On Ruminant Feed (BSE) Enforcement Activities RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II _____________________________ END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 2003 ### http://www.fda.gov/bbs/topics/enforce/2003/ENF00781.html PRODUCT 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 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 ; Completed 50 feed recall events. Thirty-tree of the 50 recall events were feed related. Fifteen of the 33 recalls were related to BSE feed regulation; CVM Update November 2004 Update on Ruminant Feed (BSE) Enforcement Activities CVM Update July 2004 Update on Ruminant Feed (BSE) Enforcement Activities http://www.fda.gov/oc/oms/ofm/budget/2007/HTML/4AnimalDrugs.htm CVM Update July 9, 2004 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 ### PRODUCT > END OF ENFORCEMENT REPORT FOR APRIL 7, 2004 ### _______________________________ END OF ENFORCEMENT REPORT FOR APRIL 28, 2004 ### _______________________________ 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 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 RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II END OF ENFORCEMENT REPORT FOR SEPTEMBER 28, 2005 ### 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 New Orleans District Telephone: 615-781-5380 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 END OF ENFORCEMENT REPORT FOR July 12, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html ### ### ### 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. 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. [BBC radio 4 FARM news] 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 Background: The Center for Veterinary Medicine (CVM) is developing a risk-based inspection system to help ensure that regulatory resources are focused on the animal feed and drug products, manufacturing processes and facilities that pose the greatest risks to animal and human health. To help identify risk factors for animal feed and drug products, manufacturing processes and facilities, we analyzed 203 firm-initiated recalls of animal drug and feed products from fiscal years 2000 through 2005. A recall is a firm\'s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers. http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/search/preview.cfm?abstract_id=838&backto=category BARB = BORN AFTER RUMINANT BAN MAMB = BORN AFTER MAMMALIAN BAN http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/200503canada/fig3desce.html Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 CJD WATCH ----- Original Message ----- The meeting will be held Tuesday, September 12, 2006, in Meeting Room A third floor, at 7519 Standish Place, Rockville, MD 20855. For additional information, please contact Zoe Gill, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6867, Fax 240-453-6882 or email: zoe.gill@fda.hhs.gov. Prior to the public meeting, the FDA will place two documents in Docket No. 2003N-0312 entitled, “List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients” and “Determining Health Consequence Scoring for Feed Contaminants.” The documents will summarize the Agency’s methods for assigning animal and human Health Consequence Scoring to physical, chemical and biological contaminants that may be present in animal feed. Details of these methods will be discussed at the meeting. An agenda for the meeting will also be placed in docket. You may submit written comments to the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Two copies of written comments are to be submitted, except that individuals may submit one copy. Information on how to submit written or electronic comments can be found at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/FAQ.cfm?AGENCY=FDA#_Toc62455540. Due to limited meeting space, registration will be required. We strongly encourage early registration. Registration is by telephone, fax or e-mail. Please use the registration form to provide registration information (including name, title, firm name, address, telephone, and fax number) to Nanette Milton, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6840, Fax 240-453-6880 or email: nanette.milton@fda.hhs.gov. Federal Register Notice Registration Form Draft Agenda August 1, 2006 Meeting Materials List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients Determining Health Consequence Scoring for Feed Contaminants i. Bovine spongiform encephalopathy (BSE) ii. Chronic wasting disease (CWD) B. Microbiological Contaminants snip...end WHAT about the atypical TSE in the bovine in Texas and Alabama I.E. BASE ? WHAT about TME? DOES this mean all of the above are not any concern in animal feed? WHAT about blood? FOR IMMEDIATE RELEASE Expanded "Mad Cow" Safeguards Announced 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 being announced today 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. "Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk may already be, this is the time to make sure the public is protected to the greatest extent possible." "Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle. FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever before to protect the public against BSE by eliminating additional potential sources of BSE exposure." 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. First, 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. Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed. Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule. Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination. To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed. "We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan, "and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance." Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA 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 has 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 our public 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. FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition, FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm concerning possible changes to the animal feed rule. Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov. ### Approach: BASE in cattle in Italy of Identification of a second bovine amyloidotic sporadic Creutzfeldt-Jakob disease Chair: Dr. Jim Logan, Cheyenne, WY Vice Chair: Dr. Joe D. Ross, Sonora, TX Dr. Deborah L. Brennan, MS; Dr. Beth Carlson, ND; Dr. John R. Clifford, DC; Dr. Thomas F. Conner, OH; Dr. Walter E. Cook, WY; Dr. Wayne E. Cunningham, CO; Dr. Jerry W. Diemer, TX; Dr. Anita J. Edmondson, CA; Dr. Dee Ellis, TX; Dr. Lisa A. Ferguson, MD; Dr. Keith R. Forbes, NY; Dr. R. David Glauer, OH; Dr. James R. Grady, CO; Dr. William L. Hartmann, MN; Dr. Carolyn Inch, CAN; Dr. Susan J. Keller, ND; Dr. Allen M. Knowles, TN; Dr. Thomas F. Linfield, MT; Dr. Michael R. Marshall, UT; Dr. Cheryl A. Miller, In; Dr. Brian V. Noland, CO; Dr. Charles Palmer, CA; Dr. Kristine R. Petrini, MN; Mr. Stan Potratz, IA; Mr. Paul E. Rodgers, CO; Dr. Joan D. Rowe, CA; Dr. Pamela L. Smith, IA; Dr. Diane L. Sutton, MD; Dr. Lynn Anne Tesar, SD; Dr. Delwin D. Wilmot, NE; Dr. Nora E. Wineland, CO; Dr. Cindy B. Wolf, MN. The Committee met on November 9, 2005, from 8:00am until 11:55am, Hershey Lodge and Convention Center, Hershey, Pennsylvania. The meeting was called to order by Dr. Jim Logan, chair, with vice chairman Dr. Joe D. Ross attending. There were 74 people in attendance. The Scrapie Program Update was provided by Dr. Diane Sutton, National Scrapie Program Coordinator, United States Department of Agriculture (USDA), Animal and Plant Health Inspection Services (APHIS), Veterinary Services (VS). The complete text of the Status Report is included in these Proceedings. Dr. Patricia Meinhardt, USDA-APHIS-VS-National Veterinary Services Laboratory (NVSL) gave the Update on Genotyping Labs and Discrepancies in Results. NVSL conducts investigations into discrepancies on genotype testing results associated with the Scrapie Eradication Program. It is the policy of the Program to conduct a second genotype test at a second laboratory on certain individual animals. Occasionally, there are discrepancies in those results. The NVSL conducts follow-up on these situations through additional testing on additional samples from the field and archive samples from the testing laboratories. For the period of time from January 1, 2005, until October 15, 2005, there were 23 instances of discrepancies in results from 35 flocks. Of those 23 instances, 14 were caused by laboratory error (paperwork or sample mix-up), 3 results from field error, 5 were not completely resolved, and 1 originated from the use of a non-approved laboratory for the first test. As a result of inconsistencies, one laboratory’s certification was revoked by APHIS-VS. To reduce/eliminate these problems, the Program has placed additional quality requirements on the testing laboratories: additional review of final reports, additional coding systems for testing operations, strict follow-up and reports to NVSL on corrective actions, dual data entry systems, and more frequent inspections. The Agricultural Research Services (ARS) Scrapie Research Update was given by Janet Alverson, USDA- ARS. Dr. Alverson reported on the effect of multiple births and fetal position within the uterus on PrP-Sc accumulation in fetal cotyledons. Fetal cotyledons of fetuses with resistant genotypes can accumulate PrP-Sc when positioned next to a fetus of susceptible genotype with cotyledons positive for PrP-Sc accumulation. Scrapie Surveillance Evaluation Working Group Update was presented by Tracey Lynn, Epidemiologist with the National Surveillance Unit, Center for Epidemiology and Animal Health (CEAH). The presentation provided a background on evaluation, a quick review of analyses completed to date by the scrapie surveillance evaluation working group, and some of the preliminary findings. The process of surveillance system evaluation is undertaken to assist a disease control program with identifying possible improvements to their surveillance system, and includes an assessment of the overall utility of the system, identification of potential gaps in coverage, and an evaluation of the overall performance of the system. The scrapie surveillance evaluation working group reviewed the structure and processes of the scrapie surveillance program, as well as various quality and effectiveness measures. Overall, 98-99% of surveillance samples come from the Regulatory Scrapie Surveillance System (RSSS), so the RSSS system has been the primary focus of the evaluation process. The working group developed a flow chart indicating the flow of sheep through RSSS, which identified potential gaps in surveillance coverage, including custom kill plants and sheep being exported to Mexico. Spatial analyses can assist in identifying areas with high density sheep populations with lower levels of RSSS sampling. Identification compliance is being evaluated by reviewing reports from slaughter plants on the proportion of animals with appropriate identification. Additional analyses remain, including defining the most appropriate economic analyses, and comparing the surveillance system with developing surveillance standards. The working group hopes to have a draft written report for review by the end of the year. Giving the Update on Scrapie Diagnostics and Susceptibility was Katherine O’Roarke, Research Microbiologist, USDA-ARS. "What’s New in Scrapie" -- Biopsy sampling of the third eyelid or tonsillar lymphoid tissue is a useful live animal test for scrapie. The biopsy sample is examined for accumulation of the abnormal prion protein using immunohistochemistry. A joint project conducted by the Veterinary Laboratory Agencies and the Moredun Institute in the United Kingdom has developed an alternative technique in which tissue is collected from the narrow band of lymphoid tissue near the rectal-anal junction. The morphology of the lymphoid follicles is similar in the tonsil, retropharyngeal lymph nodes, third eyelid, and rectal-anal mucosal tissue. A report on more than 300 sheep in the United Kingdom (UK), prepared by Drs. Lorenzo Gonzalez and Jeffrey Martin, will describe the sensitivity, specificity, and optimal collection interval for this technique in a variety of breeds of British sheep. ARS has done a preliminary evaluation of the technique in US sheep. Samples of third eyelid and rectal-mucosal tissue were collected from 56 sheep. Forty-two (42) sheep had negative biopsies at both sites; most of these sheep have been necropsied and no PrP-d was found in retropharyngeal lymph node or tonsil, showing good agreement with the antemortem biopsies. Fourteen (14) sheep had positive rectal biopsy samples; of those, only 12 had positive eyelid biopsies. These sheep will be monitored for disease development. However, the protocol is identical for all samples and it is probable that these sheep represent false negative third eyelid results. Abstracts of reports on the UK studies indicate that sensitivity of the test was 70% in the UK; similar large scale testing on US sheep is necessary. The biopsy tissue is somewhat difficult to handle in the tissue processing laboratory and adaptation to an ELISA format may improve test performance. Alexia McKnight, Assistant Professor of Radiology, University of Pennsylvania, reviewed magnetic resonance imaging (MRI) diagnostics before the committee. A synopsis containing references is attached at the end of this report. Dr. McKnight asked the question, "could MRI be a cost-effective screening test, estimated at $25-30 each with results immediately available." The committee feels that it is not practical as compared to other alternatives currently available. However, the committee expressed interest in future reference to this technology. Dr. Diane Sutton lead the Uniform Methods and Rules (UM&R) and Regulatory Issues Discussion. Several modifications to the UM&R were discussed. Eight issues were identified and communicated to the APHIS scrapie program coordinator. The committee acknowledged that APHIS and the industry is adequately addressing the year-to-year industry concerns. Dr. Kris Petrini representing the North Central United States Animal Health Association District presented five recommendations to the Committee. During the discussions regarding these recommendations it was evident that all five issues had been addressed during the year at this Committee meeting. The Committee approved a recommendation that USDA-APHIS-VS continue to provide indemnity funds for animals that have been designated for testing in Flocks Under Investigation as an alternative to third eyelid testing after consultation with the designated Scrapie Epidemiologist (DSE) and the Regional Area Epidemiologist (RAE). The 2004 Resolutions along with their responses were reviewed by the Committee. A Resolution concerning premises registration and identification was approved by the Committee and forwarded to the Committee on Nominations and Resolutions. Committee on Scrapie Status Report-Fiscal Year 2005: Cooperative State-Federal Scrapie Eradication Program Submitted by Diane Sutton, DVM and Gary Ross, DVM National Center for Animal Health Programs, APHIS, USDA In Fiscal Year 2005 the Scrapie Eradication Program focused on: (1) utilization of a genetic based approach to flock clean-up plans; (2) cleaning up infected and source flocks; (3) tracing and testing exposed animals and flocks; (4) expansion of regulatory slaughter surveillance (RSSS); (5) conducting considtent state reviews, (6) producer education; (7) upgrading of the Scrapie National Generic Database and (8) publishing the updated Scrapie Eradication Uniform Methods and Rules (UM&R). The current Scrapie Eradication UM&R is posted at http://www.aphis.usda.gov/vs/nahps/scrapie/umr-scrapie-erad.pdf. Consistent State Reviews States must meet the requirements in 9 CFR 79.6 in order to move sheep and goats in interstate commerce with minimal restrictions. Twenty seven states have enacted the required identification rules, the remaining states have submitted a work plan that describes the steps that will be taken to comply and provided a timeline for completing significant milestones. USDA is conducting onsite scrapie program consistent state reviews and has completed reviews in 12 states. States must be in full compliance by the end of their current rule making cycle. States not in full compliance at that time will be removed from the consistent state list. Removal from the list would create a significant impact on the interstate movement of sheep and goats from those States. Scrapie Flock Certification Program As of September 30, 2005, there were 1,961 flocks participating in the Scrapie Flock Certification Program (SFCP). Of these flocks 188 were certified flocks, 1,770 were complete monitored flocks, and 3 were selective monitored flocks (figure 2). There were 209 flocks newly enrolled and 53 newly certified (13 with status dates in FY 2005 and 40 with status dates in previous years) in FY 2005 (figure 3). Infected and Source Flocks As of September 30, 2005, there were 105 scrapie infected and source flocks. There were a total of 165** new infected and source flocks reported for FY 2005. The total infected and source flocks that have been released in FY 2005 was 128. The ratio of infected and source flocks cleaned up or placed on clean up plans vs. new infected and source flocks discovered in FY 2005 was 1.03 : 1*. In addition 622 scrapie cases were confirmed and reported by the National Veterinary Services Laboratories (NVSL) in FY 2005, of which 130 were RSSS cases. Fifteen cases of scrapie in goats have been reported since 1990. The last goat case was reported in May 2005. Approximately 5,626 animals were indemnified comprised of 49% non-registered sheep, 45% registered sheep, 1.4% non-registered goats and 4.6% registered goats. Regulatory Scrapie Slaughter Surveillance (RSSS) RSSS was designed to utilize the findings of the Center for Epidemiology and Animal Health (CEAH) Scrapie: Ovine Slaughter Surveillance (SOSS) study. The results of SOSS can be found at http://www.aphis.usda.gov/vs/ceah/cahm/Sheep/sheep.htm . RSSS started April 1, 2003. It is a targeted slaughter surveillance program which is designed to identify infected flocks for clean-up. During FY 2005 collections increased by 32% overall and by 90% for black and mottled faced sheep improving overall program effectiveness and efficiency as demonstrated by the 26% decrease in percent positive black faced sheep compared to FY 2004. Samples have been collected from 62,864 sheep since April 1, 2003, of which results have been reported for 59,105 of which 209 were confirmed positive. During FY 2005, 33,137 samples were collected from 81 plants. There have been 130 NVSL confirmed positive cases (30 collected in FY 2004 and confirmed in FY 2005 and 100 collected and confirmed in FY 2005) in FY 2005. Face colors of these positives were 114 black, 14 mottled, 1 white and 1 unknown. The percent positive by face color is shown in the chart below. Scrapie Testing In FY 2005, 35,845 animals have been tested for scrapie: 30,192 RSSS; 4,742 regulatory field cases; 772 regulatory third eyelid biopsies; 10 third eyelid validations; and 129 necropsy validations (chart 9). Animal ID As of October 04, 2005, 103,580 sheep and goat premises have been assigned identification numbers in the Scrapie National Generic Database. Official eartags have been issued to 73,807 of these premises. *This number based on an adjusted 12 month interval to accommodate the 60 day period for setting up flock plans. Proc. Natl. Acad. Sci. USA, 10.1073/pnas.0502296102 A newly identified type of scrapie agent can naturally infect sheep with resistant PrP genotypes ( sheep prion | transgenic mice ) Annick Le Dur *, Vincent Béringue *, Olivier Andréoletti , Fabienne Reine *, Thanh Lan Laï *, Thierry Baron , Bjørn Bratberg ¶, Jean-Luc Vilotte ||, Pierre Sarradin **, Sylvie L. Benestad ¶, and Hubert Laude * Scrapie in small ruminants belongs to transmissible spongiform encephalopathies (TSEs), or prion diseases, a family of fatal neurodegenerative disorders that affect humans and animals and can transmit within and between species by ingestion or inoculation. Conversion of the host-encoded prion protein (PrP), normal cellular PrP (PrPc), into a misfolded form, abnormal PrP (PrPSc), plays a key role in TSE transmission and pathogenesis. The intensified surveillance of scrapie in the European Union, together with the improvement of PrPSc detection techniques, has led to the discovery of a growing number of so-called atypical scrapie cases. These include clinical Nor98 cases first identified in Norwegian sheep on the basis of unusual pathological and PrPSc molecular features and "cases" that produced discordant responses in the rapid tests currently applied to the large-scale random screening of slaughtered or fallen animals. Worryingly, a substantial proportion of such cases involved sheep with PrP genotypes known until now to confer natural resistance to conventional scrapie. Here we report that both Nor98 and discordant cases, including three sheep homozygous for the resistant PrPARR allele (A136R154R171), efficiently transmitted the disease to transgenic mice expressing ovine PrP, and that they shared unique biological and biochemical features upon propagation in mice. These observations support the view that a truly infectious TSE agent, unrecognized until recently, infects sheep and goat flocks and may have important implications in terms of scrapie control and public health. Author contributions: H.L. designed research; A.L.D., V.B., O.A., F.R., T.L.L., J.-L.V., and H.L. performed research; T.B., B.B., P.S., and S.L.B. contributed new reagents/analytic tools; V.B., O.A., and H.L. analyzed data; and H.L. wrote the paper. A.L.D. and V.B. contributed equally to this work. To whom correspondence should be addressed. Hubert Laude, E-mail: laude@jouy.inra.fr www.pnas.org/cgi/doi/10.1073/pnas.0502296102 snip... A The Present Position with respect to Scrapie Scrapie is a natural disease of sheep and goats. It is a slow The field problem has been reviewed by a MAFF working group It is clear that scrapie in sheep is important commercially and Recently the question has again been brought up as to whether Whether true or not. the hypothesis that these agents might be snip... 76/10.12/4.6 http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf Neurobiology Edited by D. Carleton Gajdusek, Centre National de la Recherche There is substantial scientific evidence to support the notion that bovine Evidence of a molecular barrier limiting G.J. Raymond1, A. Bossers2, L.D. Raymond1, K.I. O?Rourke3, 1NIAID/NIH Rocky Mountain Laboratories, Hamilton, MT 59840, Abstract Chronic wasting disease (CWD) is a transmissible snip... Clearly, it is premature to draw firm conclusions about CWD snip... http://www.emboj.org/current.shtml Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC. Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of As of May 31, 2006, there were 93 scrapie infected and source flocks (Figure 3). There were 12 new infected and source flocks reported in May (Figure 4) with a total of 67 flocks reported for FY 2006 (Figure 5). The total infected and source flocks that have been released in FY 2006 are 53 (Figure 6), with 7 flocks released in May. The ratio of infected and source flocks released to newly infected and source flocks for FY 2006 = 0.79 : 1. In addition, as of May 31, 2006, 216 scrapie cases have been confirmed and reported by the National Veterinary Services Laboratories (NVSL), of which 33 were RSSS cases (Figure 7). This includes 33 newly confirmed cases in May 2006 (Figure 8). Eighteen cases of scrapie in goats have been reported since 1990 (Figure 9). The last goat case was reported in March 2006. New infected flocks, source flocks, and flocks released for FY 2006 are depicted in Chart 3. New infected and source statuses from 1997 to 2006 are depicted in Chart 4. snip... Scrapie Testing In FY 2006, 26,185 animals have been tested for scrapie : 22,634 RSSS*; 2063 regulatory field cases; 61 necropsy validations, 5 rectal biopsy and 1427 regulatory third eyelid biopsies (Chart 9). ... snip...END http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.html DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr20jy00-31 DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [2] http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr20jy00-32 Mink pelt production in the United States in 2005 totaled The number of pelts by color class as a percent of the total U.S. Value of Pelt Production Up 33 Percent Mink pelts produced during the 2005 crop year were valued at http://usda.mannlib.cornell.edu/reports/nassr/other/zmi-bb/mink0706.pdf http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_ahtme.html Authors Hamir, Amirali Technical Abstract: Raccoons (Procyon lotor) are omnivorous and their diet may include carrion. It is, therefore, possible that in the wild they may get exposed to carcasses of animals with transmissible spongiform encephalopathies (TSEs). To determine the susceptibility of raccoons to transmissible mink encephalopathy (TME), scrapie, and chronic wasting disease (CWD), each of these agents was inoculated intracerebrally into a group of 4 kits. Three uninoculated kits served as controls. All raccoons in the TME-inoculated group developed neurologic signs and were euthanized within 6 months post inoculation (PI). In the scrapie-inoculated group, 3 animals became sick and were euthanized between 18 - 22 PI. Although the fourth raccoon in this group did not show any clinical signs, it was euthanized at 24 months PI. At necropsy all clinically affected raccoons had extensive microscopic lesions of spongiform encephalopathy and protease-resistant prion protein (PrPres) was detected in the CNS by immunohistochemistry and Western blot. In the CWD-inoculated group, 1 raccoon was euthanized at 39 months PI because of severe cystitis. Its brain was negative for PrPres. At present, 5 years PI, the 3 remaining CWD-inoculated raccoons are alive and apparently healthy. They will be kept under observation for further period of 1 year (i.e 6 years PI) when the experiment will be terminated. These preliminary findings demonstrate that TME and scrapie can be transmitted to raccoons within 6 months and 2 years, respectively, whereas CWD cannot. Based on these incubation periods, it may be possible to differentiate these 3 TSEs. Such a laboratory model would be relatively simple, fast and inexpensive for strain-typing of unknown TSEs in the United States. Now that the relative susceptibiity to IC transmission of each TSE has been established, oral transmission studies of TSEs to raccoons are planned. Last Modified: 07/14/2006 Title: Experimental Transmission of Transmissible Mink Encephalopathy (Tme) to Cattle by Intracerebral Inoculation Hamir, Amirali Technical Abstract: To compare clinicopathological findings of transmissible mink encephalopathy (TME) with other transmissible spongiform encephalopathies (TSE, prion diseases) that have been shown to be experimentally transmissible to cattle (sheep scrapie, and chronic wasting disease, CWD), 2 groups of calves (n = 4 each) were intracerebrally inoculated with TME agents from 2 different sources (mink with TME and a bovine with TME). Two uninoculated calves served as controls. Within 15.3 months post inoculation (PI), all animals from both inoculated groups developed clinical signs of central nervous system (CNS) abnormality; their CNS tissues had microscopic spongiform encephalopathy (SE); and PrP**res was detected in their CNS tissues by immunohistochemistry (IHC) and Western blot (WB) techniques. These findings demonstrate that intracerebrally inoculated cattle not only amplify TME PrP**res but also develop clinical CNS signs and extensive lesions of SE. The latter has not been shown with other TSE agents (scrapie and CWD) similarly inoculated into cattle. The findings also suggest that the diagnostic techniques currently used for confirmation of bovine spongiform encephalopathy (BSE) would detect TME in cattle should it occur naturally. However, it would be a diagnostic challenge to differentiate TME in cattle from BSE. Our recent preliminary results indicate that WB may be able to differentiate between bovine TME and BSE. Title: First and Second Cattle Passage of Transmissible Mink Encephalopathy (Tme) by Intracerebral Inoculation Hamir, Amirali Interpretive Summary: Transmissible mink encephalopathy (TME) is a fatal neurologic disease. It is similar to bovine spongiform encephalopathy (BSE) or mad cow disease. To compare TME infection with other similar diseases in cattle, 2 groups of calves were inoculated in the brain with TME agents from 2 different sources. Two uninoculated calves served as controls. Within 15.3 months post inoculation, animals from both inoculated groups developed clinical signs of central nervous system (CNS) abnormality. Laboratory tests revealed lesions and presence of the TME agent in their tissues. Both findings could not be differentiated from those seen in BSE. Our findings also demonstrated that the laboratory tests that are currently used for BSE surveillance would detect TME in cattle should it occur naturally. However, it would be a diagnostic challenge to differentiate TME in cattle from BSE by clinical signs or laboratory tests that are currently available. Results of this study will have an impact on directing future research on TSEs to search for specific laboratory tests to differentiate BSE from TME in cattle. EXECUTIVE SUMMARY SECTION TWO INTRODUCTION AND PROFILE OF THE MEAT ANIMAL PRODUCING, SLAUGHTERING, AND RENDERING INDUSTRIES The U.S. Food and Drug Administration (FDA) is considering regulatory options to reduce the risk of an outbreak of transmissible spongiform encephalopathies (TSE) in the United States. In the United Kingdom, one form of TSE, bovine spongiform encephalopathy (BSE), is believed to be linked to cattle feed containing rendered protein by-products from sheep and goats infected with scrapie, a disease that is related to BSE. The FDA regulatory actions will affect a spectrum of agricultural producers including renderers, slaughterers, animal producers, and animal feed producers. After introducing the FDA options under consideration (see Section 2.1), this discussion introduces the various industry components and discusses their composition, size, and scale of economic activity. Among the affected animal producers are cattle, sheep, and goat producers. 2.1 THE PROPOSED FDA REGULATION FDA is considering five regulatory options: # A prohibition on all mammalian protein in ruminant feed. # A prohibition of all ruminant protein in ruminant feed. # A prohibition on the inclusion of designated tissues in ruminant feed. This option specifies that ruminant feed is not generally recognized as safe if it includes (1) bovine brain, spinal cord, distal ileum, and eyes; (2) any and all protein that is derived from any portions of the ovine (sheep family), caprine (goat family), cervine (deer family), and mink; or (3) dead, dying, disabled, or diseased bovine. # A prohibition on the inclusion of protein derived from sheep (including lamb), goats, deer, elk, and mink in ruminant feed. # A prohibition on the inclusion of protein derived from sheep (including lamb) and goats in ruminant feed. Under these prohibitions, any component of ruminant feed containing prohibited ingredients will be considered adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act. The regulatory options would not place restrictions on the use of ruminant protein by-products for uses other than as an ingredient in ruminant feed nor would they restrict the use of ruminant derived fats and tallows. 2.2 PROFILE OF CATTLE RANCHERS snip... 2.8 PROFILE OF MINK PRODUCERS Mink are raised for their pelts and oil. Most mink farmers kill and pelt their own animals once a year near the end of November or in early December. Once the pelts are removed, the fat is then scrapped from the hide. This fat is used to manufacture mink oil that is sought for cosmetic uses because of its hypoallergenic qualities and in leather treatments. The total value of mink production in 1995 was $143 million, an increase of 72 percent from 1994. In 1995, 446 mink farms produced a total of 2.69 million pelts (NASS, 1996b). Mink producers vary in size but most are small operations. Mink farming is concentrated in Utah (130 2-11 farms), Wisconsin (77 farms), and Minnesota (52 farms). There has been recent consolidation within the industry, with the number of farms decreasing by 8 percent from 1993 to 1994 and 3 percent from 1994 to 1995. The market price for mink pelts is subject to wide demand fluctuations based on fashion and weather. Once the pelt and fat are removed, the entire carcass is then rendered. Mink carcasses sent to rendering (minus the pelt and fat) weigh an average of 2.5 pounds, so the total estimated offal produced per year is 6.7 million pounds. Mink farmers are reported to have difficulty with getting renderers to pick-up their material because of its low volume and the infrequency of offal generation. bse3 http://www.fda.gov/cvm/Documents/bse3.pdf Re: Docket No. 04-047-1, Federal Measures To Mitigate BSE Risks: snip... Further, Wisconsin has over 60 mink ranches, whose main food source is also Thursday June 5, 1997 Department of Health and Human Services Food and Drug Administration 21 CFR Part 589 Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 589 [Docket No. 2002N-0273] (formerly Docket No. 02N-0273) AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is proposing to amend DATES: Submit written or electronic comments by December 20, 2005. ECONOMIC IMPACTS OF _PROPOSED_ FDA REGULATORY CHANGES TO REGULATION OF ANIMAL FEEDS DUE TO RISK OF BOVINE SPONGIFORM ENCEPHALOPATHY FINAL REPORT Contract No. 223-03-8500 Task Order 3 Submitted to: Economics Staff Office of Policy and Planning Office of the Commissioner Food and Drug Administration Rockville, MD 20857 Submitted by: Eastern Research Group, Inc. 110 Hartwell Ave. Lexington, MA 02421 July 25, 2005 SECTION ONE FDA is considering a modification to its rules governing animal feed by supplementing or expanding the 1997 rule restricting the feeding of mammalian protein (except for porcine and equine protein) to ruminant animals. In the regulatory option under study in this report, FDA has defined prohibited cattle material (PCM) and would prohibit it from use in all animal feeds. PCM consists of the brain and spinal cord of: • Slaughter cattle 30 months of age or older, • All non-ambulatory disabled cattle, • All cattle that died other than from slaughter, and • Mechanically separated beef from cattle from which prohibited cattle materials (i.e., brain and spinal cord) were not removed. These materials are not to be used in animal feed. Additionally, tallow that contains any PCM is considered PCM. All other tallow must meet purity requirements. No more than 0.15 percent hexane-insoluble impurities can be contained in tallow used in feed under the option considered. This study examines the impacts of this regulatory option on the affected agricultural and food industries. In so doing, it extends previous research performed by ERG on several other regulatory alternatives FDA is considering. In particular, ERG’s report of August 2004 examined different versions of an extended feed ban. Those regulatory options would prohibit a larger volume of cattle material from animal feed. FDA’s PCM alternative will directly prohibit a small share of animal offal from production of meat and bone meal (MBM) and tallow. The brain and spinal cord of an average slaughter cow weighs only 1.3 lbs. Slaughterers and renderers both have or can acquire the capability to remove such materials from the animals they process. Nevertheless, both slaughterers and renderers will often remove a larger share of the animal offal because (1) slaughterers generally cannot distinguish the age of an animal sufficiently early to affect processing, (2) independent renderers might require that their slaughter clients remove the entire skull for all animals in order to be sure that no brain materials are included in the offal they pickup, and (3) independent renderers that pick up deads and downers1 might have to remove the entire spinal column (not just the spinal cord) if the carcass has deteriorated, as is often the case in summer. The eventual disposition of PCM under this regulatory structure is uncertain. Some landfills might accept modest quantities of brain and spinal cords without further processing. More likely, some new disposal infrastructure will need to evolve in which PCM materials are processed through chemical digester units or rendered prior to disposal. Newly emergent commercial entities or existing renderers might fill this gap. Because the volumes of materials generated is not sufficiently large for efficient processing (relative to the flows for other agricultural materials 1 The term downer is used, although the animal must be humanely euthanized prior to transporting. 1-3 like renderable animal offal), disposal or rendering for disposal charges for these materials will exceed current costs for rendering. ERG used an assumed charge of $12 per hundredweight for disposal or rendering for disposal. Using the assumptions and estimates of the PCM quantities withdrawn from productive use, the overall impact of the regulatory option on slaughtering and rendering processes is modest. The amount of material removed from the rendering stream amounts to 0.1 percent of MBM production and less than 0.1 percent of tallow production. ERG also estimates the costs of meeting tallow purity requirements and the costs for renderers to add equipment and labor to remove PCM from cattle prior to processing deads and downers. Total compliance costs are estimated at $15.9 million, as shown in Table ES-1. http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0273-bkg0001-44-Ref-25-.pdf ECONOMIC IMPACTS OF _ALTERNATIVE_ CHANGES TO THE FDA REGULATION OF ANIMAL FEEDS TO ADDRESS THE RISK OF BOVINE SPONGIFORM ENCEPHALOPATHY FINAL REPORT Contract No. 223-98-8002 Task Order 12 Submitted to Economics Staff Office of Policy and Planning Office of the Commissioner Food and Drug Administration Rockville, MD 20857 Submitted by: Eastern Research Group, Inc. 110 Hartwell Ave. Lexington, MA 02421 July 25, 2005 FDA considered modifying its rules governing animal feed by supplementing or expanding the 1997 rule restricting the feeding of mammalian protein (except for porcine and equine protein) to ruminant animals. As one alternative, FDA considered prohibiting the following: • Specified risk materials (SRM), • Mechanically separated (MS) beef, • Materials from dead or non-ambulatory cattle or from cattle that died by means other than slaughter at an inspected slaughter establishment, and • Tallow containing more than 0.15 percent hexane-insoluble impurities from inclusion in any animal feed. This study examines the impacts of these items on the affected agricultural and food industries. Audit Report Animal and Plant Health Inspection Service Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II and Food Safety and Inspection Service Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III Animal and Plant Health Inspection Service - Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and Food Safety and Inspection Service - Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III Results in Brief This report evaluates elements of the interlocking safeguards in place to protect United States (U.S.) beef from Bovine Spongiform Encephalopathy, widely known as BSE or "mad cow disease." Since 1990, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), has led a multi-agency effort to monitor and prevent BSE from entering the food supply. After discovering a BSE-positive cow in December 2003, APHIS expanded its BSE surveillance program. To further protect the food supply, USDA banned materials identified as being at risk of carrying BSE (specified risk materials (SRM)), such as central nervous system tissue. As part of this effort, USDA’s Food Safety and Inspection Service (FSIS) required beef slaughter and processing facilities to incorporate controls for handling such materials into their operational plans. Onsite FSIS inspectors also inspect cattle for clinical signs in order to prevent diseased animals from being slaughtered for human consumption. To evaluate the effectiveness of the safeguards, we assessed APHIS’ implementation of the expanded surveillance program, as well as FSIS’ controls to prevent banned SRMs from entering the food supply. In June 2004, APHIS implemented its expanded surveillance program; participation by industry in this surveillance program is voluntary. As of May 2005, over 350,000 animals were sampled and tested for BSE. To date, two animals tested positive for BSE; one tested positive after implementation of the expanded surveillance program. USDA made significant efforts to implement the expanded BSE surveillance program. Much needed to be done in a short period of time to establish the necessary processes, controls, infrastructure, and networks to assist in this effort. In addition, extensive outreach and coordination was undertaken with other Federal, State, and local entities, private industry, and laboratory and veterinary networks. This report provides an assessment as to the progress USDA made in expanding its surveillance effort and the effectiveness of its controls and processes. This report also discusses the limitations of its program and data in assessing the prevalence of BSE in the U.S. herd. Surveillance Goals and Objectives In March 2004, USDA published its plan to expand the BSE surveillance program. The plan’s goal was to collect samples from as many adult1 cattle from the high-risk population as possible in 12-18 months while ensuring that there was statistically appropriate geographical representation of the adult cattle population in the United States. Overall, USDA designed the program to define whether BSE was actually present in the U.S. cattle population and if so, to what level. When USDA published its plan, Office of Inspector General (OIG) was examining the pre-expansion program. In anticipation of the coming changes, we reviewed the plan in order to determine if its design would allow the Department to reach statistically valid conclusions about the presence and level of BSE. Since the implementation plan had not been finalized, we provided recommendations for USDA to consider as they moved forward with implementing an expanded surveillance program. In August 2004, we released our report, Animal and Plant Health Inspection Service and Food Safety and Inspection Service, Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase I (Report No. 50601-9-KC), which discussed our observations of the challenges USDA faced in meeting its stated goals and made 19 recommendations for USDA to consider as it moved forward with implementation. Our prior report primarily focused on (1) the potential for unwarranted statistical conclusions to be drawn from the data USDA planned to collect, and (2) the challenges in identifying and testing high-risk cattle. In response to our report, APHIS agreed to disclose the limitations of the data and the assumptions made and its impact on any statistical representations regarding the prevalence of BSE in order to obviate misinterpretation. We reviewed the specific corrective actions APHIS and FSIS agreed to take in response to prior audit recommendations during this audit. In this report, we discuss the specific areas where corrective actions were not fully effective in addressing our concerns in the following areas: obtaining representative samples, identifying and obtaining samples from the high-risk surveillance streams, and completeness and accuracy of program data. APHIS has provided OIG unpublished drafts of its preliminary analysis, which included various statistical approaches to determining the prevalence of BSE. In general, each approach mitigates some, but not all of the limitations associated with its data and underlying assumptions in the design and implementation of its surveillance program. Some of the approaches also 1 FSIS considers bulls and cows to be mature cattle with cows ordinarily having given birth to one or more calves. FSIS defines SRMs to be present in cattle 30 months of age or older, while APHIS defines its target population for BSE sampling to be over 30 months of age. Dentition is used to estimate the age ranges of cattle. Dentition is the development of teeth and their arrangement in the mouth. USDA/OIG-A/50601-10-KC/ Page iii introduce new challenges because any conclusions are extremely sensitive to the accuracy of the underlying data. The accuracy of the underlying data is also critical to the development of a future maintenance surveillance program. We cannot fully assess any of the approaches being considered by APHIS since it has not finalized its analysis. In Finding 1, however, we do offer several observations for APHIS to consider as it develops its conclusions about the prevalence of BSE in the U.S. cattle population. Inherent Limitations in Identifying and Testing High-Risk Cattle APHIS obtained significantly more samples for testing than they originally anticipated would be needed to achieve its stated level of confidence in estimating the prevalence of BSE in the U.S. herd. Because of the voluntary nature of its program, however, we could not determine how successful APHIS was in obtaining a representative proportion of high-risk cattle for testing. Our prior report recognized the significant challenges for APHIS to obtain samples from the high-risk population because of the inherent problems with obtaining voluntary compliance and transporting carcasses for testing. APHIS took steps to obtain facilitated pathways, by entering into over 100 agreements, to collect and test brain samples for BSE. However, using USDA published data that estimates the distribution of the cattle population, as well as those that died or became nonambulatory, we could not determine whether APHIS achieved either geographical representation or representation of the desired surveillance stream (clinical suspects, fallen stock, casualty slaughter fallen stock, and routine slaughter). Findings 1 and 2 present the conditions noted that impact this evaluation. USDA Testing Protocols and Quality Assurance Procedures In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE. Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that USDA/OIG-A/50601-10-KC/ Page iv conducting additional tests would undermine confidence in USDA’s testing protocols. OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results. To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test. We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4. Controls (Firewalls) to Prevent BSE in the Food Supply USDA instituted proactive procedures to prevent tissues and products that could possibly contain the infective agent for BSE from entering the food supply. FSIS performs inspections on cattle before slaughter (ante mortem) to observe clinical signs that may indicate a central nervous system disorder or other signs that may be associated with BSE. Such animals are condemned and prohibited from slaughter for human consumption. FSIS also identified high-risk beef tissue and products as SRMs, and banned them from the food supply. FSIS inspects slaughter processes to verify that slaughterhouses have incorporated controls for handling SRMs into their operational plans; adequate procedures must be in place for removing, segregating, and disposing of SRMs. OIG reviewed the SRM plans of several establishments, observed FSIS inspection procedures, and evaluated the effectiveness of controls during the slaughter process. We did not identify SRMs entering the food supply. However, due to the lack of adequate records, we could not determine whether SRM procedures were followed and/or were adequate in 9 of 2 For purposes of this report, the term renderers also includes pet food manufacturers and plants that handle dead, dying, disabled, or diseased livestock. 3 9 CFR 320.5, states that every person that engages in business in or for commerce, as a meat broker, renderer, or animal food manufacturer … shall register with the Administrator [of FSIS]. 12 establishments visited during the audit. There is no requirement in the United States for the age of animals to be recorded, therefore, APHIS and FSIS rely on meat establishments to determine the age of cattle slaughtered using documentation or dentition. SRM restrictions apply predominantly to cattle 30 months of age or older. FSIS periodically checks the accuracy of age determinations through dentition; however, we could not determine how often these checks are made. We found that improvements can be made in the following areas. • Several of the establishments did not comply with their SRM plans and/or maintain records to support that they follow their plans. FSIS has addressed the specific cases of noncompliance identified during the audit. Findings 5 through 9 discuss our assessment of the effectiveness of USDA’s firewalls. Other Program Administration Issues FSIS and APHIS did not maintain current and comprehensive listings of renderers2 and related businesses. These entities are required to register with FSIS as a condition of engaging in business.3 As a result, should serious animal diseases be detected in the United States, USDA’s ability to quickly determine and trace the source of infections to prevent the spread of the disease could be impaired. Also, APHIS could not use the registrations to identify potential sources to mitigate geographical gaps in BSE testing. We discuss the details of this issue in Finding 11. We also determined that an APHIS area office paid costs for sampling and carcass transportation, storage, and disposal that exceeded national cost recovery guidelines and/or that were ineligible for reimbursement. The area office entered into 10 reimbursable agreements before national office cost recovery guidelines had been issued but did not adjust the agreements afterwards although instructed to do so by the national office. Instead, the area office included the questionable costs in amounts proposed (by USDA/OIG-A/50601-10-KC/ Page vi third parties) in other allowable cost categories. The area office official stated he changed supporting records because he believed he should honor the prior negotiated costs. As a result, at least $1.2 million of about $11.2 million paid were unsupported program costs. Finding 12 more fully examines the unsupported costs and why they went undiscovered. The expanded stage of USDA’s BSE surveillance program is nearing its end. Accordingly, it is vital that the conditions summarized above be considered as USDA uses the data gathered to design an effective BSE surveillance maintenance program and to report its assessment of the prevalence of BSE in the U.S. herd. In particular, APHIS must develop testing protocols which are grounded in science and flexible enough to adapt to changing circumstances. For its part, FSIS must ensure that it effectively monitors SRM handling practices to ensure they comply with Federal regulations. Implemented, these management controls will help USDA continue to effectively safeguard the U.S. beef supply for consumers. SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM p.s. please note the 47 PENDING CASES to Sept. 2005 p.s. please note the 2005 Prion D. total 120(8) p.s. please note sporadic CJD 2002(1) 1=3 TYPE UNKNOWN??? p.s. please note 2004 prion disease (6) 6=7 TYPE END OF ENFORCEMENT REPORT FOR July 12, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html New Orleans District Telephone: 615-781-5380 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 May 9, 2006 April 2006 Update on Feed Enforcement Activities to Limit the Spread of BSE 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, here called the Ruminant Feed Ban, became effective on August 4, 1997. This is an update on FDA enforcement activities regarding the ruminant feed ban. FDA's CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA's inspection database as of April 29, 2006. As of April 29, 2006, FDA had received over 44,000 inspection reports. The majority of these inspections (around 68%) were conducted by State feed safety officials, with the remainder conducted by FDA officials. Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI). An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented. A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban. These include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds. An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions. 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 – 266 LICENSED 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 the Ruminant Feed Ban. Number of active firms whose initial inspection has been reported to FDA – 1,092 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 – 5,128 Of the 2,176 active firms handling prohibited materials, their most recent inspection revealed that: PROTEIN BLENDERS These firms blend rendered animal protein for the purpose of producing quality feed ingredients that will be used by feed mills. Number of active firms whose initial inspection has been reported to FDA -- 340 RENDERERS, FEED MILLS, AND PROTEIN BLENDERS This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients. Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,558 Of the 491 of active renderers, feed mills, and protein blenders processing with prohibited materials, their most recent inspection revealed that: 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 – 14,627 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 – 17,454 Issued by: Subject: 15,323 TONS OF POTENTIAL TAINTED TSE RUMINANT PROTEIN WITHOUT MAD COW FEED WARNING IN CIRCULATION 4 STATES ______________________________ FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds. It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated. According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE." Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual. ... snip... 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. 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. [BBC radio 4 FARM news] http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm To cattle: 1 gram of infected brain material (by oral ingestion) Terry S. Singeltary Sr. 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 ======================================================== OLD TSS SUBMISSIONS; https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Comment Number: EC -10 Accepted - Volume 2 PART 2 PDF]Freas, William TSS SUBMISSION File Format: PDF/Adobe Acrobat - Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ... genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest _sporadic_ CJD; Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm [PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1 Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION] http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt # Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of Docket Management Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305 http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm Dockets Entered On October 2, 2003 Table of Contents, Docket #, OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr. http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm Daily Dockets Entered on 02/05/03 DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2. 03N-0009 Federal Preemption of State & Local Medical Device Requireme. ... Docket Management Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater Comment Number: EC -1 Accepted - Volume 1 Daily Dockets - 04/10/03 ... 00D-1662 Use of Xenotransplantation Products in Humans. EMC 1 http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm 2003D-0186 2003D-0186 APE 5 National Renderers Association, Inc. Vol#: 2 APE 6 Animal Protein Producers Industry Vol#: 2 APE 7 Darling International Inc. Vol#: 2 EMC 1 Terry S. Singeltary Sr. Vol#: 3 http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm disease in the United States comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc? LANCET INFECTIOUS DISEASE JOURNAL My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my mom to hvCJD (Heidenhain variant CJD) and have been searching for answers ever since. What I have found is that we have not been told the truth. CWD in deer and elk is a small portion of a much bigger problem. largely unsatisfied after being told that a close relative died from a rapidly progressive dementia compatible with spontaneous Creutzfeldt-Jakob disease (CJD). So he decided to gather hundreds of documents on transmissible spongiform encephalopathies (TSE) and realised that if Britons could get variant CJD from bovine spongiform encephalopathy (BSE), Americans might get a similar disorder from chronic wasting disease (CWD)the relative of mad cow disease seen among deer and elk in the USA. Although his feverish search did not lead him to the smoking gun linking CWD to a similar disease in North American people, it did uncover a largely disappointing situation. occurrence of CJD and CWD in the USA. Only a few states have made CJD reportable. Human and animal TSEs should be reportable nationwide and internationally , he complained in a letter to the Journal of the American Medical Association (JAMA 2003; 285: 733). I hope that the CDC does not continue to expect us to still believe that the 85% plus of all CJD cases which are sporadic are all spontaneous, without route or source. region in Colorado. But since early 2002, it has been reported in other areas, including Wisconsin, South Dakota, and the Canadian province of Saskatchewan. Indeed, the occurrence of CWD in states that were not endemic previously increased concern about a widespread outbreak and possible transmission to people and cattle. transmitted to cattle by intracerebral inoculation and that it can cross the mucous membranes of the digestive tract to initiate infection in lymphoid tissue before invasion of the central nervous system. Yet the plausibility of CWD spreading to people has remained elusive. is only reported in those areas known to be endemic foci of CWD. Moreover, US authorities have been criticised for not having performed enough prionic tests in farm deer and elk. issued a directive to state public-health and agriculture officials prohibiting material from CWD-positive animals from being used as an ingredient in feed for any animal species, epidemiological control and research in the USA has been quite different from the situation in the UK and Europe regarding BSE. teeth , Singeltary argues. You get it when they want you to have it, and only what they want you to have. University of Michigan (Ann Arbor, MI, USA), says that current surveillance of prion disease in people in the USA is inadequate to detect whether CWD is occurring in human beings ; adding that, the cases that we know about are reassuring, because they do not suggest the appearance of a new variant of CJD in the USA or atypical features in patients that might be exposed to CWD. However, until we establish a system that identifies and analyses a high proportion of suspected prion disease cases we will not know for sure . The USA should develop a system modelled on that established in the UK, he points out. reported the cases of three hunterstwo of whom were friendswho died from pathologically confirmed CJD, says that at present there are insufficient data to claim transmission of CWD into humans ; adding that [only] by asking [the questions of venison consumption and deer/elk hunting] in every case can we collect suspect cases and look into the plausibility of transmission further . Samii argues that by making both doctors and hunters more aware of the possibility of prions spreading through eating venison, doctors treating hunters with dementia can consider a possible prion disease, and doctors treating CJD patients will know to ask whether they ate venison. the [Samii] cases because there is no evidence that the men ate CWD-infected meat . He notes that although the likelihood of CWD jumping the species barrier to infect humans cannot be ruled out 100% and that [we] cannot be 100% sure that CWD does not exist in humans& the data seeking evidence of CWD transmission to humans have been very limited . http://infection.thelancet.com/journal/journal.isa continue to expect us to still believe that the 85% plus of all CJD cases which are sporadic are all spontaneous, without route or source. <<< Neurology (see below), not the JAMA article... Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. BRITISH MEDICAL JOURNAL BMJ THE PATHOLOGICAL PROTEIN BY Philip Yam Yam Philip Yam News Editor Scientific American www.sciam.com IN light of Asante/Collinge et al findings that BSE transmission to the -------- Original Message -------- Subject: re-BSE prions propagate as either variant CJD-like or sporadic CJD Date: Thu, 28 Nov 2002 10:23:43 -0000 From: "Asante, Emmanuel A" To: Dear Terry, I have been asked by Professor Collinge to respond to your request. I am a Senior Scientist in the MRC Prion Unit and the lead author on the paper. I have attached a pdf copy of the paper for your attention. Thank you for your interest in the paper. In respect of your first question, the simple answer is, yes. As you will find in the paper, we have managed to associate the alternate phenotype to type 2 PrPSc, the commonest sporadic CJD. It is too early to be able to claim any further sub-classification in respect of Heidenhain variant CJD or Vicky Rimmer's version. It will take further studies, which are on-going, to establish if there are sub-types to our initial finding which we are now reporting. The main point of the paper is that, as well as leading to the expected new variant CJD phenotype, BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc. can be of any further assistance please to not hesitate to ask. Best wishes. <> ____________________________________ Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics Dept. Imperial College School of Medicine (St. Mary's) Norfolk Place, LONDON W2 1PG Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email: e.asante@ic.ac.uk (until 9/12/02) New e-mail: e.asante@prion.ucl.ac.uk (active from now) ____________________________________ snip... full text ; http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm CJD WATCH http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm http://disc.server.com/Indices/167318.html
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