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BSE, BOVINE - USA (02): FEED RECALL ProMED
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<blockquote data-quote="flounder" data-source="post: 256898" data-attributes="member: 3519"><p>##################### Bovine Spongiform Encephalopathy #####################</p><p></p><p>Subject: BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 - 2006 compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE'</p><p>Date: August 8, 2006 at 6:43 pm PST </p><p>BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 - 2006 compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE' </p><p></p><p></p><p>30936 Federal Register / Vol. 62, No. 108 / Thursday, June 5, 1997 / Rules and Regulations </p><p></p><p>21 CFR Part 589 </p><p></p><p>Substances Prohibited From Use in </p><p></p><p>Animal Food or Feed; Animal Proteins </p><p></p><p>Prohibited in Ruminant Feed; Final Rule </p><p></p><p><a href="http://www.fda.gov/cvm/Images/6597bse.pdf" target="_blank">http://www.fda.gov/cvm/Images/6597bse.pdf</a> </p><p></p><p></p><p>BSE/Ruminant Feed Ban Inspections </p><p></p><p>FOOD AND DRUG ADMINISTRATION </p><p></p><p>COMPLIANCE PROGRAM GUIDANCE MANUAL </p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/98fr/03d-0498-gdl0001.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/98fr/0 ... dl0001.pdf</a> </p><p></p><p></p><p>1999 - 2000 CVM BSE </p><p></p><p></p><p></p><p>CVM Update</p><p>(THIS IS NOT A JOKE...TSS)</p><p>May 13, 1999 </p><p></p><p>BSE FEED REGULATION TEAM TO RECEIVE VICE PRESIDENTIAL AWARD </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p></p><p>-------------------------------------------------------------------------------- </p><p></p><p>Issued by:</p><p>FDA, Center for Veterinary Medicine, </p><p>Office of Management and Communications, HFV-12</p><p>7519 Standish Place, Rockville, MD 20855</p><p>Telephone: (301) 827-3800 FAX: (301) 827-4065</p><p>Internet Web Site: <a href="http://www.fda.gov/cvm" target="_blank">http://www.fda.gov/cvm</a> </p><p></p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/HAMMERUP.html" target="_blank">http://www.fda.gov/cvm/CVM_Updates/HAMMERUP.html</a> </p><p></p><p></p><p>PRODUCT</p><p>Loweís 40% Hog Concentrate - swine feed for mixing grower and </p><p>finisher rations, in 50-pound bulk bags.</p><p>Recall #V-057-0.</p><p>CODE</p><p>All codes between August 1, 1999 and November 23, 1999.</p><p>MANUFACTURER</p><p>Lowe's Feed & Grain, Inc., Bowling Green, Kentucky.</p><p>RECALLED BY</p><p>Manufacturer, by letter dated November 18, 1999, and by </p><p>telephone. Firm-initiated recall complete.</p><p>DISTRIBUTION</p><p>Ohio.</p><p>QUANTITY</p><p>12.46 tons were distributed.</p><p>REASON</p><p>Product contained protein derived from mammalian tissue and </p><p>according to regulation must bear the statement "Do not feed to </p><p>cattle or other ruminants" on the label. This regulation is </p><p>designed to prevent the establishment and amplification of BSE </p><p>through feed. This statement does not appear on the label. </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/ENF00623.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/ENF00623.html</a> </p><p></p><p></p><p></p><p>2001 </p><p></p><p></p><p>October 30, 2001 </p><p></p><p>RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES </p><p></p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/bseoctup.htm" target="_blank">http://www.fda.gov/cvm/CVM_Updates/bseoctup.htm</a> </p><p></p><p></p><p></p><p></p><p>October 10, 2001 </p><p></p><p>FDA HOLDING PUBLIC HEARING ON RUMINANT FEED (BSE) RULES </p><p></p><p>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. </p><p></p><p>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 </p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/part15.htm" target="_blank">http://www.fda.gov/cvm/CVM_Updates/part15.htm</a> </p><p></p><p></p><p></p><p>September 25, 2001 </p><p></p><p>BSE INSPECTION CHECKLIST AVAILABLE ON THE CVM INTERNET HOME PAGE </p><p></p><p></p><p>FDA's Center for Veterinary Medicine (CVM) has made available the Bovine Spongiform Encephalopathy (BSE) Inspection Checklist on the Center's Home Page on the Internet. This checklist is to be used by Federal and State inspectors to determine compliance with FDA's ruminant feed (BSE) regulations, Code of Federal Regulations, Title 21, Part 589.2000.</p><p>This rule, that prohibits the use of most mammalian protein in feeds for ruminant animals, was implemented to prevent the establishment and amplification of BSE through feed in the United States. The rule became effective on August 4, 1997. Inspections of over 10,000 renderers, feed mills, ruminant feeders, and others (such as protein blenders) have been conducted to determine compliance with the BSE feed regulations. The majority of these inspections (around 80%) were conducted by State officials and the remainder by FDA. A checklist has been used to record information on the compliance with the rules. The checklist that is being made available on the CVM Home Page is a revised version intended for use in future inspections. </p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/bsecheck.htm" target="_blank">http://www.fda.gov/cvm/CVM_Updates/bsecheck.htm</a> </p><p></p><p></p><p></p><p>CVM Update</p><p>July 7, 2001 </p><p></p><p>RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES </p><p></p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/bse72001.htm" target="_blank">http://www.fda.gov/cvm/CVM_Updates/bse72001.htm</a> </p><p></p><p></p><p></p><p>CVM Update</p><p>March 23, 2001 </p><p></p><p>RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES </p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/bsemar3.htm" target="_blank">http://www.fda.gov/cvm/CVM_Updates/bsemar3.htm</a> </p><p></p><p></p><p></p><p>CVM Update</p><p>January 10, 2001 </p><p></p><p>UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES </p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/bseup.htm" target="_blank">http://www.fda.gov/cvm/CVM_Updates/bseup.htm</a> </p><p></p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II_______________________</p><p>PRODUCT</p><p>Red Cell, Iron Rich Homogenized, Yucca Flavored Vitamin-Iron-Mineral </p><p>Supplement for all classes of horses. For Animal Use Only. NET </p><p>CONTENTS: 1 GALLON. HORSE HEALTH Products, A Division </p><p>of Farnam Companies, Inc. PO Box 34820, Phoenix AZ 85067-4820,</p><p>Recall # V-002-2.</p><p>Redglo, EQUICARE (brand), Homogenized Energy Building Liquid Multi-</p><p>Vitamin Supplement for Horses. EQUICARE PRODUCTS, A </p><p>Division of Farnam Companies, Inc., PO Box 34820, Phoenix, AZ, </p><p>Recall # V-003-2.</p><p>CODE</p><p>All codes.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Farnam Companies, Inc., Phoenix, Arizona, sent a recall letter dated </p><p>March 8, 2001, to all distributors via regular first class mail. Firm </p><p>initiated recall is ongoing.</p><p>REASON</p><p>The products contain protein material derived from </p><p>bovine mammalian tissues; however, the bags are not labeled with the </p><p>required BSE cautionary statement.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>14,000 to 15,000 gallons.</p><p>DISTRIBUTION</p><p>Nationwide.</p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00719.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00719.html</a></p><p></p><p></p><p>RECALL NUMBER, PRODUCT AND CODE:</p><p>Ruminant Custom Mix Feeds:</p><p>V-388-1 "Beef Feed" manufactured with Buckeye 40% Beef </p><p>Finisher Pellets, Item 40950.</p><p>V-389-1 "Rita's Goat Feed" manufactured with Buckeye 39% Lamb</p><p>Conc. Pellets, Item 41250.</p><p>V-390-1 "Calf-Beef/Dairy Feed" manufactured with Buckeye 32% </p><p>Golden Expectation Pellets, Item 42150</p><p>V-391-1 "Feed with Vitamin A" manufactured with Buckeye</p><p>Vitamin A-30, Item 1614</p><p>V-392-1 "Feed/A-D-E Premix" manufactured with Buckeye A-D-E </p><p>Mix, Item 152850</p><p>V-409-1 "Calf Feed" manufactured with Buckeye 32% Calf Grower </p><p>Concentrate, Item 42350 </p><p></p><p>Non-Ruminant Custom Mix Feeds:</p><p>V-393-1 "40% Poultry Feed" manufactured with Buckeye 40% </p><p>Poultry Concentrate Crumbles, Item 12100</p><p>V-394-1 "40% Hog Feed" manufactured with Buckeye 40% Gro'Em </p><p>Lean, Item 20550</p><p>V-395-1 "Horse Premium Mixer" manufactured with Buckeye 32%</p><p>Premium Mixer Pellets, Item 38000</p><p>Code: All bulk custom mix feeds manufactured prior to April 20, 2001. </p><p>The customer invoices indicate the type of Buckeye supplement used in the </p><p>bulk feed.</p><p>REASON:</p><p>The bulk custom mix feeds were prepared with ruminant feed supplements </p><p>recalled by Buckeye Nutrition due to contamination with protein derived </p><p>from mammalian tissues. The non-ruminant bulk custom mix feeds were not </p><p>labeled with the required BSE caution statement "Do Not Feed to Cattle or </p><p>Other Ruminants."</p><p>MANUFACTURER/RECALLING FIRM:</p><p>Ferrin Cooperative Equity Exchange, Inc., Carlyle, Illinois</p><p>RECALLED BY:</p><p>The firm , by letter beginning on June 28, 2001.</p><p>FIRM INITIATED RECALL:</p><p>Ongoing.</p><p>DISTRIBUTION:</p><p>IL</p><p>QUANTITY:</p><p>169 tons of ruminant feeds and 27 tons of non-ruminant feeds </p><p></p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR October 10, </p><p>2001. </p><p></p><p></p><p>#### </p><p></p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00714.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00714.html</a> </p><p></p><p></p><p>RECALL NUMBER, PRODUCT AND CODE:</p><p>Recall # Product</p><p>V-397-1 Hyland Floating Fishfood, in 50 pound bags</p><p>V-398-1 Endurance Plus Extrude Horse Feed, in 50 pound bags</p><p>V-399-1 Seminole Ultra Bloom Horse Feed, in 50 pound bags</p><p>V-400-1 Wheat Flakes, extruded product in bulk, not bagged</p><p>V-401-1 Corn Flakes, extruded product in bulk, not bagged</p><p>V-402-1 Capt. Crunch, extruded product in bulk, not bagged</p><p>V-403-1 Green Corn Puffs, extruded product in bulk, not bagged</p><p>V-404-1 Orange Corn Puffs, extruded product in bulk, not </p><p>bagged</p><p>V-405-1 Whole Kernel Corn, in 50 pound bags, unlabeled</p><p>V-406-1 Soybean Meal, in bulk, not bagged, unlabeled</p><p>ALL CODES</p><p>REASON:</p><p>The animal feed products may contain proteins derived from mammalian tissues. </p><p>The products are not labeled with the required BSE caution statement "Do Not </p><p>Feed to Cattle or Other Ruminants."</p><p>MANUFACTURER/RECALLING FIRM:</p><p>The Hyland Company, Ashland, Kentucky</p><p>RECALLED BY:</p><p>Manufacturer, by telephone on July 25, 2001, and letters on July 31, 2001. </p><p>FIRM INITIATED RECALL:</p><p>Complete</p><p>DISTRIBUTION:</p><p>KY, GA, NC, FL WV</p><p>QUANTITY:</p><p>568 tons </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR August 29, 2001. </p><p></p><p>#### </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00708.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00708.html</a> </p><p></p><p></p><p></p><p>RECALL NUMBER, PRODUCT AND CODE:</p><p>V-385-1 - Rock-N-Rooster Competition Blend, lots:</p><p>K01611 K01719 K01912 K01916 K02012 K02015</p><p>K02214 K02310 K02314 K02318 K02519 K02615</p><p>K02917 K03018 K03114 K03215 K03316 K03413</p><p>K10116 K10119 K10219 K10313 K10417 K10610</p><p>K10714 K10914 K11115 K11214 K11412 K11512</p><p>K02019 K02813 K03516 K10616 K11515</p><p>V-386-1 - Rock-N-Rooster Premium Five-Grain Scratch, lots:</p><p>K01611 K01715 K01718 K01812 K01912 K01916</p><p>K02012 K02015 K02019 K02117 K02214 K02310</p><p>K02318 K02513 K02518 K02710 K02719 K02813</p><p>K02910 K02917 K03011 K03018 K03114 K03215</p><p>K03413 K03418 K03516 K03517 K10012 K10013</p><p>K10115 K10119 K10219 K10310 K10312 K10410</p><p>K10611 K10614 K10616 K10713 K10810 K10812</p><p>K10914 K10919 K11012 K11114 K11115 K11216</p><p>K11213 K11214 K11315 K11412 K11419 K11512</p><p>K01918 K02314 K02814 K03316 K101121 </p><p>K10510 K10819 K11211 K11515</p><p>V-387-1 - Rock-N-Rooster Maintainer, lots:</p><p>K01611 K01719 K01812 K01912 K01916 K01918</p><p>K02015 K02117 K02314 K02318 K02513 K02519</p><p>K02813 K02814 K02917 K03011 K03018 K03114</p><p>K03316 K03413 K03418 K03514 K03516 K03517</p><p>K10116 K10119 K10219 K10312 K10417 K10512</p><p>K10617 K10714 K10810 K11012 K11115 K11211</p><p>K11315 K11512 K11515 K02012 K02615 K03215</p><p>K10012 K10616 K11214</p><p>REASON:</p><p>The product contained prohibited material; however, the bags were not labeled </p><p>with the required BSE cautionary statement.</p><p>MANUFACTURER/RECALLING FIRM:</p><p>Southern States Cooperative, Inc., Richmond, Virginia</p><p>RECALLED BY:</p><p>The recalling firm ceased distribution on June 6, 2001, and notified feed mill </p><p>distributors and distribution points by e-mail on June 6 and 7, 2001, to stop </p><p>sale and notify their retail customers of the stop sale and provide further </p><p>instructions for relabeling of any of the affected inventory. The firm sent </p><p>labels with the cautionary statement to their consignees.</p><p>FIRM INITIATED RECALL:</p><p>ONGOING</p><p>DISTRIBUTION:</p><p>KY, VA, MD, WV, NC, SC, GA, AL, DE, FL, MS and TN</p><p>QUANTITY:</p><p>962 tons </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR August 1, 2001. </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00704.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00704.html</a> </p><p></p><p></p><p>RECALL NUMBER, PRODUCT AND CODE:</p><p>V-353-1 through V-370-1, </p><p>Chicken feed products:</p><p>Recall # Tag # Product</p><p>V-353-1 587 B. Challenger Scratch Feed</p><p>V-354-1 588 B. 18% Gamebird Conditioner</p><p>V-355-1 2060 B. Kickin' Chicken Premium Game Cock Feed</p><p>V-356-1 2066 B. Kickin' Chicken Premium Gamebird 16%</p><p>V-357-1 586 B. Scratch Grain</p><p>V-358-1 2051 B. Pit Performer 17%</p><p>V-359-1 575 B. Classic Yard Feed</p><p>V-360-1 576 Eliminator Maintainer</p><p>V-361-1 578 Eliminator Conditioner</p><p>V-362-1 586 Producer Scratch Grain</p><p>V-363-1 4587 Producer 12% Gamebird Yard Feed</p><p>V-364-1 2065 Cleveland Trophy Cock Feed</p><p>V-365-1 80181AAA Consolidated Hen Scratch</p><p>V-366-1 2051 B&B Maintenance 12</p><p>V-367-1 2052 B&B Conditioner 14</p><p>V-368-1 2050 B&B Scratch 10</p><p>V-369-1 4590 Kingsport Original Prater Mix</p><p>V-370-1 2062 PC 10 (unlabeled bags)</p><p>ALL CODES</p><p>The "B" indicates that the Burkmann Feeds brand name is listed on the tag </p><p>labels. The suspect products are also bagged and distributed under the </p><p>following private labels:</p><p>Producer Feeds, Louisville, Kentucky</p><p>Kingsport Milling, Kingsport, Tennessee</p><p>Consolidated Nutrition, L.C., Omaha, Nebraska </p><p>B&B Feeds, Knoxville, Tennessee </p><p>Eagle Roller Mill Co., Inc., Shelby, North Carolina</p><p>Central Farm Supply of Kentucky, Inc., Louisville, Kentucky </p><p>REASON:</p><p>The chicken feed products may contain proteins derived from mammalian tissues. </p><p>The products are not labeled with the required BSE caution statement "Do Not </p><p>Feed to Cattle or Other Ruminants."</p><p>MANUFACTURER/RECALLING FIRM:</p><p>Burkmann Feeds, London, Kentucky</p><p>RECALLED BY:</p><p>On May 5, 2001, the firm mailed recall letters with attached BSE sticker-labels </p><p>to all customers outside the state of Kentucky. The recall notices were hand-</p><p>delivered to customers within the state of Kentucky by Burkmann's Sales </p><p>Representatives. Customers were asked to complete and return a recall response </p><p>form that was included with each letter documenting the numbers of bags and </p><p>varieties of products for which the customers affixed the BSE sticker-labels. </p><p>The firm expanded their recall on May 10, 2001, and mailed recall letters with </p><p>BSE labels and response forms to the affected customers.</p><p>FIRM INITIATED RECALL:</p><p>Ongoing</p><p>DISTRIBUTION:</p><p>KY, GA, NC, TN, VA</p><p>QUANTITY:</p><p>933 tons</p><p>_______________________________</p><p>RECALL NUMBER, PRODUCT AND CODE:</p><p>V-377-1, Renner's brand 45% meat and bone meal, packed in 100 pound bags.</p><p>REASON:</p><p>The product contained protein material derived from bovine mammalian tissues; </p><p>however, the bags are not labeled with the required BSE cautionary statement.</p><p>MANUFACTURER/RECALLING FIRM:</p><p>F. W. Renner & Sons, Inc., Canton, Ohio</p><p>RECALLED BY:</p><p>The recalling firm contacted the consignees by telephone on June 19, 2001.</p><p>FIRM INITIATED RECALL:</p><p>Complete</p><p>DISTRIBUTION:</p><p>OH</p><p>QUANTITY:</p><p>2,500 lbs</p><p>_______________________________</p><p>RECALL NUMBER, PRODUCT AND CODE:</p><p>V-378-1 to V-384-1, RenPro 58% (brand name) swine and poultry feeds in bulk, as </p><p>follows:</p><p>V-378-1 - Poultry Layer #215 - guaranteed analysis 15% crude protein, 3% crude </p><p>fat, and 3.5% crude fiber.</p><p>V-379-1 - Poultry Layer #216 - guaranteed analysis 16% crude protein, 3% crude </p><p>fat, and 3.5% crude fiber.</p><p>V-380-1 - Poultry Layer #217 - guaranteed analysis 17% crude protein, 3% crude </p><p>fat, and 3.5% crude fiber.</p><p>V-381-1 - Poultry Layer #218 - guaranteed analysis 18% crude protein, 3% crude </p><p>fat, and 3.5% crude fiber.</p><p>V-382-1 - Poultry Layer #219 - guaranteed analysis 19% crude protein, 3.5% crude </p><p>fat, and 4% crude fiber.</p><p>V-383-1 - Poultry Prelay #115 - guaranteed analysis 16% crude protein, 3% crude </p><p>fat, and 5% crude fiber.</p><p>V-384-1 - Poultry Developer #110 - guaranteed analysis 14% crude protein, 3% </p><p>crude fat, and 5.5% crude fiber.</p><p>MANFACTURER:</p><p>Esbenshade Mills, Mount Joy, PA</p><p>RECALLED BY:</p><p>On 5/24/01, the manufacturer notified their customers of the labeling </p><p>requirement via letter.</p><p>FIRM INITIATED RECALL:</p><p>Complete</p><p>DISTRIBUTION:</p><p>PA</p><p>QUANTITY:</p><p>None. The product turn over is two weeks or less. </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR July 25, 2001. </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00703.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00703.html</a> </p><p></p><p></p><p></p><p>RECALL NUMBER, PRODUCT AND CODE:</p><p>V-371-1, Tender Lean/Shelled Corn Cattle Feed Mix, a custom</p><p>animal feed mix, packed in 80 LB bags. CODES: None. The bags are </p><p>unlabeled. The feed was manufactured on 5/14/2001.</p><p>REASON:</p><p>The cattle feed (for ruminant animals)may contain protein derived from </p><p>mammalian tissues.</p><p>MANUFACTURER/RECALLING FIRM:</p><p>Champaign Landmark, Inc., Urbana, Ohio</p><p>RECALLED BY:</p><p>On 5/24/2001, the firm's Feed Manager personally visited the sole </p><p>farmer/consignee, at which time, he hand-delivered the firm's recall </p><p>letter.</p><p>FIRM INITIATED RECALL:</p><p>Complete</p><p>DISTRIBUTION:</p><p>Ohio</p><p>QUANTITY:</p><p>2,000 LBS </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR July 11, 2001. </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00701.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00701.html</a> </p><p></p><p></p><p></p><p>RECALL NUMBER, PRODUCT AND CODE:</p><p>V-352-1, Bulk Lamb Meal, All lots of bulk lamb meal shipped by the recalling </p><p>firm</p><p>REASON:</p><p>The product is not labeled with the required caution statement "Do not feed to </p><p>Cattle or other Ruminants."</p><p>MANUFACTURER/RECALLING FIRM:</p><p>International Proteins Corporations (IPC), St. Paul MN</p><p>RECALLED BY:</p><p>Recalling Firm, Revised labeling by letter on April 17, 2001.</p><p>FIRM INITIATED RECALL:</p><p>Ongoing.</p><p>DISTRIBUTION:</p><p>MN, IL, MO, AR and TX</p><p>QUANTITY</p><p>3,094 tons </p><p></p><p>END OF ENFORCEMENT REPORT FOR July 04, 2001. </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00700.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00700.html</a> </p><p></p><p></p><p>PODUCT:</p><p>Bulk Lamb Meal. Recall Number V-052-1.</p><p>CODES:</p><p>All lots of bulk lamb meal shipped by the recalling firm.</p><p>MANUFACTURER:</p><p>International Proteins Corporations (IPC), St. Paul, Minnesota.</p><p>RECALLED BY:</p><p>Manufacturer, sent revised labeling in a letter on April 17, 2001. Firm </p><p>initiated recall is ongoing.</p><p>DISTRIBUTION:</p><p>MN, IL, MO, AK, TX. </p><p>QUANTITY:</p><p>3,094 tons.</p><p>REASON: </p><p>The product is not labeled with the required caution statement "Do Not Feed to </p><p>Cattle or Other Ruminants." </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR June 20, 2001. </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00698.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00698.html</a> </p><p></p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS IIPRODUCT & CODES:</p><p>Animal feed products, packaged in 5, 25, 50, and 55 pound bags, and in bulk, </p><p>intended for both ruminant and non-ruminant animals. The products are as </p><p>follows: </p><p>Recall # V-195-1 through V-350-1. </p><p></p><p>RUMINANT FEED PRODUCTS: </p><p></p><p>RECALL NO. PRODUCT NO. PRODUCT NAME </p><p></p><p>V-195-1 40150 B. 30% Calf Pellet</p><p>V-196-1 40250 B. 16% Calf Pellet</p><p>V-197-1 40350 B. 16% Calf Ration</p><p>V-198-1 40450 B. 18% Calf Starter </p><p>V-199-1 40600 B. 38% Dairy Pellet</p><p>V-200-1 40650 B. 38% Dairy Pellet</p><p>V-201-1 40750 B. 16% Dairy Feed</p><p>V-202-1 40950 B. 40% Beef Pellet</p><p>V-203-1 41150 B. 18% Lamb Starter Pellet</p><p>V-204-1 41250 B. 39% Lamb Conc. Pellet</p><p>V-205-1 41350 B. 14% Lamb & Beef Pellet</p><p>V-206-1 41450 B. 16% Goat Feed</p><p>V-207-1 42150 B. 32% Expectation Pellet</p><p>V-208-1 42250 B. Llama & Alpaca Pellet</p><p>V-209-1 42350 B. 32% Calf Grower Pellet</p><p>V-210-1 42650 B. Llama & Alpaca Crums</p><p>V-211-1 42750 B. 38% Hay Booster 2</p><p>V-212-1 42850 B. 25% Pasture Booster</p><p>V-213-1 43100 B. 16% Grower/Dev Pellet</p><p>V-214-1 43150 B. 16% Grower/Dev Pellet</p><p>V-215-1 43700 WH 32% Calf Gro Pellet</p><p>V-216-1 43750 WH 32% Calf Gro Pellet</p><p>V-217-1 43850 B. 38% Dairy Mix</p><p>V-218-1 44250 B. 17% Doe Pellet</p><p>V-219-1 44350 B. 21% Buck Pellet</p><p>V-220-1 44450 Legends Ranch Pellet</p><p>V-221-1 44500 Legends 17% Breeder Pellet</p><p>V-222-1 1652 B. Vitamin E-20</p><p>V-223-1 1614 B. Vitamin A-30</p><p>V-224-1 44550 Legends 17% Breeder Pellet</p><p>V-225-1 44650 Legends 13.5% Rut Pellet</p><p>V-226-1 44750 Deer Starter (J)</p><p>V-227-1 44940 Llama Premix (J) FSC</p><p>V-228-1 45150 Empire 25% Calf Pellet</p><p>V-229-1 45450 Berry Llama Pellet</p><p>V-230-1 45950 50% Beef Conc. (Meal)</p><p>V-231-1 46250 B. 12% Sweet Livestock</p><p>V-232-1 46350 B. 1440 Bovatec Pellet</p><p>V-233-1 46400 Liberty 38% Dairy Pellet</p><p>V-234-1 46450 Liberty 38% Dairy Pellet</p><p>V-235-1 47150 B. 14% Gold-n-Grower</p><p>V-236-1 47250 B. 12% Gold-n-Conditioner</p><p>V-237-1 47450 B. 18% Gold-n-Lamb</p><p>V-238-1 47800 Homeworth Dairy Pellet</p><p>V-239-1 47850 Homeworth Dairy Pellet</p><p>V-240-1 47900 B. 36% Hi Fat Dairy Pellet</p><p>V-241-1 47950 B. 36% Hi Fat Dairy Pellet</p><p>V-242-1 48550 B. 16% Calf Pellet CA</p><p>V-243-1 49200 Mastead Dairy Base</p><p>V-244-1 49300 KLEJKA Dairy Base</p><p>V-245-1 49650 Deer Premix (J) HFB</p><p>V-246-1 49750 39% Lamb Premix (J) HFB</p><p>V-247-1 49850 Lamb Starter Premix (J) HFB</p><p>V-248-1 120850 Brood Cow Deluxe Mineral</p><p>V-249-1 152850 B. A-D-E Mix </p><p></p><p>NON-RUMINANT FEED PRODUCTS: </p><p></p><p>V-250-1 10150 B. Miracle Starter </p><p>V-251-1 10350 B. 21% Broiler Starter</p><p>V-252-1 10450 B. Pullet Grower & Developer</p><p>V-253-1 10550 B. 18% Layer Breeder Pellets</p><p>V-254-1 10750 B. 20% Gold Std. Laying Crum</p><p>V-255-1 10950 B. 17% Complete Laying Crums</p><p>V-256-1 11050 B. 16% Prosperity Layer Crums</p><p>V-257-1 11100 B. 40% Poultry Concentrate</p><p>V-258-1 11150 B. 40% Poultry Concentrate</p><p>V-259-1 11250 B. 28% Turkey Starter Crums</p><p>V-260-1 11350 20% Gig "4" Pellets</p><p>V-261-1 11450 B. 16% Prosperity Layer Pellets</p><p>V-262-1 11550 18% Game Bird Breeder Pellets</p><p>V-263-1 11650 B. 19% Ratite Grower Diet</p><p>V-264-1 11750 B. 23% Ratite Breeder Diet</p><p>V-265-1 12100 B. 40% Poultry Concentrate Crums</p><p>V-266-1 12550 B. 32% Base Poultry Mix</p><p>V-267-1 13250 B. 28% Turkey Starter</p><p>V-268-1 13450 B. 20% Poultry Grower</p><p>V-269-1 14325 B. Game Bird Mix - Coarse</p><p>V-270-1 20150 B. 18% Pig Starter Pellets</p><p>V-271-1 20250 B. 16% Pig Grower Pellets</p><p>V-272-1 20450 B. 14% Porkmaker 100 Pellets</p><p>V-273-1 20550 B. 40% Gro 'Em Lean</p><p>V-274-1 21850 B. 27% Hi-Fat Swine Base</p><p>V-275-1 23000 Mt. Hope Hevy Hog</p><p>V-276-1 30050 12% Pleasure Horse - Sweet</p><p>V-277-1 30150 Alfa + Performer 10 Sweet</p><p>V-278-1 30250 14% Grass + Perf Sweet </p><p>V-279-1 30450 12% Wrangler - Complete</p><p>V-280-1 30550 B. 12% Pleasure Horse Pellets</p><p>V-281-1 30650 B. 32% Gro' N Win Pellets</p><p>V-282-1 30750 12% Wrangler Cubes</p><p>V-283-1 30950 18% Foal Starter</p><p>V-284-1 31050 B. 14% Alfa + Dev Pellets</p><p>V-285-1 31150 B. Alfa + Performer 10 Pel</p><p>V-286-1 31200 Grass +Performer 14 Pel</p><p>V-287-1 31250 Grass +Performer 14 Pel</p><p>V-288-1 31350 12% Mustang</p><p>V-289-1 31450 Endurance - 101 Extruded</p><p>V-290-1 31550 B. Equine Energy - UK</p><p>V-291-1 31650 B. 16% Grass + Dev Pellets</p><p>V-292-1 31750 16% Grass + Dev Cubes</p><p>V-293-1 31850 16% Grass + Dev Sweet</p><p>V-294-1 31950 B. 11% Alfa Gro 'N Win Pel</p><p>V-295-1 32050 B. Sho' Win Pellets</p><p>V-296-1 32250 B. Senior Formula</p><p>V-297-1 32350 Oscar Horse Mix</p><p>V-298-1 32450 B. Ultimate Finish</p><p>V-299-1 32550 Crossfire Horse Feed</p><p>V-300-1 32650 B. Equine 16% Growth</p><p>V-301-1 32750 B. Reduced Energy Formula</p><p>V-302-1 32850 B. Training Formula</p><p>V-303-1 32950 B. Cadence Formula</p><p>V-304-1 33150 B. Track 12 Horse Feed</p><p>V-305-1 33350 Spears 16% GR + Dev Cubes</p><p>V-306-1 33400 B. 14% Supreme Horse Pellets</p><p>V-307-1 33450 B. 14% Supreme Horse Pellets</p><p>V-308-1 33650 B. Race'N Win</p><p>V-309-1 33750 B. 14% Prominent Horse Feed</p><p>V-310-1 33850 B. Unbeetable Horse Feed</p><p>V-311-1 34750 Cargill Senior Horse</p><p>V-312-1 34850 Cargill Vitality Gold</p><p>V-313-1 35150 Chagrin 12% Sweet Fd</p><p>V-314-1 35250 Smith Pure Pleasure</p><p>V-315-1 35750 Roundup 10% Horse Pellets</p><p>V-316-1 35850 12% Summerglo Horse</p><p>V-317-1 36255 B. Grass +Min&VitBase - Mexico</p><p>V-318-1 36850 Miller's 12% Horse Feed</p><p>V-319-1 37155 B. Gro'Win Base Mix - Mexico</p><p>V-320-1 38000 B. 32% Premium Mixer Pellets</p><p>V-321-1 38050 B. 32% Premium Mixer Pellets</p><p>V-322-1 38100 36% Maintenance Mixer Pellets</p><p>V-323-1 38150 36% Maintenance Mixer Pellets</p><p>V-324-1 50150 Terramycin Crumbles</p><p>V-325-1 60105 16% Rabbit Pellets</p><p>V-326-1 60125 16% Rabbit Pellets</p><p>V-327-1 60150 B. 16% Rabbit Pellets</p><p>V-328-1 60205 18% Rabbit Developer</p><p>V-329-1 60250 B. 18% Rabbit Developer</p><p>V-330-1 60450 B. 16% Rabbit Maintenance</p><p>V-331-1 90150 B. Buckeye Scratch</p><p>V-332-1 90225 Gold Standard Scratch</p><p>V-333-1 90250 Gold Standard Scratch</p><p>V-334-1 90350 Intermediate Scratch</p><p>V-335-1 90450 B. Chick Grains</p><p>V-336-1 90525 B. Shelled Corn</p><p>V-337-1 90550 B. Shelled Corn</p><p>V-338-1 90650 B. Cracked Corn</p><p>V-339-1 90825 B. Fine Cracked Corn</p><p>V-340-1 90850 B. Fine Cracked Corn</p><p>V-341-1 91000 Steam Flaked Corn</p><p>V-342-1 91050 Steam Flaked Corn</p><p>V-343-1 91750 Oats - HP Crimped</p><p>V-344-1 91850 B. HP Sweet Crimped Oats</p><p>V-345-1 95550 Land O' Lakes Shelled Corn</p><p>V-346-1 95650 Land O' Cracked Corn</p><p>V-347-1 95850 Land O' Lakes Chick Crack</p><p>V-348-1 100850 B. Alfalfa Pellets</p><p>V-349-1 101850 Cooked Full Fat Soybean</p><p>V-350-1 122200 Magnatone M-4-B Pels Bulk</p><p>MANUFACTURER:</p><p>Buckeye Feed Mills, Dalton, Ohio.</p><p>RECALLED BY:</p><p>Manufacturer visited local customers on April 17, 2001. On April 18 and 19, </p><p>2001, manufacturer mailed and faxed recall notices. Firm initiated recall is </p><p>ongoing.</p><p>DISTRIBUTION:</p><p>Al, CT, DE, FL, GA, IL, IN, IA, KY, ME, MD, MA, MO, MN, MS, NH, NJ, NY, NC, OH, </p><p>OR, PA, RI, TN, VA, WV, and WI.</p><p>QUANTITY:</p><p>2,790 tons of ruminant feed products and 14,000 tons of non-ruminant feed </p><p>products.</p><p>REASON:</p><p>The animal feed products may contain protein derived from mammalian tissues. </p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00696.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00694.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00694.html</a> RECALLS AND FIELD CORRECTIONS: VETERINARY MEDS -- CLASS II</p><p>PRODUCT:</p><p>Buckeye 26% Hi Fat Swine Mix, Sandy Lake 40% Hog Supplement, 100 lb. containers, </p><p>flexible plastic burlap bags. Recall #V-026-1.</p><p>CODE:</p><p>None are used.</p><p>MANUFACTURER:</p><p>Sandy Lake Mills, Sandy Lake, PA.</p><p>RECALLED BY:</p><p>Manufacturer, by telephone and visit. Firm initiated recall complete.</p><p>DISTRIBUTION:</p><p>Pennsylvania.</p><p>QUANTITY:</p><p>Seven containers, each weighing 100 pounds.</p><p>REASON: The product contains prohibited material (ruminant </p><p>animal proteins) used as an ingredient in the finished product swine feed. The </p><p>product is not labeled with the required caution statement "Do Not Feed to </p><p>Cattle or Other Ruminants."</p><p>________</p><p>PRODUCT:</p><p>Custom Vaquero Supplement for Cattle identified by Purina Mills. Recall #V-027-</p><p>1. </p><p>CODE:</p><p>7V87.</p><p>MANUFACTURER:</p><p>Purina Mills, Inc., Gonzalez, Texas.</p><p>RECALLED BY:</p><p>Manufacturer, contacted the one consignee on January 17, 2001.</p><p>DISTRIBUTION:</p><p>Texas.</p><p>QUANTITY:</p><p>44,355 pounds. </p><p>REASON:</p><p>The ruminant feed product contains meat and bone meal (MBM) of bovine origin.<a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00692.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00692.html</a> PRODUCT:</p><p>a) Manna Pro Floating Fish Food for Catfish . Recall #V-028-1; </p><p>b) Manna Pro Floating Fish Food - 26% For All Freshwater Fish. </p><p>Recall #V-029-1.</p><p>Both are packaged in 50 pound, plastic-lined, paper sacks.</p><p>CODE:</p><p>a) 10160164, 12090164, 01050264, 03020264, and 03140264;</p><p>b) 09110164, 09190164, 09230164, 10090164, 10160164, 11170164,</p><p>12090164 and 3200264.</p><p>MANUFACTURER:</p><p>Doane Pet Care, Brentwood, Tennessee.</p><p>RECALLED BY:</p><p>Manufacturer, by telephone on March 26, 2001. Firm-initiated recall complete.</p><p>DISTRIBUTION:</p><p>California, Pennsylvania, Ohio, Kansas, Colorado, Georgia, and Florida.</p><p>QUANTITY:</p><p>27,300 pounds of Catfish Food and 86,100 pounds of Freshwater Fish.</p><p>REASON:</p><p>The products, which contain meat by-products, were shipped without the </p><p>required BSE warning label.<a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00691.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00691.html</a> </p><p></p><p></p><p>PRODUCT:</p><p>Buckeye 40% Poultry Concentrate. Recall #V-016-1.</p><p>CODES:</p><p>The bags are uncoded. Firm is recalling product manufactured since </p><p>December 1998; however, they are only completing field corrections on </p><p>product manufactured within the last six months (November 2000).</p><p>MANUFACTURER:</p><p>Yachere Feed, Inc. Rockwood, Pennsylvania.</p><p>RECALLED BY:</p><p>Manufacturer, by visit on 3/19/01 and 3/20/01. Firm-initiated recall </p><p>complete.</p><p>DISTRIBUTION:</p><p>Pennsylvania.</p><p>QUANTITY:</p><p>Nine containers, each weighing 100 pounds.</p><p>REASON:</p><p>The animal feed contains product derived from mammalian tissues and </p><p>must bear the statement "Do not feed to cattle or other ruminants" </p><p>on the label to prevent the establishment and amplification of BSE </p><p>through feed. This statement does not appear on the label.</p><p>________</p><p>PRODUCT:</p><p>"Our Own Pig & Hog Grower" hog feed, packaged in 50 pound bags, with </p><p>paperboard tags sewn onto the bags. Recall #V-017-1.</p><p>CODES:</p><p>The bags are uncoded.</p><p>MANUFACTURER:</p><p>The Perry Coal and Feed Company, Perry, Ohio.</p><p>RECALLED BY:</p><p>Manufacturer, by telephone on March 22, 2001. Firm-initiated </p><p>recall complete.</p><p>DISTRIBUTION:</p><p>Ohio.</p><p>QUANTITY:</p><p>Approximately 350 pounds of hog feed (7/50 pound bags).</p><p>REASON:</p><p>The animal feed contains protein derived from mammalian tissues </p><p>and must bear the statement "Do not feed to cattle or other </p><p>ruminants" on the label to prevent the establishment and </p><p>amplification of BSE through feed. This statement does </p><p>not appear on the label. </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00690.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00690.html</a> </p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: VETENIARY MED -- CLASS II </p><p></p><p>PRODUCT:</p><p>Custom Mixed Poultry Feed, bagged and sold as bulk, </p><p>unlabeled poultry feed. Recall #V-014-1.</p><p>CODE:</p><p>The bags are uncoded.</p><p>MANUFACTURER:</p><p>Western Reserve Farm Coop., Middlefield, Ohio.</p><p>RECALLED BY:</p><p>Manufacturer, by telephone on February 28, 2001. </p><p>Firm-initiated recall complete.</p><p>DISTRIBUTION:</p><p>Ohio.</p><p>QUANTITY:</p><p>Approximately 820 pounds.</p><p>REASON: </p><p>The animal feed contains product derived from mammalian </p><p>tissues and must bear the statement "Do not feed to cattle </p><p>or other ruminants" on the label to prevent the establishment </p><p>and amplification of BSE through feed. This statement does not </p><p>appear on the label.</p><p>________</p><p>PRODUCT:</p><p>Custom Mixed Poultry Feed, packaged in unlabeled 100 </p><p>pound bags and sold in bulk. Recall #V-015-1.</p><p>CODE:</p><p>The bags are uncoded.</p><p>MANUFACTURER:</p><p>Medina Landmark, Inc., Medina, Ohio.</p><p>RECALLED BY:</p><p>Manufacturer, by telephone on March 5, 2001. </p><p>Firm-initiated recall complete.</p><p>DISTRIBUTION:</p><p>Ohio.</p><p>QUANTITY:</p><p>Approximately 900 pounds of feed (9/100 pound bags).</p><p>REASON: </p><p>The animal feed contains product derived from mammalian </p><p>tissues and must bear the statement "Do not feed to cattle </p><p>or other ruminants" on the label to prevent the establishment and </p><p>amplification of BSE through feed. This statement does </p><p>not appear on the label. </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR APRIL 11, 2001. </p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00688.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00688.html</a> </p><p></p><p></p><p>2002 </p><p></p><p></p><p>To help prevent the establishment and amplification of </p><p></p><p>BSE through feed in the United States, FDA implemented </p><p></p><p>a final rule that prohibits the use of most mammalian </p><p></p><p>protein in feeds for ruminant animals. This rule, Title </p><p></p><p>21 Part 589.2000 of the Code of Federal Regulations, became </p><p></p><p>effective on August 4, 1997. To date, active monitoring </p><p></p><p>by the U.S. Department of Agriculture (USDA) has found </p><p></p><p>no cases of bovine spongiform encephalopathy (BSE) in </p><p></p><p>U.S. cattle. This is an update on FDA enforcement activities </p><p></p><p>regarding the ruminant feed (BSE) regulation. </p><p></p><p>FDA's enforcement plan for the ruminant feed regulation </p><p></p><p>includes education, as well as inspections, with FDA </p><p></p><p>taking compliance actions for intentional or repeated noncompliance. </p><p></p><p>FDA's Center for Veterinary Medicine (CVM) </p><p></p><p>has assembled data from the inspections that have been </p><p></p><p>conducted AND whose final inspection report has been </p><p></p><p>submitted to CVM (i.e., "inspected/reported") as of March </p><p></p><p>11, 2002. There is a lag time between the completion of </p><p></p><p>an inspection and the submission of a final inspection report </p><p></p><p>to CVM. This lag period includes the time required to </p><p></p><p>conduct quality assurance on the report and to evaluate </p><p></p><p>the findings before a final report is submitted. </p><p></p><p>As of March 11, CVM had received inspection reports </p><p></p><p>covering inspections (both initial inspections and re-inspections) </p><p></p><p>of 10,458 different firms. The majority of these in- </p><p></p><p>RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES </p><p></p><p><a href="http://www.fda.gov/cvm/Documents/MayJune.pdf" target="_blank">http://www.fda.gov/cvm/Documents/MayJune.pdf</a> </p><p></p><p></p><p>July/August 2002 </p><p></p><p>The following individuals/firms received warning </p><p></p><p>letters for violations related to 21 CFR Part 589.2000 – </p><p></p><p>Animal Proteins Prohibited in Ruminant Feed. This regulation </p><p></p><p>is intended to prevent the establishment and </p><p></p><p>REGULATORY ACTIVITIES </p><p></p><p>by Karen A. Kandra </p><p></p><p>amplification of Bovine Spongiform Encephalopathy </p><p></p><p>(BSE): </p><p></p><p>• Jeffrey T. Buck, Owner, All American Feed & Tractor, </p><p></p><p>Sandpoint, ID </p><p></p><p>• Kenneth M. Van Dyke, President, Van Dyke Grain </p><p></p><p>Elevators, Inc., North Plains, OR </p><p></p><p>• Philip C. Anderson, General Manager, Darling International, </p><p></p><p>Inc., Tacoma, WA </p><p></p><p>Violations included failure to maintain sufficient </p><p></p><p>records and written procedures to prevent cross-contamination; </p><p></p><p>failure to keep written procedures for cleaning </p><p></p><p>out or flushing equipment after mixing feeds containing </p><p></p><p>prohibited material; failure to provide written </p><p></p><p>procedures for separating products that contain or </p><p></p><p>may contain prohibited material from ingredients </p><p></p><p>used in ruminant feeds, from the time of receipt until </p><p></p><p>the time of shipment; and, failure to label meat </p><p></p><p>and bone meal with the required cautionary statement </p><p></p><p>"Do Not Feed to Cattle or Other Ruminants." </p><p></p><p></p><p>snip... </p><p></p><p><a href="http://www.fda.gov/cvm/Documents/JulyAugust.pdf" target="_blank">http://www.fda.gov/cvm/Documents/JulyAugust.pdf</a> </p><p></p><p></p><p></p><p>November 12, 2002 </p><p></p><p>MATERIAL FROM CWD-POSITIVE ANIMALS SHOULD NOT BE USED FOR ANIMAL FEED </p><p></p><p>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 </p><p></p><p>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. </p><p></p><p></p><p>-------------------------------------------------------------------------------- </p><p></p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/CWdup.htm" target="_blank">http://www.fda.gov/cvm/CVM_Updates/CWdup.htm</a> </p><p></p><p></p><p>2003D-0186</p><p>Guidance for Industry: Use of Material From Deer and Elk In Animal Feed </p><p></p><p></p><p></p><p>EMC 1</p><p>Terry S. Singeltary Sr.</p><p>Vol #:</p><p>1 </p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm" target="_blank">http://www.fda.gov/ohrms/dockets/dailys ... 060903.htm</a> </p><p></p><p></p><p></p><p>CVM Update</p><p><November 21, 2002 </p><p></p><p>Clarification of FDA Position on Use In Animal Feed of Material From Certain Free Range Deer and Elk </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/CWDNOV21.htm" target="_blank">http://www.fda.gov/cvm/CVM_Updates/CWDNOV21.htm</a> </p><p></p><p></p><p></p><p>CONTAINS NON-BINDING RECOMMENDATIONS </p><p></p><p>158 </p><p></p><p>Guidance for Industry </p><p></p><p>Use of Material from Deer and Elk in Animal Feed </p><p></p><p>Comments and suggestions regarding this guidance should be sent to the Division of </p><p></p><p>Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, </p><p></p><p>Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on </p><p></p><p>the Internet at <a href="http://www.fda.gov/dockets/ecomments" target="_blank">http://www.fda.gov/dockets/ecomments</a>. Once on this Internet site, select </p><p></p><p>"[03D-0186][Use of Material from Deer and Elk in Animal Feed]" and follow the </p><p></p><p>directions. All written comments should be identified with Docket No. 03D-0186. </p><p></p><p>For questions regarding this guidance, contact Burt Pritchett, Center for Veterinary </p><p></p><p>Medicine (HFV- 222), Food and Drug Administration, 7500 Standish Place, Rockville, </p><p></p><p>MD 20855, 301-827-0177. E-mail: <a href="mailto:bpritche@cvm.fda.gov">bpritche@cvm.fda.gov</a> </p><p></p><p>Additional copies of this guidance document may be requested from the Communications </p><p></p><p>Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 </p><p></p><p>Standish Place, Rockville, MD 20855, and may be viewed on the Internet at </p><p></p><p><a href="http://www.fda.gov/cvm" target="_blank">http://www.fda.gov/cvm</a>. </p><p></p><p>U.S. Department of Health and Human Services </p><p></p><p>Food and Drug Administration </p><p></p><p>Center for Veterinary Medicine </p><p></p><p>September 15, 2003 </p><p></p><p>CONTAINS NON-BINDING RECOMMENDATIONS </p><p></p><p>1 </p><p></p><p>158 </p><p></p><p>Guidance for Industry1 </p><p></p><p>Use of Material from Deer and Elk in Animal Feed </p><p></p><p>I. Introduction </p><p></p><p>FDA's guidance documents, including this guidance, do not establish legally </p><p></p><p>enforceable responsibilities. Instead, guidances describe the Agency's current </p><p></p><p>thinking on a topic and should be viewed only as recommendations, unless </p><p></p><p>specific regulatory or statutory requirements are cited. The use of the word </p><p></p><p>"should" in Agency guidances means that something is suggested or </p><p></p><p>recommended, but not required. </p><p></p><p>Under FDA's BSE feed regulation (21 CFR 589.2000) most material from deer and elk is </p><p></p><p>prohibited for use in feed for ruminant animals. This guidance document describes FDA's </p><p></p><p>recommendations regarding the use in all animal feed of all material from deer and elk that </p><p></p><p>are positive for Chronic Wasting Disease (CWD) or are considered at high risk for CWD. </p><p></p><p>The potential risks from CWD to humans or non-cervid animals such as poultry and swine </p><p></p><p>are not well understood. However, because of recent recognition that CWD is spreading </p><p></p><p>rapidly in white-tailed deer, and because CWD's route of transmission is poorly </p><p></p><p>understood, FDA is making recommendations regarding the use in animal feed of rendered </p><p></p><p>materials from deer and elk that are CWD-positive or that are at high risk for CWD. </p><p></p><p>II. Background </p><p></p><p>CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the </p><p></p><p>animal family cervidae (cervids). Only deer and elk are known to be susceptible to CWD </p><p></p><p>by natural transmission. The disease has been found in farmed and wild mule deer, </p><p></p><p>white-tailed deer, North American elk, and in farmed black-tailed deer. CWD belongs to </p><p></p><p>a family of animal and human diseases called transmissible spongiform encephalopathies </p><p></p><p>1 This guidance has been prepared by the Division of Animal Feeds in the Center for Veterinary Medicine </p><p></p><p>(CVM) at the Food and Drug Administration. </p><p></p><p>This guidance represents the Food and Drug Administration's current </p><p></p><p>thinking on the use of material from deer and elk in animal feed. It does not </p><p></p><p>create or confer any rights for or on any person and does not operate to bind </p><p></p><p>FDA or the public. You can use an alternative approach if the approach </p><p></p><p>satisfies the requirements of applicable statutes or regulations. If you want to </p><p></p><p>discuss an alternative approach, contact the FDA staff responsible for </p><p></p><p>implementing this guidance. If you cannot identify the appropriate FDA </p><p></p><p>staff, call the appropriate number listed on the title page of this guidance. </p><p></p><p>CONTAINS NON-BINDING RECOMMENDATIONS </p><p></p><p>2 </p><p></p><p>(TSEs). These include bovine spongiform encephalopathy (BSE or "mad cow" disease) </p><p></p><p>in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jakob diseases </p><p></p><p>(CJD and vCJD) in humans. There is no known treatment for these diseases, and there is </p><p></p><p>no vaccine to prevent them. In addition, although validated postmortem diagnostic tests </p><p></p><p>are available, there are no validated diagnostic tests for CWD that can be used to test for </p><p></p><p>the disease in live animals. </p><p></p><p>III. Use in animal feed of material from CWD-positive deer and elk </p><p></p><p>Material from CWD-positive animals may not be used in any animal feed or feed </p><p></p><p>ingredients. Pursuant to Sec. 402(a)(5) of the Federal Food, Drug, and Cosmetic Act, </p><p></p><p>animal feed and feed ingredients containing material from a CWD-positive animal would </p><p></p><p>be considered adulterated. FDA recommends that any such adulterated feed or feed </p><p></p><p>ingredients be recalled or otherwise removed from the marketplace. </p><p></p><p>IV. Use in animal feed of material from deer and elk considered at high risk for CWD </p><p></p><p>Deer and elk considered at high risk for CWD include: (1) animals from areas declared </p><p></p><p>by State officials to be endemic for CWD and/or to be CWD eradication zones; and (2) </p><p></p><p>deer and elk that at some time during the 60-month period immediately before the time of </p><p></p><p>slaughter were in a captive herd that contained a CWD-positive animal. </p><p></p><p>FDA recommends that materials from deer and elk considered at high risk for CWD no </p><p></p><p>longer be entered into the animal feed system. Under present circumstances, FDA is not </p><p></p><p>recommending that feed made from deer and elk from a non-endemic area be recalled if a </p><p></p><p>State later declares the area endemic for CWD or a CWD eradication zone. In addition, </p><p></p><p>at this time, FDA is not recommending that feed made from deer and elk believed to be </p><p></p><p>from a captive herd that contained no CWD-positive animals be recalled if that herd is </p><p></p><p>subsequently found to contain a CWD-positive animal. </p><p></p><p>V. Use in animal feed of material from deer and elk NOT considered at high risk </p><p></p><p>for CWD </p><p></p><p>FDA continues to consider materials from deer and elk NOT considered at high risk for </p><p></p><p>CWD to be acceptable for use in NON-RUMINANT animal feeds in accordance with </p><p></p><p>current agency regulations, 21 CFR 589.2000. Deer and elk not considered at high risk </p><p></p><p>include: (1) deer and elk from areas not declared by State officials to be endemic for </p><p></p><p>CWD and/or to be CWD eradication zones; and (2) deer and elk that were not at some </p><p></p><p>time during the 60-month period immediately before the time of slaughter in a captive </p><p></p><p>herd that contained a CWD-positive animal. ...snip ; </p><p></p><p></p><p><a href="http://www.fda.gov/cvm/Guidance/guide158.pdf" target="_blank">http://www.fda.gov/cvm/Guidance/guide158.pdf</a> </p><p></p><p></p><p>CVM Update</p><p>April 15, 2002 </p><p></p><p>RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES </p><p></p><p><a href="http://www.fda.gov/cvm/CVM_Updates/bseap02.htm" target="_blank">http://www.fda.gov/cvm/CVM_Updates/bseap02.htm</a> </p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II</p><p>_____________________________</p><p>PRODUCT</p><p>Land O'Lakes Farmland Feed 32% Grow Big Floater, For Catfish Grown In Ponds or Artificial Culture Systems, packaged in 50-lb. bags, product #1960014, contains animal protein products. Recall # V-003-3.</p><p>CODE</p><p>None.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Land O'Lakes Farmland Feed LLC, Arden Hills, MN, by fax on August 21, 2002.</p><p>Manufacturer: Land O'Lakes Farmland Feed LLC, Kansas City, KS. FDA initiated recall is complete.</p><p>REASON</p><p>Label lacks BSE warning statement.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>Approx. 18,872/50-lb. bags.</p><p>DISTRIBUTION</p><p>KS, TX, CO, NE, IL, MO, IA, OK and SD </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2002/ENF00765.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00765.html</a> </p><p></p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II</p><p>_____________________________</p><p>PRODUCT</p><p>12% Horse Feed, packaged under the Griffith & Sons label, in 100 lb bags. Recall # V-001-3.</p><p>CODE</p><p>The bags are not coded. All of their 12% Horse Feed product manufactured and distributed from 5/14/2002 to 6/21/2002 is subject to this recall.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Griffith & Sons Feed and Farm Supply, Staffordsville, KY, by telephone and visits on June 21, 2002.</p><p>Manufacturer: Griffith & Sons Feed and Farm Supply, Staffordsville, OH. Firm initiated recall is complete.</p><p>REASON</p><p>The Horse Feed product contains beef protein and is not labeled with the required BSE cautionary statement.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>1,200 lbs (12 / 100 lb bags).</p><p>DISTRIBUTION</p><p>OH. </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR OCTOBER 09, 2002 </p><p></p><p>#### </p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2002/ENF00764.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00764.html</a> </p><p></p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II</p><p>_______________________</p><p>PRODUCT</p><p>Product is flavor enhancer intended for use in pet food, labeled in part: </p><p>"8280 FLAVOR GENERATOR #1" packaged in 1,000 and 2,000 pound bags. </p><p>Recall # V-163-2.</p><p>CODE</p><p>All lots shipped prior to 04/09/02.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Roche Vitamins, Inc., Fort Worth, TX, by telephone on April 5, 2002. </p><p>FDA initiated recall is complete.</p><p>REASON</p><p>Product contains beef protein but is not labeled with the warning </p><p>statement regarding prohibited for use as feed for ruminants.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>680,200 lbs.</p><p>DISTRIBUTION</p><p>KS, CA, KY and IN.</p><p><a href="http://www.fda.gov/bbs/topics/enforce/2002/ENF00762.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00762.html</a> </p><p></p><p>RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II_______________________</p><p>PRODUCT</p><p>Homestead Poultry Starter Grower Medicated 55 lb. bags. Recall # V-154-2.</p><p>CODE</p><p>Not coded.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Shur-Gain USA Inc., Elma, NY, by visit on June 24, 2002.</p><p>Manufacturer: Shur-Gain, St. Marys, Ontario, Canada.</p><p>FDA initiated recall is complete.</p><p>REASON</p><p>Contains ruminant proteins but lacks caution statement.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>31 bags.</p><p>DISTRIBUTION</p><p>NY.</p><p>END OF ENFORCEMENT REPORT FOR AUGUST 14, 2002 </p><p></p><p>#### </p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2002/ENF00756.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00756.html</a> RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II</p><p>_______________________</p><p>PRODUCT</p><p>UNLABELED hog feed in 100 lb. bags containing assorted grains (primarily </p><p>corn), and Miller's Hog Supplement 36% protein.</p><p>UNLABELED dairy feed in 100 lb. bags, contains assorted grains (primarily </p><p>corn), soybeans and molasses. Recall # V-142-2.</p><p>CODE</p><p>Not CODEd.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: R. B. Crowell & Sons/Thompson Grain, Inc., Manchester, </p><p>NY, by telephone on May 7 and 8, 2002.</p><p>Manufacturer: John R. Power, Palmyra, NY.</p><p>State initiated recall is complete.</p><p>REASON</p><p>Unlabeled animal feeds/possible cross contamination.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>.75 tons per month.</p><p>DISTRIBUTION</p><p>NY.</p><p>_______________________</p><p>PRODUCT</p><p>Cereal Food Fines - Bulk PRODUCT. Recall # V-145-2.</p><p>CODE</p><p>All PRODUCT prior to October 2, 2001.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Souder Feed & Grain Carlisle, PA, by letters dated October 9, 2001. </p><p>State initiated recall is ongoing.</p><p>REASON</p><p>PRODUCT doesn't bear caution statement - do not feed to </p><p>cattle or other ruminants.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>6,141 tons.</p><p>DISTRIBUTION</p><p>MO, NY and PA.<a href="http://www.fda.gov/bbs/topics/enforce/2002/ENF00747.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00747.html</a> </p><p>RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II</p><p>_______________________</p><p>PRODUCT</p><p>BioFlavor F2425, BioFlavor F21002 and BioFlavor C20058. The product, </p><p>packaged in 50 lb. bags, is labeled in part, " *** PALATABILITY ENHANCER </p><p>INTENDED FOR CAT FOOD USE AT LESS THAN 10% *** INGREDIENT LISTING: *** </p><p>Beef Broth *** ". Recall # V-140-2</p><p>CODE</p><p>Product Codes</p><p>F2425 107B-RB-1</p><p>107B-RB-2</p><p>149C</p><p>201D</p><p>202C</p><p>205D</p><p>210A</p><p>F21002 143B</p><p>143D</p><p>146D</p><p>144B</p><p>144D</p><p>139D</p><p>142D</p><p>150D</p><p>151D</p><p>152C</p><p>152D</p><p>201C</p><p>205C</p><p>206C</p><p>208A</p><p>211A</p><p>C20058 143D</p><p>144C</p><p>146C</p><p>208B</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Bioproducts, Inc., Fairlawn, OH, by telephone and letter </p><p>on April 5, 2002.</p><p>Manufacturer: Bioproducts, Inc., Aurora, MO.</p><p>Firm initiated recall is ongoing.</p><p>REASON</p><p>Animal feed product with beef protein does not contain required BSE </p><p>statement on labels.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>354,150 lbs.</p><p>DISTRIBUTION</p><p>TX, KS, MO and MI.</p><p>_______________________</p><p>PRODUCT</p><p>Steamed Bonemeal in 50-lb. bags, product code C# 13581, packaged under </p><p>two different labels: Premium Steamed Bonemeal Manufactured by Buchheit </p><p>Premium Feeds, Perryville, MO, and Steamed Bonemeal Manufactured for </p><p>Siemer's Enterprises Inc., Teutopolis, IL.</p><p>Recall # V-141-2.</p><p>CODE</p><p>Not coded.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Buchheit, Inc., Perryville, MO, by telephone on May 14, 2002.</p><p>FDA initiated recall is ongoing.</p><p>REASON</p><p>Label lacks BSE warning statement.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>Approx. 902/50-lb. bags.</p><p>DISTRIBUTION</p><p>MO and IL. </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR JUNE 5, 2002 </p><p></p><p>#### </p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2002/ENF00746.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00746.html</a> PRODUCT</p><p>The following 10 animal feed products were subject to this recall:</p><p>1- Sexton Brothers MIXED FEED-WM, Recall # V-019-2</p><p>2- Sexton Brothers 9% SWEET FEED, Recall # V-020-2</p><p>3- Sexton Brothers 13% SWEET FEED, Recall # V-021-2</p><p>4- Sexton Brothers WHEAT, Recall # V-022-2</p><p>5- Sexton Brothers 44% SOYBEAN MEAL, Recall # V-023-2</p><p>6- Sexton Brothers 14% GOAT FEED, Recall # V-024-2</p><p>7- Sexton Brothers WHEAT MIDDS, Recall # V-025-2</p><p>8- Sexton Brothers SHELLED CORN, Recall # V-026-2</p><p>9- Sexton Brothers OATS, Recall # V-027-2</p><p>10-Sexton Brothers 17% GOAT FEED, Recall # V-028-2</p><p>The feed products were packaged in 50 LB bags, under the Willard </p><p>Milling Company label.</p><p>CODE</p><p>No codes.</p><p>All recalled products that were distributed prior to July </p><p>30, 2001 are affected by this recall.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Willard Milling, Inc. Willard, KY, by letter and telephone on July 30, </p><p>2001. State initiated recall is complete.</p><p>REASON</p><p>Products may contain protein derived from mammalian tissues.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>Approx. 140 tons </p><p>DISTRIBUTION</p><p>OH, KY, IN, and WV. </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR January 23, 2002 </p><p></p><p></p><p>#### </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2002/ENF00727.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00727.html</a> </p><p></p><p>PRODUCT</p><p>The following custom mixed animal feeds are recalled --- </p><p>a) [non-ruminant]: Horse Feed, Hog Feed, and 14% Pig Feed. </p><p>Recall # V-157-2;</p><p>b) [ruminant]: Dairy Feed, Steer Feed, New Goat Feed, Cattle Feed, and </p><p>Beef Feed. Recall # V-158-2.</p><p>CODE</p><p>The product is coded only with the manufacturing date and invoice </p><p>numbers. All feed products manufactured and shipped since July 9, 2001 </p><p>are affected by this recall.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Shepard Grain Company, Inc., Urbana, OH, by telephone on </p><p>January 11, 2002.</p><p>Manufacturer: Shepard Grain Company, Inc., W. Liberty, OH.</p><p>FDA initiated recall is complete.</p><p>REASON</p><p>Ruminant and non-ruminant animal feeds contain BSE prohibited material, </p><p>and are either misbranded or adulterated.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>41,129 LBS (20.5 tons).</p><p>DISTRIBUTION</p><p>OH. </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR AUGUST 28, 2002 </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2002/ENF00758.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00758.html</a> </p><p></p><p></p><p></p><p>2003 </p><p></p><p></p><p></p><p>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. ... </p><p></p><p></p><p>Bovine Spongiform Encephalopathy </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>CVM and Ruminant Feed (BSE) Inspections </p><p></p><p>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. </p><p></p><p></p><p>UPDATE: BSE Found in Washington State </p><p></p><p>USDA Reports Cow Tested Positive for BSE – FDA Sends Investigators </p><p>On December 23, 2003, the U.S. Department of Agriculture (USDA) announced that a Holsteincow in the State of Washingtonhad tested presumptively positive for bovine spongiform encephalopathy (BSE or "mad cow disease"). Following this announcement, FDA dispatched several teams of investigators to trace back and trace forward the potential involvement of any FDA-regulated commodities. USDA, which is responsible for the safety of certain meat and poultry products as well as animal health, led the investigation of this BSE case. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>FDA Emergency Operations Center </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>New Measures to Prevent BSE </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>The new safeguards are science-based and further bolster these already effective safeguards. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics: </p><p></p><p>Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.)</p><p>Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant); </p><p>Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and </p><p>The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product. </p><p>The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdomcattle in the 1980's and 1990's. </p><p></p><p>This interim final rule will implement four specific changes in FDA's present animal feed rule. The rule: </p><p></p><p>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. </p><p>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. </p><p>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. </p><p>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. </p><p>To accompany these new measures designed to provide a further layer of protection against BSE, FDA plans to 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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>Warning Letters Issued for Violations of BSE Regulations </p><p></p><p>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. </p><p></p><p>On August 25, 2003, the FDA's Chicago Distric</p></blockquote><p></p>
[QUOTE="flounder, post: 256898, member: 3519"] ##################### Bovine Spongiform Encephalopathy ##################### Subject: BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 - 2006 compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE' Date: August 8, 2006 at 6:43 pm PST BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 - 2006 compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE' 30936 Federal Register / Vol. 62, No. 108 / Thursday, June 5, 1997 / Rules and Regulations 21 CFR Part 589 Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Final Rule [url=http://www.fda.gov/cvm/Images/6597bse.pdf]http://www.fda.gov/cvm/Images/6597bse.pdf[/url] BSE/Ruminant Feed Ban Inspections FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL [url=http://www.fda.gov/ohrms/dockets/98fr/03d-0498-gdl0001.pdf]http://www.fda.gov/ohrms/dockets/98fr/0 ... dl0001.pdf[/url] 1999 - 2000 CVM BSE CVM Update (THIS IS NOT A JOKE...TSS) May 13, 1999 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: FDA, Center for Veterinary Medicine, Office of Management and Communications, HFV-12 7519 Standish Place, Rockville, MD 20855 Telephone: (301) 827-3800 FAX: (301) 827-4065 Internet Web Site: [url=http://www.fda.gov/cvm]http://www.fda.gov/cvm[/url] [url=http://www.fda.gov/cvm/CVM_Updates/HAMMERUP.html]http://www.fda.gov/cvm/CVM_Updates/HAMMERUP.html[/url] PRODUCT Loweís 40% Hog Concentrate - swine feed for mixing grower and finisher rations, in 50-pound bulk bags. Recall #V-057-0. CODE All codes between August 1, 1999 and November 23, 1999. MANUFACTURER Lowe's Feed & Grain, Inc., Bowling Green, Kentucky. RECALLED BY Manufacturer, by letter dated November 18, 1999, and by telephone. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 12.46 tons were distributed. REASON Product contained protein derived from mammalian tissue and according to regulation must bear the statement "Do not feed to cattle or other ruminants" on the label. This regulation is designed to prevent the establishment and amplification of BSE through feed. This statement does not appear on the label. [url=http://www.fda.gov/bbs/topics/ENFORCE/ENF00623.html]http://www.fda.gov/bbs/topics/ENFORCE/ENF00623.html[/url] 2001 October 30, 2001 RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES [url=http://www.fda.gov/cvm/CVM_Updates/bseoctup.htm]http://www.fda.gov/cvm/CVM_Updates/bseoctup.htm[/url] October 10, 2001 FDA HOLDING PUBLIC HEARING ON RUMINANT FEED (BSE) RULES The Food and Drug Administration (FDA) is holding a public hearing to solicit information and views on its present animal feeding regulation "Animal Proteins Prohibited in Ruminant Feed" -- Code of Federal Regulations, Title 21, Part 589.2000. The purpose of the rule is to help prevent the establishment and amplification of bovine spongiform encephalopathy (BSE) in U.S. cattle herds through feed and thereby help minimize any risks from BSE to animal or human health. FDA recognizes that new information has emerged on BSE and variant Creutzfeldt-Jakob Disease (vCJD) since the rule went into effect in 1997. Therefore, FDA is requesting information and views from individuals and organizations on the present rule and whether changes in the rule or other additional measures are necessary. The Agency is particularly interested in soliciting comments and views from individuals, industry, consumer groups, health professionals, and researchers with expertise in BSE and related animal and human diseases. ...snip [url=http://www.fda.gov/cvm/CVM_Updates/part15.htm]http://www.fda.gov/cvm/CVM_Updates/part15.htm[/url] September 25, 2001 BSE INSPECTION CHECKLIST AVAILABLE ON THE CVM INTERNET HOME PAGE FDA's Center for Veterinary Medicine (CVM) has made available the Bovine Spongiform Encephalopathy (BSE) Inspection Checklist on the Center's Home Page on the Internet. This checklist is to be used by Federal and State inspectors to determine compliance with FDA's ruminant feed (BSE) regulations, Code of Federal Regulations, Title 21, Part 589.2000. This rule, that prohibits the use of most mammalian protein in feeds for ruminant animals, was implemented to prevent the establishment and amplification of BSE through feed in the United States. The rule became effective on August 4, 1997. Inspections of over 10,000 renderers, feed mills, ruminant feeders, and others (such as protein blenders) have been conducted to determine compliance with the BSE feed regulations. The majority of these inspections (around 80%) were conducted by State officials and the remainder by FDA. A checklist has been used to record information on the compliance with the rules. The checklist that is being made available on the CVM Home Page is a revised version intended for use in future inspections. [url=http://www.fda.gov/cvm/CVM_Updates/bsecheck.htm]http://www.fda.gov/cvm/CVM_Updates/bsecheck.htm[/url] CVM Update July 7, 2001 RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES [url=http://www.fda.gov/cvm/CVM_Updates/bse72001.htm]http://www.fda.gov/cvm/CVM_Updates/bse72001.htm[/url] CVM Update March 23, 2001 RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES [url=http://www.fda.gov/cvm/CVM_Updates/bsemar3.htm]http://www.fda.gov/cvm/CVM_Updates/bsemar3.htm[/url] CVM Update January 10, 2001 UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES [url=http://www.fda.gov/cvm/CVM_Updates/bseup.htm]http://www.fda.gov/cvm/CVM_Updates/bseup.htm[/url] RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II_______________________ PRODUCT Red Cell, Iron Rich Homogenized, Yucca Flavored Vitamin-Iron-Mineral Supplement for all classes of horses. For Animal Use Only. NET CONTENTS: 1 GALLON. HORSE HEALTH Products, A Division of Farnam Companies, Inc. PO Box 34820, Phoenix AZ 85067-4820, Recall # V-002-2. Redglo, EQUICARE (brand), Homogenized Energy Building Liquid Multi- Vitamin Supplement for Horses. EQUICARE PRODUCTS, A Division of Farnam Companies, Inc., PO Box 34820, Phoenix, AZ, Recall # V-003-2. CODE All codes. RECALLING FIRM/MANUFACTURER Farnam Companies, Inc., Phoenix, Arizona, sent a recall letter dated March 8, 2001, to all distributors via regular first class mail. Firm initiated recall is ongoing. REASON The products contain protein material derived from bovine mammalian tissues; however, the bags are not labeled with the required BSE cautionary statement. VOLUME OF PRODUCT IN COMMERCE 14,000 to 15,000 gallons. DISTRIBUTION Nationwide. [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00719.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00719.html[/url] RECALL NUMBER, PRODUCT AND CODE: Ruminant Custom Mix Feeds: V-388-1 "Beef Feed" manufactured with Buckeye 40% Beef Finisher Pellets, Item 40950. V-389-1 "Rita's Goat Feed" manufactured with Buckeye 39% Lamb Conc. Pellets, Item 41250. V-390-1 "Calf-Beef/Dairy Feed" manufactured with Buckeye 32% Golden Expectation Pellets, Item 42150 V-391-1 "Feed with Vitamin A" manufactured with Buckeye Vitamin A-30, Item 1614 V-392-1 "Feed/A-D-E Premix" manufactured with Buckeye A-D-E Mix, Item 152850 V-409-1 "Calf Feed" manufactured with Buckeye 32% Calf Grower Concentrate, Item 42350 Non-Ruminant Custom Mix Feeds: V-393-1 "40% Poultry Feed" manufactured with Buckeye 40% Poultry Concentrate Crumbles, Item 12100 V-394-1 "40% Hog Feed" manufactured with Buckeye 40% Gro'Em Lean, Item 20550 V-395-1 "Horse Premium Mixer" manufactured with Buckeye 32% Premium Mixer Pellets, Item 38000 Code: All bulk custom mix feeds manufactured prior to April 20, 2001. The customer invoices indicate the type of Buckeye supplement used in the bulk feed. REASON: The bulk custom mix feeds were prepared with ruminant feed supplements recalled by Buckeye Nutrition due to contamination with protein derived from mammalian tissues. The non-ruminant bulk custom mix feeds were not labeled with the required BSE caution statement "Do Not Feed to Cattle or Other Ruminants." MANUFACTURER/RECALLING FIRM: Ferrin Cooperative Equity Exchange, Inc., Carlyle, Illinois RECALLED BY: The firm , by letter beginning on June 28, 2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: IL QUANTITY: 169 tons of ruminant feeds and 27 tons of non-ruminant feeds END OF ENFORCEMENT REPORT FOR October 10, 2001. #### [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00714.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00714.html[/url] RECALL NUMBER, PRODUCT AND CODE: Recall # Product V-397-1 Hyland Floating Fishfood, in 50 pound bags V-398-1 Endurance Plus Extrude Horse Feed, in 50 pound bags V-399-1 Seminole Ultra Bloom Horse Feed, in 50 pound bags V-400-1 Wheat Flakes, extruded product in bulk, not bagged V-401-1 Corn Flakes, extruded product in bulk, not bagged V-402-1 Capt. Crunch, extruded product in bulk, not bagged V-403-1 Green Corn Puffs, extruded product in bulk, not bagged V-404-1 Orange Corn Puffs, extruded product in bulk, not bagged V-405-1 Whole Kernel Corn, in 50 pound bags, unlabeled V-406-1 Soybean Meal, in bulk, not bagged, unlabeled ALL CODES REASON: The animal feed products may contain proteins derived from mammalian tissues. The products are not labeled with the required BSE caution statement "Do Not Feed to Cattle or Other Ruminants." MANUFACTURER/RECALLING FIRM: The Hyland Company, Ashland, Kentucky RECALLED BY: Manufacturer, by telephone on July 25, 2001, and letters on July 31, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: KY, GA, NC, FL WV QUANTITY: 568 tons END OF ENFORCEMENT REPORT FOR August 29, 2001. #### [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00708.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00708.html[/url] RECALL NUMBER, PRODUCT AND CODE: V-385-1 - Rock-N-Rooster Competition Blend, lots: K01611 K01719 K01912 K01916 K02012 K02015 K02214 K02310 K02314 K02318 K02519 K02615 K02917 K03018 K03114 K03215 K03316 K03413 K10116 K10119 K10219 K10313 K10417 K10610 K10714 K10914 K11115 K11214 K11412 K11512 K02019 K02813 K03516 K10616 K11515 V-386-1 - Rock-N-Rooster Premium Five-Grain Scratch, lots: K01611 K01715 K01718 K01812 K01912 K01916 K02012 K02015 K02019 K02117 K02214 K02310 K02318 K02513 K02518 K02710 K02719 K02813 K02910 K02917 K03011 K03018 K03114 K03215 K03413 K03418 K03516 K03517 K10012 K10013 K10115 K10119 K10219 K10310 K10312 K10410 K10611 K10614 K10616 K10713 K10810 K10812 K10914 K10919 K11012 K11114 K11115 K11216 K11213 K11214 K11315 K11412 K11419 K11512 K01918 K02314 K02814 K03316 K101121 K10510 K10819 K11211 K11515 V-387-1 - Rock-N-Rooster Maintainer, lots: K01611 K01719 K01812 K01912 K01916 K01918 K02015 K02117 K02314 K02318 K02513 K02519 K02813 K02814 K02917 K03011 K03018 K03114 K03316 K03413 K03418 K03514 K03516 K03517 K10116 K10119 K10219 K10312 K10417 K10512 K10617 K10714 K10810 K11012 K11115 K11211 K11315 K11512 K11515 K02012 K02615 K03215 K10012 K10616 K11214 REASON: The product contained prohibited material; however, the bags were not labeled with the required BSE cautionary statement. MANUFACTURER/RECALLING FIRM: Southern States Cooperative, Inc., Richmond, Virginia RECALLED BY: The recalling firm ceased distribution on June 6, 2001, and notified feed mill distributors and distribution points by e-mail on June 6 and 7, 2001, to stop sale and notify their retail customers of the stop sale and provide further instructions for relabeling of any of the affected inventory. The firm sent labels with the cautionary statement to their consignees. FIRM INITIATED RECALL: ONGOING DISTRIBUTION: KY, VA, MD, WV, NC, SC, GA, AL, DE, FL, MS and TN QUANTITY: 962 tons END OF ENFORCEMENT REPORT FOR August 1, 2001. [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00704.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00704.html[/url] RECALL NUMBER, PRODUCT AND CODE: V-353-1 through V-370-1, Chicken feed products: Recall # Tag # Product V-353-1 587 B. Challenger Scratch Feed V-354-1 588 B. 18% Gamebird Conditioner V-355-1 2060 B. Kickin' Chicken Premium Game Cock Feed V-356-1 2066 B. Kickin' Chicken Premium Gamebird 16% V-357-1 586 B. Scratch Grain V-358-1 2051 B. Pit Performer 17% V-359-1 575 B. Classic Yard Feed V-360-1 576 Eliminator Maintainer V-361-1 578 Eliminator Conditioner V-362-1 586 Producer Scratch Grain V-363-1 4587 Producer 12% Gamebird Yard Feed V-364-1 2065 Cleveland Trophy Cock Feed V-365-1 80181AAA Consolidated Hen Scratch V-366-1 2051 B&B Maintenance 12 V-367-1 2052 B&B Conditioner 14 V-368-1 2050 B&B Scratch 10 V-369-1 4590 Kingsport Original Prater Mix V-370-1 2062 PC 10 (unlabeled bags) ALL CODES The "B" indicates that the Burkmann Feeds brand name is listed on the tag labels. The suspect products are also bagged and distributed under the following private labels: Producer Feeds, Louisville, Kentucky Kingsport Milling, Kingsport, Tennessee Consolidated Nutrition, L.C., Omaha, Nebraska B&B Feeds, Knoxville, Tennessee Eagle Roller Mill Co., Inc., Shelby, North Carolina Central Farm Supply of Kentucky, Inc., Louisville, Kentucky REASON: The chicken feed products may contain proteins derived from mammalian tissues. The products are not labeled with the required BSE caution statement "Do Not Feed to Cattle or Other Ruminants." MANUFACTURER/RECALLING FIRM: Burkmann Feeds, London, Kentucky RECALLED BY: On May 5, 2001, the firm mailed recall letters with attached BSE sticker-labels to all customers outside the state of Kentucky. The recall notices were hand- delivered to customers within the state of Kentucky by Burkmann's Sales Representatives. Customers were asked to complete and return a recall response form that was included with each letter documenting the numbers of bags and varieties of products for which the customers affixed the BSE sticker-labels. The firm expanded their recall on May 10, 2001, and mailed recall letters with BSE labels and response forms to the affected customers. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: KY, GA, NC, TN, VA QUANTITY: 933 tons _______________________________ RECALL NUMBER, PRODUCT AND CODE: V-377-1, Renner’s brand 45% meat and bone meal, packed in 100 pound bags. REASON: The product contained protein material derived from bovine mammalian tissues; however, the bags are not labeled with the required BSE cautionary statement. MANUFACTURER/RECALLING FIRM: F. W. Renner & Sons, Inc., Canton, Ohio RECALLED BY: The recalling firm contacted the consignees by telephone on June 19, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 2,500 lbs _______________________________ RECALL NUMBER, PRODUCT AND CODE: V-378-1 to V-384-1, RenPro 58% (brand name) swine and poultry feeds in bulk, as follows: V-378-1 - Poultry Layer #215 - guaranteed analysis 15% crude protein, 3% crude fat, and 3.5% crude fiber. V-379-1 - Poultry Layer #216 - guaranteed analysis 16% crude protein, 3% crude fat, and 3.5% crude fiber. V-380-1 - Poultry Layer #217 - guaranteed analysis 17% crude protein, 3% crude fat, and 3.5% crude fiber. V-381-1 - Poultry Layer #218 - guaranteed analysis 18% crude protein, 3% crude fat, and 3.5% crude fiber. V-382-1 - Poultry Layer #219 - guaranteed analysis 19% crude protein, 3.5% crude fat, and 4% crude fiber. V-383-1 - Poultry Prelay #115 - guaranteed analysis 16% crude protein, 3% crude fat, and 5% crude fiber. V-384-1 - Poultry Developer #110 - guaranteed analysis 14% crude protein, 3% crude fat, and 5.5% crude fiber. MANFACTURER: Esbenshade Mills, Mount Joy, PA RECALLED BY: On 5/24/01, the manufacturer notified their customers of the labeling requirement via letter. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: None. The product turn over is two weeks or less. END OF ENFORCEMENT REPORT FOR July 25, 2001. [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00703.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00703.html[/url] RECALL NUMBER, PRODUCT AND CODE: V-371-1, Tender Lean/Shelled Corn Cattle Feed Mix, a custom animal feed mix, packed in 80 LB bags. CODES: None. The bags are unlabeled. The feed was manufactured on 5/14/2001. REASON: The cattle feed (for ruminant animals)may contain protein derived from mammalian tissues. MANUFACTURER/RECALLING FIRM: Champaign Landmark, Inc., Urbana, Ohio RECALLED BY: On 5/24/2001, the firm's Feed Manager personally visited the sole farmer/consignee, at which time, he hand-delivered the firm's recall letter. FIRM INITIATED RECALL: Complete DISTRIBUTION: Ohio QUANTITY: 2,000 LBS END OF ENFORCEMENT REPORT FOR July 11, 2001. [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00701.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00701.html[/url] RECALL NUMBER, PRODUCT AND CODE: V-352-1, Bulk Lamb Meal, All lots of bulk lamb meal shipped by the recalling firm REASON: The product is not labeled with the required caution statement “Do not feed to Cattle or other Ruminants.” MANUFACTURER/RECALLING FIRM: International Proteins Corporations (IPC), St. Paul MN RECALLED BY: Recalling Firm, Revised labeling by letter on April 17, 2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: MN, IL, MO, AR and TX QUANTITY 3,094 tons END OF ENFORCEMENT REPORT FOR July 04, 2001. [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00700.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00700.html[/url] PODUCT: Bulk Lamb Meal. Recall Number V-052-1. CODES: All lots of bulk lamb meal shipped by the recalling firm. MANUFACTURER: International Proteins Corporations (IPC), St. Paul, Minnesota. RECALLED BY: Manufacturer, sent revised labeling in a letter on April 17, 2001. Firm initiated recall is ongoing. DISTRIBUTION: MN, IL, MO, AK, TX. QUANTITY: 3,094 tons. REASON: The product is not labeled with the required caution statement "Do Not Feed to Cattle or Other Ruminants." END OF ENFORCEMENT REPORT FOR June 20, 2001. [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00698.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00698.html[/url] RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS IIPRODUCT & CODES: Animal feed products, packaged in 5, 25, 50, and 55 pound bags, and in bulk, intended for both ruminant and non-ruminant animals. The products are as follows: Recall # V-195-1 through V-350-1. RUMINANT FEED PRODUCTS: RECALL NO. PRODUCT NO. PRODUCT NAME V-195-1 40150 B. 30% Calf Pellet V-196-1 40250 B. 16% Calf Pellet V-197-1 40350 B. 16% Calf Ration V-198-1 40450 B. 18% Calf Starter V-199-1 40600 B. 38% Dairy Pellet V-200-1 40650 B. 38% Dairy Pellet V-201-1 40750 B. 16% Dairy Feed V-202-1 40950 B. 40% Beef Pellet V-203-1 41150 B. 18% Lamb Starter Pellet V-204-1 41250 B. 39% Lamb Conc. Pellet V-205-1 41350 B. 14% Lamb & Beef Pellet V-206-1 41450 B. 16% Goat Feed V-207-1 42150 B. 32% Expectation Pellet V-208-1 42250 B. Llama & Alpaca Pellet V-209-1 42350 B. 32% Calf Grower Pellet V-210-1 42650 B. Llama & Alpaca Crums V-211-1 42750 B. 38% Hay Booster 2 V-212-1 42850 B. 25% Pasture Booster V-213-1 43100 B. 16% Grower/Dev Pellet V-214-1 43150 B. 16% Grower/Dev Pellet V-215-1 43700 WH 32% Calf Gro Pellet V-216-1 43750 WH 32% Calf Gro Pellet V-217-1 43850 B. 38% Dairy Mix V-218-1 44250 B. 17% Doe Pellet V-219-1 44350 B. 21% Buck Pellet V-220-1 44450 Legends Ranch Pellet V-221-1 44500 Legends 17% Breeder Pellet V-222-1 1652 B. Vitamin E-20 V-223-1 1614 B. Vitamin A-30 V-224-1 44550 Legends 17% Breeder Pellet V-225-1 44650 Legends 13.5% Rut Pellet V-226-1 44750 Deer Starter (J) V-227-1 44940 Llama Premix (J) FSC V-228-1 45150 Empire 25% Calf Pellet V-229-1 45450 Berry Llama Pellet V-230-1 45950 50% Beef Conc. (Meal) V-231-1 46250 B. 12% Sweet Livestock V-232-1 46350 B. 1440 Bovatec Pellet V-233-1 46400 Liberty 38% Dairy Pellet V-234-1 46450 Liberty 38% Dairy Pellet V-235-1 47150 B. 14% Gold-n-Grower V-236-1 47250 B. 12% Gold-n-Conditioner V-237-1 47450 B. 18% Gold-n-Lamb V-238-1 47800 Homeworth Dairy Pellet V-239-1 47850 Homeworth Dairy Pellet V-240-1 47900 B. 36% Hi Fat Dairy Pellet V-241-1 47950 B. 36% Hi Fat Dairy Pellet V-242-1 48550 B. 16% Calf Pellet CA V-243-1 49200 Mastead Dairy Base V-244-1 49300 KLEJKA Dairy Base V-245-1 49650 Deer Premix (J) HFB V-246-1 49750 39% Lamb Premix (J) HFB V-247-1 49850 Lamb Starter Premix (J) HFB V-248-1 120850 Brood Cow Deluxe Mineral V-249-1 152850 B. A-D-E Mix NON-RUMINANT FEED PRODUCTS: V-250-1 10150 B. Miracle Starter V-251-1 10350 B. 21% Broiler Starter V-252-1 10450 B. Pullet Grower & Developer V-253-1 10550 B. 18% Layer Breeder Pellets V-254-1 10750 B. 20% Gold Std. Laying Crum V-255-1 10950 B. 17% Complete Laying Crums V-256-1 11050 B. 16% Prosperity Layer Crums V-257-1 11100 B. 40% Poultry Concentrate V-258-1 11150 B. 40% Poultry Concentrate V-259-1 11250 B. 28% Turkey Starter Crums V-260-1 11350 20% Gig "4" Pellets V-261-1 11450 B. 16% Prosperity Layer Pellets V-262-1 11550 18% Game Bird Breeder Pellets V-263-1 11650 B. 19% Ratite Grower Diet V-264-1 11750 B. 23% Ratite Breeder Diet V-265-1 12100 B. 40% Poultry Concentrate Crums V-266-1 12550 B. 32% Base Poultry Mix V-267-1 13250 B. 28% Turkey Starter V-268-1 13450 B. 20% Poultry Grower V-269-1 14325 B. Game Bird Mix - Coarse V-270-1 20150 B. 18% Pig Starter Pellets V-271-1 20250 B. 16% Pig Grower Pellets V-272-1 20450 B. 14% Porkmaker 100 Pellets V-273-1 20550 B. 40% Gro 'Em Lean V-274-1 21850 B. 27% Hi-Fat Swine Base V-275-1 23000 Mt. Hope Hevy Hog V-276-1 30050 12% Pleasure Horse - Sweet V-277-1 30150 Alfa + Performer 10 Sweet V-278-1 30250 14% Grass + Perf Sweet V-279-1 30450 12% Wrangler - Complete V-280-1 30550 B. 12% Pleasure Horse Pellets V-281-1 30650 B. 32% Gro' N Win Pellets V-282-1 30750 12% Wrangler Cubes V-283-1 30950 18% Foal Starter V-284-1 31050 B. 14% Alfa + Dev Pellets V-285-1 31150 B. Alfa + Performer 10 Pel V-286-1 31200 Grass +Performer 14 Pel V-287-1 31250 Grass +Performer 14 Pel V-288-1 31350 12% Mustang V-289-1 31450 Endurance - 101 Extruded V-290-1 31550 B. Equine Energy - UK V-291-1 31650 B. 16% Grass + Dev Pellets V-292-1 31750 16% Grass + Dev Cubes V-293-1 31850 16% Grass + Dev Sweet V-294-1 31950 B. 11% Alfa Gro 'N Win Pel V-295-1 32050 B. Sho' Win Pellets V-296-1 32250 B. Senior Formula V-297-1 32350 Oscar Horse Mix V-298-1 32450 B. Ultimate Finish V-299-1 32550 Crossfire Horse Feed V-300-1 32650 B. Equine 16% Growth V-301-1 32750 B. Reduced Energy Formula V-302-1 32850 B. Training Formula V-303-1 32950 B. Cadence Formula V-304-1 33150 B. Track 12 Horse Feed V-305-1 33350 Spears 16% GR + Dev Cubes V-306-1 33400 B. 14% Supreme Horse Pellets V-307-1 33450 B. 14% Supreme Horse Pellets V-308-1 33650 B. Race'N Win V-309-1 33750 B. 14% Prominent Horse Feed V-310-1 33850 B. Unbeetable Horse Feed V-311-1 34750 Cargill Senior Horse V-312-1 34850 Cargill Vitality Gold V-313-1 35150 Chagrin 12% Sweet Fd V-314-1 35250 Smith Pure Pleasure V-315-1 35750 Roundup 10% Horse Pellets V-316-1 35850 12% Summerglo Horse V-317-1 36255 B. Grass +Min&VitBase - Mexico V-318-1 36850 Miller's 12% Horse Feed V-319-1 37155 B. Gro'Win Base Mix - Mexico V-320-1 38000 B. 32% Premium Mixer Pellets V-321-1 38050 B. 32% Premium Mixer Pellets V-322-1 38100 36% Maintenance Mixer Pellets V-323-1 38150 36% Maintenance Mixer Pellets V-324-1 50150 Terramycin Crumbles V-325-1 60105 16% Rabbit Pellets V-326-1 60125 16% Rabbit Pellets V-327-1 60150 B. 16% Rabbit Pellets V-328-1 60205 18% Rabbit Developer V-329-1 60250 B. 18% Rabbit Developer V-330-1 60450 B. 16% Rabbit Maintenance V-331-1 90150 B. Buckeye Scratch V-332-1 90225 Gold Standard Scratch V-333-1 90250 Gold Standard Scratch V-334-1 90350 Intermediate Scratch V-335-1 90450 B. Chick Grains V-336-1 90525 B. Shelled Corn V-337-1 90550 B. Shelled Corn V-338-1 90650 B. Cracked Corn V-339-1 90825 B. Fine Cracked Corn V-340-1 90850 B. Fine Cracked Corn V-341-1 91000 Steam Flaked Corn V-342-1 91050 Steam Flaked Corn V-343-1 91750 Oats - HP Crimped V-344-1 91850 B. HP Sweet Crimped Oats V-345-1 95550 Land O' Lakes Shelled Corn V-346-1 95650 Land O' Cracked Corn V-347-1 95850 Land O' Lakes Chick Crack V-348-1 100850 B. Alfalfa Pellets V-349-1 101850 Cooked Full Fat Soybean V-350-1 122200 Magnatone M-4-B Pels Bulk MANUFACTURER: Buckeye Feed Mills, Dalton, Ohio. RECALLED BY: Manufacturer visited local customers on April 17, 2001. On April 18 and 19, 2001, manufacturer mailed and faxed recall notices. Firm initiated recall is ongoing. DISTRIBUTION: Al, CT, DE, FL, GA, IL, IN, IA, KY, ME, MD, MA, MO, MN, MS, NH, NJ, NY, NC, OH, OR, PA, RI, TN, VA, WV, and WI. QUANTITY: 2,790 tons of ruminant feed products and 14,000 tons of non-ruminant feed products. REASON: The animal feed products may contain protein derived from mammalian tissues. [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00696.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00694.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00694.html[/url] RECALLS AND FIELD CORRECTIONS: VETERINARY MEDS -- CLASS II PRODUCT: Buckeye 26% Hi Fat Swine Mix, Sandy Lake 40% Hog Supplement, 100 lb. containers, flexible plastic burlap bags. Recall #V-026-1. CODE: None are used. MANUFACTURER: Sandy Lake Mills, Sandy Lake, PA. RECALLED BY: Manufacturer, by telephone and visit. Firm initiated recall complete. DISTRIBUTION: Pennsylvania. QUANTITY: Seven containers, each weighing 100 pounds. REASON: The product contains prohibited material (ruminant animal proteins) used as an ingredient in the finished product swine feed. The product is not labeled with the required caution statement "Do Not Feed to Cattle or Other Ruminants." ________ PRODUCT: Custom Vaquero Supplement for Cattle identified by Purina Mills. Recall #V-027- 1. CODE: 7V87. MANUFACTURER: Purina Mills, Inc., Gonzalez, Texas. RECALLED BY: Manufacturer, contacted the one consignee on January 17, 2001. DISTRIBUTION: Texas. QUANTITY: 44,355 pounds. REASON: The ruminant feed product contains meat and bone meal (MBM) of bovine origin.[url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00692.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00692.html[/url] PRODUCT: a) Manna Pro Floating Fish Food for Catfish . Recall #V-028-1; b) Manna Pro Floating Fish Food - 26% For All Freshwater Fish. Recall #V-029-1. Both are packaged in 50 pound, plastic-lined, paper sacks. CODE: a) 10160164, 12090164, 01050264, 03020264, and 03140264; b) 09110164, 09190164, 09230164, 10090164, 10160164, 11170164, 12090164 and 3200264. MANUFACTURER: Doane Pet Care, Brentwood, Tennessee. RECALLED BY: Manufacturer, by telephone on March 26, 2001. Firm-initiated recall complete. DISTRIBUTION: California, Pennsylvania, Ohio, Kansas, Colorado, Georgia, and Florida. QUANTITY: 27,300 pounds of Catfish Food and 86,100 pounds of Freshwater Fish. REASON: The products, which contain meat by-products, were shipped without the required BSE warning label.[url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00691.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00691.html[/url] PRODUCT: Buckeye 40% Poultry Concentrate. Recall #V-016-1. CODES: The bags are uncoded. Firm is recalling product manufactured since December 1998; however, they are only completing field corrections on product manufactured within the last six months (November 2000). MANUFACTURER: Yachere Feed, Inc. Rockwood, Pennsylvania. RECALLED BY: Manufacturer, by visit on 3/19/01 and 3/20/01. Firm-initiated recall complete. DISTRIBUTION: Pennsylvania. QUANTITY: Nine containers, each weighing 100 pounds. REASON: The animal feed contains product derived from mammalian tissues and must bear the statement "Do not feed to cattle or other ruminants" on the label to prevent the establishment and amplification of BSE through feed. This statement does not appear on the label. ________ PRODUCT: "Our Own Pig & Hog Grower" hog feed, packaged in 50 pound bags, with paperboard tags sewn onto the bags. Recall #V-017-1. CODES: The bags are uncoded. MANUFACTURER: The Perry Coal and Feed Company, Perry, Ohio. RECALLED BY: Manufacturer, by telephone on March 22, 2001. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Approximately 350 pounds of hog feed (7/50 pound bags). REASON: The animal feed contains protein derived from mammalian tissues and must bear the statement "Do not feed to cattle or other ruminants" on the label to prevent the establishment and amplification of BSE through feed. This statement does not appear on the label. [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00690.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00690.html[/url] RECALLS AND FIELD CORRECTIONS: VETENIARY MED -- CLASS II PRODUCT: Custom Mixed Poultry Feed, bagged and sold as bulk, unlabeled poultry feed. Recall #V-014-1. CODE: The bags are uncoded. MANUFACTURER: Western Reserve Farm Coop., Middlefield, Ohio. RECALLED BY: Manufacturer, by telephone on February 28, 2001. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Approximately 820 pounds. REASON: The animal feed contains product derived from mammalian tissues and must bear the statement “Do not feed to cattle or other ruminants” on the label to prevent the establishment and amplification of BSE through feed. This statement does not appear on the label. ________ PRODUCT: Custom Mixed Poultry Feed, packaged in unlabeled 100 pound bags and sold in bulk. Recall #V-015-1. CODE: The bags are uncoded. MANUFACTURER: Medina Landmark, Inc., Medina, Ohio. RECALLED BY: Manufacturer, by telephone on March 5, 2001. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Approximately 900 pounds of feed (9/100 pound bags). REASON: The animal feed contains product derived from mammalian tissues and must bear the statement “Do not feed to cattle or other ruminants” on the label to prevent the establishment and amplification of BSE through feed. This statement does not appear on the label. END OF ENFORCEMENT REPORT FOR APRIL 11, 2001. [url=http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00688.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00688.html[/url] 2002 To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997. To date, active monitoring by the U.S. Department of Agriculture (USDA) has found no cases of bovine spongiform encephalopathy (BSE) in U.S. cattle. This is an update on FDA enforcement activities regarding the ruminant feed (BSE) regulation. FDA’s enforcement plan for the ruminant feed regulation includes education, as well as inspections, with FDA taking compliance actions for intentional or repeated noncompliance. FDA’s Center for Veterinary Medicine (CVM) has assembled data from the inspections that have been conducted AND whose final inspection report has been submitted to CVM (i.e., “inspected/reported”) as of March 11, 2002. There is a lag time between the completion of an inspection and the submission of a final inspection report to CVM. This lag period includes the time required to conduct quality assurance on the report and to evaluate the findings before a final report is submitted. As of March 11, CVM had received inspection reports covering inspections (both initial inspections and re-inspections) of 10,458 different firms. The majority of these in- RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES [url=http://www.fda.gov/cvm/Documents/MayJune.pdf]http://www.fda.gov/cvm/Documents/MayJune.pdf[/url] July/August 2002 The following individuals/firms received warning letters for violations related to 21 CFR Part 589.2000 – Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and REGULATORY ACTIVITIES by Karen A. Kandra amplification of Bovine Spongiform Encephalopathy (BSE): • Jeffrey T. Buck, Owner, All American Feed & Tractor, Sandpoint, ID • Kenneth M. Van Dyke, President, Van Dyke Grain Elevators, Inc., North Plains, OR • Philip C. Anderson, General Manager, Darling International, Inc., Tacoma, WA Violations included failure to maintain sufficient records and written procedures to prevent cross-contamination; failure to keep written procedures for cleaning out or flushing equipment after mixing feeds containing prohibited material; failure to provide written procedures for separating products that contain or may contain prohibited material from ingredients used in ruminant feeds, from the time of receipt until the time of shipment; and, failure to label meat and bone meal with the required cautionary statement “Do Not Feed to Cattle or Other Ruminants.” snip... [url=http://www.fda.gov/cvm/Documents/JulyAugust.pdf]http://www.fda.gov/cvm/Documents/JulyAugust.pdf[/url] 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. -------------------------------------------------------------------------------- [url=http://www.fda.gov/cvm/CVM_Updates/CWdup.htm]http://www.fda.gov/cvm/CVM_Updates/CWdup.htm[/url] 2003D-0186 Guidance for Industry: Use of Material From Deer and Elk In Animal Feed EMC 1 Terry S. Singeltary Sr. Vol #: 1 [url=http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm]http://www.fda.gov/ohrms/dockets/dailys ... 060903.htm[/url] CVM Update <November 21, 2002 Clarification of FDA Position on Use In Animal Feed of Material From Certain Free Range Deer and Elk This CVM Update has been withdrawn by Draft Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed | doc| | pdf |, May 14, 2003. See CVM Update Draft Guidance on Use of Material from Deer and Elk in Animal Feed Available for Comment; CVM Updates on Deer and Elk in Animal Feed Withdrawn. [url=http://www.fda.gov/cvm/CVM_Updates/CWDNOV21.htm]http://www.fda.gov/cvm/CVM_Updates/CWDNOV21.htm[/url] 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 [url=http://www.fda.gov/dockets/ecomments]http://www.fda.gov/dockets/ecomments[/url]. 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: [email=bpritche@cvm.fda.gov]bpritche@cvm.fda.gov[/email] 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 [url=http://www.fda.gov/cvm]http://www.fda.gov/cvm[/url]. 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 ; [url=http://www.fda.gov/cvm/Guidance/guide158.pdf]http://www.fda.gov/cvm/Guidance/guide158.pdf[/url] CVM Update April 15, 2002 RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES [url=http://www.fda.gov/cvm/CVM_Updates/bseap02.htm]http://www.fda.gov/cvm/CVM_Updates/bseap02.htm[/url] RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II _____________________________ PRODUCT Land O'Lakes Farmland Feed 32% Grow Big Floater, For Catfish Grown In Ponds or Artificial Culture Systems, packaged in 50-lb. bags, product #1960014, contains animal protein products. Recall # V-003-3. CODE None. RECALLING FIRM/MANUFACTURER Recalling Firm: Land O'Lakes Farmland Feed LLC, Arden Hills, MN, by fax on August 21, 2002. Manufacturer: Land O'Lakes Farmland Feed LLC, Kansas City, KS. FDA initiated recall is complete. REASON Label lacks BSE warning statement. VOLUME OF PRODUCT IN COMMERCE Approx. 18,872/50-lb. bags. DISTRIBUTION KS, TX, CO, NE, IL, MO, IA, OK and SD [url=http://www.fda.gov/bbs/topics/enforce/2002/ENF00765.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00765.html[/url] RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II _____________________________ PRODUCT 12% Horse Feed, packaged under the Griffith & Sons label, in 100 lb bags. Recall # V-001-3. CODE The bags are not coded. All of their 12% Horse Feed product manufactured and distributed from 5/14/2002 to 6/21/2002 is subject to this recall. RECALLING FIRM/MANUFACTURER Recalling Firm: Griffith & Sons Feed and Farm Supply, Staffordsville, KY, by telephone and visits on June 21, 2002. Manufacturer: Griffith & Sons Feed and Farm Supply, Staffordsville, OH. Firm initiated recall is complete. REASON The Horse Feed product contains beef protein and is not labeled with the required BSE cautionary statement. VOLUME OF PRODUCT IN COMMERCE 1,200 lbs (12 / 100 lb bags). DISTRIBUTION OH. END OF ENFORCEMENT REPORT FOR OCTOBER 09, 2002 #### [url=http://www.fda.gov/bbs/topics/enforce/2002/ENF00764.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00764.html[/url] RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II _______________________ PRODUCT Product is flavor enhancer intended for use in pet food, labeled in part: "8280 FLAVOR GENERATOR #1" packaged in 1,000 and 2,000 pound bags. Recall # V-163-2. CODE All lots shipped prior to 04/09/02. RECALLING FIRM/MANUFACTURER Roche Vitamins, Inc., Fort Worth, TX, by telephone on April 5, 2002. FDA initiated recall is complete. REASON Product contains beef protein but is not labeled with the warning statement regarding prohibited for use as feed for ruminants. VOLUME OF PRODUCT IN COMMERCE 680,200 lbs. DISTRIBUTION KS, CA, KY and IN. [url=http://www.fda.gov/bbs/topics/enforce/2002/ENF00762.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00762.html[/url] RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II_______________________ PRODUCT Homestead Poultry Starter Grower Medicated 55 lb. bags. Recall # V-154-2. CODE Not coded. RECALLING FIRM/MANUFACTURER Recalling Firm: Shur-Gain USA Inc., Elma, NY, by visit on June 24, 2002. Manufacturer: Shur-Gain, St. Marys, Ontario, Canada. FDA initiated recall is complete. REASON Contains ruminant proteins but lacks caution statement. VOLUME OF PRODUCT IN COMMERCE 31 bags. DISTRIBUTION NY. END OF ENFORCEMENT REPORT FOR AUGUST 14, 2002 #### [url=http://www.fda.gov/bbs/topics/enforce/2002/ENF00756.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00756.html[/url] RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II _______________________ PRODUCT UNLABELED hog feed in 100 lb. bags containing assorted grains (primarily corn), and Miller's Hog Supplement 36% protein. UNLABELED dairy feed in 100 lb. bags, contains assorted grains (primarily corn), soybeans and molasses. Recall # V-142-2. CODE Not CODEd. RECALLING FIRM/MANUFACTURER Recalling Firm: R. B. Crowell & Sons/Thompson Grain, Inc., Manchester, NY, by telephone on May 7 and 8, 2002. Manufacturer: John R. Power, Palmyra, NY. State initiated recall is complete. REASON Unlabeled animal feeds/possible cross contamination. VOLUME OF PRODUCT IN COMMERCE .75 tons per month. DISTRIBUTION NY. _______________________ PRODUCT Cereal Food Fines - Bulk PRODUCT. Recall # V-145-2. CODE All PRODUCT prior to October 2, 2001. RECALLING FIRM/MANUFACTURER Souder Feed & Grain Carlisle, PA, by letters dated October 9, 2001. State initiated recall is ongoing. REASON PRODUCT doesn't bear caution statement - do not feed to cattle or other ruminants. VOLUME OF PRODUCT IN COMMERCE 6,141 tons. DISTRIBUTION MO, NY and PA.[url=http://www.fda.gov/bbs/topics/enforce/2002/ENF00747.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00747.html[/url] RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II _______________________ PRODUCT BioFlavor F2425, BioFlavor F21002 and BioFlavor C20058. The product, packaged in 50 lb. bags, is labeled in part, " *** PALATABILITY ENHANCER INTENDED FOR CAT FOOD USE AT LESS THAN 10% *** INGREDIENT LISTING: *** Beef Broth *** ". Recall # V-140-2 CODE Product Codes F2425 107B-RB-1 107B-RB-2 149C 201D 202C 205D 210A F21002 143B 143D 146D 144B 144D 139D 142D 150D 151D 152C 152D 201C 205C 206C 208A 211A C20058 143D 144C 146C 208B RECALLING FIRM/MANUFACTURER Recalling Firm: Bioproducts, Inc., Fairlawn, OH, by telephone and letter on April 5, 2002. Manufacturer: Bioproducts, Inc., Aurora, MO. Firm initiated recall is ongoing. REASON Animal feed product with beef protein does not contain required BSE statement on labels. VOLUME OF PRODUCT IN COMMERCE 354,150 lbs. DISTRIBUTION TX, KS, MO and MI. _______________________ PRODUCT Steamed Bonemeal in 50-lb. bags, product code C# 13581, packaged under two different labels: Premium Steamed Bonemeal Manufactured by Buchheit Premium Feeds, Perryville, MO, and Steamed Bonemeal Manufactured for Siemer's Enterprises Inc., Teutopolis, IL. Recall # V-141-2. CODE Not coded. RECALLING FIRM/MANUFACTURER Buchheit, Inc., Perryville, MO, by telephone on May 14, 2002. FDA initiated recall is ongoing. REASON Label lacks BSE warning statement. VOLUME OF PRODUCT IN COMMERCE Approx. 902/50-lb. bags. DISTRIBUTION MO and IL. END OF ENFORCEMENT REPORT FOR JUNE 5, 2002 #### [url=http://www.fda.gov/bbs/topics/enforce/2002/ENF00746.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00746.html[/url] PRODUCT The following 10 animal feed products were subject to this recall: 1- Sexton Brothers MIXED FEED-WM, Recall # V-019-2 2- Sexton Brothers 9% SWEET FEED, Recall # V-020-2 3- Sexton Brothers 13% SWEET FEED, Recall # V-021-2 4- Sexton Brothers WHEAT, Recall # V-022-2 5- Sexton Brothers 44% SOYBEAN MEAL, Recall # V-023-2 6- Sexton Brothers 14% GOAT FEED, Recall # V-024-2 7- Sexton Brothers WHEAT MIDDS, Recall # V-025-2 8- Sexton Brothers SHELLED CORN, Recall # V-026-2 9- Sexton Brothers OATS, Recall # V-027-2 10-Sexton Brothers 17% GOAT FEED, Recall # V-028-2 The feed products were packaged in 50 LB bags, under the Willard Milling Company label. CODE No codes. All recalled products that were distributed prior to July 30, 2001 are affected by this recall. RECALLING FIRM/MANUFACTURER Willard Milling, Inc. Willard, KY, by letter and telephone on July 30, 2001. State initiated recall is complete. REASON Products may contain protein derived from mammalian tissues. VOLUME OF PRODUCT IN COMMERCE Approx. 140 tons DISTRIBUTION OH, KY, IN, and WV. END OF ENFORCEMENT REPORT FOR January 23, 2002 #### [url=http://www.fda.gov/bbs/topics/enforce/2002/ENF00727.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00727.html[/url] PRODUCT The following custom mixed animal feeds are recalled --- a) [non-ruminant]: Horse Feed, Hog Feed, and 14% Pig Feed. Recall # V-157-2; b) [ruminant]: Dairy Feed, Steer Feed, New Goat Feed, Cattle Feed, and Beef Feed. Recall # V-158-2. CODE The product is coded only with the manufacturing date and invoice numbers. All feed products manufactured and shipped since July 9, 2001 are affected by this recall. RECALLING FIRM/MANUFACTURER Recalling Firm: Shepard Grain Company, Inc., Urbana, OH, by telephone on January 11, 2002. Manufacturer: Shepard Grain Company, Inc., W. Liberty, OH. FDA initiated recall is complete. REASON Ruminant and non-ruminant animal feeds contain BSE prohibited material, and are either misbranded or adulterated. VOLUME OF PRODUCT IN COMMERCE 41,129 LBS (20.5 tons). DISTRIBUTION OH. END OF ENFORCEMENT REPORT FOR AUGUST 28, 2002 [url=http://www.fda.gov/bbs/topics/enforce/2002/ENF00758.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00758.html[/url] 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 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. UPDATE: BSE Found in Washington State USDA Reports Cow Tested Positive for BSE – FDA Sends Investigators On December 23, 2003, the U.S. Department of Agriculture (USDA) announced that a Holsteincow in the State of Washingtonhad tested presumptively positive for bovine spongiform encephalopathy (BSE or “mad cow disease”). Following this announcement, FDA dispatched several teams of investigators to trace back and trace forward the potential involvement of any FDA-regulated commodities. USDA, which is responsible for the safety of certain meat and poultry products as well as animal health, led the investigation of this BSE case. 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.) Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant); Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product. The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdomcattle in the 1980's and 1990's. 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. 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. 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. 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 plans to 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. 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 Distric [/QUOTE]
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