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CVM's OR Develops New PCR-Based Method for Testing Animal Feed

Posted Jan 19 2010 10:24am
CVM's OR Develops New PCR-Based Method for Testing Animal Feed

The Office of Research (OR) of the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) recently developed a new method for testing animal feed for prohibited materials. The method relies on polymerase chain reaction (PCR), a molecular technique that amplifies small amounts of genetic material (DNA or RNA) to produce larger amounts for analysis. Once the new PCR-based method is routinely used, it will enhance the FDA’s ability to make sure animal feed is safe and free of prohibited materials that may spread the agent thought to cause bovine spongiform encephalopathy (BSE).

BSE is a fatal disease that causes progressive degeneration of the central nervous system (brain and spinal cord) in cattle. BSE, commonly called “mad cow disease,” was first detected in the United Kingdom (U.K.) in 1986. Studies quickly established an association between outbreaks of BSE and the use of cattle feed containing protein from cattle and other ruminants, such as sheep and goats. In 1988, the U.K. issued the world’s first feed ban prohibiting ruminant meat-and-bone meal from being fed to cattle and other ruminants.

On June 5, 1997, the FDA issued a similar feed ban that prohibited most mammalian protein from being used to make animal feed for ruminants (ref 1). In April 2008, the FDA strengthened the feed ban by prohibiting high-risk materials from being used to make all animal feed, including pet food. High-risk materials are those materials from cattle that have the highest chance of carrying the agent thought to cause BSE, such as the brains and spinal cords from cattle that are 30 months of age or older.

Testing Feed Samples: The Current Process To make sure that animal feed manufacturers comply with the feed ban, the FDA tests feed samples for prohibited materials. Feed samples are typically collected by field investigators in the Office of Regulatory Affairs (ORA), the FDA’s investigative arm. The samples are analyzed by feed microscopy, a technique that uses a microscope to visually identify the components in the sample. Samples that test positive for a prohibited mammalian protein by feed microscopy then undergo PCR testing to confirm the positive result.

In 2001, the FDA validated a PCR-based method capable of detecting mammalian protein in animal feed (ref 2). OR’s feed analysts used the 2001 method for several years when they were asked by ORA to confirm the presence of prohibited materials in animal feed, although the method was never used by field investigators in ORA. In 2006, OR validated an improved version of the 2001 PCR-based method. After extensive hands-on training, ORA’s field investigators began using the 2006 method (ref 3) to confirm positive feed microscopy results.

The Traditional PCR-Based Method Both the 2001 and 2006 PCR-based methods rely on agarose gel electrophoresis. Gel electrophoresis is a technique that separates materials by size using an electric field applied to a gel. In agarose gel electrophoresis, the gel is made from agarose, a gelatinous substance derived from seaweed.

The DNA from an animal feed sample is extracted and amplified using PCR. A small amount of the DNA is then placed in a pre-cut hole, or “well,” at the top of the agarose gel. When an electric field is applied to the gel, the DNA pieces in the sample move towards the bottom of the gel. The rate of speed depends on size. Smaller pieces move faster than larger pieces. The DNA pieces separate into distinct bands based on size, where one band represents DNA pieces of the same size. The size of a piece of DNA is determined by the number of base pairs (abbreviated “bp”) it contains. The higher the bp number, the more base pairs make up that particular piece of DNA; and the more base pairs, the larger the piece of DNA.

When a fluorescent dye is added to the gel, the bands fluoresce under ultraviolet (UV) light and a photograph is taken which shows the location of the fluorescing bands within the gel (see Figure 1). Based on the location of the bands, the size of the DNA pieces can be determined.

Because the DNA pieces in a sample move in a straight line from the top to the bottom of the gel, the sample is said to be in a “lane.” One gel usually has several lanes for analyzing multiple samples at the same time.

Figure 1. Photographic Image of the Traditional PCR-Based Method

The arrow at the top left of the image is pointing to the wells which appear as dark rectangles at the top of the gel. Lane “M” contains a set of standard DNA pieces with known sizes. Lanes 1 through 10 contain the feed samples that are to be tested for prohibited materials. Lanes 11 and 12 are the negative control samples and do not contain any prohibited materials. Lane 13 is the positive control sample and contains cattle protein, a prohibited material. A fluorescing band at the 271 bp location means that the animal feed sample likely contains prohibited cattle protein.

The 2006 Method: Limitations PCR-based methods that rely on UV light for visualizing the bands commonly have problems. Most of the problems encountered during OR’s validation testing of the 2006 method had to do with the process of agarose gel electrophoresis or interpreting the resulting photograph (ref 3). For example, when a group of feed samples containing negative, slightly positive, and highly positive samples is analyzed, the resulting photograph is often a hard-to-read compromise between the lowest-intensity bands, which are faint to undetectable, and the highest-intensity bands, which are so bright that they hide nearby lanes (ref 4). Also, the instrument that takes the photograph of the gel is usually set to automatically focus on the brightest bands, causing bands of lesser intensity to be barely visible or not visible at all (see Figure 2). Another problem with the 2006 method is that it takes at least 8 hours to analyze a sample.

Figure 2. Photographic Example of the Limitations of the 2006 Method

The upper photograph was taken using the automatic settings for the instrument that takes the photograph of the agarose gel. The instrument focused on the brightest bands in the gel, causing one positive feed sample to barely show up (light arrow on the right) and a second positive sample to not show up at all (dark arrow on the left). The lower photograph is the same gel after the settings were manually adjusted. Now, both positive samples can be clearly seen.

The 2009 Method: Goals and Solutions OR’s first goal was to develop a faster, simpler method based on real-time PCR. In real-time PCR, a fluorescent dye is used to tell how much DNA is being produced during the reaction. The fluorescent dye binds to the DNA and the bound DNA fluoresces and emits a light signal that is detected by the PCR instrument (see Figure 3).

OR’s second goal was to evaluate the new method using strict in-house testing requirements and a peer verification trial.

Because there are no set federal guidelines to evaluate methods to detect prohibited materials in animal feed, OR had to develop its own objective criteria (called acceptance criteria) to assess the new real-time PCR-based method. The acceptance criteria used in the assessment had previously been used by OR to evaluate four kits currently on the market to detect prohibited mammalian protein in animal feed (refs 5 and 6). OR also used a statistical approach to determine if the acceptance criteria were met.

An important criterion was the ability of the new method to detect mammalian protein when present in animal feed at a concentration of at least 0.1%. This value was chosen because (a) 0.1% was the concentration used in the validation trials for the 2001 and 2006 PCR-based methods (refs 2 and 3); and (b) 0.1% is the concentration that is normally detected by feed microscopy (ref 7).

The new real-time PCR-based method met strict requirements for sensitivity (ability to detect true positive samples), selectivity (ability to detect true negative samples), and specificity (ability to detect only the targeted animal species). It also met strict requirements for ruggedness and real-time platform. The ruggedness test determines how well the method tolerates small changes to its set operating limits and measures the method’s reliability under normal use. The real-time platform test assesses how well the PCR portion of the method works using different laboratory instruments.

After strict in-house testing, the new method underwent a peer verification trial to assess how well it worked when used by other laboratories and if the instructions on how to use it were clear. Two outside laboratories participated in the peer verification trial. The results showed that the method had 100% specificity in identifying three types of prohibited materials, cattle meat-and-bone meal, lamb meal, and goat meat meal. There was only a 0.6% rate of false positive results. The peer verification trial proved that the new real-time PCR-based method can easily and reliably be used by other laboratories.

Figure 3. Computer Image of the New Real-Time PCR-Based Method

The level of fluorescence is shown on the y-axis and the cycles of PCR amplification is shown on the x-axis. The baseline level of fluorescence is 30 fluorescence units (horizontal solid line). The negative control sample (horizontal dotted line) does not contain any prohibited materials and fluoresces below the baseline level. A feed sample that contains a prohibited material fluoresces above the baseline level. The point at which the sample’s fluorescence exceeds the baseline level is called the inflection point (vertical line). The inflection point is also called the Cycle Threshold (Ct) value. In the above image, the Ct value is 18.83. The lower the Ct value, the higher the concentration of DNA from prohibited materials in the sample.

The 2009 Method: Advantages In less than 2.5 hours, the new real-time PCR-based method can detect processed materials from cattle, sheep, and goats, as well as a select set of processed materials from chickens, turkeys, and geese (ref 8). The method can also detect animal materials that have been processed in both North America and the European Union (E.U.). The processing conditions in the E.U. are very different from those in North America, resulting in meat-and-bone meals with different characteristics. Because it can detect meat-and-bone meals processed in both North America and the E.U., the 2009 method is more useful and versatile than the 2006 method.

Besides being faster and more versatile, another advantage of the new real-time PCR-based method is that all the components are available as a pair of commercial kits that are made under strict quality controls. One kit contains the reagents needed to extract the DNA from the feed sample for amplification by PCR. The second kit contains the reagents needed to perform the PCR test. Having all the necessary reagents available for laboratories in ready-to-use kits that have already been examined for quality control further reduces the time needed to analyze a sample.

Future Plans The new 2009 real-time PCR-based method will become the FDA’s “one-stop shop” for testing animal feed. It will replace feed microscopy as the FDA’s method of choice for screening animal feed for prohibited materials. It will also be used to confirm the presence of prohibited materials in animal feed, replacing the 2006 PCR-based method.

OR is working with CVM’s Office of Surveillance and Compliance on a plan to replace the 2006 method with the improved 2009 method. An integral part of the plan includes training sessions for ORA’s federal field investigators at OR’s research laboratories in Laurel, Maryland. State field investigators will also be invited to the training sessions. So far, OR has conducted three 3-day sessions to provide extensive hands-on training in this new method. Fourteen federal field investigators from ORA and 20 state field investigators from various states participated.

Once it fully replaces both feed microscopy and the 2006 PCR-based method, the new 2009 real-time PCR-based method will increase the FDA’s ability to detect prohibited mammalian protein in animal feed and prevent BSE in U.S. cattle. This strengthens the FDA’s mission to protect animal and public health by keeping the food supply safe for both animals and people.

References 1.Federal Register, vol. 62, no. 108, p. 30976. June 5, 1997. Substances prohibited from use in animal food or feed: Animal proteins prohibited in ruminant feed. Final Rule. 21 CFR 589.2000. 2.Myers, M.J., S.L. Friedman, D.E. Farrell, D.A. Dove-Pettit, M.F. Bucker, S. Kelly, S. Madzo, W. Campbell, R.F. Wang, D. Paine, and C.E. Cerniglia. 2001. Validation of a polymerase chain reaction method for the detection of rendered bovine-derived materials in feedstuffs. J. Food Prot. 64:564-566. 3.Myers M.J., H.F. Yancy, J. Derr, J. Sedwick, M. Araneta, J. Wetherington, G. Mowlds, K. Riter, H. Lin, J. Armour, H. Koch, P. Istafanos, Y. Shen, R. Younkins, D. Pinero, F. Jackson, D. Farmer, W.M. Kiessling, and L.A.D Hoostelaere. 2006. Validation of a PCR-based method for the detection of various rendered materials in feedstuffs using a forensic DNA extraction kit. J. Food Prot. 69:205-210. 4.Yancy, H.F., A. Mohla, D.E. Farrell, and M.J. Myers. Evaluation of a rapid PCR-based method for detection of animal materials. 2005. J. Food Prot. 68:2651-2355. 5.Myers M.J., H.F. Yancy, D.E. Farrell, J.D. Washington, and R.A. Frobish. Evaluation of two commercial lateral-flow test kits for detection of animal proteins in animal feed. 2005. J. Food Prot. 68:2656-2664. 6.Myers M.J., H.F. Yancy, D.E. Farrell, J.D. Washington, C.M. Deavers, and R.A. Frobish. Assessment of Two Enzyme-Linked Immunosorbent Assay Tests Marketed for Detection of Ruminant Proteins in Finished Feed. 2007. J. Food Prot. 68:2656-2664. 7.Myers, M.J. Detecting animal tissues in feed and feed ingredients. Improving the Safety of Fresh Meat, J.N. Sofos, ed. 2005. Wood Head Publishing Ltd.: Cambridge, UK, pp. 55-79. 8.Yancy, H. F., J.D. Washington, L. Callahan, J.A. Mason, C.M. Deaver, D.E. Farrell, and M.J. Myers. 2009. Development, Evaluation, and Peer-Verification of a Rapid Real-Time PCR Method for the Detection of Animal Material. J. Food Prot. 72:2368-23


http://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm197767.htm


Greetings !


WELL, IT SEEMS that the infamous FDA partial and voluntary mad cow feed ban of August 4, 1997, is what it was, nothing but ink on paper. In other words it failed time and time again, and the FDA et al CANNOT ENFORCE IT, so they must try something else. ...TSS




Sunday, January 17, 2010

BSE USA feed inspection violations 01/01/2009 to 01/17/2010 FDA BSE/Ruminant Feed Inspections Firms Inventory Report


http://madcowfeed.blogspot.com/2010/01/bse-usa-feed-inspection-violations.html



Friday, January 15, 2010

New York Firm Recalls Beef Carcass That Contains Prohibited Materials (BSE)


http://bse-atypical.blogspot.com/2010/01/new-york-firm-recalls-beef-carcass-that.html



Friday, September 4, 2009

FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009


http://madcowfeed.blogspot.com/2009/09/foia-request-on-feed-recall-product.html



Saturday, August 29, 2009

FOIA REQUEST FEED RECALL 2009 Product may have contained prohibited materials Bulk Whole Barley, Recall # V-256-2009


http://madcowfeed.blogspot.com/2009/08/foia-request-feed-recall-2009-product.html



C O N F I R M E D


----- Original Message ----- From: "Terry S. Singeltary Sr." To: Sent: Thursday, November 05, 2009 9:25 PM Subject: [BSE-L] re-FOIA REQUEST ON FEED RECALL PRODUCT contaminated with prohibited material Recall # V-258-2009 and Recall # V-256-2009


http://madcowfeed.blogspot.com/2009/11/re-foia-request-on-feed-recall-product.html



Thursday, November 12, 2009

BSE FEED RECALL Misbranding of product by partial label removal to hide original source of materials 2009


http://madcowfeed.blogspot.com/2009/11/bse-feed-recall-misbranding-of-product.html



CVM Annual Report Fiscal Year 2008: October 1, 2007-September 30, 2008

PUTTING LIPSTICK ON A PIG AND TAKING HER TO A DANCE...TSS

BSE Feed Rule Enforcement: A Decade of Success OFF TO A FAST START


http://madcowfeed.blogspot.com/2008/06/texas-firm-recalls-cattle-heads-that.html



The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.


http://www.oie.int/boutique/extrait/06heim937950.pdf



IN A NUT SHELL ;

(Adopted by the International Committee of the OIE on 23 May 2006)

11. Information published by the OIE is derived from appropriate declarations made by the official Veterinary Services of Member Countries. The OIE is not responsible for inaccurate publication of country disease status based on inaccurate information or changes in epidemiological status or other significant events that were not promptly reported to the Central Bureau,


http://www.oie.int/eng/Session2007/RF2006.pdf



Monday, November 23, 2009

BSE GBR RISK ASSESSMENTS UPDATE NOVEMBER 23, 2009 COMMISSION OF THE EUROPEAN COMMUNITIES AND O.I.E.


http://docket-aphis-2006-0041.blogspot.com/2009/11/bse-gbr-risk-assessments-update.html



Saturday, January 2, 2010

Human Prion Diseases in the United States January 1, 2010 ***FINAL***


http://prionunitusaupdate2008.blogspot.com/2010/01/human-prion-diseases-in-united-states.html



my comments to PLosone here ;


http://www.plosone.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd&root=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd






OLD HISTORY ON MAD COW FEED BAN USA ;

p.s. i doubt if many of these old fda url links work anymore, and you cannot blame them $


From: TSS
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

http://www.fda.gov/cvm/Images/6597bse.pdf


BSE/Ruminant Feed Ban Inspections

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM GUIDANCE MANUAL

http://www.fda.gov/ohrms/dockets/98fr/03d-0498-gdl0001.pdf


1999 - 2000 CVM BSE

CVM Update (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: http://www.fda.gov/cvm

http://www.fda.gov/cvm/CVM_Updates/HAMMERUP.html


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.

http://www.fda.gov/bbs/topics/ENFORCE/ENF00623.html


2001

October 30, 2001

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bseoctup.htm


October 10, 2001

FDA HOLDING PUBLIC HEARING ON RUMINANT FEED (BSE) RULES

The Food and Drug Administration (FDA) is holding a public hearing to solicit information and views on its present animal feeding regulation "Animal Proteins Prohibited in Ruminant Feed" -- Code of Federal Regulations, Title 21, Part 589.2000. The purpose of the rule is to help prevent the establishment and amplification of bovine spongiform encephalopathy (BSE) in U.S. cattle herds through feed and thereby help minimize any risks from BSE to animal or human health.

FDA recognizes that new information has emerged on BSE and variant Creutzfeldt-Jakob Disease (vCJD) since the rule went into effect in 1997. Therefore, FDA is requesting information and views from individuals and organizations on the present rule and whether changes in the rule or other additional measures are necessary. The Agency is particularly interested in soliciting comments and views from individuals, industry, consumer groups, health professionals, and researchers with expertise in BSE and related animal and human diseases. ...snip

http://www.fda.gov/cvm/CVM_Updates/part15.htm


September 25, 2001

BSE INSPECTION CHECKLIST AVAILABLE ON THE CVM INTERNET HOME PAGE

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.

http://www.fda.gov/cvm/CVM_Updates/bsecheck.htm


CVM Update July 7, 2001

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bse72001.htm


CVM Update March 23, 2001

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bsemar3.htm


CVM Update January 10, 2001

UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bseup.htm


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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00719.html


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.

####

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00714.html


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.

####

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00708.html


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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00704.html


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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00703.html


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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00701.html



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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00700.html


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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00698.html


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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00696.html

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00694.html

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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00692.html


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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00691.html



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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00690.html



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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00688.html



2002

To help prevent the establishment and amplification of

BSE through feed in the United States, FDA implemented

a final rule that prohibits the use of most mammalian

protein in feeds for ruminant animals. This rule, Title

21 Part 589.2000 of the Code of Federal Regulations, became

effective on August 4, 1997. To date, active monitoring

by the U.S. Department of Agriculture (USDA) has found

no cases of bovine spongiform encephalopathy (BSE) in

U.S. cattle. This is an update on FDA enforcement activities

regarding the ruminant feed (BSE) regulation.

FDA’s enforcement plan for the ruminant feed regulation

includes education, as well as inspections, with FDA

taking compliance actions for intentional or repeated noncompliance.

FDA’s Center for Veterinary Medicine (CVM)

has assembled data from the inspections that have been

conducted AND whose final inspection report has been

submitted to CVM (i.e., “inspected/reported”) as of March

11, 2002. There is a lag time between the completion of

an inspection and the submission of a final inspection report

to CVM. This lag period includes the time required to

conduct quality assurance on the report and to evaluate

the findings before a final report is submitted.

As of March 11, CVM had received inspection reports

covering inspections (both initial inspections and re-inspections)

of 10,458 different firms. The majority of these in-

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/Documents/MayJune.pdf


July/August 2002

The following individuals/firms received warning

letters for violations related to 21 CFR Part 589.2000 –

Animal Proteins Prohibited in Ruminant Feed. This regulation

is intended to prevent the establishment and

REGULATORY ACTIVITIES

by Karen A. Kandra

amplification of Bovine Spongiform Encephalopathy

(BSE):

• Jeffrey T. Buck, Owner, All American Feed & Tractor,

Sandpoint, ID

• Kenneth M. Van Dyke, President, Van Dyke Grain

Elevators, Inc., North Plains, OR

• Philip C. Anderson, General Manager, Darling International,

Inc., Tacoma, WA

Violations included failure to maintain sufficient

records and written procedures to prevent cross-contamination;

failure to keep written procedures for cleaning

out or flushing equipment after mixing feeds containing

prohibited material; failure to provide written

procedures for separating products that contain or

may contain prohibited material from ingredients

used in ruminant feeds, from the time of receipt until

the time of shipment; and, failure to label meat

and bone meal with the required cautionary statement

“Do Not Feed to Cattle or Other Ruminants.”

snip...

http://www.fda.gov/cvm/Documents/JulyAugust.pdf


November 12, 2002

MATERIAL FROM CWD-POSITIVE ANIMALS SHOULD NOT BE USED FOR ANIMAL FEED

This CVM Update has been _withdrawn_ by Draft Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed doc pdf , May 14, 2003

See CVM Update Draft Guidance on Use of Material from Deer and Elk in Animal Feed Available for Comment; CVM Updates on Deer and Elk in Animal Feed Withdrawn.

--------------------------------------------------------------------------------

http://www.fda.gov/cvm/CVM_Updates/CWdup.htm


2003D-0186 Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

EMC 1 Terry S. Singeltary Sr. Vol #: 1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm


CVM Update

Clarification of FDA Position on Use In Animal Feed of Material From Certain Free Range Deer and Elk

This CVM Update has been withdrawn by Draft Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed doc pdf , May 14, 2003.

See CVM Update Draft Guidance on Use of Material from Deer and Elk in Animal Feed Available for Comment; CVM Updates on Deer and Elk in Animal Feed Withdrawn.

http://www.fda.gov/cvm/CVM_Updates/CWDNOV21.htm


CONTAINS NON-BINDING RECOMMENDATIONS

158

Guidance for Industry

Use of Material from Deer and Elk in Animal Feed

Comments and suggestions regarding this guidance should be sent to the Division of

Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,

Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on

the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet site, select

"[03D-0186][Use of Material from Deer and Elk in Animal Feed]" and follow the

directions. All written comments should be identified with Docket No. 03D-0186.

For questions regarding this guidance, contact Burt Pritchett, Center for Veterinary

Medicine (HFV- 222), Food and Drug Administration, 7500 Standish Place, Rockville,

MD 20855, 301-827-0177. E-mail: bpritche@cvm.fda.gov

Additional copies of this guidance document may be requested from the Communications

Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500

Standish Place, Rockville, MD 20855, and may be viewed on the Internet at

http://www.fda.gov/cvm.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Veterinary Medicine

September 15, 2003

CONTAINS NON-BINDING RECOMMENDATIONS

1

158

Guidance for Industry1

Use of Material from Deer and Elk in Animal Feed

I. Introduction

FDA’s guidance documents, including this guidance, do not establish legally

enforceable responsibilities. Instead, guidances describe the Agency’s current

thinking on a topic and should be viewed only as recommendations, unless

specific regulatory or statutory requirements are cited. The use of the word

“should” in Agency guidances means that something is suggested or

recommended, but not required.

Under FDA’s BSE feed regulation (21 CFR 589.2000) most material from deer and elk is

prohibited for use in feed for ruminant animals. This guidance document describes FDA’s

recommendations regarding the use in all animal feed of all material from deer and elk that

are positive for Chronic Wasting Disease (CWD) or are considered at high risk for CWD.

The potential risks from CWD to humans or non-cervid animals such as poultry and swine

are not well understood. However, because of recent recognition that CWD is spreading

rapidly in white-tailed deer, and because CWD’s route of transmission is poorly

understood, FDA is making recommendations regarding the use in animal feed of rendered

materials from deer and elk that are CWD-positive or that are at high risk for CWD.

II. Background

CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the

animal family cervidae (cervids). Only deer and elk are known to be susceptible to CWD

by natural transmission. The disease has been found in farmed and wild mule deer,

white-tailed deer, North American elk, and in farmed black-tailed deer. CWD belongs to

a family of animal and human diseases called transmissible spongiform encephalopathies

1 This guidance has been prepared by the Division of Animal Feeds in the Center for Veterinary Medicine

(CVM) at the Food and Drug Administration.

This guidance represents the Food and Drug Administration’s current

thinking on the use of material from deer and elk in animal feed. It does not

create or confer any rights for or on any person and does not operate to bind

FDA or the public. You can use an alternative approach if the approach

satisfies the requirements of applicable statutes or regulations. If you want to

discuss an alternative approach, contact the FDA staff responsible for

implementing this guidance. If you cannot identify the appropriate FDA

staff, call the appropriate number listed on the title page of this guidance.

CONTAINS NON-BINDING RECOMMENDATIONS

2

(TSEs). These include bovine spongiform encephalopathy (BSE or “mad cow” disease)

in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jakob diseases

(CJD and vCJD) in humans. There is no known treatment for these diseases, and there is

no vaccine to prevent them. In addition, although validated postmortem diagnostic tests

are available, there are no validated diagnostic tests for CWD that can be used to test for

the disease in live animals.

III. Use in animal feed of material from CWD-positive deer and elk

Material from CWD-positive animals may not be used in any animal feed or feed

ingredients. Pursuant to Sec. 402(a)(5) of the Federal Food, Drug, and Cosmetic Act,

animal feed and feed ingredients containing material from a CWD-positive animal would

be considered adulterated. FDA recommends that any such adulterated feed or feed

ingredients be recalled or otherwise removed from the marketplace.

IV. Use in animal feed of material from deer and elk considered at high risk for CWD

Deer and elk considered at high risk for CWD include: (1) animals from areas declared

by State officials to be endemic for CWD and/or to be CWD eradication zones; and (2)

deer and elk that at some time during the 60-month period immediately before the time of

slaughter were in a captive herd that contained a CWD-positive animal.

FDA recommends that materials from deer and elk considered at high risk for CWD no

longer be entered into the animal feed system. Under present circumstances, FDA is not

recommending that feed made from deer and elk from a non-endemic area be recalled if a

State later declares the area endemic for CWD or a CWD eradication zone. In addition,

at this time, FDA is not recommending that feed made from deer and elk believed to be

from a captive herd that contained no CWD-positive animals be recalled if that herd is

subsequently found to contain a CWD-positive animal.

V. Use in animal feed of material from deer and elk NOT considered at high risk

for CWD

FDA continues to consider materials from deer and elk NOT considered at high risk for

CWD to be acceptable for use in NON-RUMINANT animal feeds in accordance with

current agency regulations, 21 CFR 589.2000. Deer and elk not considered at high risk

include: (1) deer and elk from areas not declared by State officials to be endemic for

CWD and/or to be CWD eradication zones; and (2) deer and elk that were not at some

time during the 60-month period immediately before the time of slaughter in a captive

herd that contained a CWD-positive animal. ...snip ;

http://www.fda.gov/cvm/Guidance/guide158.pdf


CVM Update April 15, 2002

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bseap02.htm


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

http://www.fda.gov/bbs/topics/enforce/2002/ENF00765.html



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

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http://www.fda.gov/bbs/topics/enforce/2002/ENF00764.html



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.

http://www.fda.gov/bbs/topics/enforce/2002/ENF00762.html



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

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http://www.fda.gov/bbs/topics/enforce/2002/ENF00756.html

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.

http://www.fda.gov/bbs/topics/enforce/2002/ENF00747.html

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

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http://www.fda.gov/bbs/topics/enforce/2002/ENF00746.html


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

####

http://www.fda.gov/bbs/topics/enforce/2002/ENF00727.html



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

http://www.fda.gov/bbs/topics/enforce/2002/ENF00758.html


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 District Office issued a Warning Letter to the president of Lincoln Land Livestock Co., Inc., Mascoutah, Illinois. On April 14 - 15, 2003, FDA conducted inspection of the animal feed handling facility. The investigator found that products that contained or may contain prohibited material failed to bear the caution statement, “Do not feed to cattle or other ruminants.” The inspection also disclosed that the firm did not maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants.

On November 7, 2002, the FDA’s Dallas District Office issued a Warning Letter to the President and Manager of Sunnymead Ranch, Inc., Idalou, Texas. An FDA inspection of this feed mill found significant deviations from 21 CFR 589.2000. FDA’s inspection revealed that the firm manufactures feed for sheep, that may contain residues of prohibited material. The sheep feed is mixed in the same equipment that is used for mixing chicken feed containing bovine meat and bone meal. In addition, the firm failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissue to animal protein or feeds that may be used for ruminants. The Warning Letter cautioned, “As a feed manufacturer and ruminant feeder of sheep intended for slaughter as food, you are responsible for ensuring that your operations are in full compliance with the law.”

On May 22, 2003, the FDA’s New Orleans District Office issued a Warning Letter to the Manager and Owner of Millstone Agri Distributors, Maryville, Tennessee. An FDA inspection of the firm on February 13, 2003, found significant deviations from the requirements of Title 21, Code of Federal Regulations (21 CFR), Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed.

FDA’s investigation found the following violations of 21 CFR 589.2000:

Failure to separate the receipt, processing, and storage of products containing prohibited material from products not containing prohibited material; Failure to establish written procedures, including clean-out and flushing procedures, to avoid commingling and cross-contamination of common equipment; Failure to maintain records sufficient to track prohibited materials throughout the receipt, processing, and distribution of products; Failure to provide for measures to avoid commingling or cross-contamination of feeds intended for ruminants and feeds intended for non-ruminants that may contain prohibited materials; Failure to label non-ruminant products with the required cautionary statement “Do not Feed to Cattle or Other Ruminants.” The investigation specifically found that dog food containing prohibited material was added as an ingredient to the product “Premium Rooster Kicker.” The failure of these feeds to bear the required BSE warning statement causes them to be misbranded. Consent Decree of Permanent Injunction Against X-Cel Feeds, Inc. Feed Manufacturer Enjoined for Violations of the 1997 Animal Feed Rule

On July 11, 2003, FDA announced the filing of a Consent Decree of Permanent Injunction against X-Cel, Feeds Inc., and individual officers based on violations of the Federal Food, Drug, and Cosmetic Act.

X-Cel, a feed manufacturer headquartered in Tacoma, Washington, failed to comply with FDA regulations (the 1997 Animal Feed Rule) designed to prevent the establishment and spread of Bovine Spongiform Encephalopathy (BSE, also known as "Mad Cow Disease") should it ever be found in the United States and FDA regulations concerning the manufacture of medicated feeds.

The Department of Justice, Civil Division, Office of Consumer Litigation and the United States Attorney's Office of the Western District of Washington filed the Consent Decree in the United States District Court of the Western District in Tacoma, Washington. It permanently enjoins X-Cel from manufacturing animal feeds in violation of the Federal Food, Drug, and Cosmetic Act and requires the firm, its officers, and employees to take specific steps to avoid future violations including, implementing clean-out procedures, obtaining protein supplier certifications and implementing standard operating procedures for compliance until it satisfies FDA that it has corrected its problems. ...

http://www.fda.gov/ora/about/enf_story/archive/2003/ch5/cvm1.htm


CVM Update September 30, 2003

Update On Ruminant Feed (BSE) Enforcement Activities

http://www.fda.gov/cvm/CVM_Updates/BSEInspec03.htm


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II ______________________________

PRODUCT Consolidated Nutrition 32 % Floating Catfish Food, packaged in 50-lb bags. Recall # V-100-3. CODE Best By MAR 25 04; and Best By APR 16 04, The codes are ink-jetted on the bags. RECALLING FIRM/MANUFACTURER Doane Pet Care Company, Inc., Washington Courthouse, OH, by telephone and letter on April 16, 2003 and April 17, 2003. FDA initiated recall is ongoing.

REASON The fish feed product lacks the required BSE warning statement, and the nutritional ingredient statement on the label.

VOLUME OF PRODUCT IN COMMERCE 210/50 lb bags. DISTRIBUTION OH, PA, and MI.

http://www.fda.gov/bbs/topics/enforce/2003/ENF00796.html



RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II _____________________________

PRODUCT Red Rooster Booster, Super Gallo (brand), 60 capsules. Recall # V-011-3. CODE All codes. RECALLING FIRM/MANUFACTURER Thomas Laboratories, Tolleson, AZ, by letters on or about November 8, 2002. State initiated recall is ongoing.

REASON Is not labeled "Do not feed to cattle or other ruminants" and contains a bovine tissue derivative.

VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Nationwide.

_____________________________

PRODUCT CATTLE FEED, Flock #999, Date: 12/5/02, Quantity 8000, Load A, Feed C205, Grower# Z001, Tag C100. Recall # V-012-3. CODE C-205, C-210, C-220, C-302, C-406 and all other codes manufactured and distributed by Grove River Mills, Inc., RECALLING FIRM/MANUFACTURER Grove River Mills Inc., Pendergrass, GA, by telephone and letter on December 9, 2002.

Firm initiated recall is ongoing.

REASON Cattle Feed contaminated with prohibited materials.

VOLUME OF PRODUCT IN COMMERCE 235,668 lbs. DISTRIBUTION GA.

END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 2003

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http://www.fda.gov/bbs/topics/enforce/2003/ENF00781.html


PRODUCT Unlabeled bulk "Cattle Feed" sold by weight to user/farmers who pick it up at the firm. Product is a ruminant feed used to feed beef cattle. Recall # V-046-3. CODE Product is bulk and uncoded. RECALLING FIRM/MANUFACTURER Zephyr Feed Company, Zephyrhills, FL., by letters on March 19, 2003 and March 26, 2003.

FDA initiated recall is ongoing.

REASON Cattle feed was distributed to farmers that may contain prohibited protein for ruminants.

VOLUME OF PRODUCT IN COMMERCE 517,990 lbs. DISTRIBUTION FL.

END OF ENFORCEMENT REPORT FOR APRIL 23, 2003

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http://www.fda.gov/bbs/topics/enforce/2003/ENF00792.html


_______________________________


PRODUCT Steamed bone meal under the following labels: 1) Upco Steamed Bone Meal for Dogs, Cats, and Horses, packaged in 1-lb. laminated pouches. 2) Benepet Steamed Bone Meal for Dogs, Cats, and Horses, packaged in a 1-lb. plastic jar. Recall # V-295-3. CODE Upco brand: 010584, 012214, 012431,020672, 021124, 021834, 030616, 030901, 031293, 031301, 031401, 031981, 032382, 032626, 033136, 040171, 041316, 051635, 051991, 052320, 060505, 061115, 061783, 071006, 072328, 080212, 080826, 081621, 082217, 082274, 082683, 083095, 092381, 101613, 102772, 111087, 111201, 111694, 112112. Benepet brand: 011004, 012435, 021191, 021374, 022111, 032203, 032821, 041432, 042611, 051181, 051992, 060371, 061129, 061203, 080816, 081185, 082802, 090422, 092295, 111202, 120572, 120612. RECALLING FIRM/MANUFACTURER Ameri-Pac, Inc., St. Joseph, MO, via telephone on June 27, 2003 and by letter dated July 24, 2003. FDA initiated recall is complete.

REASON Label lacks the cautionary statement "Do Not Feed to Cattle or Other Ruminants."

VOLUME OF PRODUCT IN COMMERCE 23.3 tons Upco brand and 6.7 tons Benepet brand.

DISTRIBUTION MO.

http://www.fda.gov/bbs/topics/enforce/2003/ENF00816.html


RECALLING FIRM/MANUFACTURER Liver Powder, Super Gallo (brand), 16 oz. bag. Recall # V-005-4. CODE All codes. RECALLING FIRM/MANUFACTURER Thomas Veterinary Drug, Tolleson, AZ, by letter, on September 20, 2002. Kentucky State initiated recall is complete.

REASON Product is not labeled "Do not feed to cattle or other ruminants".

VOLUME OF PRODUCT IN COMMERCE 320. DISTRIBUTION AR, NC, WV, KY, LA, TN, HI, CA and AL.

http://www.fda.gov/bbs/topics/enforce/2003/ENF00828.html


2004

SELECTED FY 2004 ACCOMPLISHMENTS

USING RISK-BASED MANAGEMENT PRACTICES

Bovine Spongiform Encephalopathy (BSE)

• For fiscal year 2004, inspected over 6,806 renderers, feed mills, and other firms,

including on-farm mixers and ruminant feeders, to determine compliance with the

BSE feed regulations. At the end of the FY 2004, 17 firms were classified as being

out of compliance at the time of their last inspection. Re-inspections of these

facilities determined to be out of compliance with the BSE regulation are still ongoing;

• FDA and state investigators specifically inspected a high-interest subset of 645 firms

as part of our annual BSE performance goal feed inspections obligation. This subset

represented 100 percent of all known renderers and feed mills processing products

containing prohibited material;

• In July 2004, co-published with USDA an advanced notice of proposed rulemaking

(ANPRM) requesting comments and scientific information on several additional

regulatory measures that would strengthen the feed regulation;

230

• Developed a real-time Polymerase Chain Reaction (PCR) based method capable of

detecting cattle, swine, sheep, goats, horses, or deer material along with poultry,

goose, and turkey for use in analyzing samples of animal feeds and feed ingredients

in support of the animal protein prohibition;

• Evaluated two commercially available diagnostic test marketed to detect mammalian

proteins in animal feed and feed ingredients;

• Issued 10 Warning Letters for animal proteins prohibited in ruminant feed, and 15

class II recalls involving 15 firms and 25 products in response to violations of the

BSE rule;

snip...full text ;

http://www.fda.gov/oc/oms/ofm/budget/2006/PDFs/Summary/Pages226thru251.pdf


Completed 50 feed recall events. Thirty-tree of the 50 recall events were feed related. Fifteen of the 33 recalls were related to BSE feed regulation;

http://www.fda.gov/cvm/CVMAccomp.htm


CVM Update November 23, 2004

November 2004 Update on Ruminant Feed (BSE) Enforcement Activities

http://www.fda.gov/cvm/CVM_Updates/bseup112304.htm


CVM Update July 29, 2004

July 2004 Update on Ruminant Feed (BSE) Enforcement Activities

http://www.fda.gov/cvm/CVM_Updates/bse72004up.htm


FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight Bovine Spongiform Encephalopathy (BSE) FDA animal feed experts joined the USDA team to provide technical expertise in an audit conducted by the Canadian Food Inspection Agency in response to the detection of two cases of BSE in Canada in 2004. Records were reviewed, meetings were held and facilities across Canada were inspected. USDA issued a report of its findings on February 25, 2005. Issued 10 Warning Letters for animal proteins prohibited in ruminant feed, and 15 class II recalls involving 15 firms and 25 products in response to violations of the BSE rule. Provided BSE inspection training to FDA investigators as well as state inspectors during the fiscal year. Provided personnel and expertise on BSE and animal feed issues to the U.S. Department of Agriculture in support of its efforts to reopen foreign markets for U.S. beef. Continued the development of a real-time Polymerase Chain Reaction (PCR) based method capable of detecting cattle, swine, sheep, goats, horses, or deer material along with poultry, goose, and turkey for use in analyzing samples of animal feeds and feed ingredients in support of the animal protein prohibition. "Real-time" means that we can detect the presence of prohibited material as the reaction is taking place, so we do not have to further process the sample. Completed the evaluation of a third commercially available diagnostic test marketed for the detection of ruminant proteins in animal feed. Like the other diagnostic tests previously evaluated, this test was much less sensitive than the methods the Agency uses (microscopy and PCR) for analysis of animal feed. FDA implemented an advanced analytical procedure for detection of prohibited material in animal feed into an assignment issued for 900 domestic and 900 import feed samples. This novel approach combines light microscopy with polymerase chain reaction (PCR) to determine and detect DNA from ruminants and non-ruminant mammalian species, supporting the BSE/Ruminant Feed Ban. (Field Activity) Following the finding of a BSE positive animal in Texas, FDA, USDA/APHIS, the Texas Animal Health Commission, and the Texas Feed and Fertilizer Control Service successfully conducted a feed investigation with two main objectives. The first objective was to identify all protein sources in the animal's feed history that could potentially have been the source of the BSE agent. The second objective was to verify that cattle leaving the herd after 1997 that were identified by USDA/APHIS as animals of concern, such as progeny and feed cohorts, were rendered at facilities in compliance with the BSE/ruminant feed ban regulation. (Field Activity) Awarded contracts with state and local governments to perform BSE, feed manufacturers and illegal tissue residue inspections. Auditor training was conducted for feed contracts. (Field Activity) Reviewed and awarded Cooperative Agreement grants for BSE infrastructure improvement in eight states. The Agency and the States maintained and continued to develop new partnerships (e.g., BSE inspections) that have contributed to the exchange of inspection and sampling data and have facilitated the receipt of training and distribution of equipment to the states. (Field Activity) snip... full text ;

http://www.fda.gov/oc/oms/ofm/budget/2007/HTML/4AnimalDrugs.htm


CVM Update

July 9, 2004

FDA and USDA Request Comments and Scientific Information on Possible New BSE Safeguards

Today, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) announced that they will publish an advance notice of proposed rulemaking ( ANPRM ) -- that requests comments and scientific information on several additional measures related to animal feed under consideration to help prevent the spread of bovine spongiform encephalopathy (BSE, also known as “Mad Cow Disease”) in the United States. Some of these measures include:

removing specified risk materials (SRMs) from all animal feed, including pet food, in order to control the risks of cross contamination throughout feed manufacture and distribution and on the farm due to misfeeding;

requiring dedicated equipment or facilities for handling and storing feed and ingredients during manufacturing and transportation, to prevent cross contamination;

prohibiting the use of all mammalian and poultry protein in ruminant feed, to prevent cross contamination; and

prohibiting materials from non-ambulatory disabled cattle and dead stock from use in all animal feed.

FDA has tentatively concluded that it should propose to remove SRMs from all animal feed and is currently working on a proposal to accomplish this goal. Comments on the issues raised by FDA in the ANPRM are due to FDA 30 days after they publish in the Federal Register.

FDA’s 1997 ruminant feed rule has been a critical safeguard to stop the spread of BSE through the U.S. cattle population by prohibiting the feeding of most mammalian protein to cattle and other ruminant animals.

After a BSE-positive cow was detected in late December 2003, FDA announced its plans to publish interim final rules on BSE that would take effect immediately upon publication. For animal feed, FDA stated that the rule would eliminate the present exemption in the ruminant feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source, ban the use of "poultry litter" as a feed ingredient for ruminant animals, and ban the use of "plate waste" as a feed ingredient for ruminants. In addition, FDA said that to further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed, the rule would require equipment, facilities, or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed.

On February 4, 2004 , shortly after FDA announced its plans to publish interim final rules on BSE, an International Review Team (IRT) convened by USDA issued a report and additional actions to protect the public against BSE.

The proposed actions were significantly different from those FDA announced in late January. Some of those proposals would make some of FDA’s actions unnecessary. Rather than publishing a regulation that would take effect automatically, USDA and FDA are soliciting public comment on the IRT’s suggestions, as well as other measures designed to protect North America against BSE. By seeking comment on the IRT’s recommendations, the agencies hope to put into effect the most comprehensive, science-based improvements possible.

http://www.fda.gov/cvm/CVM_Updates/bseanprm.htm


CVM Update April 22, 2004

April 2004 Update on Ruminant Feed (BSE) Enforcement Activities

http://www.fda.gov/cvm/CVM_Updates/bse42004.htm


CVM Update February 6, 2004

Update on Ruminant Feed (BSE) Enforcement Activities

http://www.fda.gov/cvm/CVM_Updates/BSE0206up.htm


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE-CLASS II _______________________________

PRODUCT Grand Vite, Nutritional Supplement, in tubs. 5, 10 and 25 pounds. Designed for horses only. Recall # V-006-4. CODE Lot 1473. RECALLING FIRM/MANUFACTURER Grand Meadows, Inc., Orange, CA, by facsimile, on September 3, and September 5, 2003. FDA initiated recall is complete.

REASON Product contains prohibited animal protein and is not labeled to prevent feeding to ruminants.

VOLUME OF PRODUCT IN COMMERCE 131 packages of 5, 10 and 25 pounds.

DISTRIBUTION Nationwide.

_______________________________

PRODUCT a) Halter 15% Pig Meal, in 50 pound paper bags. Recall # V-008-4; b) Halter 18% Layer Pellet, in 50 pound paper bags. Recall # V-009-4. CODE No codes. RECALLING FIRM/MANUFACTURER Halter Feed & Grain Inc., Massillon, OH, by telephone and letter on December 3, 8, and 10, 2003. FDA initiated recall is ongoing.

REASON Animal feed that contains protein derived from mammalian tissue was not labeled with the required BSE caution statement, "Do not feed to cattle and other ruminants".

VOLUME OF PRODUCT IN COMMERCE 80 bags (4 tons). DISTRIBUTION OH.

END OF ENFORCEMENT REPORT FOR January 14, 2004

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--------------------------------------------------------------------------------

http://www.fda.gov/bbs/topics/enforce/2004/ENF00830.html


PRODUCT ZuPreem Feline Diet, 14.0 oz cans for Non-Domesticated Carnivores in the families Fedlidae, Canidea, and Hyenadea. Recall # V-115-4. CODE 6910 S1 SF01 military time of production: 06:05. RECALLING FIRM/MANUFACTURER Menu Foods, Inc., Pennsauken, NJ, by telephone on February 2, 2004. FDA initiated recall is complete.

REASON LACF Feiline Diet for non-domestic carnivores does not carry the BSE warning statement.

VOLUME OF PRODUCT IN COMMERCE 1,620 cases. DISTRIBUTION KS.

_______________________________

PRODUCT Product is a horse supplement packed into a 5 lb. Plastic container with a yellow/green/red/brown label printed in part "FORMULA: Each 5 pounds contains: Chondroitin Sulfate 27,000 mg D-Glucosamine HCL 100,000 mg Collagen hydrolyzed 27,000 MSM (methysulfonylmethane) 2,500 mg. Carti-Flex COMPLEX net wt. 5 lbs, a concentrated natural joint supplement containing Glucosamine HCL, Chondroitin sulfate, Hydrolixed collagen and MSM". Recall # V-116-4. CODE All codes without the required cautionary statement are under recall. RECALLING FIRM/MANUFACTURER Interfarma Corporation, Miami, FL, by letters on February 4, 2004. FDA initiated recall is ongoing.

REASON This animal feed product does not contain the required BSE cautionary statement: "Do Not Feed to Cattle or Other Ruminants".

VOLUME OF PRODUCT IN COMMERCE 80 cases 4-5 lb. Containers per case. DISTRIBUTION Venezuela, Nicaragua and Guatemala.

END OF ENFORCEMENT REPORT FOR MARCH 24, 2004

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http://www.fda.gov/bbs/topics/enforce/2004/ENF00840.html


PRODUCT Custom deer feed made for a Wisconsin farm. The product was in bags holding about 40 pounds each. Recall # V-122-4. CODE 1-30-04 on the product invoice and mixing record. RECALLING FIRM/MANUFACTURER Crivitz Feed Mill, Crivitz, WI, by telephone on February 20, 2004.

Wisconsin State initiated recall is complete.

REASON The recalled deer feed contained steamed bone meal which is prohibited material in feed for ruminants.

VOLUME OF PRODUCT IN COMMERCE 515 pounds. DISTRIBUTION WI.

END OF ENFORCEMENT REPORT FOR APRIL 7, 2004

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http://www.fda.gov/bbs/topics/enforce/2004/ENF00842.html



PRODUCT Custom dairy cattle feed made for two customers. Recall # V-123-4. CODE None. RECALLING FIRM/MANUFACTURER Maribel Grain Co., Maribel, WI, by visit on February 25, 2004. Firm initiated recall is complete.

REASON Possible cross contamination of cattle feed by steamed bone meal which is prohibited material.

VOLUME OF PRODUCT IN COMMERCE 2,040 pounds. DISTRIBUTION WI.

______________________________


PRODUCT B & G Seed Co., PIG GROWER, 50 lbs. Recall # V-126-4. CODE All. RECALLING FIRM/MANUFACTURER B & G Seed Company, Inc., Hull, GA, by telephone on March 30, 2004.

Firm initiated recall is ongoing.

REASON Feed contains meat & bone meal (prohibited material), without the mandatory ruminant warning on the label.

VOLUME OF PRODUCT IN COMMERCE 25/50 lb. bags. DISTRIBUTION GA.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00843.html


_______________________________

PRODUCT Cloverbelt 38% (38% protein concentrate for use in animal feed) in bulk. Recall # V-127-4. CODE The recall product is a bulk feed commingled in a bin prior to sale - no lot number. RECALLING FIRM/MANUFACTURER Cloverbelt Lumber & Feed Co., Conrath, WI, by telephone on February 23, 2004.

Firm initiated recall is complete.

REASON Possible cross contamination of the 38% protein concentrate with prohibited material (bone meal).

VOLUME OF PRODUCT IN COMMERCE 18 tons. DISTRIBUTION WI.

END OF ENFORCEMENT REPORT FOR APRIL 28, 2004

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http://www.fda.gov/bbs/topics/enforce/2004/ENF00845.html


PRODUCT a) Bulk whole corn. Recall # V-150-4; b) Bulk rolled corn. Recall # V-151-4; c) Bulk rolled corn with added fat. Recall # V-152-4. CODE No coding information is used. RECALLING FIRM/MANUFACTURER Fresno Farming LlC, Traver, CA, by letters on June 30, 2004.

Firm initiated recall is ongoing.

REASON Corm for feed may be contaminated with ruminant meat and bone meal.

VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Unknown.

____________________________


http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html


_______________________________


PRODUCT a) Product is 9 Mile Steer Feed, packaged in white poly weaved bags, each containing 100 lbs. A white label tied to the inlet of each bag with twine identifies the product. Recall # V-187-4; b) Product is 9 Mile Pig and Sow Feed, packaged in white poly weaved bags, each bag containing 100 lbs. A white label tied to the inlet of each bag with twine identifies the product. Recall # V-188-4. CODE The products contain no code date. RECALLING FIRM/MANUFACTURER Farmers Elevator, Co., Houston, OH, by telephone and letters dated September 8, 2004. Firm initiated recall is ongoing.

REASON Products may contain protein derived from mammalian tissues which is prohibited in ruminant (steer) feed. FDA regulation, if the feed is intended for non-ruminants (pigs), the bag labels must bear the statement ìDo not feed to cattle or other ruminantsî.

VOLUME OF PRODUCT IN COMMERCE 700 lbs. Steer feed and 1,500 lb. Pig and sow fed.

DISTRIBUTION OH.

PRODUCT a) Premier Catfish Food, packaged in 50 pound bags (white paper with an orange label). Recall #V-190-4; b) Happy Fisherman Fish Food, pellet form, 50 pound bags. Recall # V-191-4. CODE a) T1 Best By 08/27/05; b) T21 Best By 11 DEC 05 and T11 Best By 02 OCT 05. RECALLING FIRM/MANUFACTURER Sunshine Mills, Inc., Tupelo, MS, by telephone beginning on April 14, 2004. Firm initiated recall is complete.

REASON The catfish food contains prohibited material (meat & bone meal) but does not contain the cautionary statement, "Do not feed to cattle or other ruminants" on the label.

VOLUME OF PRODUCT IN COMMERCE 1,092 ‚ 50 pound bags.

DISTRIBUTION TX and MO.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________

PRODUCT Product is custom made steer/cattle feed packaged in 100 lb. poly bags. The product has no labeling. Recall # V-001-5. CODE The product has no lot code. All custom made feed purchased between June 24, 2004 and September 8, 2004. RECALLING FIRM/MANUFACTURER Farmers Elevator Co, Houston, OH, by telephone and letter dated September 27, 2004.

Firm initiated recall is ongoing.

REASON Feed may contain protein derived from mammalian tissues which is prohibited in ruminant feed.

VOLUME OF PRODUCT IN COMMERCE Approximately 80 1û2 tons of steer/cattle feed.

DISTRIBUTION OH.

_______________________________

PRODUCT Product is custom made sheep/goat feed packaged in 100 lb. poly bags. The product has no labeling. Recall # V-002-5. CODE The product has no lot code. All custom made feed purchased between June 24, 2004 and September 8, 2004. RECALLING FIRM/MANUFACTURER Farmers Elevator Co, Houston, OH, by telephone and letter dated September 27, 2004.

Firm initiated recall is ongoing.

REASON Feed may contain protein derived from mammalian tissues which is prohibited in ruminant feed.

VOLUME OF PRODUCT IN COMMERCE Approximately 8 tons. DISTRIBUTION OH.

_______________________________

PRODUCT Product is custom made deer feed packaged in 100 lb. poly bags. The product has no labeling. Recall # V-003-5. CODE The product has no lot code. All custom made feed purchased between June 24, 2004 and September 8, 2004. RECALLING FIRM/MANUFACTURER Farmers Elevator Co, Houston, OH, by telephone and letter dated September 27, 2004.

Firm initiated recall is ongoing.

REASON Feed may contain protein derived from mammalian tissues which is prohibited in ruminant feed.

VOLUME OF PRODUCT IN COMMERCE Approximately 6 tons. DISTRIBUTION OH.

END OF ENFORCEMENT REPORT FOR October 20, 2004

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http://www.fda.gov/bbs/topics/enforce/2004/ENF00870.html



RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________________

PRODUCT a) Hi-Tek Rations Horse Nuggets***Performance*** Net Wt. 40 lb (18.14 kg). Recall # V-006-5; b) Hi-Tek Rations***Aqua-Tek***Quality Floating Fish Food***Net Wt. 50 Lbs (22.68kg). Product is packed in paper bags in amounts specified. Recall # V-007-5. CODE a) Lot # 073128; b) Lot #071202. RECALLING FIRM/MANUFACTURER HI-TEK Rations, Inc., Dublin, GA, by letter on September 17, 2004.

Firm initiated recall is ongoing.

REASON Product may contain prohibited ruminants; however, label does not have required caution statement.

VOLUME OF PRODUCT IN COMMERCE 10 tons. DISTRIBUTION AL, GA, NC, SC, WV.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00880.html


2005


VM Update December 5, 2005

November 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/BSE1105.htm


CVM Update June 20, 2005

June 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/bse0605.htm


CVM Update March 17, 2005

March 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/BSE0305.htm


PRODUCT a) Bulk nonmedicated custom swine and poultry feeds, Recall # V-006-6; b) Bulk medicated swine and poultry feeds, Recall # V-007-6 CODE N/A RECALLING FIRM/MANUFACTURER Gold Eagle Cooperative, Goldfield, IA, by telephone or visit beginning August 30, 2005.

Firm initiated recall is complete.

REASON Swine and poultry feeds which may contain prohibited material are not labeled with the warning statement not to feed to cattle or other ruminants.

VOLUME OF PRODUCT IN COMMERCE Approx. 15,323.68 tons of nonmedicated and medicated feed

DISTRIBUTION IA, GA, MD, and MN

http://www.fda.gov/bbs/topics/enforce/2005/ENF00925.html


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II ______________________________

PRODUCT Hydrolyzed Feather Meal, 50 lb. bags, Recall # V-109-5 CODE Lot number: 11579 RECALLING FIRM/MANUFACTURER Recalling Firm: Griffin Industries, Inc., Cold Springs, KY, by telephone on September 2, 2005. Manufacturer: Griffin Industries, Inc., Henderson, KY.

Firm initiated recall is ongoing.

REASON Product may contain prohibited material and is not identified with the cautionary statement: "Do not feed to cattle or other ruminants".

VOLUME OF PRODUCT IN COMMERCE 863/50 lb. bags DISTRIBUTION IN

END OF ENFORCEMENT REPORT FOR SEPTEMBER 28, 2005

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http://www.fda.gov/bbs/topics/enforce/2005/ENF00919.html



2006

CVM Update May 9, 2006

April 2006 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/BSE0506.htm


Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006 Date: June 27, 2006 at 7:42 am PST Public Health Service Food and Drug Administration

New Orleans District 297 Plus Park Blvd. Nashville, TN 37217

Telephone: 615-781-5380 Fax: 615-781-5391

May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner Louisiana.DBA Riegel By-Products 2621 State Street Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).

Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.

This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.

You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez Acting District Director New Orleans District

http://www.fda.gov/foi/warning_letters/g5883d.htm


MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE Sun Jul 16, 2006 09:22 71.248.128.67

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________

PRODUCT a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals, Recall # V-079-6; b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg), Recall # V-080-6; c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL FEED, Recall # V-081-6; d) Feather Meal, Recall # V-082-6 CODE a) Bulk b) None c) Bulk d) Bulk RECALLING FIRM/MANUFACTURER H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006.

Firm initiated recall is ongoing.

REASON Possible contamination of animal feeds with ruminent derived meat and bone meal.

VOLUME OF PRODUCT IN COMMERCE 10,878.06 tons DISTRIBUTION Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

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http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html


Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs Date: August 6, 2006 at 6:14 pm PST PRODUCT Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6 CODE All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J. Baker recalled feed products. RECALLING FIRM/MANUFACTURER Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm initiated recall is complete.

REASON The feed was manufactured from materials that may have been contaminated with mammalian protein.

VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs DISTRIBUTION MI

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

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http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125 TONS Products manufactured from 02/01/2005 until 06/06/2006 Date: August 6, 2006 at 6:16 pm PST PRODUCT a) CO-OP 32% Sinking Catfish, Recall # V-100-6; b) Performance Sheep Pell W/Decox/A/N, medicated, net wt. 50 lbs, Recall # V-101-6; c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6; d) CO-OP 32% Sinking Catfish Food Medicated, Recall # V-103-6; e) "Big Jim’s" BBB Deer Ration, Big Buck Blend, Recall # V-104-6; f) CO-OP 40% Hog Supplement Medicated Pelleted, Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6; g) Pig Starter Pell II, 18% W/MCDX Medicated 282020, Carbadox -- 0.0055%, Recall # V-106-6; h) CO-OP STARTER-GROWER CRUMBLES, Complete Feed for Chickens from Hatch to 20 Weeks, Medicated, Bacitracin Methylene Disalicylate, 25 and 50 Lbs, Recall # V-107-6; i) CO-OP LAYING PELLETS, Complete Feed for Laying Chickens, Recall # 108-6; j) CO-OP LAYING CRUMBLES, Recall # V-109-6; k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED, net wt 50 Lbs, Recall # V-110-6; l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs, Recall # V-111-6; m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs, Recall # V-112-6 CODE Product manufactured from 02/01/2005 until 06/06/2006 RECALLING FIRM/MANUFACTURER Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and visit on June 9, 2006. FDA initiated recall is complete.

REASON Animal and fish feeds which were possibly contaminated with ruminant based protein not labeled as "Do not feed to ruminants".

VOLUME OF PRODUCT IN COMMERCE 125 tons DISTRIBUTION AL and FL

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

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http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ????? Date: August 6, 2006 at 6:19 pm PST PRODUCT Bulk custom made dairy feed, Recall # V-114-6 CODE None RECALLING FIRM/MANUFACTURER Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006.

Firm initiated recall is ongoing. REASON Custom made feeds contain ingredient called Pro-Lak, which may contain ruminant derived meat and bone meal.

VOLUME OF PRODUCT IN COMMERCE ?????

DISTRIBUTION KY END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

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http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


WE know now, and we knew decades ago, that 5.5 grams of suspect feed in TEXAS was enough to kill 100 cows.

look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE;

Risk of oral infection with bovine spongiform encephalopathy agent in primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.

snip...

BSE bovine brain inoculum

100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg

Primate (oral route)* 1/2 (50%)

Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)

RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)

PrPres biochemical detection

The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was

inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of

bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.

Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula

Published online January 27, 2005

http://www.thelancet.com/journal/journal.isa


It is clear that the designing scientists must

also have shared Mr Bradley’s surprise at the results because all the dose

levels right down to 1 gram triggered infection.

http://www.bseinquiry.gov.uk/files/ws/s145d.pdf


2

6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100

grams) was probably given with the benefit of hindsight; particularly if one

considers that later in the same answer Mr Bradley expresses his surprise that it

could take as little of 1 gram of brain to cause BSE by the oral route within the

same species. This information did not become available until the "attack rate"

experiment had been completed in 1995/96. This was a titration experiment

designed to ascertain the infective dose. A range of dosages was used to ensure

that the actual result was within both a lower and an upper limit within the study

and the designing scientists would not have expected all the dose levels to trigger

infection. The dose ranges chosen by the most informed scientists at that time

ranged from 1 gram to three times one hundred grams. It is clear that the designing

scientists must have also shared Mr Bradley’s surprise at the results because all the

dose levels right down to 1 gram triggered infection.

http://www.bseinquiry.gov.uk/files/ws/s147f.pdf


Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]

http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram


http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)

http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle

03-025IFA 03-025IFA-2 Terry S. Singeltary

Page 1 of 17

From: Terry S. Singeltary Sr. [flounder9@verizon.net]

Sent: Thursday, September 08, 2005 6:17 PM

To: fsis.regulationscomments@fsis.usda.gov

Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;

SUB CLINICAL PRION INFECTION

MRC-43-00

Issued: Monday, 28 August 2000

NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH

FINDINGS RELEVANT TO CJD AND BSE

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


Board Number: I-12 Title: Risk Factors for Animal Drug and Feed Products, Manufacturing Processes and Facilities: Analysis of Recalls, 2000 – 2005

V. Wiles , E. A. Grove , K. B. Ekelman , CVM, FDA, Rockville, MD

Background: The Center for Veterinary Medicine (CVM) is developing a risk-based inspection system to help ensure that regulatory resources are focused on the animal feed and drug products, manufacturing processes and facilities that pose the greatest risks to animal and human health. To help identify risk factors for animal feed and drug products, manufacturing processes and facilities, we analyzed 203 firm-initiated recalls of animal drug and feed products from fiscal years 2000 through 2005. A recall is a firm\'s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers.

Methods: We reviewed records for 203 firm-initiated recalls of animal drug and feed products from fiscal years 2000 to 2005 to identify the types of errors associated with recalled animal drug and feed products and to determine which recalled products and errors were associated with the highest levels of health hazards. The relative level of health hazard attributed to each recalled product by FDA is reflected in an assigned recall classification number (i.e., I, II, or III).

Results: Of the 203 firm-initiated recalls of animal drug and feed products from fiscal years 2000 through 2005, 103 (approximately 51%) were for non-medicated feeds, 33 (approximately 16%) were for medicated feeds, and 64 (approximately 32%) were for animal drugs. For recalls of non-medicated feeds, 18% were classified as posing a high level of health hazard (recall classification I) and 76% were classified as posing a moderate health hazard (recall classification II). For recalls of medicated feeds, 13% were classified as posing a high level of health hazard and 53% were classified as posing a moderate level of health hazard. For recalls of animal drugs, 5% were classified as posing a high level of health hazard and 42% were classified as posing a moderate level of health hazard. The most common errors identified for recalls of non-medicated feeds were those related to the BSE rule. The most common errors identified for recalls of medicated feeds were incorrect levels of drugs in feeds or feeding medicated feeds to species or ages for which the drugs in the feeds were not approved. Other errors associated with recalls of non-medicated and medicated feeds included chemical or microbiological contamination, labeling errors, and general manufacturing errors. The most common errors associated with recalls of animal drugs were due to concerns about the drugs’ stability, sterility and labeling.

Conclusions: CVM is using information from the analysis of the animal feed and drug products associated with 203 firm-initiated recalls from fiscal years 2000 through 2005 to help rank the relative risks from the products, manufacturing processes and facilities.

Category: I. Risk Management, Risk Assessment,and Risk Communication for Medical Products and Foods

http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/search/preview.cfm?abstract_id=838&backto=category


BAB = BORN AFTER BAN

BARB = BORN AFTER RUMINANT BAN

BAMB = BORN AFTER MAMMALIAN BAN

http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/200503canada/fig3desce.html




http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html



http://sciencebushwhacked.blogspot.com/2009/01/fda-scientists-complain-about.html



http://sciencebushwhacked.blogspot.com/2009/01/fda-scientists-complain-about.html



http://fdafailedus.blogspot.com/



NEW TSE TERM FOR FDA = BAWB I.E. 'BORN AFTER WHAT BAN' ;-(TSS)
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