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

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

A decade ago FDA launched what would become an unprecedented inspectional program. We set out to enforce the BSE feed rule, adopted in 1997, to prevent the establishment and amplification of bovine spongiform encephalopathy (BSE) by prohibiting the feeding of mammalian protein (“prohibited materials”) to ruminant animals. The regulation had national and international attention, because of then-recent evidence from the UK that humans could contract a fatal disease (variant Creutzfeldt-Jakob Disease) related to BSE by consuming meat products derived from BSE-infected cattle.

Enforcing the regulation presented a unique challenge. BSE had not been reported in the United States, and there were no practical tests to detect the presence of the causative agent during the preclinical state in live animals. Nor were there practical tests to determine the species origin of protein products found in animal feed. In addition, the regulation reached the activities of thousands of firms in a number of diverse industries – including renderers, protein blenders, and feed manufacturers. Many of these firms had no experience complying with regulations like the BSE feed rule and were not in FDA’s inventory of regulated firms.

Nevertheless, CVM set a goal of 100 percent compliance with the regulation. We wanted compliance not only with the regulation’s paperwork requirements, but also actual compliance – that is, prohibited materials would in fact not be fed to ruminants. We would achieve the goal through a campaign to educate regulated groups and by inspecting 100 percent of the regulated firms in major segments of the affected industries.

During FY 1998, the first year of enforcement, we inspected slightly more than 2,600 firms, approximately 50 percent of all renderers, but only 15 percent of all feed manufacturers. And we found that 15-50 percent of the inspected firms were not in compliance with all aspects of the regulation.

ACCOMPLISHMENTS AT THE MIDWAY POINT

By the end of FY 2003, we had achieved our goal of inspecting 100 percent of the nation’s renderers, protein blenders, and feed manufacturers – more than 6,600 firms – for compliance with the regulation. We had also inspected an additional 6,900 firms including ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, and animal feed transporters.

In addition, we had nearly reached our goal of 100 percent compliance with the regulation’s requirements; less than 1 percent of the firms known to handle prohibited material had violations serious enough to require official action at their latest inspection. But that was still too many violations – we issued seven Warning Letters and instituted 14 product recalls for violations of the regulation during the year.

5 YEARS LATER – NO SIGNIFICANT VIOLATIONS

FDA and State investigators conducted more than 7,500 inspections during FY 2008. We found no serious violations; thus, no enforcement action was required. From the start of the program in FY 1998 until the end of the fiscal year 2008, we had conducted more than 66,000 inspections at more than 24,000 different facilities.

A decade ago we set a goal of 100 percent actual compliance with the rule. Although there is no way to determine definitively that the goal has been met, inspection results from recent years and the absence of any feed-related BSE cases in the United States suggests that we have effectively achieved full compliance with the feed ban.

A TEAM EFFORT

These achievements were possible only through the efforts of a number of groups and individuals, including FDA District Offices and State agencies, whose investigators have conducted the thousands of inspections; industry associations, who have educated their member firms; and CVM and Agency Headquarters staff, including CVM’s Office of Research scientists, who have done groundbreaking work in developing rapid and efficient test methods for prohibited protein materials.

THE YEARS AHEAD

This year, we turn a page in the history of enforcing the BSE rule. A 2008 amendment of the rule, to expand the scope of prohibited material, presents new enforcement challenges. We describe the rule change, and our efforts to ensure compliance, in the section “Controlling Risk from Bovine Spongiform Encephalopathy (BSE).”

A MESSAGE FROM THE DIRECTOR CVM Director, Dr. Bernadette Dunham

A Tribute to Dr. Stephen Sundlof

Dr. Steve Sundlof, my predecessor who left CVM to become Director of the Center for Food Safety and Applied Nutrition, is my mentor and friend. It was his vision that led to the publication of the CVM Annual Report, and I am proud to continue the series. Dr. Sundlof was Center Director for more than 13 years; during those years, he most capably led the Center through a number of highly visible and sometimes controversial issues. He initiated a number of undertakings, both within and outside the Center, that have contributed much to the Center’s productivity and contributions to public and animal health. His legacy with CVM is a great one, and we thank him for all that he did.

Celebrating out Accomplishments

This has been an extraordinary year for recognition from outside the Center of the work of our CVM staff members. The details of the recognition are in the opening vignette at the front of this report, in the various sections that describe our accomplishments in various areas, and in the Awards Appendix. I congratulate those on our staff whose efforts bring great credit to themselves, the Center, and the Agency.

But I want also to acknowledge the work of the many staff members whose names do not appear on awards lists or who do not have prestigious assignments to national and international groups. Their efforts – working hard day in and day out to accomplish their assigned tasks, supporting the work of others in many cases – are vitally necessary to the success of the Center’s programs. We thank them for what they – the unsung heroes – do to help the Center accomplish its mission of protecting public and animal health.

We have an enormously talented staff in CVM, with accomplishments that extend well beyond their contributions to their work assignments. We see an example in the excellent set of photographs, taken by staff members, that are displayed throughout this report. It is regrettable that we were unable to publish all of the excellent photographs in this year’s report. However, you can look for them in CVM’s future Annual Reports. I thank everyone who took the time to submit their photographic work.

HIGHLIGHTS OF FY 2008: ACCOMPLISHMENTS THROUGH THE WORK OF OUR PEOPLE

The pages of this report contain descriptions of a great number of accomplishments made by our people during the year, often with the collaboration of our partners and stakeholders. I have selected the following as examples of public and animal health significance, public interest, and level of achievement during the year. You will find more details on each accomplishment elsewhere in this report.

Animal Health Literacy Campaign

We want people to be knowledgeable about current animal health issues, to learn how to apply that knowledge for the benefit of their animals and their own health, and to know that CVM is an important source of relevant information. So when the idea for an Animal Health Literacy Campaign came from staff members within CVM – a result of our efforts to be a high performance organization – Center management enthusiastically endorsed the project. The program got off to a good start in FY 2008, and we intend to expand the program to include strategic interaction with industry groups in the future. As with the “One Health” initiative, veterinarians are key players in increasing animal health literacy levels, and we encourage their involvement in the literacy campaign.

Animal Feed Safety

The melamine-contaminated pet food recall of 2007, and several contamination incidents involving human food, changed the way consumers, Congress, and regulators think about food safety. The incidents highlighted the fact that the United States is part of a global economy, and that imports are a significant part of the human food and animal feed chain. FDA responded with its Food Protection Plan (food = feed) and an Import Safety Action Plan. These plans encompass animal feed, including pet food, which are within CVM’s responsibility. Among other actions, the Agency began the process during the year to establish offices in five foreign locations, starting with China. CVM will be part of this international presence.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the Agency to establish a range of standards, databases and notification systems to protect pets and other animals from unsafe food. We went right to work on this ambitious agenda in FY 2008, holding public meetings, reviewing public comment, drafting documents, and taking other actions leading toward implementation of the Congressional mandates. Our work including taking a close look at a “Pet Event Tracking Network,” a concept proposed during the 50-State Gateway to Food Protection Meeting convened to facilitate implementation of the Food Protection Plan. The Pet Event Tracking Network would be an early warning system to detect companion animal feedborne outbreaks and would provide Federal regulators the opportunity to partner with State and local health organizations.

Our research staff developed a method for detecting melamine in pet food in FY 2007. Then, in FY 2008, with the news of melamine contamination of infant formula in China, our scientists quickly modified the method so that it could be used in detecting melamine in infant formula – this time protecting human health!

Extension and Expansion of User Fees to Expedite New Animal Drug Approvals

Building on the success of the Animal Drug User Fee Act of 2003 (ADUFA I) – kudos to our Office of New Animal Drug Evaluation, which has met every ADUFA goal so far – and acknowledging the need to speed the approval process for generic new animal drugs, Congress passed two laws this past year: the Animal Drug User Fee Amendments of 2008 (ADUFA II), and the Animal Generic Drug User Fee Act of 2008. CVM participated actively with industry associations in the negotiations leading to the passage of these new laws. When ADUFA II went into effect October 1, 2008, the Office of New Animal Drug Evaluation was ready with updated procedures and training for implementation of the law’s new features that will make the program even better for the industry and CVM. With the new laws, we plan to do more to improve the efficiency and effectiveness of our drug review program, both for pioneer and generic applications.

Guidance on Controversial Pre-Market Decisions

When we set about preparing and releasing guidance on two controversial subjects – genetically engineered animals and animal clones – we knew that we needed to utilize the best science, develop a clear regulatory policy, and communicate the relevant information to the public in an understandable manner. Working with experts elsewhere in the Agency, our staff did a superb job.

Our draft guidance document on genetically engineered animals provides timely information on the regulatory environment – including specific guidance on pre-market approval requirements – to genetically engineered animal sponsors who are approaching the commercialization stage. Importantly, the guidance also describes to the consumer the protections in place to ensure the safe use of this technology.

The number of comments we received on the draft animal cloning risk assessment – 30,000 – highlighted the level of public concern and controversy on this topic. We knew that release of the final draft – which confirmed our position that clones and their progeny from several animal species are as safe as food from conventional animals and therefore do not need pre-market approval – would need to be done with great care. So we made it clear to the public as we released the risk assessment that we based all our decisions about food and animal safety on the best science available, using extensive amounts of data, and that we were working openly and using only publicly available information. We worked with communications experts on FDA’s staff to make sure we delivered complete, accurate, and understandable information to consumers.

During the year we continued to be at the forefront of the rapidly developing One Health Initiative. One Health is the collaborative effort of multiple disciplines – working locally, nationally, and globally – to obtain optimal health for people, animals, and our environment. Nearly two dozen Federal and State agencies and professional and scientific organizations – including the American Medical Association and the American Veterinary Medical Association – are participants.

The increasing threats posed by emerging zoonotic diseases (those that can be transmitted from animal to humans), food and waterborne diseases, and environmental change led to the creation of the initiative.

Because the scope of One Health includes animal health, CVM is squarely within the parameters of the initiative. Here are three examples:

Avian influenza.Our scientists made progress during the year in developing methodology to detect use of certain antiviral drugs in poultry. The methodology will be used to enforce CVM’s order prohibiting the use of those drugs in poultry. The goal is to preserve the drugs’ efficacy for human use in the event of an influenza pandemic. Foodborne antimicrobial resistance.This past year brought renewed attention to the effort, long led by CVM, to reduce resistance-related risk to human health from the use of antimicrobials in animals. For example, Congress included in ADUFA II a reporting provision related to the marketing of antimicrobial drugs, and Congress held hearings on the subject of antimicrobial resistance during the year. Our scientists continued to provide leadership and scientific expertise on this issue, on a national and international basis. They worked not only to help other nations cope with resistance issues, but also to ensure that decisions of other nations and international bodies will be based on objective evidence for determining the degree of risk. Bovine spongiform encephalopathy (BSE). Scientific evidence strongly suggests that humans can contract variant Cruetzfeldt-Jakob Disease by consuming meat products derived from BSE-infected cattle. Compliance during the past decade with our BSE feed rule, which is aimed at protecting both animal and human health, is one of the most impressive regulatory accomplishments in which CVM has participated. The success is a result of a joint effort involving FDA, State regulatory agencies, livestock production industries, the feed and rendering industries, and others. This year, we began gearing up for a new level of public protection – we have been training inspectors, coordinating with industry on education programs, and otherwise preparing to implement the amended BSE feed rule that expands the prohibition on use of cattle protein in animal food.

SNIP...

Controlling Risk from BSE THE CHALLENGE

BSE is a chronic, degenerative, always fatal neurological disease affecting the central nervous system of cattle. BSE belongs to a family of diseases known as transmissible spongiform encephalopathies that include several ruminant and nonruminant animal diseases. Laboratory and epidemiological evidence strongly suggests that people can contract a human transmissible spongiform encephalopathy, variant Cruetzfeldt-Jakob Disease, by consuming meat products derived from BSE-infected cattle. In the absence of adequate controls, BSE could spread among the cattle population through feed ingredients derived from infected cattle.

FY 2008 ACCOMPLISHMENTS

Much of our effort to combat BSE in 2008 focused on enforcing and strengthening our BSE feed regulation, which prohibits the use of certain mammalian-origin proteins in ruminant feed. A major initiative involved an amendment of the BSE feed rule to strengthen public health protection. The goal is to prevent the establishment and amplification of BSE in the United States through animal feed. Following are highlights of some of our achievements that accomplished FDA’s strategic goal of consumer protection, and the Department-wide objective of improving the safety of food products.

U.S. AND WORLDWIDE BSE DETECTION

As in the previous fiscal year, FY 2008 did not see the discovery of any BSE-infected cattle in the United States. During the same time period, four new BSE cases were detected in Canada. Worldwide, the incidence of BSE continued to decline significantly.

STRENGTHENING THE BSE FEED REGULATION

Overview of Rule Revision

FDA’s 1997 BSE feed rule prohibits the use of mammalian-origin proteins in feed fed to ruminants,19 while allowing the use of these materials in feed for non-ruminant animals.20 In April 2008, the Agency revised the regulation to strengthen further the feed-related safeguards against BSE in the United States. The revised rule prohibits the use of the highest risk cattle materials in the food or feed of all animals, ruminants and non-ruminants, including pet food.

Need for Revision

Compliance with the 1997 rule has been extremely high. No cases of BSE in animals born after the introduction of the ban have been detected, and no new BSE cases have been reported in the United States since March 2006. Nevertheless, the FDA concluded that additional protections were needed. One reason was that inspections of feed manufacturing firms had identified a small number of instances of inadequate cleanout procedures, mislabeling, and recordkeeping deficiencies. Although few in number, such lapses could allow food and feed intended for nonruminants to get into the food supply for ruminants. In addition, the amount of feed material needed to transmit the disease is so small that it is possible that the procedures followed by a seemingly compliant firm may not be sufficiently robust to prevent cross-contamination of cattle feed with enough infectious material to cause new cases of BSE. This scenario best explains why cases of BSE continued to be found in cattle born in the United Kingdom after implementation of that country’s ruminant-to-ruminant feed ban.

Details of the Revised Rule

The new rule is intended to mitigate compliance failures and prevent the potential transmission of the BSE agent through cross-contamination or on-farm misfeeding of prohibited material to ruminants. Thus, the new rule is expected to further reduce risk of any ruminant exposure to the BSE agent not eliminated by the 1997 feed rule.

Revisions to definition of prohibited material. Scientific data indicate that roughly 90 percent of BSE infectivity in cattle is contained in the brain and spinal cord of older cattle.21 For this reason, the new rule focuses primarily on removing the brains and spinal cords of older cattle from all animal feed. Specifically, the new rule prohibits the use of the following cattle materials in the food or feed of all animals, including pet food:

The entire carcass of BSE-positive cattle; The brains and spinal cords from cattle 30 months of age and older; The entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older and from which brains and spinal cords were not removed; Tallow that is derived from BSE-positive cattle; tallow that is derived from other materials prohibited by this rule that contains more than 0.15 percent insoluble impurities; and Mechanically separated beef that is derived from the materials prohibited by this rule. We refer to these materials as “cattle materials prohibited in animal feed,” or CMPAF.

The final rule allows renderers to process the entire carcasses of dead stock cattle22 under 30 month of age for use in nonruminant feed. (The risk of BSE in cattle less than 30 months of age is considered to be exceedingly low.) The proposed rule would have required removal of the brain and spinal cord from all cattle, regardless of age, because of FDA concerns that government inspectors are not routinely available in rendering plants to verify the ages of dead cattle. The Agency changed the final rule, based on comments that age determination of dead stock cattle in the rendering plants is feasible. The regulation allows renderers the option of determining the age of the cattle and processing cattle under 30 months of age without removing the brain and spinal cord. However, the final rule requires renderers to develop and maintain written procedures for determining the age of and/or removing the brain and spinal cord from dead cattle.

FDA also based its proposal on European surveillance data that showed that cattle not inspected and passed for human consumption (dead stock) were included among the cattle at highest risk of BSE. However, the comments supported the conclusion that very little risk reduction is gained by excluding material from such cattle that are less than 30 months of age.

Inspections and record-keeping. During inspections at rendering facilities, FDA intends to verify that renderers maintain records sufficient to demonstrate that material rendered for use in animal feed does not contain CMPAF. In addition to written procedures for determining the age of cattle, the regulations also specify written procedures for effectively excluding the brain and spinal cord from animals 30 months of age and older. Investigators will be verifying that actual practices are effective in providing compliance with the regulation. The Agency revised the final rule to clarify that a renderer’s records must include certification from each supplier, or other documentation acceptable to FDA, that CMPAF has been excluded from materials to be rendered for use in animal feed.

Disposing of CMPAF. As a result of this final rule, a large volume of byproducts from the beef and cattle industries will no longer be allowed to be rendered for animal feed use. Alternative means of disposing of this material include landfill, composting, incineration, alkaline hydrolysis, and burial.

Country exception. In response to comments to the proposed rule, FDA revised the final rule so that the Agency may designate a country as not subject to the new requirements; that is, animal protein from the country would not have to have CMPAF removed if it is intended for consumption by nonruminant animals. Any country seeking such a designation must submit a written request to the Director of CVM, providing information about that country’s BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining the country’s BSE status.

Conclusion

Two and a half years passed from the time of the proposed rule (October 2005) until publication of the final rule (April 2008). During that time, FDA reviewed more than 800 comments, including comments from industry, State and local governments, trade associations, academia, and consumers. Among other time-consuming steps, the Agency reviewed comments challenging FDA’s estimate of the cost of the new regulation. This review required an extensive reanalysis of the economic impact of the rule. We believe that the time and effort required, including that needed to draft changes to the proposed rule, were worthwhile. The revised regulation provides an additional margin of safety by reducing the consequences of inadvertent cross-contamination or on-farm misfeeding, thereby helping to ensure that the U.S. beef supply remains safe.

We plan to publish a Guidance for Industry to assist the industry in complying with the revised regulation. More information about BSE and the BSE rule is available on the CVM Web site at


http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy.htm





INTERNATIONAL INVOLVEMENT

We provided information to trading partners and the World Organisation for Animal Health that included feed ban enforcement data and updates on FDA’s science-based enhancements to animal feed controls for preventing transmission of BSE through feed.

A CVM staff member, Dr. Dragan Momcilovic, continued to serve as the only U.S. member of the Board of SAFEED-PAP,23 a European project that is aimed at the development of improved testing methods for detection of prohibited animal protein in feed. The participants, mostly regulatory scientists, include representatives of national laboratories and several universities. A large number of European nations, in addition to Japan, China, and the United States, participate in the project.

TRAINING, EDUCATION, AND ENFORCEMENT

We continued to train inspection personnel, so that the BSE feed rule will be enforced effectively and efficiently. We also continued to provide educational outreach to the regulated industry.

Specifically, during FY 2008 we conducted a formal, full-day training course for inspection personnel. We also provided training/outreach information to feed regulators and industry personnel at a number of other meetings. CVM will increase training activities in FY 2009 to ensure proper training for inspectors for the implementation of the 2008 amendment to the BSE rule.

Additionally, we provided updates on BSE inspections and enforcement, as well as information about the new BSE rule, at several meetings sponsored by the Association of American Feed Control Officials; two of the workshops were open to industry representatives. We presented the same information at a meeting sponsored by FDA’s Division of Federal-State Relations for representatives of States that have contracts to do inspection work for FDA. We will continue educational outreach to industry during FY 2009 to help with compliance with the revised feed rule.

During FY 2008, the FDA district offices and State agencies conducted more than 7,889 inspections for BSE feed rule compliance at renderers, feed manufacturers, and other firms. More than 98 percent of the inspections were found to be NAI (no action indicated), meaning that the firms were in compliance. No firms were classified OAI (official action indicated); that is, no serious violations were found. We did classify approximately 0.8 percent of the inspections as VAI (voluntary action indicated). Typically VAI involves minor recordkeeping violations, which can be corrected at the time of the inspection. As a result, no formal enforcement actions (Warning Letters, injunctions, or seizures of violative products, for example) were taken during FY 2008.

DEVELOPING ANALYTICAL METHODS FOR DETECTING PROHIBITED PROTEIN

During the year, we completed peer validation of the real time polymerase chain reaction (PCR) method developed by CVM scientists to detect prohibited animal proteins in animal feed. The method will detect cattle, sheep, and goat materials produced under processing conditions used in the United States and European Union. The real time PCR method represents a significant improvement over the current PCR method, because a single analyst can analyze 12 samples in a little more than 2 hours. The current method requires 8 hours to analyze these same 12 samples. At the end of the fiscal year, we were working actively with the FDA field laboratories to transfer the method to those laboratories for use in surveillance and compliance activities. The process of transferring the method included training in the methodology prior to releasing it for use by the laboratories.

With the help of a visiting scientist, CVM scientists during the year were able to modify further the real-time PCR method into a multiplex real-time PCR method, which permits the detection of cattle, sheep, goat, deer, and elk in a single reaction tube. This test will also permit detection of ruminant proteins rendered in the European Union. One goal of this effort is to create an assay in which both the DNA extraction and PCR assay reagents are contained in two ready-to-use, commercially available kits. By having all the assay components ready to use from commercial kits, the FDA field laboratories will not need to make up any component, nor will they need to constantly conduct quality control checks of reagents that they need to prepare. Eliminating variation in reagents between different testing laboratories avoids a potential source of error when performing this method.

SNIP...END OF BSe ;

full text ;


http://www.fda.gov/AboutFDA/CentersOffices/CVM/ucm185152.htm#BSEFeedRuleEnforcement:ADecadeofSuccess






NOW, LETS GET TO THE FACTS, and or the truth ;


10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007

Date: March 21, 2007 at 2:27 pm PST

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II

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PRODUCT

Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007

CODE

Cattle feed delivered between 01/12/2007 and 01/26/2007

RECALLING FIRM/MANUFACTURER

Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.

Firm initiated recall is ongoing.

REASON

Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.

VOLUME OF PRODUCT IN COMMERCE

42,090 lbs.

DISTRIBUTION

WI

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PRODUCT

Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007

CODE

The firm does not utilize a code - only shipping documentation with commodity and weights identified.

RECALLING FIRM/MANUFACTURER

Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.

REASON

Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.

VOLUME OF PRODUCT IN COMMERCE

9,997,976 lbs.

DISTRIBUTION

ID and NV

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007

http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html


NEW URL

http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm



PLEASE NOTE, THE FDA URLS FOR OLD WARNING LETTERS ARE OBSOLETE AND DO NOT WORK IN MOST CASES. I LOOKED UP THE OLD ONE ABOVE AND FOUND IT, BUT HAVE NOT DONE THAT FOR THE OTHERS TO FOLLOW. THE DATA IS VALID THOUGH!


Thursday, March 19, 2009

MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL NOW, WHY IN THE WORLD DO WE TO TALK ABOUT THIS ANYMORE $$$

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



Subject: MAD COW PROTEIN IN COMMERCE USA 2006 RECALL UPDATE From: "Terry S. Singeltary Sr." <[log in to unmask]> Reply-To: SAFETY <[log in to unmask]> Date: Mon, 9 Oct 2006 14:10:37 -0500 Content-Type: text/plain Parts/Attachments: text/plain (558 lines) Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV Date: September 6, 2006 at 7:58 am PST

PRODUCT a) EVSRC Custom dairy feed, Recall # V-130-6; b) Performance Chick Starter, Recall # V-131-6; c) Performance Quail Grower, Recall # V-132-6; d) Performance Pheasant Finisher, Recall # V-133-6. CODE None RECALLING FIRM/MANUFACTURER Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is complete.

REASON Dairy and poultry feeds were possibly contaminated with ruminant based protein.

VOLUME OF PRODUCT IN COMMERCE 477.72 tons DISTRIBUTION AL

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snip...

http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html



Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA, MS, AL, GA, AND TN 11,000+ TONS Date: August 16, 2006 at 9:19 am PST RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

______________________________

snip...

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PRODUCT Bulk custom dairy pre-mixes, Recall # V-120-6 CODE None RECALLING FIRM/MANUFACTURER Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm initiated recall is complete.

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

VOLUME OF PRODUCT IN COMMERCE 350 tons DISTRIBUTION AL and MS

______________________________

PRODUCT a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet, 50 lb. bags, Recall # V-121-6; b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet, 50 lb. bags, Recall # V-122-6; c) Tucker Milling, LLC #31232 Game Bird Grower, 50 lb. bags, Recall # V-123-6; d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD Medicated, 50 lb bags, Recall # V-124-6; e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags, Recall # V-125-6; f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags, Recall # V-126-6; g) Tucker Milling, LLC #30116, TM Broiler Finisher, 50 lb bags, Recall # V-127-6 CODE All products manufactured from 02/01/2005 until 06/20/2006 RECALLING FIRM/MANUFACTURER Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit on June 20, 2006, and by letter on June 23, 2006. Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated recall is ongoing.

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

VOLUME OF PRODUCT IN COMMERCE 7,541-50 lb bags

DISTRIBUTION AL, GA, MS, and TN

END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006

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http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.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

###

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



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

###

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



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) Infectious dose:

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

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



http://list.uvm.edu/cgi-bin/wa?A2=SAFETY;pbpHeQ;20061009141037-0500B



Office of Inspector General Semiannual Report to Congress FY 2007 - 2nd Half

Two Texas Companies Sentenced and Fined for Misbranding Meat Products In April 2007, two closely held and related Texas companies pled guilty in Federal court and were sentenced to 12 months of probation and ordered to pay $10,250 in fines for misbranding meat products. One of the companies sold adulterated meat products to a retail store in New Mexico. Additionally, portions of the invoices failed to properly and consistently identify the meat products as being from cattle more than 30 months old at time of slaughter. This information is required to be disclosed because of bovine spongiform encephalopathy (BSE, or "mad cow disease") concerns. No adulterated meat reached consumers.

http://www.usda.gov/oig/webdocs/sarc071212.pdf



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



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



Sunday, September 6, 2009

MAD COW USA 1997 SECRET VIDEO

http://madcowusda.blogspot.com/2009/09/mad-cow-usa-1997-video.html



U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ? see video at bottom

http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html



DAMNING TESTIMONY FROM STANLEY PRUSINER THE NOBEL PEACE PRIZE WINNER ON PRIONS SPEAKING ABOUT ANN VENEMAN

http://maddeer.org/video/embedded/prusinerclip.html



2009 UPDATE ON ALABAMA AND TEXAS MAD COWS 2005 and 2006

http://bse-atypical.blogspot.com/2006/08/bse-atypical-texas-and-alabama-update.html



Sunday, December 28, 2008

MAD COW DISEASE USA DECEMBER 28, 2008 an 8 year review of a failed and flawed policy

http://bse-atypical.blogspot.com/2008/12/mad-cow-disease-usa-december-28-2008-8.html



Wednesday, August 20, 2008

Bovine Spongiform Encephalopathy Mad Cow Disease typical and atypical strains, was there a cover-up ? August 20, 2008

http://bse-atypical.blogspot.com/2008/08/bovine-spongiform-encephalopathy-mad.html



Monday, May 11, 2009

Rare BSE mutation raises concerns over risks to public health

http://bse-atypical.blogspot.com/2009/05/rare-bse-mutation-raises-concerns-over.html



Thursday, December 04, 2008 2:37 PM

"we have found that H-BSE can infect humans."

personal communication with Professor Kong. ...TSS

see full text ;

http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html



Sunday, June 07, 2009

L-TYPE-BSE, H-TYPE-BSE, C-TYPE-BSE, IBNC-TYPE-BSE, TME, CWD, SCRAPIE, CJD, NORTH AMERICA

http://bse-atypical.blogspot.com/2009/06/l-type-bse-h-type-bse-c-type-bse-ibnc.html



Sunday, May 10, 2009

Identification and characterization of bovine spongiform encephalopathy cases diagnosed and NOT diagnosed in the United States

http://bse-atypical.blogspot.com/2009/05/identification-and-characterization-of.html



Docket APHIS-2006-0026 Docket Title Bovine Spongiform Encephalopathy; Animal Identification and Importation of Commodities Docket Type Rulemaking Document APHIS-2006-0026-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities Public Submission APHIS-2006-0026-0012 Public Submission Title Comment from Terry S Singletary

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801e47e1



Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0028 Public Submission Title Comment from Terry S Singletary

Comment 2006-2007 USA AND OIE POISONING GLOBE WITH BSE MRR POLICY

THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted products from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as I have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species.

MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???

go figure. ...

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8151



Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0028.1 Public Submission Title Attachment to Singletary comment

January 28, 2007

Greetings APHIS,

I would kindly like to submit the following to ;

BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f8152&disposition=attachment&contentType=msw8



Sunday, August 10, 2008

A New Prionopathy OR more of the same old BSe and sporadic CJD

http://creutzfeldt-jakob-disease.blogspot.com/2008/08/new-prionopathy-or-more-of-same-old-bse.html



SEAC OCTOBER 2009

• Are some commoner types of neurodegenerative disease (including Alzheimer's disease and Parkinson's disease) also transmissible? Some recent scientific research has suggested this possibility

http://www.seac.gov.uk/pdf/hol-response091008.pdf



Saturday, June 13, 2009

Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009

http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html



http://creutzfeldt-jakob-disease.blogspot.com/2009/08/characteristics-of-established-and.html



Tuesday, July 14, 2009

U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST

WHERE did we go wrong $$$

http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html



>>> In the papers, the government alleges the meatpacking plant slaughtered and processed downer cows for nearly four years - from January 2004 to September 2007 - <<<>95%) downer or dead dairy cattle and a few horses. She had never been fed.

We believe that these findings may indicate the presence of a previously unrecognized scrapie-like disease in cattle and wish to alert dairy practitioners to this possibility.

snip...

PROCEEDINGS OF THE SEVENTH ANNUAL WESTERN CONFERENCE FOR FOOD ANIMAL VETERINARY MEDICINE, University of Arizona, March 17-19, 1986

http://www.bseinquiry.gov.uk/files/mb/m09a/tab01.pdf



http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf



IS THERE A SCRAPIE-LIKE DISEASE IN CATTLE ?

YOU BET THERE IS, AND HAS BEEN, AND WE BEEN FEEDING THE MOST HIGH RISK I.E. DEAD STOCK DOWNER COWS TO OUR CHILDREN FOR DECADES, who will follow these children for human TSE from mad cow disease here in the USA in the years, decades to come, and how many will they expose from the 'pass it forward' friendly fire modes ???

http://downercattle.blogspot.com/2008/12/evaluation-of-fsis-management-controls.html



Saturday, May 2, 2009

U.S. GOVERNMENT SUES WESTLAND/HALLMARK MEAT OVER USDA CERTIFIED DEADSTOCK DOWNER COW SCHOOL LUNCH PROGRAM

http://downercattle.blogspot.com/2009/05/us-government-sues-westlandhallmark.html



Thursday, May 1, 2008 DEAD STOCK DOWNER COW BAN i.e. non-ambulatory policy still not changed by USDA May 1, 2008

http://downercattle.blogspot.com/2008/05/dead-stock-downer-cow-ban-ie-non.html



Sunday, May 17, 2009

WHO WILL WATCH THE CHILDREN ? SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE

http://downercattle.blogspot.com/2009/05/who-will-watch-children.html



http://downercattle.blogspot.com/






Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518