CFIA Launches Feed Investigation
March 28, 2009 - The Canadian Food Inspection Agency (CFIA) has launched an investigation into potentially contaminated feed products from a rendering facility in Alberta. The safety of the Canadian food supply is not affected.
The vast majority of the potentially contaminated feed has been identified, contained and will be disposed of. The company is working closely with the CFIA to quickly identify and dispose of all potentially contaminated feed.
Information to date indicates that a limited amount of poultry feed may have been inadvertently contaminated with specified risk material (SRM) earlier this month. The feed potentially contaminated with SRM poses no health risk to poultry and does not affect the safety of poultry meat and eggs.
In cattle infected with bovine spongiform encephalopathy (BSE), SRM are the tissues known to harbour the disease. These tissues are removed from all cattle slaughtered for human consumption, and are prohibited from use in animal feed, pet food and fertilizer.
As the investigation proceeds, updates will be provided on the CFIA web site.
For information:
Canadian Food Inspection Agency Media Relations: (613) 773-6600
http://www.inspection.gc.ca/english/anima/feebet/rumin/20090328investe.shtml
heck, here in Texas, FDA et al thinks as much as 5.5 grams of SRM is just fine for a heifer weighing about 600 lbs.
and in reality, 5.5 grams is enough to kill a small herd of cattle with mad cow disease. ...
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 $$$
LET's go back to the infamous TOKEN, charade, that happened on January 30, 2001, at the Texas Purina feed lot around Gonzales. NOW remember, this thing was set up from the word go, as to some big showing that the FDA was DOING SOMETHING BIG. let's look at exactly what was said then, and then i will run some figures by you, of what banned mad cow feed has gone into commerce, of which most was fed out. but, as wrong as the comments made were about what amount of infectious material will kill a cow in this statement, even if you were to go by those wrong figures of about .......... oh what was it ???
''FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.''
http://www.fda.gov/bbs/topics/news/2001/new00752.html
you can take that with how ever many grains of salt you wish, but i read that as saying, it was only 5 1/2 grams, and the old cow ways 600 pounds, so know way that even if the feed was tainted, there was not enough to cause disease. the fda, usda et al, knew at that exact moment when they wrote that statement, they knew then that the 5 1/2 grams was enough to kill a small herd of cows. it was old science. but again, they chose to deceive. THIS WAS 2001, and it's now 2009, and they still are choosing to deceive, and the new administration appears willing to continue the USA mad cow charade. NOW, since the charade at the purina mill in 2001, i am going to list a few figures of suspect, banned mad cow feed that went out into commerce, even in 2008, 2007, 2006, back a few years, and you can compare, what enormous amounts of banned suspect mad cow feed and other products continue to go out. when you consider, and they knew all along, that .005 grams is lethal, my God, how much of this poison was consumed?
see long list of years and years of feeding SRMs here in the USA all the way up to 2008, the USA is still feeding cows to cows, srms to cows, and other species. ...TSS
SEE FULL TEXT ;
http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html
Wednesday, March 18, 2009
HERE WE GO AGAIN, FDA TO DELAY ENHANCED MAD COW FEED BAN RULE
http://madcowfeed.blogspot.com/2009/03/here-we-go-again-fda-to-delay-enhanced.html
Saturday, January 24, 2009
Bovine Spongiform Encephalopathy h-BSE ATYPICAL USA 2008 Annual Report Research Project: Study of Atypical Bse
Location: Virus and Prion Diseases of Livestock
2008 Annual Report
http://bse-atypical.blogspot.com/2009/01/bovine-spongiform-encephalopathy-h-bse.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
Wednesday, February 04, 2009
Creutzfeldt-Jacob disease presenting as severe depression: a case report
http://creutzfeldt-jakob-disease.blogspot.com/2009/02/creutzfeldt-jacob-disease-presenting-as.html
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION
http://cjdquestionnaire.blogspot.com/
TSS
Monday, March 30, 2009
Friday, March 27, 2009
Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related E
March 31 - April 1, 2009
Panel Member List FIFRA Scientific Advisory Panel Open Meeting, March 31 - April 1, 2009
Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods
Environmental Protection Agency Conference Center Lobby Level, One Potomac Yard (South Bldg.), 2777 Crystal Dr., Arlington, VA 22202
FIFRA SAP Website: http://www.epa.gov/scipoly/sap/ Docket Number EPA-HQ-OPP-2008-0859 OPP Docket Telephone: 703-305-5805
FIFRA SAP Session Chair
Steven G. Heeringa, Ph.D. Research Scientist & Director for Statistical Design University of Michigan Institute for Social Research Ann Arbor, MI
Designated Federal Official
Myrta R. Christian, M.S. US Environmental Protection Agency Office of Science Coordination & Policy FIFRA Scientific Advisory Panel EPA East Building, MC 7201M 1200 Pennsylvania Avenue, NW Washington, DC 20460 Tel: 202-564-8450, Fax: 202-564-8382, mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:Christian.myrta@epa.gov
FIFRA Scientific Advisory Panel Members
John R. Bucher, Ph.D., DABT Associate Director Environmental Toxicology Program National Institute of Environmental Health Sciences Research Triangle Park, NC
Janice E. Chambers, Ph.D., DABT, ATS William L. Giles Distinguished Professor Director, Center for Environmental Health Sciences College of Veterinary Medicine Mississippi State University Mississippi State, MS
Kirby C. Donnelly, Ph.D. Professor and Head Department of Environmental and Occupational Health School of Rural Public Health Texas A&M University System Health Science Center College Station, TX
Carey N. Pope, Ph.D. Professor, Head & Sitlington Chair of Toxicology Department of Physiological Sciences Oklahoma State University College of Veterinary Medicine Stillwater, OK
Kenneth M. Portier, Ph.D. Program Director, Statistics American Cancer Society National Home Office Atlanta, GA
Daniel Schlenk, Ph.D. Professor of Aquatic Ecotoxicology & Environmental Toxicology Department of Environmental Sciences University of California, Riverside Riverside, CA
FQPA Science Review Board Members
Jason C. Bartz, Ph.D. Assistant Professor Department of Medical Microbiology & Immunology Creighton University School of Medicine Omaha, Nebraska
Dr. Jason C. Bartz is an Assistant Professor in the Department of Medical Microbiology and Immunology in the School of Medicine at Creighton University where he conducts research on prion diseases. Dr. Bartz received a Ph.D. in veterinary science from the University of Wisconsin where he focused on interspecies transmission and adaptation of prions to new host species. Dr. Bartz has over 15 years of experience in prion disease research and is currently investigating the biology of prion strains. Specifically, Dr. Bartz is interested in the mechanisms of strain-specific routes of neuroinvasion, prion strain targeting in the central nervous system and prion strain interference. Dr. Bartz has been an advisor to panels of the National Institutes of Health and the Department of Defense.
Byron Caughey, Ph.D. Senior Investigator & Chief - TSE/Prion Biochemistry Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, Montana
Dr. Byron Caughey is a Senior Investigator and Chief of the TSE/prion Biochemistry Section of the Laboratory of Persistent Viral Diseases, Rocky Mountain Laboratories, National Institute for Allergy and Infectious Diseases, National Institutes of Health in Hamilton, Montana. Dr. Caughey got his Ph.D. in Biochemistry from the University of Wisconsin-Madison in 1985. In 1986, after post-doctoral studies in neurochemistry at Duke University, he began TSE/prion research at Rocky Mountain Laboratories. Dr. Caughey has published extensively in the TSE/prion field on biochemical, biophysical, cell biological, diagnostic and therapeutic aspects of TSE/prion diseases. He has served on journal editorial boards and is currently a senior editor for the Journal of Virology. He has been a member of institutional scientific review committees for the Institute for Animal Health (UK) and the NIDDK (NIH), and chaired the TSEs Review Panel for the 2006 USDA Scientific Quality Review. He has been an ad hoc reviewer for numerous granting agencies and is currently a member of the scientific advisory boards of the funding agencies PrioNet Canada and Alberta Prion Research Institute.
Kenneth D. Clinkenbeard, D.V.M., Ph.D. Professor & Coordinator, Veterinary Biomedical Sciences Graduate Program Department of Veterinary Pathobiology College of Veterinary Medicine Oklahoma State University Stillwater, Oklahoma
Dr. Kenneth D. Clinkenbeard is Professor of Veterinary Pathobiology and coordinator of the Veterinary Biomedical Sciences Graduate Program at the College of Veterinary Medicine, Oklahoma State University where he teaches graduate and veterinary students and conducts research in the areas of infectious disease pathogenesis and ecology. Ken earned his PhD degree at The Johns Hopkins University School of Medicine in physiological chemistry in Albert Lehninger’s department studying enzymology and was a NIH postdoctoral fellow under Nobel prize winner Dr. Edwin G. Krebs at the University of California at Davis, where he also earned his DVM degree. Dr. Clinkenbeard has over thirty-five years experience working with infectious diseases including disseminate histoplasmosis in dogs and cats; shipping fever, pinkeye, and E coli O157:H7 in cattle; tularemia and plague in wildlife; and chronic wasting disease in cervids. Recently, he has along with his collaborators from DNA Solutions, Inc. developed an in vitro model for detection and study of chronic wasting disease using an immortalized whitetail deer cell line developed in his laboratory under Phase II Small Business Innovative Research funding from the DoD.
Christina Egan, Ph.D. Director, Biodefense Laboratory Wadsworth Center New York State Department of Health Albany, New York
Dr. Christina Egan is the Director of the Biodefense Laboratory at the Wadsworth Center, New York State Department of Health (NYSDOH). Dr. Egan has been with the NYSDOH since 1999 joining the Wadsworth Center as a New York State Emerging Infectious Disease fellow and then as a research scientist and member of the Bioterrorism Response Team which was responsible for the analysis of environmental and clinical specimens for anthrax in 2001. Dr. Egan has 10 years experience working with biological pathogens and high containment laboratories and has obtained specialized certification as a C.B.S.P (Certified Biosafety Professional) through the National Registry of Microbiologists. She has been involved in the development of new diagnostic assays designed to test clinical specimens and environmental samples for bacterial, toxins, and viral agents and oversees the validation process of these molecular assays. Additionally, she has been involved with the development and presentation of many training courses for laboratorians, first responders, Civil Support Teams, and members of the law enforcement community in New York State. She has participated on a number of different federal, state, and scientific panels and committees such as Association of Analytical Communities Biothreat Methods Committee to create standards for biothreat detection method and the EPA Science Advisory Board. She has numerous publications and book chapters related to the development of diagnostic assays for biothreat assays and other issues related to public health preparedness and is an Assistant Professor in the SUNY School of Public Health, Departments of Biomedical Sciences and Environmental Health Sciences.
Kurt Giles, D. Phil. Assistant Adjunct Professor Department of Neurology Institute for Neurodegenerative Diseases University of California at San Francisco San Francisco, California
Dr. Kurt Giles is an Assistant Adjunct Professor at the University of California San Francisco (UCSF). He is director of the transgenics core and a senior scientist at the Institute for Neurodegenerative Diseases (directed by Nobel laureate Dr Stanley B. Prusiner). Kurt received his Ph.D. in pharmacology from Oxford University, United Kingdom, where he used biochemical tools to determine abnormally functioning proteins in Alzheimer’s disease. This was followed by post-doctoral research at the Weizmann Institute of Science, Israel, where he expanded on these studies focusing on protein structure analysis. Kurt has held faculty positions at the Weizmann Institute and at Oxford University prior to moving to UCSF. He has taught undergraduate and graduate courses, and given workshops in many countries, and serves on the editorial board of the journal Biochemistry and Molecular Biology Education. He is also involved in education outreach with High Schools. Kurt has over 15 years experience in neurodegenerative disease research, and he uses transgenic mouse models to understand the molecular basis of various neurodegenerative diseases. He is an expert in prion diseases, where his research encompasses determining the molecular basis for transmission of prion strains between species, understanding the endogenous function of the prion protein, and devising methods to inactivate prions. He has also pioneered the use of survival analysis techniques to more rigorously quantify prion inactivation. Kurt has published widely on the use of transgenic mouse models to measure prion infectivity, and on the inactivation of prions.
Nancy J. Hanson, Ph.D. Associate Professor Department of Medical Microbiology Director of Molecular Biology Center for Research in Anti-Infectives and Biotechnology Creighton University School of Medicine Omaha, Nebraska
Dr. Nancy D. Hanson is an Associate Professor and Director of Molecular Biology for the Center for Research in Anti-Infectives and Biotechnology in the Department of Medical Microbiology and Immunology at Creighton University. Dr. Hanson received her PhD in Medical Microbiology from the University of Nebraska Medical Center. She joined the faculty of Creighton University in 1995. Dr. Hanson has an active research laboratory and has trained several Master and PhD level students. Her area of expertise involves the study of molecular mechanisms of antibiotic resistance in Gram-negative organisms such as E. coli, K. pneumoniae, Salmonella spp. and Pseudomonas aeruginosa. Her research explores two aspects of antibiotic resistance mechanisms: 1) the regulation of the genes involved in resistance and 2) the development of PCR-based diagnostic tests that can be used by clinical laboratories to detect resistance genes in clinical isolates. Dr. Hanson has served as an ad-hoc grant reviewer for National Institutes of Health study sections, the Wellcome Trust, and the British Society for Antimicrobial Chemotherapy. Dr. Hanson has been the invited speaker for the Australian Society of Microbiology, General Society for Microbiology held in Edinburgh Scotland, the American Society of Microbiology and the Interscience Conference on Antimicrobial Agents and Chemotherapy. She serves as an ad-hoc reviewer for 12 scientific journals. Dr. Hanson has also been involved in the Fulbright mentoring program training recipients of the fellowship from countries such as Nigeria and Egypt. In 2007, Dr. Hanson was awarded researcher of the year by the Nebraska Chapter of the Cystic Fibrosis Foundation for her work on P. aeruginosa infecting patients with cystic fibrosis.
Corinne I. Lasmezas, D.V.M., Ph.D. Professor, Department of Infectology The Scripps Research Institute, Scripps Florida Jupiter, Florida
Dr. Corinne I. Lasmézas is Professor at the Department of Infectology of The Scripps Research Institute, Scripps Florida where she directs a research laboratory focusing on the study of prion diseases. Corinne Lasmézas has a Doctorate of Veterinary Medicine from the University of Toulouse, France, and a Ph.D. in Neurosciences from the University Pierre&Marie Curie in Paris, France. She has over fifteen years of experience in the study of prion diseases. Her research in France has contributed to demonstrate the transmissibility to humans of bovine spongiform encephalopathy by showing the similarity of this prion strain with that of the human variant Creutzfeldt-Jakob Disease. She has established a non-human primate model for the study of the pathogenesis and iatrogenic risk from the bovine prion. She has studied prion pathogenesis in rodent models, including the involvement of the lymphoreticular system, the relationship between infectivity and the misfolded prion protein, prion therapy and the interaction of the prion protein with cell surface proteins. Since 2005 Corinne Lasmézas continues her research in the USA at the newly created Department of Infectology of the Scripps Research Institute located in Jupiter, Florida, where her group focuses on the mechanisms of neurodegeneration in prion diseases, the search for a therapy, and a better understanding of the molecular mechanisms underlying prion replication and the strain phenomenon. She serves as a scientific reviewer for research programs and journals, and is a member of several advisory panels in Europe for issues related to ruminant and human prion diseases including the iatrogenic risk linked to human derived medicinal products.
Laura Manuelidis, M.D. Professor & Head of Neuropathology Department of Surgery Yale University School of Medicine New Haven, Connecticut
Dr. Laura Manuelidis is a Professor and Head of the Section of Neuropathology in the Department of Surgery at Yale, as well as on the interdepartmental faculty of Virology and Neuroscience. She received her MD at Yale and trained in both pathology and neuropathology. Major research contributions have been the discovery and sequencing of alpha satellite DNA and retroviral LINES in the 1970s, with the development of non-isotopic in-situ methods for defining chromosome and nuclear structure at high resolution. She also has done broad diagnostic work as Chief of the Neuropathology service for many years, and has been deeply involved in Creutzfeldt-Jakob disease (CJD) research. The first small animal models of CJD were developed at Yale in the 1970s and these have been fundamental for pathogenesis and infectivity studies. Recent tissue culture models of various CJD and a variety of distinct scrapie agent strains have simplified the study of these agents, including variant CJD (vCJD). The vCJD human isolate is derived from the "mad cow disease" agent (UK BSE). Dr. Manuelidis has been a consultant for the NIH, FDA, NATO, the Wellcome Trust, SEAC and the USDA and continues to participate in editorial boards and activities.
Suzette A. Priola, Ph.D. Senior Investigator & Chief - TSE/Prion Molecular Biology Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, Montana
Dr. Suzette A. Priola is a Senior Investigator and Chief of the TSE/Prion Molecular Biology Section in the Laboratory of Persistent Viral Diseases at the National Institutes of Health’s Rocky Mountain Laboratories. She obtained her PhD in Microbiology and Immunology from the University of California, Los Angeles and specializes in infectious diseases of the central nervous system. She has over 18 years of research experience in the field of prion diseases during which time her laboratory has identified novel prion disease inhibitors and studied multiple different aspects of prion pathogenesis including how prions infect cells and the molecular basis of prion species barriers and strains. She was a member of the Food and Drug Administration (FDA) Transmissible Spongiform Encephalopathy (TSE) Advisory Committee for five years and Chair for almost three years. She has served as a consultant to both the FDA’s Center for Biologics Evaluation and Research and the World Health Organization (WHO) and was a member of the National Prion Research Program administered by the Department of Defense’s Congressionally Directed Medical Research Programs. She has been an editorial board member at the Journal of Biological Chemistry and is currently on the editorial board of the journal Virology.
Juergen A. Richt, DVM, Ph.D. Regents Distinguished Professor Kansas State University College of Veterinary Medicine Diagnostic Medicine/Pathobiology Manhattan, Kansas
Dr. Jürgen A. Richt, DVM, PhD, is the Regents Distinguished Professor at the College of Veterinary Medicine at Kansas State University in Manhattan, KS. He received his DVM from the University of München, Germany, and his PhD in Virology from the University of Giessen, Germany. Dr. Richt has been working in the area of emerging zoonotic diseases for more than 20 years. In his early research years, Dr. Richt focused on the immunopathogenesis and molecular biology of Borna Disease Virus (BDV). After his move to the United States, Dr. Richt’s work focused on influenza virus infections in animals, especially swine, and on animal transmissible spongiform encephalopathies (TSEs) or prion diseases. Dr. Richt has published more than 90 peer-reviewed manuscripts in his area of expertise. He is one of the Editors for the journal Virus Genes and on the Editorial Board of numerous other journals. His research program is funded by the NIH and the CDC. He was recently appointed to the Scientific Advisory Board of OIE, Paris, France.
Lynne Sehulster, Ph.D. Health Scientist Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, Georgia
Dr. Lynne Sehulster is a Health Scientist in the Division of Healthcare Quality Promotion (DHQP) within the National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID) at the Centers for Disease Control and Prevention (CDC). She has been at CDC for 12 years. She received her MS and PhD in Microbiology from Rutgers, the State University of New Jersey, and has her certificate as a Microbiologist with the American Society of Clinical Pathologists (M[ASCP]). Prior to coming to CDC, she completed a postdoctoral assignment in the Department of Virology and Epidemiology at Baylor College of Medicine in Houston doing laboratory research in hepatitis B virus inactivation. She subsequently served as an infectious disease epidemiologist for 15 years at the Texas Department of Health (currently known as the Texas Department of State Health Services). While in Texas she was the state health department’s point of contact for viral hepatitis and influenza epidemiology and surveillance activities. Her current areas of expertise at CDC focus on environmental infection control, transmission of infectious diseases, and microbial inactivation. She advises the agency, health care professionals, and the public on issues concerning indoor environmental cleaning, sterilization and disinfection, prion inactivation and risk assessment, and environmental management of emerging diseases. She also provides perspective to CDC on regulated medical waste and other healthcare facility issues such as laundry and environmental services. She is the coordinator of and contributor to the CDC/HICPAC “Guidelines for Environmental Infection Control in Health-Care Facilities” that was released in 2003.
Claudio Soto, Ph.D. Professor, Department of Neurology University of Texas Medical School at Houston Houston, Texas
Dr. Claudio Soto is the Director of the George and Cynthia Mitchell Center for Neurodegenerative Diseases and Professor on the Departments of Neurology, Neuroscience & Cell Biology and Biochemistry & Molecular Biology at the University of Texas Medical Branch in Galveston. Dr. Soto holds the Green Distinguished University Chair in Neuroscience, the largest endowed professorship in the University of Texas. Currently he is also the Founder, Vice-President and Chief Scientific Officer of AMPRION Inc. He received his PhD in biochemistry and molecular biology from the University of Chile in 1993 and was a postdoctoral fellow at the Catholic University of Chile and at the New York University School of Medicine, where he became an assistant professor of research in 1995. Between 1999-2003, Dr Soto was Senior Scientist, Chairman of the Department of Molecular Neuropathology and Senior Executive Scientific Advisor for Neurobiology at Serono International in Switzerland. For the past 13 years, he and his colleagues have engaged in research into the molecular basis of neurodegenerative diseases associated to the misfolding and brain accumulation of proteins, particularly focusing in Alzheimer’s and prion-related disorders. His work has led to the development of novel strategies for treatment and diagnosis of these diseases. He has published more than 90 peer review scientific publications and contributed to more than 15 books, including one written entirely by Dr. Soto. Many of his studies have been published in the most prestigious scientific journals (including Cell, Nature, Science, Nature medicine, EMBO Journal, etc) and several of them have produced a large impact in the scientific community.
http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html
AGENDAFIFRA SCIENTIFIC ADVISORY PANEL (SAP)OPEN MEETINGMarch 31 - April 1, 2009FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/OPP Docket Telephone: (703) 305-5805Docket Number: EPA-HQ- OPP-2008-0859U.S. Environmental Protection AgencyConference Center - Lobby LevelOne Potomac Yard (South Bldg.)2777 S. Crystal Drive, Arlington, VA 22202Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test MethodsPlease note that all times are approximate(See note at the end of the Agenda)Tuesday, March 31, 20098:30 A.M. Opening of Meeting and Administrative Procedures by Designated Federal Official – Myrta R. Christian, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA8:35 A.M. Introduction and Identification of Panel Members - Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair8:50 A.M. Welcome and Opening Remarks – Steven Bradbury, Ph.D., Deputy Director, Office of Pesticide Programs, EPA9:00 A.M Background and Overview - Jeff Kempter, Senior Advisor, Antimicrobials Division, Office of Pesticide Programs, EPA9:20 A.M. A Regulatory Approach to C&D for CWD and EPA’s Role in the Process – Dean Goeldner, D.V.M., Chronic Wasting Disease Program Manager, USDA-APHIS-VS-NCAHP-RHP, Riverdale, MD9:40 A.M. FDA Approach to Claims for Reducing TSE Infectivity on Medical Devices - Sheila Murphey, M.D., Chief, Infection Control Devices Branch; Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation; Center for Devices and Radiologic Health; FDA, Rockville, MD10:15 A.M. Break10:30 A.M. EPA’s “White Paper” – Richard Wiggins, Ph.D., National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA, Research Triangle Park, NC10:50 A.M. EPA’s Guidance for Efficacy Test Methods for Products Bearing11:15 A.M. Prion Infectivity Assays – Christopher J. Silva, Research Chemist, Foodborne contaminants Research Unit, Western Regional Research Center, Albany, CA11:40 A.M. Transmissible Spongiform Encephalopathies (TSEs/Prion Diseases): Target Criteria for Assessing Agent Clearance – David M. Asher, MD, Chief, Laboratory of Bacterial, Parasitic and Unconventional Agents; Division of Emerging and Transfusion-Transmitted Diseases; Office of Blood Research and Review; Center for Biologics Evaluation and Research; FDA, Rockville, Maryland3:45 P.M. Charge to Panel – Question 11. White Paper Issue: Whether EPA’s draft review paper, “Scientific Information Concerning the Issue of Whether Prions Are a ‘Pest’ under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),” adequately identifies and summarizes available, relevant scientific studies.Prion-Related Claims – Richard Wiggins, Ph.D., National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA, Research Triangle Park, NC12:00 P.M. Lunch1:00 P.M. Public Comment3:30 P.M. BreakIn 2005, EPA established a Work Group to develop a Notice of Proposed Rulemaking (NPRM) that defines a prion as a “pest” under FIFRA. To assure that it considers key available scientific studies that are relevant to the issue of whether a prion is a “pest” under FIFRA, the Work Group drafted a review paper. While the paper received intra-Agency review, it was not subjected to peer review outside of EPA. Accordingly, EPA seeks the SAP’s peer review of the attached, draft review paper (USEPA 2008). Some of the key references cited in the review paper have been provided to the SAP.EPA wishes to point out that the NPRM will also focus on legal and policy matters that are not addressed in depth in the “white paper.” EPA is presenting this paper to the SAP solely for review as to its characterization of the scientific issues, and is not asking the SAP to interpret legal/policy issues such as Congress’ intent in drafting FIFRA.•Please comment on the accuracy of the characterization of the nature of prions, and the adequacy of the review of the relevant scientific information to support that characterization, as presented in EPA’s draft paper, “Scientific Information Concerning the Issue of Whether Prions Are a ‘Pest’ under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).”5:00 P.M. AdjournmentOPEN MEETINGAGENDAFIFRA SCIENTIFIC ADVISORY PANEL (SAP)March 31 - April 1, 2009FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/ OPP Docket Telephone: (703) 305-5805Docket Number: EPA-HQ- OPP-2008-0859U.S. Environmental Protection AgencyConference Center - Lobby LevelOne Potomac Yard (South Bldg.) 2777 S. Crystal Drive, Arlington, VA 22202Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test MethodsWednesday, April 1, 20098:30 A.M. Opening of Meeting - Administrative Procedures by Designated Federal Official - Myrta R. Christian, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA8:35 A.M. Introduction and Identification of Panel Members -Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair8:50 A.M. Follow-up from Previous Day’s Discussion – Jeff Kempter, Senior Advisor, Antimicrobial Division, Office of Pesticide Programs, EPA9:15 A.M. Charge to Panel – Question 22. Efficacy Guidance Test Method Issue: Whether the specific test systems recommended in the draft guidance document are scientifically appropriate to support the registration of pesticide products with prion-related claims.The draft efficacy guidance document (USEPA 2009) recommends a carrier-based, animal infectivity test method, if the intended use of a product is for treating environmental surfaces, and a suspension-based, animal infectivity test method if the intended use of a product is for treating liquids. The draft efficacy guidance document also states that the test methods may either be end-point titration or incubation time interval assays. EPA is interested in knowing the SAP’s opinion on whether these recommended test systems are scientifically sound and appropriate approaches to evaluating the efficacy of pesticide products with prion-related claims. EPA would also like to know whether the SAP recommends that other test methods be considered to evaluate the efficacy of pesticide products used either on•b.3. Efficacy Guidance Performance Criterion Issue: Whether the product performance criterion specified in the draft guidance document to support the registration of pesticide products with prion-related claims is scientifically sound.environmental surfaces or in liquid media.Please comment on the scientific appropriateness of:a.Carrier-based, animal infectivity assays recommended by EPA’s guidance for evaluating the efficacy of pesticide products used on environmental surfaces (e.g., hard, nonporous surfaces).Suspension-based, animal infectivity assays recommended by EPA’s guidance for evaluating the efficacy of pesticide products used in liquid media (e.g., wastewater).Any other known test methods for evaluating the efficacy of pesticide products used on either environmental surfaces or in liquid media.10:30 A.M. Break10:45 A.M. Charge to Panel - Question 3The draft efficacy guidance document recommends a target efficacy criterion of six (6) logs of reduction of infectivity in the treated versus untreated (control) groups. This criterion is widely used in the current scientific literature. EPA would like the SAP’s comment on this proposed product performance criterion.•Please comment on the scientific soundness of the product performance criterion recommended in the draft guidance document to support the registration of pesticide products with a prion claim.12:00 P.M. Lunch1:00 P.M. Charge to Panel – Question 44. Efficacy Guidance Labeling Claim Issue: Whether the labeling claim described in the draft guidance document is scientifically appropriate based on the recommended test systems and product performance standard.The draft efficacy guidance document recommends a carefully worded labeling claim statement: “Has been demonstrated to reduce infectivity of prions (TSE agents) based on testing using (insert type of organism in which the prions were raised) (insert prion type).” EPA believes that claims that may normally be applied to microorganisms (e.g., “destroy,” “mitigate,” “eliminate,” “control”) may be misleading when applied to prions. Because currently available test methods can only measure a reduction in infectivity, and the total elimination or destruction of prions cannot be•5. Efficacy Guidance Hierarchy Issue: Whether different prion types exhibit variation in the degree of resistance to inactivation by pesticide chemicals and whether a hierarchy of resistance by prion type can be reliably determined at this time.Comparisons of different types of prions in a common animal infectivity assay indicate there may be significant differences with regard to their ability to resist inactivation by pesticide chemicals. For example, Peretz et al. (2006) compared the resistance of hamster scrapie and human CJD prions in transgenic mice expressing either hamster PrP or a chimeric mouse-human PrP transgene and found that human sCJD prion tested was 100,000 fold more difficult to inactivate than hamster Sc237 prion. Preliminary additional studies indicate that the cow BSE prion may be even more resistant to inactivation than the human CJD prion (Giles et al. 2006; 2008 in press).measured, EPA believes that “reduce infectivity” is the only appropriate claim.Please comment on the scientific appropriateness of the term “reduce infectivity” in a label claim to reflect the action of a pesticide on prions.3:00 P.M. Break3:15 P.M. Charge to Panel – Question 5•Please comment on whether a hierarchy of resistance among prion types can be reliably demonstrated for different pesticide chemicals based on the available data.5:00 P.M. AdjournmentPlease be advised that agenda times are approximate; when the discussion for one topic is completed, discussions for the next topic will begin. For further information, please contact the
http://www.epa.gov/scipoly/sap/meetings/2009/march/033109agenda.pdf
FIFRA Scientific Advisory Panel; Notice of Public Meeting PDF Version (3 pp, 80K, About PDF)
[Federal Register: December 17, 2008 (Volume 73, Number 243)] [Notices] [Page 76639-76641] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr17de08-76]
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ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0859; FRL-8392-9]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA). ACTION: Notice.
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SUMMARY: There will be a 2-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review Scientific Issues Associated with Designating a Prion as a ``Pest'' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods.
http://www.epa.gov/EPA-MEETINGS/2008/December/Day-17/m29977.htm
Associated with Designating a Prion as a "Pest" under the Federal insecticide,. Fungicide, and Rodenticide Act (FlFRA), and Related Efficacy Test Methods. These ... whether Prions Are a Pest' under the Federal insecticide, Fungicide, and Rodenticide Act (fifra)." 2. Efficacy Guidance Test Method issue: Whether the ...
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064808df7ef&disposition=attachment&contentType=pdf
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648027c28e
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648027c28e&disposition=attachment&contentType=pdf
Friday, August 29, 2008 CREEKSTONE VS USDA COURT OF APPEALS, BUSH SAYS, NO WAY, NO HOW
http://madcowtesting.blogspot.com/2008/08/creekstone-vs-usda-court-of-appeals.html
Subject: Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION
Date: August 24, 2005 at 2:47 pm PST
August 24, 2005
Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION
Greetings APHIS ET AL,
My name is Terry S. Singeltary Sr.
I would kindly like to comment on [Docket No. 05-004-1] RIN 0579-AB93 ;
PROPOSED RULES
Exportation and importation of animals and animal products:
Whole cuts of boneless beef from-
Japan,
48494-48500 [05-16422]
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480086ebc&disposition=attachment&contentType=msw6
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA
https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed
PLEASE SEE FULL TEXT HERE ;
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA
http://madcowfeed.blogspot.com/2008/07/docket-no-03-080-1-usda-issues-proposed.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-2006-0041-0006 Public Submission Title Comment from Terry S Singletary Sr Views Add Comments How To Comment
snip...
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....
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2006-0041-0006
From: Terry S. Singeltary Sr.
To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:FREAS@CBER.FDA.GOV
Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:william.freas@fda.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:rosanna.harvey@fda.hhs.gov
Sent: Friday, December 01, 2006 2:59 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION
snip...
ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)
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 blood 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. ...
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
snip... 48 pages...
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
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
Saturday, January 24, 2009
Bovine Spongiform Encephalopathy h-BSE ATYPICAL USA 2008 Annual Report Research Project: Study of Atypical Bse
Location: Virus and Prion Diseases of Livestock
2008 Annual Report
http://bse-atypical.blogspot.com/2009/01/bovine-spongiform-encephalopathy-h-bse.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
----- Original Message -----
From: "Terry S. Singeltary Sr." mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:flounder9@verizon.net To: "Bovine Spongiform Encephalopathy" mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:BSE-L@aegee.org Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:heggem.daniel@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:sibert.christopher@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:denne.jane@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:hazen.susan@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:mcrosby@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:erobinson@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:enegin@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:cjdvoice@yahoogroups.com; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:madcow@lists.iatp.org
Sent: Monday, April 28, 2008 9:48 PM
Subject: Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency
http://madcowfeed.blogspot.com/2008/08/texas-firm-recalls-cattle-heads-that.html
TSS
Panel Member List FIFRA Scientific Advisory Panel Open Meeting, March 31 - April 1, 2009
Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods
Environmental Protection Agency Conference Center Lobby Level, One Potomac Yard (South Bldg.), 2777 Crystal Dr., Arlington, VA 22202
FIFRA SAP Website: http://www.epa.gov/scipoly/sap/ Docket Number EPA-HQ-OPP-2008-0859 OPP Docket Telephone: 703-305-5805
FIFRA SAP Session Chair
Steven G. Heeringa, Ph.D. Research Scientist & Director for Statistical Design University of Michigan Institute for Social Research Ann Arbor, MI
Designated Federal Official
Myrta R. Christian, M.S. US Environmental Protection Agency Office of Science Coordination & Policy FIFRA Scientific Advisory Panel EPA East Building, MC 7201M 1200 Pennsylvania Avenue, NW Washington, DC 20460 Tel: 202-564-8450, Fax: 202-564-8382, mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:Christian.myrta@epa.gov
FIFRA Scientific Advisory Panel Members
John R. Bucher, Ph.D., DABT Associate Director Environmental Toxicology Program National Institute of Environmental Health Sciences Research Triangle Park, NC
Janice E. Chambers, Ph.D., DABT, ATS William L. Giles Distinguished Professor Director, Center for Environmental Health Sciences College of Veterinary Medicine Mississippi State University Mississippi State, MS
Kirby C. Donnelly, Ph.D. Professor and Head Department of Environmental and Occupational Health School of Rural Public Health Texas A&M University System Health Science Center College Station, TX
Carey N. Pope, Ph.D. Professor, Head & Sitlington Chair of Toxicology Department of Physiological Sciences Oklahoma State University College of Veterinary Medicine Stillwater, OK
Kenneth M. Portier, Ph.D. Program Director, Statistics American Cancer Society National Home Office Atlanta, GA
Daniel Schlenk, Ph.D. Professor of Aquatic Ecotoxicology & Environmental Toxicology Department of Environmental Sciences University of California, Riverside Riverside, CA
FQPA Science Review Board Members
Jason C. Bartz, Ph.D. Assistant Professor Department of Medical Microbiology & Immunology Creighton University School of Medicine Omaha, Nebraska
Dr. Jason C. Bartz is an Assistant Professor in the Department of Medical Microbiology and Immunology in the School of Medicine at Creighton University where he conducts research on prion diseases. Dr. Bartz received a Ph.D. in veterinary science from the University of Wisconsin where he focused on interspecies transmission and adaptation of prions to new host species. Dr. Bartz has over 15 years of experience in prion disease research and is currently investigating the biology of prion strains. Specifically, Dr. Bartz is interested in the mechanisms of strain-specific routes of neuroinvasion, prion strain targeting in the central nervous system and prion strain interference. Dr. Bartz has been an advisor to panels of the National Institutes of Health and the Department of Defense.
Byron Caughey, Ph.D. Senior Investigator & Chief - TSE/Prion Biochemistry Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, Montana
Dr. Byron Caughey is a Senior Investigator and Chief of the TSE/prion Biochemistry Section of the Laboratory of Persistent Viral Diseases, Rocky Mountain Laboratories, National Institute for Allergy and Infectious Diseases, National Institutes of Health in Hamilton, Montana. Dr. Caughey got his Ph.D. in Biochemistry from the University of Wisconsin-Madison in 1985. In 1986, after post-doctoral studies in neurochemistry at Duke University, he began TSE/prion research at Rocky Mountain Laboratories. Dr. Caughey has published extensively in the TSE/prion field on biochemical, biophysical, cell biological, diagnostic and therapeutic aspects of TSE/prion diseases. He has served on journal editorial boards and is currently a senior editor for the Journal of Virology. He has been a member of institutional scientific review committees for the Institute for Animal Health (UK) and the NIDDK (NIH), and chaired the TSEs Review Panel for the 2006 USDA Scientific Quality Review. He has been an ad hoc reviewer for numerous granting agencies and is currently a member of the scientific advisory boards of the funding agencies PrioNet Canada and Alberta Prion Research Institute.
Kenneth D. Clinkenbeard, D.V.M., Ph.D. Professor & Coordinator, Veterinary Biomedical Sciences Graduate Program Department of Veterinary Pathobiology College of Veterinary Medicine Oklahoma State University Stillwater, Oklahoma
Dr. Kenneth D. Clinkenbeard is Professor of Veterinary Pathobiology and coordinator of the Veterinary Biomedical Sciences Graduate Program at the College of Veterinary Medicine, Oklahoma State University where he teaches graduate and veterinary students and conducts research in the areas of infectious disease pathogenesis and ecology. Ken earned his PhD degree at The Johns Hopkins University School of Medicine in physiological chemistry in Albert Lehninger’s department studying enzymology and was a NIH postdoctoral fellow under Nobel prize winner Dr. Edwin G. Krebs at the University of California at Davis, where he also earned his DVM degree. Dr. Clinkenbeard has over thirty-five years experience working with infectious diseases including disseminate histoplasmosis in dogs and cats; shipping fever, pinkeye, and E coli O157:H7 in cattle; tularemia and plague in wildlife; and chronic wasting disease in cervids. Recently, he has along with his collaborators from DNA Solutions, Inc. developed an in vitro model for detection and study of chronic wasting disease using an immortalized whitetail deer cell line developed in his laboratory under Phase II Small Business Innovative Research funding from the DoD.
Christina Egan, Ph.D. Director, Biodefense Laboratory Wadsworth Center New York State Department of Health Albany, New York
Dr. Christina Egan is the Director of the Biodefense Laboratory at the Wadsworth Center, New York State Department of Health (NYSDOH). Dr. Egan has been with the NYSDOH since 1999 joining the Wadsworth Center as a New York State Emerging Infectious Disease fellow and then as a research scientist and member of the Bioterrorism Response Team which was responsible for the analysis of environmental and clinical specimens for anthrax in 2001. Dr. Egan has 10 years experience working with biological pathogens and high containment laboratories and has obtained specialized certification as a C.B.S.P (Certified Biosafety Professional) through the National Registry of Microbiologists. She has been involved in the development of new diagnostic assays designed to test clinical specimens and environmental samples for bacterial, toxins, and viral agents and oversees the validation process of these molecular assays. Additionally, she has been involved with the development and presentation of many training courses for laboratorians, first responders, Civil Support Teams, and members of the law enforcement community in New York State. She has participated on a number of different federal, state, and scientific panels and committees such as Association of Analytical Communities Biothreat Methods Committee to create standards for biothreat detection method and the EPA Science Advisory Board. She has numerous publications and book chapters related to the development of diagnostic assays for biothreat assays and other issues related to public health preparedness and is an Assistant Professor in the SUNY School of Public Health, Departments of Biomedical Sciences and Environmental Health Sciences.
Kurt Giles, D. Phil. Assistant Adjunct Professor Department of Neurology Institute for Neurodegenerative Diseases University of California at San Francisco San Francisco, California
Dr. Kurt Giles is an Assistant Adjunct Professor at the University of California San Francisco (UCSF). He is director of the transgenics core and a senior scientist at the Institute for Neurodegenerative Diseases (directed by Nobel laureate Dr Stanley B. Prusiner). Kurt received his Ph.D. in pharmacology from Oxford University, United Kingdom, where he used biochemical tools to determine abnormally functioning proteins in Alzheimer’s disease. This was followed by post-doctoral research at the Weizmann Institute of Science, Israel, where he expanded on these studies focusing on protein structure analysis. Kurt has held faculty positions at the Weizmann Institute and at Oxford University prior to moving to UCSF. He has taught undergraduate and graduate courses, and given workshops in many countries, and serves on the editorial board of the journal Biochemistry and Molecular Biology Education. He is also involved in education outreach with High Schools. Kurt has over 15 years experience in neurodegenerative disease research, and he uses transgenic mouse models to understand the molecular basis of various neurodegenerative diseases. He is an expert in prion diseases, where his research encompasses determining the molecular basis for transmission of prion strains between species, understanding the endogenous function of the prion protein, and devising methods to inactivate prions. He has also pioneered the use of survival analysis techniques to more rigorously quantify prion inactivation. Kurt has published widely on the use of transgenic mouse models to measure prion infectivity, and on the inactivation of prions.
Nancy J. Hanson, Ph.D. Associate Professor Department of Medical Microbiology Director of Molecular Biology Center for Research in Anti-Infectives and Biotechnology Creighton University School of Medicine Omaha, Nebraska
Dr. Nancy D. Hanson is an Associate Professor and Director of Molecular Biology for the Center for Research in Anti-Infectives and Biotechnology in the Department of Medical Microbiology and Immunology at Creighton University. Dr. Hanson received her PhD in Medical Microbiology from the University of Nebraska Medical Center. She joined the faculty of Creighton University in 1995. Dr. Hanson has an active research laboratory and has trained several Master and PhD level students. Her area of expertise involves the study of molecular mechanisms of antibiotic resistance in Gram-negative organisms such as E. coli, K. pneumoniae, Salmonella spp. and Pseudomonas aeruginosa. Her research explores two aspects of antibiotic resistance mechanisms: 1) the regulation of the genes involved in resistance and 2) the development of PCR-based diagnostic tests that can be used by clinical laboratories to detect resistance genes in clinical isolates. Dr. Hanson has served as an ad-hoc grant reviewer for National Institutes of Health study sections, the Wellcome Trust, and the British Society for Antimicrobial Chemotherapy. Dr. Hanson has been the invited speaker for the Australian Society of Microbiology, General Society for Microbiology held in Edinburgh Scotland, the American Society of Microbiology and the Interscience Conference on Antimicrobial Agents and Chemotherapy. She serves as an ad-hoc reviewer for 12 scientific journals. Dr. Hanson has also been involved in the Fulbright mentoring program training recipients of the fellowship from countries such as Nigeria and Egypt. In 2007, Dr. Hanson was awarded researcher of the year by the Nebraska Chapter of the Cystic Fibrosis Foundation for her work on P. aeruginosa infecting patients with cystic fibrosis.
Corinne I. Lasmezas, D.V.M., Ph.D. Professor, Department of Infectology The Scripps Research Institute, Scripps Florida Jupiter, Florida
Dr. Corinne I. Lasmézas is Professor at the Department of Infectology of The Scripps Research Institute, Scripps Florida where she directs a research laboratory focusing on the study of prion diseases. Corinne Lasmézas has a Doctorate of Veterinary Medicine from the University of Toulouse, France, and a Ph.D. in Neurosciences from the University Pierre&Marie Curie in Paris, France. She has over fifteen years of experience in the study of prion diseases. Her research in France has contributed to demonstrate the transmissibility to humans of bovine spongiform encephalopathy by showing the similarity of this prion strain with that of the human variant Creutzfeldt-Jakob Disease. She has established a non-human primate model for the study of the pathogenesis and iatrogenic risk from the bovine prion. She has studied prion pathogenesis in rodent models, including the involvement of the lymphoreticular system, the relationship between infectivity and the misfolded prion protein, prion therapy and the interaction of the prion protein with cell surface proteins. Since 2005 Corinne Lasmézas continues her research in the USA at the newly created Department of Infectology of the Scripps Research Institute located in Jupiter, Florida, where her group focuses on the mechanisms of neurodegeneration in prion diseases, the search for a therapy, and a better understanding of the molecular mechanisms underlying prion replication and the strain phenomenon. She serves as a scientific reviewer for research programs and journals, and is a member of several advisory panels in Europe for issues related to ruminant and human prion diseases including the iatrogenic risk linked to human derived medicinal products.
Laura Manuelidis, M.D. Professor & Head of Neuropathology Department of Surgery Yale University School of Medicine New Haven, Connecticut
Dr. Laura Manuelidis is a Professor and Head of the Section of Neuropathology in the Department of Surgery at Yale, as well as on the interdepartmental faculty of Virology and Neuroscience. She received her MD at Yale and trained in both pathology and neuropathology. Major research contributions have been the discovery and sequencing of alpha satellite DNA and retroviral LINES in the 1970s, with the development of non-isotopic in-situ methods for defining chromosome and nuclear structure at high resolution. She also has done broad diagnostic work as Chief of the Neuropathology service for many years, and has been deeply involved in Creutzfeldt-Jakob disease (CJD) research. The first small animal models of CJD were developed at Yale in the 1970s and these have been fundamental for pathogenesis and infectivity studies. Recent tissue culture models of various CJD and a variety of distinct scrapie agent strains have simplified the study of these agents, including variant CJD (vCJD). The vCJD human isolate is derived from the "mad cow disease" agent (UK BSE). Dr. Manuelidis has been a consultant for the NIH, FDA, NATO, the Wellcome Trust, SEAC and the USDA and continues to participate in editorial boards and activities.
Suzette A. Priola, Ph.D. Senior Investigator & Chief - TSE/Prion Molecular Biology Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, Montana
Dr. Suzette A. Priola is a Senior Investigator and Chief of the TSE/Prion Molecular Biology Section in the Laboratory of Persistent Viral Diseases at the National Institutes of Health’s Rocky Mountain Laboratories. She obtained her PhD in Microbiology and Immunology from the University of California, Los Angeles and specializes in infectious diseases of the central nervous system. She has over 18 years of research experience in the field of prion diseases during which time her laboratory has identified novel prion disease inhibitors and studied multiple different aspects of prion pathogenesis including how prions infect cells and the molecular basis of prion species barriers and strains. She was a member of the Food and Drug Administration (FDA) Transmissible Spongiform Encephalopathy (TSE) Advisory Committee for five years and Chair for almost three years. She has served as a consultant to both the FDA’s Center for Biologics Evaluation and Research and the World Health Organization (WHO) and was a member of the National Prion Research Program administered by the Department of Defense’s Congressionally Directed Medical Research Programs. She has been an editorial board member at the Journal of Biological Chemistry and is currently on the editorial board of the journal Virology.
Juergen A. Richt, DVM, Ph.D. Regents Distinguished Professor Kansas State University College of Veterinary Medicine Diagnostic Medicine/Pathobiology Manhattan, Kansas
Dr. Jürgen A. Richt, DVM, PhD, is the Regents Distinguished Professor at the College of Veterinary Medicine at Kansas State University in Manhattan, KS. He received his DVM from the University of München, Germany, and his PhD in Virology from the University of Giessen, Germany. Dr. Richt has been working in the area of emerging zoonotic diseases for more than 20 years. In his early research years, Dr. Richt focused on the immunopathogenesis and molecular biology of Borna Disease Virus (BDV). After his move to the United States, Dr. Richt’s work focused on influenza virus infections in animals, especially swine, and on animal transmissible spongiform encephalopathies (TSEs) or prion diseases. Dr. Richt has published more than 90 peer-reviewed manuscripts in his area of expertise. He is one of the Editors for the journal Virus Genes and on the Editorial Board of numerous other journals. His research program is funded by the NIH and the CDC. He was recently appointed to the Scientific Advisory Board of OIE, Paris, France.
Lynne Sehulster, Ph.D. Health Scientist Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, Georgia
Dr. Lynne Sehulster is a Health Scientist in the Division of Healthcare Quality Promotion (DHQP) within the National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID) at the Centers for Disease Control and Prevention (CDC). She has been at CDC for 12 years. She received her MS and PhD in Microbiology from Rutgers, the State University of New Jersey, and has her certificate as a Microbiologist with the American Society of Clinical Pathologists (M[ASCP]). Prior to coming to CDC, she completed a postdoctoral assignment in the Department of Virology and Epidemiology at Baylor College of Medicine in Houston doing laboratory research in hepatitis B virus inactivation. She subsequently served as an infectious disease epidemiologist for 15 years at the Texas Department of Health (currently known as the Texas Department of State Health Services). While in Texas she was the state health department’s point of contact for viral hepatitis and influenza epidemiology and surveillance activities. Her current areas of expertise at CDC focus on environmental infection control, transmission of infectious diseases, and microbial inactivation. She advises the agency, health care professionals, and the public on issues concerning indoor environmental cleaning, sterilization and disinfection, prion inactivation and risk assessment, and environmental management of emerging diseases. She also provides perspective to CDC on regulated medical waste and other healthcare facility issues such as laundry and environmental services. She is the coordinator of and contributor to the CDC/HICPAC “Guidelines for Environmental Infection Control in Health-Care Facilities” that was released in 2003.
Claudio Soto, Ph.D. Professor, Department of Neurology University of Texas Medical School at Houston Houston, Texas
Dr. Claudio Soto is the Director of the George and Cynthia Mitchell Center for Neurodegenerative Diseases and Professor on the Departments of Neurology, Neuroscience & Cell Biology and Biochemistry & Molecular Biology at the University of Texas Medical Branch in Galveston. Dr. Soto holds the Green Distinguished University Chair in Neuroscience, the largest endowed professorship in the University of Texas. Currently he is also the Founder, Vice-President and Chief Scientific Officer of AMPRION Inc. He received his PhD in biochemistry and molecular biology from the University of Chile in 1993 and was a postdoctoral fellow at the Catholic University of Chile and at the New York University School of Medicine, where he became an assistant professor of research in 1995. Between 1999-2003, Dr Soto was Senior Scientist, Chairman of the Department of Molecular Neuropathology and Senior Executive Scientific Advisor for Neurobiology at Serono International in Switzerland. For the past 13 years, he and his colleagues have engaged in research into the molecular basis of neurodegenerative diseases associated to the misfolding and brain accumulation of proteins, particularly focusing in Alzheimer’s and prion-related disorders. His work has led to the development of novel strategies for treatment and diagnosis of these diseases. He has published more than 90 peer review scientific publications and contributed to more than 15 books, including one written entirely by Dr. Soto. Many of his studies have been published in the most prestigious scientific journals (including Cell, Nature, Science, Nature medicine, EMBO Journal, etc) and several of them have produced a large impact in the scientific community.
http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html
AGENDAFIFRA SCIENTIFIC ADVISORY PANEL (SAP)OPEN MEETINGMarch 31 - April 1, 2009FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/OPP Docket Telephone: (703) 305-5805Docket Number: EPA-HQ- OPP-2008-0859U.S. Environmental Protection AgencyConference Center - Lobby LevelOne Potomac Yard (South Bldg.)2777 S. Crystal Drive, Arlington, VA 22202Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test MethodsPlease note that all times are approximate(See note at the end of the Agenda)Tuesday, March 31, 20098:30 A.M. Opening of Meeting and Administrative Procedures by Designated Federal Official – Myrta R. Christian, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA8:35 A.M. Introduction and Identification of Panel Members - Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair8:50 A.M. Welcome and Opening Remarks – Steven Bradbury, Ph.D., Deputy Director, Office of Pesticide Programs, EPA9:00 A.M Background and Overview - Jeff Kempter, Senior Advisor, Antimicrobials Division, Office of Pesticide Programs, EPA9:20 A.M. A Regulatory Approach to C&D for CWD and EPA’s Role in the Process – Dean Goeldner, D.V.M., Chronic Wasting Disease Program Manager, USDA-APHIS-VS-NCAHP-RHP, Riverdale, MD9:40 A.M. FDA Approach to Claims for Reducing TSE Infectivity on Medical Devices - Sheila Murphey, M.D., Chief, Infection Control Devices Branch; Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation; Center for Devices and Radiologic Health; FDA, Rockville, MD10:15 A.M. Break10:30 A.M. EPA’s “White Paper” – Richard Wiggins, Ph.D., National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA, Research Triangle Park, NC10:50 A.M. EPA’s Guidance for Efficacy Test Methods for Products Bearing11:15 A.M. Prion Infectivity Assays – Christopher J. Silva, Research Chemist, Foodborne contaminants Research Unit, Western Regional Research Center, Albany, CA11:40 A.M. Transmissible Spongiform Encephalopathies (TSEs/Prion Diseases): Target Criteria for Assessing Agent Clearance – David M. Asher, MD, Chief, Laboratory of Bacterial, Parasitic and Unconventional Agents; Division of Emerging and Transfusion-Transmitted Diseases; Office of Blood Research and Review; Center for Biologics Evaluation and Research; FDA, Rockville, Maryland3:45 P.M. Charge to Panel – Question 11. White Paper Issue: Whether EPA’s draft review paper, “Scientific Information Concerning the Issue of Whether Prions Are a ‘Pest’ under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),” adequately identifies and summarizes available, relevant scientific studies.Prion-Related Claims – Richard Wiggins, Ph.D., National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA, Research Triangle Park, NC12:00 P.M. Lunch1:00 P.M. Public Comment3:30 P.M. BreakIn 2005, EPA established a Work Group to develop a Notice of Proposed Rulemaking (NPRM) that defines a prion as a “pest” under FIFRA. To assure that it considers key available scientific studies that are relevant to the issue of whether a prion is a “pest” under FIFRA, the Work Group drafted a review paper. While the paper received intra-Agency review, it was not subjected to peer review outside of EPA. Accordingly, EPA seeks the SAP’s peer review of the attached, draft review paper (USEPA 2008). Some of the key references cited in the review paper have been provided to the SAP.EPA wishes to point out that the NPRM will also focus on legal and policy matters that are not addressed in depth in the “white paper.” EPA is presenting this paper to the SAP solely for review as to its characterization of the scientific issues, and is not asking the SAP to interpret legal/policy issues such as Congress’ intent in drafting FIFRA.•Please comment on the accuracy of the characterization of the nature of prions, and the adequacy of the review of the relevant scientific information to support that characterization, as presented in EPA’s draft paper, “Scientific Information Concerning the Issue of Whether Prions Are a ‘Pest’ under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).”5:00 P.M. AdjournmentOPEN MEETINGAGENDAFIFRA SCIENTIFIC ADVISORY PANEL (SAP)March 31 - April 1, 2009FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/ OPP Docket Telephone: (703) 305-5805Docket Number: EPA-HQ- OPP-2008-0859U.S. Environmental Protection AgencyConference Center - Lobby LevelOne Potomac Yard (South Bldg.) 2777 S. Crystal Drive, Arlington, VA 22202Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test MethodsWednesday, April 1, 20098:30 A.M. Opening of Meeting - Administrative Procedures by Designated Federal Official - Myrta R. Christian, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA8:35 A.M. Introduction and Identification of Panel Members -Steven G. Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair8:50 A.M. Follow-up from Previous Day’s Discussion – Jeff Kempter, Senior Advisor, Antimicrobial Division, Office of Pesticide Programs, EPA9:15 A.M. Charge to Panel – Question 22. Efficacy Guidance Test Method Issue: Whether the specific test systems recommended in the draft guidance document are scientifically appropriate to support the registration of pesticide products with prion-related claims.The draft efficacy guidance document (USEPA 2009) recommends a carrier-based, animal infectivity test method, if the intended use of a product is for treating environmental surfaces, and a suspension-based, animal infectivity test method if the intended use of a product is for treating liquids. The draft efficacy guidance document also states that the test methods may either be end-point titration or incubation time interval assays. EPA is interested in knowing the SAP’s opinion on whether these recommended test systems are scientifically sound and appropriate approaches to evaluating the efficacy of pesticide products with prion-related claims. EPA would also like to know whether the SAP recommends that other test methods be considered to evaluate the efficacy of pesticide products used either on•b.3. Efficacy Guidance Performance Criterion Issue: Whether the product performance criterion specified in the draft guidance document to support the registration of pesticide products with prion-related claims is scientifically sound.environmental surfaces or in liquid media.Please comment on the scientific appropriateness of:a.Carrier-based, animal infectivity assays recommended by EPA’s guidance for evaluating the efficacy of pesticide products used on environmental surfaces (e.g., hard, nonporous surfaces).Suspension-based, animal infectivity assays recommended by EPA’s guidance for evaluating the efficacy of pesticide products used in liquid media (e.g., wastewater).Any other known test methods for evaluating the efficacy of pesticide products used on either environmental surfaces or in liquid media.10:30 A.M. Break10:45 A.M. Charge to Panel - Question 3The draft efficacy guidance document recommends a target efficacy criterion of six (6) logs of reduction of infectivity in the treated versus untreated (control) groups. This criterion is widely used in the current scientific literature. EPA would like the SAP’s comment on this proposed product performance criterion.•Please comment on the scientific soundness of the product performance criterion recommended in the draft guidance document to support the registration of pesticide products with a prion claim.12:00 P.M. Lunch1:00 P.M. Charge to Panel – Question 44. Efficacy Guidance Labeling Claim Issue: Whether the labeling claim described in the draft guidance document is scientifically appropriate based on the recommended test systems and product performance standard.The draft efficacy guidance document recommends a carefully worded labeling claim statement: “Has been demonstrated to reduce infectivity of prions (TSE agents) based on testing using (insert type of organism in which the prions were raised) (insert prion type).” EPA believes that claims that may normally be applied to microorganisms (e.g., “destroy,” “mitigate,” “eliminate,” “control”) may be misleading when applied to prions. Because currently available test methods can only measure a reduction in infectivity, and the total elimination or destruction of prions cannot be•5. Efficacy Guidance Hierarchy Issue: Whether different prion types exhibit variation in the degree of resistance to inactivation by pesticide chemicals and whether a hierarchy of resistance by prion type can be reliably determined at this time.Comparisons of different types of prions in a common animal infectivity assay indicate there may be significant differences with regard to their ability to resist inactivation by pesticide chemicals. For example, Peretz et al. (2006) compared the resistance of hamster scrapie and human CJD prions in transgenic mice expressing either hamster PrP or a chimeric mouse-human PrP transgene and found that human sCJD prion tested was 100,000 fold more difficult to inactivate than hamster Sc237 prion. Preliminary additional studies indicate that the cow BSE prion may be even more resistant to inactivation than the human CJD prion (Giles et al. 2006; 2008 in press).measured, EPA believes that “reduce infectivity” is the only appropriate claim.Please comment on the scientific appropriateness of the term “reduce infectivity” in a label claim to reflect the action of a pesticide on prions.3:00 P.M. Break3:15 P.M. Charge to Panel – Question 5•Please comment on whether a hierarchy of resistance among prion types can be reliably demonstrated for different pesticide chemicals based on the available data.5:00 P.M. AdjournmentPlease be advised that agenda times are approximate; when the discussion for one topic is completed, discussions for the next topic will begin. For further information, please contact the
http://www.epa.gov/scipoly/sap/meetings/2009/march/033109agenda.pdf
FIFRA Scientific Advisory Panel; Notice of Public Meeting PDF Version (3 pp, 80K, About PDF)
[Federal Register: December 17, 2008 (Volume 73, Number 243)] [Notices] [Page 76639-76641] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr17de08-76]
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ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0859; FRL-8392-9]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA). ACTION: Notice.
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SUMMARY: There will be a 2-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review Scientific Issues Associated with Designating a Prion as a ``Pest'' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods.
http://www.epa.gov/EPA-MEETINGS/2008/December/Day-17/m29977.htm
Associated with Designating a Prion as a "Pest" under the Federal insecticide,. Fungicide, and Rodenticide Act (FlFRA), and Related Efficacy Test Methods. These ... whether Prions Are a Pest' under the Federal insecticide, Fungicide, and Rodenticide Act (fifra)." 2. Efficacy Guidance Test Method issue: Whether the ...
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064808df7ef&disposition=attachment&contentType=pdf
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648027c28e
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648027c28e&disposition=attachment&contentType=pdf
Friday, August 29, 2008 CREEKSTONE VS USDA COURT OF APPEALS, BUSH SAYS, NO WAY, NO HOW
http://madcowtesting.blogspot.com/2008/08/creekstone-vs-usda-court-of-appeals.html
Subject: Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION
Date: August 24, 2005 at 2:47 pm PST
August 24, 2005
Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION
Greetings APHIS ET AL,
My name is Terry S. Singeltary Sr.
I would kindly like to comment on [Docket No. 05-004-1] RIN 0579-AB93 ;
PROPOSED RULES
Exportation and importation of animals and animal products:
Whole cuts of boneless beef from-
Japan,
48494-48500 [05-16422]
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480086ebc&disposition=attachment&contentType=msw6
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA
https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed
PLEASE SEE FULL TEXT HERE ;
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA
http://madcowfeed.blogspot.com/2008/07/docket-no-03-080-1-usda-issues-proposed.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-2006-0041-0006 Public Submission Title Comment from Terry S Singletary Sr Views Add Comments How To Comment
snip...
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....
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2006-0041-0006
From: Terry S. Singeltary Sr.
To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:FREAS@CBER.FDA.GOV
Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:william.freas@fda.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:rosanna.harvey@fda.hhs.gov
Sent: Friday, December 01, 2006 2:59 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION
snip...
ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)
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 blood 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. ...
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
snip... 48 pages...
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
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
Saturday, January 24, 2009
Bovine Spongiform Encephalopathy h-BSE ATYPICAL USA 2008 Annual Report Research Project: Study of Atypical Bse
Location: Virus and Prion Diseases of Livestock
2008 Annual Report
http://bse-atypical.blogspot.com/2009/01/bovine-spongiform-encephalopathy-h-bse.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
----- Original Message -----
From: "Terry S. Singeltary Sr." mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:flounder9@verizon.net To: "Bovine Spongiform Encephalopathy" mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:BSE-L@aegee.org Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:heggem.daniel@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:sibert.christopher@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:denne.jane@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:hazen.susan@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:mcrosby@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:erobinson@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:enegin@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:cjdvoice@yahoogroups.com; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000202/!x-usc:mailto:madcow@lists.iatp.org
Sent: Monday, April 28, 2008 9:48 PM
Subject: Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency
http://madcowfeed.blogspot.com/2008/08/texas-firm-recalls-cattle-heads-that.html
TSS
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 $$$
LET's go back to the infamous TOKEN, charade, that happened on January 30, 2001, at the Texas Purina feed lot around Gonzales. NOW remember, this thing was set up from the word go, as to some big showing that the FDA was DOING SOMETHING BIG. let's look at exactly what was said then, and then i will run some figures by you, of what banned mad cow feed has gone into commerce, of which most was fed out. but, as wrong as the comments made were about what amount of infectious material will kill a cow in this statement, even if you were to go by those wrong figures of about .......... oh what was it ???
''FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.''
http://www.fda.gov/bbs/topics/news/2001/new00752.html
you can take that with how ever many grains of salt you wish, but i read that as saying, it was only 5 1/2 grams, and the old cow ways 600 pounds, so know way that even if the feed was tainted, there was not enough to cause disease. the fda, usda et al, knew at that exact moment when they wrote that statement, they knew then that the 5 1/2 grams was enough to kill a small herd of cows. it was old science. but again, they chose to deceive. THIS WAS 2001, and it's now 2009, and they still are choosing to deceive, and the new administration appears willing to continue the USA mad cow charade. NOW, since the charade at the purina mill in 2001, i am going to list a few figures of suspect, banned mad cow feed that went out into commerce, even in 2008, 2007, 2006, back a few years, and you can compare, what enormous amounts of banned suspect mad cow feed and other products continue to go out. when you consider, and they knew all along, that .005 grams is lethal, my God, how much of this poison was consumed?
WASHINGTON, June 26, 2008 - Beltex Corporation, doing business as Frontier Meats, a Fort Worth, Texas, establishment, is recalling approximately 2,850 pounds of fresh cattle heads which may contain specified risk materials (SRMs), the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.
http://www.fsis.usda.gov/News_&_Events/Recall_020_2008_Release/index.asp
Data reported as of: 05/10/2008
Search by: State = TX, and FDA District = DAL-DO, and Firm Type = FR,HF,NL, and Last BSE Insp Date From 01/01/2007 To 05/31/2008 and BSE Program Risk = DP,HP,NP, and Last BSE District Decision = OAI, and Handles Feed for Rum. Animals = Y,N,R Sort by: Last BSE District Decision
FDA District
DAL-DO
Firm Id (FEI)
3006607060
Firm Name
Texas Legend Ranch
Street Address
2803 Highway 473
City
Kendalia
State
TX
Zip Code
78027-2016
Opr. Status
OPR
Firm Type(s)
FR, OF
Prgm Risk
NP
Last BSE Insp Date
03/25/2008
Last BSE Dist. Dcsn''
OAI
Handles Feed for Rum. Animals?
Y
snip...end
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented.
http://www.fda.gov/cvm/CVM_Updates/BSE0108.htm
http://madcowfeed.blogspot.com/2008/06/texas-firm-recalls-cattle-heads-that.html
http://madcowfeed.blogspot.com/2008/05/fda-bseruminant-feed-inspections-firms.html
In 2007, in one weekly enforcement report, the fda recalled 10,000,000+ pounds of BANNED MAD COW FEED, 'in commerce', and i can tell you that most of it was fed out ;
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST 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
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
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
snip...
see listings and references of enormous amounts of banned mad cow protein 'in commerce' in 2006 and 2005 ;
see full text ;
Friday, April 25, 2008
Substances Prohibited From Use in Animal Food or Feed [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46
http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html
SPECIFIED RISK MATERIALS
http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html
SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS
http://cjdmadcowbaseoct2007.blogspot.com/2008/04/srm-mad-cow-recall-406-thousand-pounds.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
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3; Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique, France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious Disease control, Sweden; 5Georg August University, Germany; 6German Primate Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans. Secondly, we aimed at examining the course of the disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian v CJD as fast as intracerebrally inoculated animals.
The work referenced was performed in partial fulfillment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).
http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf
Calves were challenged by mouth with homogenised brain from confirmed cases of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were then left to develop BSE, but were not subjected to the normal stresses that they might have encountered in a dairy herd. Animals in all four groups developed BSE. There has been a considerable spread of incubation period in some of the groups, but it appears as if those in the 1 and 10g challenge groups most closely fit the picture of incubation periods seen in the epidemic. Experiments in progress indicate that oral infection can occur in some animals with doses as low as 0.01g and 0.001g. .........
http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose
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
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
http://www.gao.gov/new.items/d02183.pdf
http://www.gao.gov/new.items/d05101.pdf
GAO says US barriers to mad cow disease are full of holes Robert Roos News Editor
Note: This story was updated March 1, 2002, to include additional information about recent federal actions to prevent mad cow disease.
Feb 28, 2002 (CIDRAP News) - Congress's General Accounting Office (GAO) concludes in a new report that the United States remains vulnerable to bovine spongiform encephalopathy (BSE), or mad cow disease, because of inadequate import barriers and weak enforcement of rules to contain any BSE-contaminated products that might reach US shores.
http://www.cidrap.umn.edu/cidrap/content/other/bse/news/gaorept.html
##################### Bovine Spongiform Encephalopathy #####################
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; 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
______________________________
PRODUCT a) Dairy feed, custom, Recall # V-134-6; Custom Dairy Feed with Monensin, Recall # V-135-6. CODE None. Bulk product RECALLING FIRM/MANUFACTURER Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on June 28, 2006. Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated recall is complete. REASON Possible contamination of dairy feeds with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE 1,484 tons
DISTRIBUTION TN and WV
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
##################### Bovine Spongiform Encephalopathy #####################
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
______________________________
PRODUCT Bulk custom made dairy feed, Recall # V-115-6 CODE None RECALLING FIRM/MANUFACTURER Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or about July 14, 2006. FDA 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 Approximately 2,223 tons DISTRIBUTION KY
______________________________
PRODUCT Bulk custom made dairy feed, Recall # V-116-6 CODE None RECALLING FIRM/MANUFACTURER Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006. FDA 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 1,220 tons DISTRIBUTION KY
______________________________
PRODUCT Bulk custom made dairy feed, Recall # V-117-6 CODE None RECALLING FIRM/MANUFACTURER Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated recall is completed. REASON Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE 40 tons
DISTRIBUTION LA and MS
______________________________
PRODUCT Bulk Dairy Feed, Recall V-118-6 CODE None RECALLING FIRM/MANUFACTURER Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA initiated recall is complete. REASON Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE 7,150 tons
DISTRIBUTION MS
______________________________
PRODUCT Bulk custom dairy pre-mixes, Recall # V-119-6 CODE None RECALLING FIRM/MANUFACTURER Walthall County Co-op, Tylertown, MS, by telephone on June 26, 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 87 tons
DISTRIBUTION MS
______________________________
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; 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
###
http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.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
###
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; 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
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
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
CJD WATCH MESSAGE BOARD TSS
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; 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 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
Department of Health and Human Services Public Health Service Food and Drug Administration
Minneapolis District Office Central Region 212 Third Avenue South Minneapolis, MN 55401 Telephone: (612) 758-7119 FAX: (612) 334-4142
June 9, 2005
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Refer to MIN 05-15
Michael J. Langenhorst President Anamax Corporation P.O. Box 10067 Green Bay, WI 54307
Dear Mr. Langenhorst:
Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, 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). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].
Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:
1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.
2. 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 that may be used for ruminants.
Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S .C. 343(a)(1)).
The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.
Your response should be directed to Compliance Officer Jane E . Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.
Sincerely,
/S/
W. Charles Becoat Director Minneapolis District
http://www.fda.gov/foi/warning_letters/g5373d.pdf
2. WITH A RECENT NATION WIDE MAD COW FEED BAN RECALL in the past few months that consisted of some 10,878.06 TONS, then another Mad Cow feed ban warning letter in May, IT should seem prudent to ask why our feed bans continue to fail in 2006, and continue to fail today ? 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.
Page 2 of 98 8/3/2006
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
see full text ;
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
######## Bovine Spongiform Encephalopathy <BSE-L@UNI-KARLSRUHE.DE> #########
Public Health Service Food and Drug Administration
New Orleano District Nashville Branch Office Plus Park Blvd. Nashville, TN 37217 Tel: 615-781-6388 FAX: 615-781-6383
May 22, 2003
VIA FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. John F. Turner, Owner, Manager Millstone Agri Distributors 3721 E. Lamar Alexander Highway Maryville, TN 37804
Warning Letter No 03-NSV-16
Dear Mr. Turner:
An inspection of your animal feed manufacturing operation, located at Maryville, Tennessee conducted by a U.S. Food and Drug Administration investigator on February 13, 2003, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations (21 CFR.), Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow this rule, products you manufactured and distributed are adulterated within the meaning of Sections 402(a)(2)(C) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) since they contain an unsafe food additive and were prepared, packed, or held under insanitary conditions . . . whereby [they] may have been rendered injurious to health. Feed you manufactured also was misbranded within the meaning of Section 403(a)(1) of the Act because of your failure to follow this rule.
Our investigation found the following violations of 21 C.F.R. 589.2000:
1. Failure to separate the receipt, processing, and storage of products containing prohibited material from products not containing prohibited material [21 C.F.R. 589.2000(e)(1)(iv)];
2. Failure to establish written procedures, including clean-out and flushing procedures, to avoid commingling and cross-contamination of common equipment [21 C.F.R. 589.2000(e)(1)(iii)(B)];
3. Failure to maintain records sufficient to track prohibited materials throughout the receipt, processing, and distribution of your products [21 C.F.R. 589.2000(c)(1)(ii)];
4. Failure to provide for measures to avoid commingling or cross-contamination of feeds intended for ruminants and feeds intended for nonruminants that may contain prohibited materials [21 C.F.R. 589.2000(c)(1)(iii)]. Specifically, our investigation found that the ruminant product 10% Beef Conditioned was formulated primarily with screenings and fines derived from previously manufactured non-ruminant products, Premium Rooster Kicker in particular, that contain or may contain prohibited material. Such deviations cause the ruminant product 10% Beef Conditioner being manufactured at this facility to be adulterated within the meaning of Sections 402(a)(2)(C) and 402(a)(4) of the Act;
5. Failure to label your non-ruminant products with the required cautionary statement Do not Feed to Cattle or Other Ruminants [21 C.F.R. 589.2000(c)(1)(ii)]. Our investigation specifically found that dog food containing prohibited material was added as an ingredient to your product Premium Rooster Kicker. The failure of these feeds to bear the required BSE warning statement causes them to be misbranded within the meaning of Section 403(f) of the Act.
The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDAs Small Entity Compliance Guide to assist you with complying with the regulations.
You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. You should notify this office in writing within 15 working days of receipt of this letter of the steps you have taken to bring your iirm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 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 that corrections have been made.
Your reply should be directed to the attention of Joseph E. Hayes, Compliance Officer, U.S. Food and Drug Administration, 297 Plus Park Boulevard, Nashville, TN 37217.
Sincerely,
/s/ Carl E. Draper Director, New Orleans District Office
http://www.fda.gov/foi/warning_letters/g4056d.htm
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTERS JULY 20, 2004 USA
Date: Tue, 20 Jul 2004 09:14:11 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS
Public Health Service Food and Drug Administration
San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700
VIA HAND DELIVERY
Our Reference No. 1000123954
June 23, 2004
Ronald M. Foster, Manager Randall C. Boyce, Manager Trevor O. Foster, Manager George P. Foster, Manager Fresno Farming LLC P.O. Box 457 1000 Davis Street Livingston, California
WARNING LETTER
Dear Mssrs. Foster, Boyce, Foster, and Foster:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your medicated animal feed mill operation, Fresco Farming LLC, located in Traver, California from April 14, 2004 through May 6, 2004, and found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow this rule, products you manufactured and distributed are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Our inspection found the following violations of 21 C.F.R. 589.2000:
1. Failure to provide for measures to avoid commingling or cross-contamination of products that contain or may contain protein derived from mammalian tissues into animal protein or feeds that may be used for ruminants to comply with 21 C.F.R. 589.2000(e)(1)(iii).
* Your firm uses a vacuum system to clean up spilled product in the tunnel area. This tunnel area houses the two receiving conveyor systems and the elevators for the two conveyor systems. When product, including ruminant meat and bone meal, is spilled onto the floor of this area, the spilled product is vacuumed up by the vacuum system and, via a discharge hose, was placed into a conveyor system that your firm had designated as free of ruminant meat and bone meal. Your firm admitted that it was unaware of the vacuum system discharging into the conveyor systems designated as free of ruminant meat and bone meal and that this had been in place since April 2003. Your firm remedied this problem during FDAs April/May 2004 inspection by removing the discharge hose connection to the conveyer system that your firm had designated as free of ruminant meat and bone meal . * Your firm uses a dust collection system that pulls dust from systems that receive both ruminant meat and bone meal and feed ingredients intended for ruminants. This dust system then discharged collected product back into the two conveyor systems via a cross connection, thereby making it likely that ruminant meat and bone meal became commingled with ruminant feed ingredients. Your firm admitted that it was unaware of the cross connection and that it had been in place since April 2003. Your firm removed the cross connection during FDAs April/May 2004 inspection.
2. Failure to maintain written procedures specifying the clean-out procedure or other means, and specifying the procedures for separating products that contain or may contain protein derived from mammalian tissue from all other protein products from the time of receipt until the time of shipment, to comply with 21 C.F.R. 589.2000(e)(1)(iv). This observation was also noted during FDAs July/August 2003 inspection of your firm.
* There are no written procedures for separating products that contain prohibited material from ingredients used in ruminant feeds from the time of receipt until the time of shipment. * The written procedure for cleaning out or flushing equipment after mixing feeds containing prohibited material was not adequate to prevent contamination of ruminant feed with prohibited material.
3. Failure to maintain records sufficient to track materials that contain protein derived from mammalian tissues throughout their receipt, processing, and distribution to comply with 21 C.F.R. 589.2000(e)(1)(i). This observation was also noted during FDAs July/August 2003 inspection of your firm.
* Specifically, your firm has failed to develop and implement complete written procedures to separate ruminant meat and bone meal from feed ingredients intended for ruminants from the time of receipt until the time of distribution. The written procedures that do exist fail to address the use of equipment common to ruminant meat and bone meal and ruminant feed ingredients.
The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for use as animal feed, you are responsible for assuring that 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 such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations and prevent their recurrence. If corrective actions cannot be completed in fifteen (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 that corrections have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention: Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, California 94502-7070. If you have questions regarding this letter, please contact Ms. Kishida at (510) 337-6824.
Sincerely,
/s/
CD Moss, Acting DD for Barbara J. Cassens District Director San Francisco District
cc: VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED C. Michael Blasco, Feed Mill Manager Fresno Farming LLC P.O. Box 430 Traver, California 93673
http://www.fda.gov/foi/warning_letters/g4849d.htm
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863
July 12, 2004
WARNING LETTER CHI-16-04
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. Donald E. Hamilton, President/Owner Illini Feeds, Inc. P.O. Box 86, 1145 State Hwy. 94 Aledo, Illinois 61231
Dear Mr. Hamilton:
On February 19 and 20, 2004, the Food and Drug Administration (FDA) conducted an inspection of your animal feed handling facility located at 1145 State Highway 94, Aledo, Illinois. The inspection found 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). The deviations cause the swine feed manufactured by your facility to be misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found that salvaged pet food containing prohibited material was added as an ingredient to the swine products manufactured at your facility. During the inspection, our investigator found that you failed to label your non-ruminant products with the required caution statement - Do not feed to cattle or other ruminants. [21 CFR 589.2000(d)(1)]
The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for use in animal feed, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct this violation, and you should establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action without further notice, such as seizure and/or injunction.
During the inspection, you told the investigator that you would put the required cautionary statement on your products that contain prohibited material, and maintain tracking documents for all incoming ingredients, including animal proteins prohibited in ruminant feed. Please notify this office in writing within 15 working days of receiving this letter of any further steps you have taken to assure that your firm is in compliance with the law. Your response should also include an explanation of each step taken to correct the violations, and prevent their recurrence. Please include copies of any available documentation such as written procedures, corrected labeling, etc., demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the above address.
Sincerely,
/s/
Scott J. MacIntire District Director
http://www.fda.gov/foi/warning_letters/g4840d.htm
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863
June 15, 2004
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. David W. Bernauer CEO and Chairman of the Board Walgreen co. 200 Wilmot Rd. Deerfield, IL 60015
Dear Mr. Bernauer:
Inspection of your firms warehouse at 5100 Lake Terrace N.E., Mt. Vernon, Illinois, by the Illinois Department of Public Health and the U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and March 2, 2004, documented numerous insanitary conditions which caused the food and drug products stored there to become adulterated.
Our inspection showed that the food and drug products stored and held at your facility violated the Federal Food, Drug, and Cosmetic Act (the Act), rendering them adulterated. These adulterated fwd and drug products: a) consisted in whole or in part of filthy substances, including rodent fecal pellets, rodent hair, and insects, in violation of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had been held under insanitary conditions whereby they have become contaminated with rodent filth, in violation of Sections 402(a)(4) and 501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].
Evidence of rodent activity documented throughout the old and new warehouse included dead mice in traps, excreta pellets, and gnawed paper material observed in, on, and near food and drugs stored in the warehouse. Rodents gnaw holes were observed into several packaged food products with rodent hairs at gnaw holes into products. Many more fecal pellets were on food and drug packages and still more were found near the stored foods, drugs, and cosmetics in the warehouse.
Other conditions observed during the inspection that could be contributing factors to rodent infestation include damaged and/or poorly fitting rail and truck dock doors, gaps around a conduit entry into the building, and the structural condition of the concrete and expansion gaps at floor/wall/support beam junctions in various areas of the warehouse allowing the entry or harborage of pests. Additionally, the investigators observed cobwebs, dead insects, dust, debris, product spillage, and papers in the warehouse, indicating a general lack of good sanitation practices.
Also, products that contain or may contain animal protein prohibited ruminant feed (BSE material) failed to bear the caution statement, Do not feed to cattle or other ruminants. Specifically, pet food products were salvaged, repackaged, and donated to [redacted] and other similar organizations in the area, without the proper labeling and agreement that they would not be used for ruminants. Please refer to Title 21, Code of Federal Regulations, Section 589.2000, concerning these requirements.
Our laboratory confirmed the findings of rodent excreta, rodent hairs on product gnaw holes, and rodent gnawed fibers (packaging material) sampled from the warehouse during the inspection.
The above listed violations are not intended to be all-inclusive. It is your responsibility to assure adherence with each requirement of the Act and its implementing regulations. The investigators reported that you destroyed food products that showed evidence of contamination and began to take some steps to correct the insanitary conditions in your facility. We request that you take prompt action to correct all violations.
Please provide this office, within 15 working days of receipt of this letter, a detailed response stating the actions you plan to take and have taken to correct and prevent the recurrence of these objectionable conditions. Provide the time within which corrections will be completed, reasons why any corrective action cannot be completed, and documentation to show that corrections have been made. Failure to take prompt action to correct all violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the Chicago District Office.
Sincerely,
/s/
Scott J. MacIntire District Director
cc: Stephen J. Lawrence, Distribution Center Manager Walgreen Co. 5100 Lake Terrace NE Mount Vernon, IL 62864-9665
http://www.fda.gov/foi/warning_letters/g4853d.htm
USA BSE GBR SHOULD BE GBR III, but someone dropped the ball...
TSS
######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ##########
DEPARTMENT OF HEALTH & HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
April 9, 2001 WARNING LETTER
01-PHI-12 CERTIFIED MAIL RETURN RECEIPT REQUESTED
Brian J. Raymond, Owner Sandy Lake Mills 26 Mill Street P.O. Box 117 Sandy Lake, PA 16145 PHILADELPHIA DISTRICT
Tel: 215-597-4390
Dear Mr. Raymond:
Food and Drug Administration Investigator Gregory E. Beichner conducted an inspection of your animal feed manufacturing operation, located in Sandy Lake, Pennsylvania, on March 23, 2001, and determined that your firm manufactures animal feeds including feeds containing prohibited materials. The inspection found significant deviations from the requirements set forth in Title 21, code of Federal Regulations, part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) . Such deviations cause products being manufactured at this facility to be misbranded within the meaning of Section 403(f), of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found failure to label your swine feed with the required cautionary statement "Do Not Feed to cattle or other Ruminants" The FDA suggests that the statement be distinguished by different type-size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
In addition, we note that you are using approximately 140 pounds of cracked corn to flush your mixer used in the manufacture of animal feeds containing prohibited material. This flushed material is fed to wild game including deer, a ruminant animal. Feed material which may potentially contain prohibited material should not be fed to ruminant animals which may become part of the food chain.
The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of FDA's Small Entity Compliance Guide to assist you with complying with the regulation... blah, blah, blah...
http://www.fda.gov/foi/warning_letters/g1115d.pdf
DEPARTMENT OF HEALTH & HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
April 9, 2001 WARNING LETTER
01-PHI- 11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Eugene P. Yachere, Owner Yachere Feed, Inc. 200 Main Street Rockwood, PA 15557
Dear Mr. Yachere:
Food and Drug Administration Investigator Gregory E. Beichner conducted an inspection of your animal feed manufacturing operation, located in Rockwood, Pennsylvania, on March 14, 2001, and determined that your firm manufactures animal feeds including feeds containing prohibited materials. The inspection found significant deviations from the requirements set forth in Title 21, code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy {BSE). Such deviations cause products being manufactured at this facility to be misbranded and adulterated within the meaning of Section 403(f), 402(a) (2) (C), and 402(a) (4) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection found failure to label your poultry feed products with the required cautionary statement "Do Not Feed to Cattle or other Ruminants". The FDA suggests that the statement be distinguished by different type-size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
Our inspection also found that all animal feeds you manufacture may contain prohibited material since you failed to provide for measures to avoid commingling and cross-contamination of feeds containing prohibited materials with feeds containing no prohibited materials. Additionally, you were unable to provide any documentation including manufacturing/production records which would identify animal feeds processed on the same equipment directly after the manufacture of poultry feeds containing prohibited material.
The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring....
Blah, Blah, Blah, same old crap...
http://www.fda.gov/foi/warning_letters/g1114d.pdf
And now they are feeding ruminants to fish!
Subject: MAD FISH WARNING LETTERS (you 'veghead's just thought you were free of TSEs;-) Date: Tue, 3 Jul 2001 From Terry S. Singeltary Sr. <flounder@wt.net
Bovine Spongiform Encephalopathy (love them farm raised catfish)
WARNING LETTER
June 12, 2001
Mr. Scott Nelson, Owner Integral Fish Foods, Inc. 715 South 7th Street Grand Junction, CO 81501
Ref. #: DEN-01-35
Dear Mr. Nelson,
An inspection of your fish feed manufacturing operation located at Grand Junction, Colorado, conducted by a Colorado Department of Agriculture Inspector on March 20, 2001, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and/or distributed by your facility to be adulterated within the meaning of section 402(a)(4) and misbranded within the meaning of Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection found that your procedures to prevent cross-contamination are inadequate in that:
You do not have written procedures specifying the clean-out procedures for your feed mixer.
Our investigation also found that you fail to label your products, Fat Cat Catfish Fingerling Feed and Gold Nugget Trout Fry Feed #2 Crumble, each containing meat and bone meal, with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants". The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulations.
Page 2 - Integral Fish Foods, Inc. June 12, 2001
We find it quite disturbing that the above violations STILL EXIST CONSIDERING YOU HAVE BEEN ADVISED ON 2 PREVIOUS OCCASIONS OF THESE REQUIREMENTS, INCLUDING APRIL 7, 1999 and MARCH 6, 2000....
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237.3097 Telephone: (513) 679-2700
CERTIFIED MAIL RETURN RECEIPT REQUESTED
WARNING LETTER CIN-WL-6466-01
March 5, 2001
John T. Dunbar President Champaign Landmark, Inc. 304 Bloomfield Avenue Urbana, OH 43078
Dear Mr. Dunbar:
An inspection of your feed mill was conducted by a Food and Drug Administration (FDA) investigator on February 13-15, 2001. This inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and distributed by your facility to be misbranded within the meaning of Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act).
The investigator examined 30 Mixing and Delivery Tickets for products containing prohibited materials. 15 of those tickets lacked the required cautionary statement "Do not feed to Cattle or Other Ruminants". We suggest that you find a more reliable method than simply handwriting the statement on the back of the ticket. We also suggest the statement be distinguished by different type size, color, or other means of highlighting so it is easily noticed by the purchaser.
Other issues in addition to the deficiency noted above:
We question whether flushing with xxxxx of crushed corn is adequate to clean your mixer, especially for products containing dried molasses. If you haven't already done so, you should establish that the flush method you use cleans out the remainder of preceding batches containing prohibited materials.
During the inspection, our investigator verbally advised that your batch records should clearly document that the mixing system was cleaned or flushed in accordance with your approved procedures. It was not clear that writing "yes" on the mixing record meant the system should be flushed or that it had been done. The person conducting the clean-out or flush should document the procedure by initialing and dating the batch record immediately after the step is completed.
snip...
http://www.fda.gov/foi/warning_letters/m5239n.pdf
Mr. Terry D. Viktorin Co-Owner Z$W Mill, Inc. P.O. Box 236 Torrington, Wyoming 82240
http://www.fda.gov/foi/warning_letters/g1083d.pdf
Bryan Enterprises 29946 Route 30 West Hanoverton, Oh. 44423
cross contamination violations, no records, etc.
http://www.fda.gov/foi/warning_letters/m5227n.pdf
Hartville Elevator Company, Inc. cross contamination, no records etc.
http://www.fda.gov/foi/warning_letters/m5195n.pdf
DEPARTMENT OF HEALTH AND HUMAN SERVICE
April 4, 2001
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. Mat Geib Owner Greeley Elevator Company 700 6th Street Greeley, Colorado 80631
Ref. #: DEN-01-26
Dear Mr. Geib:
An inspection of your animal feed manufacturing operation located at Greeley, Colorado, conducted by Colorado Department of Agriculture Inspectors on February 20, 2001, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and/or distributed by your facility to be adulterated within the meaning of section 402(a)(4) and misbranded within the meaning of Section 403(F) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection found that your procedures to prevent cross-contamination are inadequate in that:
You do not have written procedures specifying the clean-out procedures for your feed mixer.
You do not maintain records sufficient to track materials containing meat and bone meal throughout their receipt, processing, and distribution.
Our investigation also found that you fail to label your product, Greeco Lay Mash with meat and bone meal, with the required cautionary statement 'Do Not Feed to Cattle or Other Ruminants".
The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulations.
Page 2 - Greeley Elevator Company March 27, 2001
We find it quite disturbing that the above violations still exist considering you have been advised on at least 2 occasions of these requirements. In fact, during the previous inspection of April, 2000, you advised the Inspector you no longer use meat and bone meal. At the beginning of the current inspection the Inspector was again told by the firm's agronomist that no meat and bone meal was being used. On inspection of the mixing area and the basement storage area, the Inspector found both labeled and unlabeled bags of meat and bone meat and was told by an employee that it was used in the Greeco Lay Mash formula.
You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to make immediate and lasting corrections will result in regulatory action without further notice including seizure, and/or injunction.
You should notify this office in writing within 15 working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, that has been taken, or will be 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 time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your response should be sent to Tom Warwick, Compliance Officer, Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. He may be reached at (303) 236-3054 if you have any questions about this matter.
Sincerely, Thomas A. Allison District Director
http://www.fda.gov/foi/warning_letters/g1126d.pdf
April 16, 2001
Richard A. Warren Manager Perry Coal and Feed Company 4204 Main Street Perry, Ohio 44081
[a summary of violations]
* no written procedures for cleaning out and flushing equipment after mixing feeds containing prohibited material.
* NO processing records or records documenting that the system was cleaned or flushed.
http://www.fda.gov/foi/warning_letters/g1140d.pdf
April 16, 2001 Alan R. Beckwith General Manager Jeffers
on Milling Company 168 East Jefferson Street Jefferson, Ohio 44047
[a summary of violations]
* no written procedures for cleaning out or flushing equipment after mixing feeds containing prohibited materials
* Your firm DOES NOT perform a flush out...
* NO records etc.
http://www.fda.gov/foi/warning_letters/g1141d.pdf
April 16, 2001 Gary E. Berrier Owner Dorset Milling P.O. Box 2 2358 State Route 193 Dorset, Ohio 44032
[summary of violations]
* no written procedures for cleaning and flushing
* firm does not always perform a flush out
* NO processing records
* firm has not been labeling feeds that may contain the cross contamination
* firm does also does not maintain records of sales of feed that contain, or may contain, prohibited protein materials
http://www.fda.gov/foi/warning_letters/g1142d.pdf
Subject: MORE AND MORE U.S.A. MAD COW FEED BAN VIOLATIONS OF THE INFAMOUS 8/4/97 FEED BAN 'THAT NEVER WAS'
Date: May 25, 2001 at 12:50 pm PST
Mr. Jerry M. Behimer, President Material Resources, LLC - Gateway Co-Packing Company 901 Kingshighway Washington, IL 62204
Dear Mr. Behimer;
snip;
Specifically, our investigator found the following violations during the inspection;
* Your firm does not provide adequate measures to avoid commingling or cross-contamination of prohibited and non-prohibited protein material.
* Your firm has no written procedures that document measures that have been adopted to prevent commingling or cross-contamination, between feeds that contain prohibited protein with feeds that contain non-prohibited materials.
* Your firm lacks adequate records to track products that contain, or may contain, prohibited material, prohibited material throughout their receipt and processing.
The above is not intended to be an all-inclusive list of violations...
snip...
http://www.fda.gov/foi/warning_letters/g1247d.pdf
==============
Reid Kooch, President Wallowa County Grain Growers, Inc. 911 S. River Enterprise, Oregon 97828
Dear Mr. Kooch:
snip...
Our Investigation found a failure to separate the receipt, processing and storage of the product containing prohibited material from non-prohibited material; failure to establish a written system, including clean-out, and flushing procedures, to avoid commingling and cross-contamination of common equipment; failure to maintain records sufficient to track the materials throughout the receipt, processing and distribution of your products.
The above is not intended to be an all-inclusive list of deviation from the regulations...
snip...
http://www.fda.gov/foi/warning_letters/g1265d.pdf
Subject: MORE SERIOUS BREACHES OF U.S.A. MAD COW 'PARTIAL' FEED BAN, that never was...
Date: May 16, 2001 at 12:07 pm PST
thought i would bring to your attention the fact that the FDA has again been issuing these same letters to feed manufacturers for years, to no avail, same as the infamous 'Dear Manufacturer' letters to the Nutritional Supplement manufacturers. Those letters have been circulating since the late 80s early 90s. AGAIN, to no avail, these manufacturers, as with the brain dead feed manufacturers, are laughing all the way to the bank, even though the risks of spreading these human/animal TSEs are very real. Apparently, the FDA has absolutely NO enforcement of regulations over them.
Terry S. Singeltary Sr., Bacliff, Texas USA
D.W. Knight President Farmers Mill & Elevator Company 265 Main Street Dexter, Georgia 31019
snip...
Of particular concern is that these same violations were pointed out during the previous inspection of this facility on October 21, 1998. That inspection was conducted by the Georgia Department of Agriculture. The two violations noted were the failure to establish flush procedures for the use of prohibited materials and feed labels not including the cautionary statement.
http://www.fda.gov/foi/warning_letters/g1197d.pdf
Kenneth H. Sherwood, President Alaska Garden and Pet Supply, Inc. 114 N. Orca Anchorage, Alaska 99501
http://www.fda.gov/foi/warning_letters/g1211d.pdf
'ANIMAL PROTEIN' SEARCH 9/9/02
==============================
Darling International, Inc. 5/07/02 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF] [HTML] All American Feed & Tractor 4/01/02 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF] [HTML] Tyson Foods 2/12/02 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF] [HTML] The Feed Bucket 12/11/01 Atlanta District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF] [HTML] Finlayson Ag Center 11/08/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF] [HTML] Dixon Feeds, Inc. 10/24/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF] [HTML] Buckeye Feed Mills, Inc. 9/20/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF] [HTML] Wilcox Farms, Inc. 9/14/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF] [HTML]
http://www.accessdata.fda.gov/scripts/wlcfm/full_text.cfm?full_text=animal+protein&Search=Search
now, compare search on 8/8/01...tss
'ANIMAL PROTEIN' SEARCH 8/8/01
==============================
Date: Tue, 28 Aug 2001 11:13:43 -0700
Reply-To: BSE-L Sender: Bovine Spongiform Encephalopathy BSE-L
From: "Terry S. Singeltary Sr."
Subject: MAD COW FEED BAN WARNING LETTERS U.S.A. AUGUST 8, 2001
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421
Telephone: 426-486-8788 FAX: 426-483-4996
August 8, 2001
VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 01-75
William W. Himmelspach, Owner 22195 S.W. 78th Tualatin, Oregon 97062
WARNING LETTER
Dear Mr. Himmelspach:
An investigation at your animal feed manufacturing operation located at 22195 S.W. 78th Tualatin, Oregon 97062, conducted by a Food and Drug Administration investigator on July 12, 2001, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured at this facility to be adulterated within the meaning of Section 402(a)(2)(C), and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act).
Our investigation found a failure to separate the receipt, processing, and storage of the product containing prohibited material from non-prohibited material; failure to establish a written system, including clean-out and flushing procedures, to avoid commingling and cross-contamination of common equipment; and failure to maintain records sufficient to track the materials throughout the receipt, processing, and distribution of your products.
In addition, our investigation found a failure to label your products with the required cautionary, statement "Do Not Feed to Cattle or Other Ruminants," Your pig feeds, containing prohibited materials, were not labeled with the cautionary statement, and you reuse poly-tote bags for ruminant feed and pig feed, where the bags could become contaminated with prohibited material. The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with
William W. Himmelspach Tualatin, Oregon Re: Warning Letter SEA 01-75 Page 2
your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulation.
You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 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 that corrections have been made.
Your reply should be directed to the Food and Drug Administration, Attention: Bruce Williamson, Compliance Officer. If you have any questions please contact Mr. Williamson at (425) 483-4976.
Sincerely,
Charles M. Breen District Director
Enclosure; Form FDA 483 Small Entity Compliance Guide
http://www.fda.gov/foi/warning_letters/g1619d.pdf
Warning Letters Index - Search Form Results Company Name Date Issued Issuing Office
Subject
File Adrian Elevator, Inc. 5/03/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Alaska Garden and Pet Supply, Inc. 4/27/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File Bryan Enterprises 2/20/01 Cincinnati District Office Feed Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Carrollton Farmers Exchange 7/12/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Centerburg Mill and General Store, Inc 3/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Centerburg Mill and General Store, Inc. 5/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Central Ohio Farmers Cooperative, Inc. 5/24/01 Cincinnati District Office Animal Protein Prohibited in Ruminant Feed
View File Champaign Landmark, Inc. 3/05/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded
View File Countryline Co-Op, Inc. 5/14/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Dorset Milling 4/16/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Earl B. Olson Feed Mill 4/23/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Faler Feed Store, Inc. 3/21/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Farmers Mill & Elevator Company 3/30/01 Atlanta District Office Animal Proteins Prohibited in Ruminant Feed
View File Farnam Companies, Inc. 7/20/01 Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Greeley Elevator Company 4/04/01 Denver District Office Animal Proteins Prohibited in Ruminant Feed
View File Hartville Elevator Company, Inc. 2/22/01 Cincinnati District Office Feed Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Himmelspach, William W. 8/08/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File Integral Fish Foods, Inc. 6/12/01 Denver District Office Animal Proteins Prohibited in Ruminant Feed
View File Jefferson Milling Company 4/16/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Lime Creek Ag Services, Inc. 4/25/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Material Resources LLC 5/04/01 Chicago District Office Animal Proteins Prohibited in Ruminant Feed
View File Material Resources, LLC 5/04/01 Chicago District Office Animal Protein Prohibited in Ruminant Feed
View File Medina Landmark, Inc. 3/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Minister Farmers Cooperative Exchange, Inc. 4/10/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Feed Mill
View File Peco Foods, Inc. 2/23/01 New Orleans District Office CGMP Requirements for Medicated Feeds/Animal Proteins Prohibited in Ruminant Feed
View File Perry Coal and Feed Company 4/16/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Rietdyk's Milling Company 3/05/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File River Valley Co-Op 3/22/01 Cincinnati District Office Animal Proteins Prohibeted in Ruminant Feed
View File River Valley Co-Op 5/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Round Lake Farmers Coop. 5/30/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Rudy, Inc. 3/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Rudy, Inc. 5/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Sandy Lake Mills 4/09/01 Philadelphia District Office Animal Proteins Prohibited in Ruminant Feed
View File Shields Feed and Supply Company 3/07/01 New Orleans District Office Animal Proteins Prohibited in Ruminant Feed
View File Stewart's Farm Supply 3/21/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Superior Feeds 6/06/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File The Scoular Company 5/30/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File University of Minnesota 5/10/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Valley Feed Mill, Inc. 5/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Wallowa County Grain Growers, Inc. 5/17/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File Wallowa County Grain Growers, Inc. 5/17/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File Western Reserve Farm Cooperative 3/21/01 Cincinnati District Office Animal Protein Prohibited in Ruminant Feed
View File Yachere Feed, Inc. 4/09/01 Philadelphia District Office Animal Proteins Prohibited in Ruminant Feed
View File Z & W Mill, Inc. 3/27/01 Denver District Office Animal Proteins Prohibited in Ruminant Feed
View File
http://63.75.126.221/scripts/wlcfm/resultswl.cfm
(TYPE IN 'ANIMAL PROTEIN')
Food and Drug Administration
Cincinnati District Office Central Region 6T51 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700
CERTIFIED MAIL RETURN RECEIPT REQUESTED
WARNING LETTER CIN-WL-6934-01
March 23, 2001
Randall A. Hegenderfer President The Centerburg Mill and General Store, Inc 108 North Hartford Avenue, Box 207 Centerburg, OH 43011
Dear Mr. Hegenderfer:
An inspection of your feed mill was conducted by a Food and Drug Administration (FDA) investigator on March 1, 2001. This inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigator was verbally told that you have separate processing equipment for products containing prohibited materials, but the equipment is not identified, there are no written procedures to address separation of the products, and there are no processing records for products which contain, or may contain, prohibited material.
Your records must allow your firm to track products that contain, or may contain, prohibited material throughout their receipt, processing, and distribution. This includes records of cash sales.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulation.
You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 15 days, state the reason for the delay and the date by which the
Page -2-
corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Deborah Grelle, Director of Compliance, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Oh 45237, telephone (513) 679-2700 extension 160.
Sincerely yours,
Henry L. Fielden District Director
Enclosure: Small Entity Compliance Guide
Cc: David Schleich, Chief Plant Industry Division Ohio Department of Agriculture 8995 East Main Street Reynoldsburg, OH 43068-3399
===========================
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700
CERTIFIED MAIL RETURN RECEIPT REQUESTED
WARNING LETTER CIN-WL.-6916.-01
March 22, 2001
Michael S. McCandlish Branch Manager River Valley Co-Op 508 North Oak Street Baltimore, OH 43105
Dear Mr. McCandlish:
An inspection of your feed mill was conducted by a Food and Drug Administration (FDA) investigator on March 2, 2001. This inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) and misbranded within the meaning of Section 403(0 of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection found your firm fails to label feeds which contain, or may contain, prohibited materials with the required cautionary statement "Do not feed to Cattle or Other Ruminants". We suggest this statement be distinguished by different type size or color or other means of highlighting the statement so it is easily noticed by the purchaser.
Our investigation found your procedures to prevent cross contamination are inadequate in that:
· There are no written procedures for cleaning out or flushing equipment after mixing feeds containing prohibited material.
You should establish adequate procedures and verify that the flush/clean-out method you use cleans out the remainder of preceding batches containing prohibited materials. Note: If you flush with feed ingredients, or sequence with non-ruminant feed, you must label these products with the required cautionary statement "Do not feed to Cattle or Other Ruminants"
There are no processing records or records documenting that the system was cleaned or flushed in accordance with your approved procedures.
Customer records are not adequate to track products that contain, or may contain, prohibited material.
Page-2-
This letter is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulation.
You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 15 days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Note: The need for clean-out procedures and the required cautionary statement was previously discussed with you on May 5, 1999 by Dennis Frayel, an investigator with the Ohio Department of Agriculture (ODA). At that time you verbally told the ODA representative that these deficiencies would be corrected. Please explain why corrections were not made following the ODA inspection.
Your reply should be directed to Deborah Grelle, Director of Compliance, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Oh 45237, telephone (513) 679-2700 extension 160.
Sincerely yours,
Henry L. Fielden District Director
Enclosure: Small Entity Compliance Guide
Cc: David Sehleich, Chief Plant Industry Division Ohio Department of Agriculture 8995 East Main Street Reynoldsburg, OH 43068-3399
Michael D. Wood River Valley Co-Op 254 West High Street London, OH 43140
==================
Centerburg Mill and General Store, Inc 3/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1049d.pdf
Medina Landmark, Inc. 3/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1048d.pdf
River Valley Co-Op 3/22/01 Cincinnati District Office Animal Proteins Prohibeted in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1045d.pdf
Rudy, Inc. 3/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1047d.pdf
Faler Feed Store, Inc. 3/21/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
url was not available, shows 'error'...tss
Stewart's Farm Supply 3/21/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1043d.pdf
Western Reserve Farm Cooperative 3/21/01 Cincinnati District Office
Animal Protein Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1038d.pdf
http://63.75.126.221/scripts/wlcfm/recentfiles.cfm
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER Animal Proteins Prohibited in Ruminant Feed/Misbranded DEC. 9, 2004
Date: Tue, 21 Dec 2004 16:04:44 -0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: cjdvoice@yahoogroups.com
Public Health Service Food and Drug Administration
New Orleans District Southeast Region 6600 Plaza Drive, Suite 400 New Orleans, Louisiana 70127 Telephone: 504-253-4519 Facsimile: 504-253-4520
December 9, 2004
WARNING LETTER NO. 2005-NOL-07
FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. Alan O. Bostick, President Sunshine Mills, Inc. 500 6th Street SW Red Bay, Alabama 35582
Dear Mr. Bostick:
On September 7 and 14, 2004, a United States Food and Drug Administration (FDA) investigator inspected your animal feed manufacturing facility, located at 2103 South Gloster Street, Tupelo, Mississippi. 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. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products you manufactured and/or distributed are misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection indicated you manufacture products containing beef meat and bone meal. Products that contain or may contain protein derived from mammalian tissues, as defined by 21 CFR 589.2000(a), and are intended for use in animal feed, must be labeled with the cautionary statement Do not feed to cattle or other ruminants. This is required by 21 CFR 589.2000(c)(1)(i). Your firm failed to label your non-ruminant products with this required cautionary statement. Specifically, the products that contained protein derived from mammalian tissues but lacked the required statement included your Happy Fisherman and Premier catfish feeds. Under 21 CFR 589.2000(g)(2), failure of these feeds to bear the required cautionary statement causes them to be misbranded under Section 403(a)(1) of the Act.
The above is not intended to be an all-inclusive list of deviations from regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring your overall operation and products you manufacture and distribute are in compliance with the law. A copy of FDAs Small Entity Compliance Guide is enclosed to assist you in complying with the regulations.
You should take prompt action to correct these violations and establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.
We are aware you sent label corrections for the last shipment of each of the mislabeled products. You also stated you plan [redacted] However, you should notify this office in writing, within 15 working days of the receipt of this letter, of the 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 violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for delay and date by which corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at the above address. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (504) 253-4519.
Sincerely,
/s
H. Tyler Thornburg District Director New Orleans District
Enclosures: FDA Form 483 FDAs Small Entity Compliance Guide 21 CFR 589.2000
cc: [redacted] General Manager Sunshine Mills, Inc. 2103 South Gloster Street Tupelo, Mississippi 38801
http://www.fda.gov/foi/warning_letters/g5105d.htm
-------- Original Message --------
Subject: MAD DEER FEED BAN WARNING LETTER RECALL 6 TONS DISTRIBUTED USA Date: Wed, 20 Oct 2004 14:53:56 -0500
From: "Terry S. Singeltary Sr." <flounder@WT.NET>
Reply-To: Bovine Spongiform Encephalopathy <BSE-L@UNI-KARLSRUHE.DE>
To: BSE-L@UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy #####################
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
http://www.fda.gov/
################# BSE-L-subscribe-request@uni-karlsruhe.de #################
-------- Original Message --------
Subject: Re: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) !
Date: Tue, 24 Jun 2003 16:59:41 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
References: <3EE5D269.9040504@wt.net>
i hate to keep kicking a mad cow here, but i thought since the FDA et al still refuses to tell us about _all_ the ruminant-to-ruminant feed ban violations, i thought i would go over a few of the old ones i might have missed. BOY, did i miss one. has all this feed been confirmed to have been recalled? how much is still out there?
RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
________
PRODUCT & 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.
snip...
END OF ENFORCEMENT REPORT FOR June 6, 2001.
http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00696.html
wish someone would give us that update they were speaking of a year or so ago;
Database Change
IMPORTANT: After March 11, 2002, FDA discontinued the database that was used to compile these listings. The Agency started a new database on April 15, 2002, and future updates on BSE enforcement and inspectional findings will draw from it. The format of the information presented here may change, due to design changes of the new database. The site was to be updated after a period of time to allow for transition into the new database system. Please note that the information presently available below is outdated. This site will be updated very shortly.
http://www.fda.gov/cvm/efoi/InpectionListDescriptionforHP.htm
i guess figuring the time period on the reply from the FOIA request of being about a year or so, and still no results, why should this surprise me?
USA/CANADA/MEXICO BSE GBR SHOULD BE CHANGED TO BSE GBR III ASAP!
TSS
Date: Sun, 12 Jan 2003 12:56:44 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Re: USA ruminant-to-ruminant feed ban warning letters ???
######## Bovine Spongiform Encephalopathy #########
Greetings List Members,
as you know, i finally had to request to the FOIA for the USA madcow feed ban warning letters. so i thought some of you may be interested in an update on this matter.
so here it is;
Subject: Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed Ban Violations Jan. 2001 to Jan. 2003
Date: Mon, 6 Jan 2003 08:32:43 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L
Food and Drug Administration Office of Information Resources Management Division of Freedom of Information (HFI-35) 5600 Fishers Lane Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.
1/6/03
Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed Ban Violations Jan. 2001 to Jan. 2003
Greetings FDA and To Whom it may concern,
i wish to request all ruminant-to-ruminant feed ban violations from Jan. 2001 to Jan. 2003. it seems none has been posted since May 2001 on the FDA site. I also kindly request that all fees be wavered due to the fact this is public information, public health is at risk, and this will be distributed 'freely' to the public...
thank you, kind regards,
I am sincerely,
Terry S. Singeltary Sr. P.O. Box Bacliff, Texas USA 77518
CJD Watch
==========================================================
now since then, just this past Friday 1/10/03, i get this from FDA;
REPLY FROM DPH/FDA to TSS;
PLEASE note, my request was for all R-T-R feed ban violations from Jan. 2001 to Jan. 2003. BUT in the reply, they posted Jan. 2002 to Jan. 2003. i called and this is to be corrected. hopefully this FOIA request will ignite some enthusiasm from the FDA into posting to the public any R-T-R MAD COW FEED BAN violations, since GW et al new policy on secrecy took effect on this matter in May of 2002 (correcting my below 'since May 2001).
TSS
Department of Health & Human Services
Food and Drug Administration Rockville MD 20857
1/7/03
In reply refer to;
xxxxxxx
Dear Requester,
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding;
RUMINANT-TO-RUMINANT FEED - BAN VIOLATIONS 1/02 - 1/03
We will respond as soon as possible and may charge you a fee for processing your request. If you have any questions about your request, please call Edna G. Wilkerson, Information Technician, at 301-827-6564 or write to us at;
Food and Drug Administration Division of Freedom of Information 5600 Fishers Lance, HFI - 35 Rockville, MD 20857
If you call or write, use the reference number above which will help us to answer your questions more quickly...
===========================================================
now, Sunday, i read this in the Houston Chronicle 1/12/03;
SENATOR AIMS TO UPGRADE FREEDOM OF INFORMATION
TEXAS Sen. John Coprnyn says he wants to improve public access to government records in Washington, a position that appears to put him at odds with the Bush administration.
Cornyn, a moderate Republican who sits on the Senate Judiciary Committee, said he'll work on legislation in the coming weeks to improve the Freedom of Information Act.
"FOIA needs to be strenghened," he said, "We need to quicken the turnaround time and create a mechanism that allows an indepentent, third party to decide whether a record should be kept secret."
Echoing sentiments he expressed while serving as Texas attorney general, Cornyn added: "I believe in a system of governement that allows consent of the people. And people can't consent if they don't what their elected officials are doing."
Since taking office two years ago, the Bush Administration has taken steps to restrict access to governement information, an effort that was accelerated in the name of national security following the Sept. 11 terrorist attacks......
Greetings again BSE-L list members,
how would _USA_ ruminant-to-ruminant feed ban warning letters have anything to do with terrorism and National Security?
WE KNOW HOW THE FOIA WORKS DON'T WE ;
Monday, September 1, 2008 RE-FOIA OF DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [No. 00-072-1] September 1, 2008
http://foiamadsheepmadrivervalley.blogspot.com/2008/09/re-foia-of-declaration-of-extraordinary.html
WHO WOULD WANT A USDA CERTIFIED MAD COW BRAIN TO EAT ???
OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .
World 37,727 33 363,222 344
Mexico 37,727 33 338,475 326
Romania 0 0 24,747 19
0206290010: HEARTS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 581,872 418 7,564,955 5,685 Angola 0 0 211,527 46 Cambodia (Kampuchea) 0 0 22,682 60 China 0 0 49,887 36 Colombia 0 0 22,657 28 Gabon 0 0 24,947 11 Hong Kong 0 0 24,494 45 Indonesia 400,639 261 4,420,683 2,747 Italy 0 0 24,494 20 Korea 0 0 124,089 71 Mexico 181,233 157 2,494,078 2,517 Poland 0 0 47,359 20 Russia 0 0 98,058 85
0206290020: KIDNEYS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram)
December 2004 2004, through December Quantity Value Quantity Value .World 303,293 175 3,009,780 1,684 Angola 0 0 60,075 15 Bahamas 0 0 11,431 8 Cayman Islands 0 0 4,450 10 China 0 0 48,988 26 Gabon 48,200 15 489,329 206 Hong Kong 0 0 48,988 26 Indonesia 0 0 47,174 17 Ivory Coast 188,414 96 1,694,772 959 Jamaica 10,546 5 78,933 37 Mexico 56,133 59 203,788 204 Moldova 0 0 295,091 166 Romania 0 0 26,761 10
0206290040: SWEATBREADS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 0 0 95,209 83 Bulgaria 0 0 25,243 22 Ghana 0 0 0 0 Mexico 0 0 69,859 58 Netherlands 0 0 107 4
0206290050: LIPS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 1,389,825 2,709 7,355,294 13,917 Bahamas 0 0 40,000 5 Mexico 1,386,800 2,706 7,293,673 13,895 Montserrat 0 0 18,596 15 Namibia 3,025 3 3,025 3
0206290090: OFFAL OF BOVINE ANIMALS, EDIBLE, NESOI, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 2,386,597 2,913 22,701,393 25,320 Antigua Barbuda 2,141 6 3,162 11 Argentina 590 4 1,044 7 Aruba 1,000 4 1,476 10 Bahamas 0 0 117,929 184 Bulgaria 0 0 315,543 301 Canada 337,392 255 3,544,821 3,347 Cayman Islands 0 0 5,350 21 China 0 0 22,185 37 Colombia 0 0 24,127 36 Cyprus 0 0 25,052 20 Denmark 0 0 46,416 25 Dominican Republic 0 0 24,086 16 Egypt 0 0 145 3 Gabon 96,208 92 316,411 271 Germany 0 0 2,545,197 554 Greece 0 0 190,564 146 Guatemala 0 0 117,362 197 Haiti 0 0 13,125 25
Haiti 0 0 13,125 25 Honduras 23,940 34 23,940 34 Hong Kong 0 0 48,343 130 Indonesia 7,470 9 640,472 249 Italy 0 0 47,849 38 Ivory Coast 192,410 184 1,133,273 1,012 Jamaica 80,703 54 124,514 86 Japan 25,094 53 432,608 2,659 Korea 0 0 23,596 25 Malaysia 97,997 48 457,516 203 Mexico 1,376,419 1,977 9,425,957 13,261 Netherlands 20,229 20 245,555 129 New Zealand 0 0 0 0 Panama 23,399 44 161,425 117 Philippines 0 0 22,184 39 Poland 0 0 805,355 477 Romania 48,988 33 1,294,879 1,191 Senegal 0 0 52,909 103 Singapore 0 0 728 3 Spain 0 0 202 4 St Christopher-Nevis 0 0 1,020 3 St Lucia 0 0 5,313 8 Switzerland 0 0 6,506 35 Taiwan 46,920 86 97,268 127 Trinidad and Tobago 0 0 38,102 84 Turks and Caicos Islands 5,697 9 6,082 13 United Kingdom 0 0 291,303 76 Uruguay 0 0 499 4
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020629.html
0206100000: OFFAL OF BOVINE ANIMALS, EDIBLE, FRESH OR CHILLED
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 149,260 308 1,312,166 2,933 Bahamas 2,174 3 6,710 6 Canada 15,265 14 115,659 129 Cayman Islands 0 0 1,312 5 China 48,988 44 48,988 44 Egypt 0 0 27,654 81 Gabon 0 0 97,462 80 Hong Kong 0 0 48,988 30 Indonesia 0 0 38,000 33 Ivory Coast 0 0 127,000 108 Kuwait 0 0 12,487 36 Mexico 82,833 247 667,881 2,070 Philippines 0 0 26,797 88 Taiwan 0 0 43,544 30 Turks and Caicos Islands 0 0 1,907 3 United Arab Emirates 0 0 47,777 190
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020610.html
0206210000: TONGUES OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 432,185 755 3,479,807 6,127 Bangladesh 23,623 38 47,380 77 Honduras 15,163 28 17,105 31 Hong Kong 0 0 47,151 86 Indonesia 0 0 83,245 193 Japan 0 0 25,697 57 Kazakhstan 0 0 145,001 175 Mexico 368,562 638 3,046,441 5,384 Nicaragua 6,537 13 6,537 13 Philippines 18,300 38 61,250 111
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020621.html
0206220000: LIVERS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 5,712,394 4,115 55,278,021 38,020 Albania 0 0 74,863 45 Angola 24,677 22 888,634 430 Antigua Barbuda 2,682 3 5,111 5 Azerbaijan 97,471 45 633,575 324 Bahamas 1,836 3 10,561 8 Belarus 0 0 355,818 130 Belgium 488,886 295 2,998,386 1,265 Bulgaria 0 0 355,234 310 Canada 18,416 49 372,057 910 Dominican Republic 0 0 13,599 7 Ecuador 0 0 8,378 5 France 0 0 92,361 29 Georgia 0 0 243,876 170 Germany 609,187 323 2,104,312 908 Greece 0 0 149,205 87 Guatemala 0 0 19,962 11 Honduras 65,432 30 196,264 104 India 0 0 67,491 55 Indonesia 769,971 1,139 4,495,414 7,077 Iraq 0 0 48,984 21 Italy 0 0 9,002 12 Ivory Coast 0 0 24,701 8 Jamaica 170,782 137 170,782 137 Kazakhstan 0 0 868,130 762 Korea 0 0 23,593 17 Kuwait 0 0 1,560 7 Latvia 0 0 577,885 166 Liberia 0 0 24,950 16 Liechtenstein 0 0 24,369 11 Lithuania 0 0 996,660 552 Madagascar 0 0 24,494 10 Mali 0 0 49,211 40 Mexico 264,561 131 5,094,330 5,868 Moldova 249,107 125 2,743,394 1,314 Mozambique 0 0 24,093 17 Netherlands 0 0 49,520 26 Nicaragua 31,131 19 48,335 25 Philippines 24,504 14 97,948 156 Poland 1,553,201 953 23,262,526 13,113 Romania 0 0 199,072 121 Russia 0 0 544,267 225 Saudi Arabia 70,805 88 243,230 381 Senegal 0 0 285,311 302 Turkey 884,029 496 1,733,636 881 Ukraine 0 0 244,559 132 United Kingdom 362,446 235 4,709,748 1,792 Venezuela 0 0 45,360 19 Zaire 23,270 9 23,270 9
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020622.html
0201203550: MEAT OF BOVINE ANIMALS, NESOI, CUTS WITH BONE IN, PROCESSED, FRESH OR CHILLED
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 293,718 1,252 703,296 2,552 Anguilla 0 0 11,482 35 Aruba 0 0 4,775 24 Bahamas 19,416 50 247,589 684 Barbados 0 0 14,377 33 Bermuda 0 0 1,361 3 Cayman Islands 0 0 13,502 48 Colombia 244,578 738 244,578 738 France 6,242 368 6,700 400 Germany 1,564 48 1,564 48 Guatemala 21,918 49 21,918 49 Honduras 0 0 19,051 24 Hong Kong 0 0 14,618 76 Indonesia 0 0 1,008 3 Italy 0 0 750 6 Korea 0 0 6,023 35 Marshall Islands 0 0 37,817 121 Mexico 0 0 20,347 21 Netherlands Antilles 0 0 449 8 St Lucia 0 0 436 4 Suriname 0 0 240 4 Switzerland 0 0 2,402 81 Trinidad and Tobago 0 0 6,047 18 Turks and Caicos Islands 0 0 26,262 90
0201206000: MEAT OF BOVINE ANIMALS, CUTS WITH BONE IN, EXCEPT PROCESSED, FRESH ORCHILLED
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 86,480 824 698,955 4,793 Antigua Barbuda 0 0 410 6 Bahamas 10,521 27 60,334 200 Bahrain 0 0 3,721 11 Canada 39,462 342 472,538 3,481 Chile 0 0 9,694 29 Dominican Republic 0 0 28,327 37 French Polynesia 0 0 1,596 10 Greece 0 0 2,825 16 Honduras 0 0 9,887 20 Japan 0 0 0 0 Mexico 0 0 9,189 28 Netherlands Antilles 478 8 4,250 44 Philippines 0 0 393 3 Saudi Arabia 1,053 15 22,470 102 St Lucia 0 0 372 3 Svalbard, Jan Mayen Island 34,064 430 57,812 715 Trinidad and Tobago 0 0 6,258 59 Turks and Caicos Islands 902 3 8,879 29
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020120.html
Greetings,
IN 2009, it would be a miracle that every cow in the United States of America was not exposed to mad cow disease via feed, the number one firewall all the officials brag about all the time $$$
----- Original Message -----
From: "TERRY SINGELTARY" <flounder9@VERIZON.NET>
To: <BSE-L@LISTS.AEGEE.ORG>
Sent: Wednesday, March 18, 2009 4:25 PM
Subject: [BSE-L] HERE WE GO AGAIN, FDA TO DELAY ENHANCED MAD COW FEED BAN RULE
-------------------- BSE-L@LISTS.AEGEE.ORG --------------------
Industry News - PM FDA to delay enhanced feed ban rule
By Tom Johnston on 3/18/2009
The Food and Drug Administration will extend by 60 days the April 27 effective date of the agency's enhanced ban on high-risk cattle material in feed for all animals, according to industry sources.
The decision comes as the Obama administration reviews rules not yet in effect and considers extending the implementation dates by 60 days. In such cases, agencies also are directed to allow for an additional 30 days for public comment.
FDA will soon publish a notice in the Federal Register.
Packers and renderers, among others in the food chain, have been pressing FDA to delay implementing the enhanced feed ban and allow for additional public comment in light of hardships they already have begun to incur in the run-up to the rule's implementation. To view the final rule, click here.
Primary among the challenges, they say, is disposal of banned materials such as spinal cords and brains from cattle older than 30 months of age. Some renderers, for example, already have been refusing to take such materials or older dead stock off of packers' hands, forcing them to find other methods of disposal that can be costly and problematic.
Editor's Note: More details about the impacts of this rule will be included in a feature article in the May issue of Meatingplace magazine.
http://www.meatingplace.com/MembersOnly/webNews/details.aspx?item=11718
SIGH!
does this really surprise anyone $
i said it during the clinton era, i said for 8 years during the bush blunder, and i am saying now. it seems the industry i.e. has bought it's way deeply into the white house, no matter whom is in office. the people do not own it anymore.
there was nothing more to look at except $$$
there is nothing more to talk about.
the partial, and voluntary august 4, 1997 ruminant to ruminant feed ban was nothing more than ink on paper, and that's all it is today.
sadly, that's all this has ever been about, money. science, public health, nothing else matters. just ask old stan the man, the prion man ;
Tuesday, March 17, 2009
BSE Feed Ban Enhancement: Implementation Questions and Answers Updated March 10, 2009
http://madcowfeed.blogspot.com/2009/03/bse-feed-ban-enhancement-implementation.html
DAMNING TESTIMONY FROM STANLEY PRUSINER THE NOBEL PEACE PRIZE WINNER ON PRIONS SPEAKING ABOUT ANN VENEMAN
''they don't wanna know, the dont' care'' "they don't want our comments'' ''level of absolute ignorance'' ''beef export'' ''nothing else matters'' ''yes, i think prions are bad to eat, and you can die from them''
http://maddeer.org/video/embedded/prusinerclip.html
Saturday, February 21, 2009 Renderers say industry not prepared for FDA feed ban rule ??? WHAT, IT'S 2009 FOR PETE'S SAKE $$$ Two recent articles caught my eye ;
Renderers say industry not prepared for FDA feed ban rule
Food Chemical News
February 2, 2009
and
BSE, rendering relate to human safety
Emma Struve 02/17/2009
http://madcowfeed.blogspot.com/2009/02/renderers-say-industry-not-prepared-for.html
Risk of Introduction of BSE into Japan by the Historical Importation of Live Cattle from the United Kingdom (USA AND CANADA)
http://bseusa.blogspot.com/2009/03/risk-of-introduction-of-bse-into-japan.html
Wednesday, January 28, 2009
TAFS1 Position Paper on Specified Risk Materials (January, 2009)
TAFS INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation
(January 2009)
TAFS1 Position Paper on Specified Risk Materials
http://madcowspontaneousnot.blogspot.com/2009/01/tafs1-position-paper-on-specified-risk.html
TAFS1 Position Paper on Testing of Cattle for BSE (Revision January 2009)
http://madcowtesting.blogspot.com/2009/02/tafs1-position-paper-on-testing-of.html
Wednesday, February 11, 2009 Atypical BSE North America Update February 2009
http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html
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
___________________________________
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
___________________________________
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
Friday, November 21, 2008
Plasma & Serum Proteins Receive Continued FDA Approval
http://madcowfeed.blogspot.com/2008/11/plasma-serum-proteins-receive-continued.html
http://madcowfeed.blogspot.com/
Thursday, November 27, 2008 Prion diseases are efficiently transmitted by blood transfusion in sheep
http://vcjdblood.blogspot.com/2008/11/prion-diseases-are-efficiently.html
Scientists warn of first ever case of human mad cow disease from blood plasma
http://vcjdtransfusion.blogspot.com/2009/02/scientists-warn-of-first-ever-case-of.html
November 25, 2008
Update On Feed Enforcement Activities To Limit The Spread Of BSE
http://madcowfeed.blogspot.com/2008/11/november-2008-update-on-feed.html
Docket APHIS-2007-0033 Docket Title Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Docket Type Rulemaking Document APHIS-2007-0033-0001 Document Title Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Public Submission APHIS-2007-0033-0002.1 Public Submission Title Attachment to Singeltary comment
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648027c28e
Manuscript Draft Manuscript Number: Title: HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory Article Type: Personal View Corresponding Author: Mr. Terry S. Singeltary, Corresponding Author's Institution: na First Author: Terry S Singeltary, none Order of Authors: Terry S Singeltary, none; Terry S. Singeltary Abstract: TSEs have been rampant in the USA for decades in many species, and they all have been rendered and fed back to animals for human/animal consumption. I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2007.
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648027c28e&disposition=attachment&contentType=pdf
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 Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE
IS THERE A SCRAPIE-LIKE DISEASE IN CATTLE ?
In April of 1985, a mink rancher in Wisconsin reported a debilitating neurologic disease in his herd which we diagnosed as TME by histopathologic findings confirmed by experimental transmission to mink and squirrel monkeys. The rancher was a ''dead stock'' feeder using mostly (>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
http://downercattle.blogspot.com/
TSS
Saturday, March 14, 2009 Agriculture Secretary Tom Vilsack Announces Final Rule for Handling of Non-Ambulatory Cattle
Release No. 0060.09 Contact: Amanda Eamich (202) 720-9113
http://downercattle.blogspot.com/2009/03/agriculture-secretary-tom-vilsack.html
Friday, November 30, 2007
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION
http://cjdquestionnaire.blogspot.com/
FDA FAILED US
http://fdafailedus.blogspot.com/
SCIENCE BUSHWHACKED
http://sciencebushwhacked.blogspot.com/
Sunday, July 20, 2008 Red Cross told to fix blood collection or face charges 15 years after warnings issued, few changes made to ensure safety
http://vcjdblood.blogspot.com/2008/07/red-cross-told-to-fix-blood-collection.html
TSS
-------------------- BSE-L@LISTS.AEGEE.ORG --------------------
-------------------- BSE-L@LISTS.AEGEE.ORG --------------------
LET's go back to the infamous TOKEN, charade, that happened on January 30, 2001, at the Texas Purina feed lot around Gonzales. NOW remember, this thing was set up from the word go, as to some big showing that the FDA was DOING SOMETHING BIG. let's look at exactly what was said then, and then i will run some figures by you, of what banned mad cow feed has gone into commerce, of which most was fed out. but, as wrong as the comments made were about what amount of infectious material will kill a cow in this statement, even if you were to go by those wrong figures of about .......... oh what was it ???
''FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.''
http://www.fda.gov/bbs/topics/news/2001/new00752.html
you can take that with how ever many grains of salt you wish, but i read that as saying, it was only 5 1/2 grams, and the old cow ways 600 pounds, so know way that even if the feed was tainted, there was not enough to cause disease. the fda, usda et al, knew at that exact moment when they wrote that statement, they knew then that the 5 1/2 grams was enough to kill a small herd of cows. it was old science. but again, they chose to deceive. THIS WAS 2001, and it's now 2009, and they still are choosing to deceive, and the new administration appears willing to continue the USA mad cow charade. NOW, since the charade at the purina mill in 2001, i am going to list a few figures of suspect, banned mad cow feed that went out into commerce, even in 2008, 2007, 2006, back a few years, and you can compare, what enormous amounts of banned suspect mad cow feed and other products continue to go out. when you consider, and they knew all along, that .005 grams is lethal, my God, how much of this poison was consumed?
WASHINGTON, June 26, 2008 - Beltex Corporation, doing business as Frontier Meats, a Fort Worth, Texas, establishment, is recalling approximately 2,850 pounds of fresh cattle heads which may contain specified risk materials (SRMs), the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.
http://www.fsis.usda.gov/News_&_Events/Recall_020_2008_Release/index.asp
Data reported as of: 05/10/2008
Search by: State = TX, and FDA District = DAL-DO, and Firm Type = FR,HF,NL, and Last BSE Insp Date From 01/01/2007 To 05/31/2008 and BSE Program Risk = DP,HP,NP, and Last BSE District Decision = OAI, and Handles Feed for Rum. Animals = Y,N,R Sort by: Last BSE District Decision
FDA District
DAL-DO
Firm Id (FEI)
3006607060
Firm Name
Texas Legend Ranch
Street Address
2803 Highway 473
City
Kendalia
State
TX
Zip Code
78027-2016
Opr. Status
OPR
Firm Type(s)
FR, OF
Prgm Risk
NP
Last BSE Insp Date
03/25/2008
Last BSE Dist. Dcsn''
OAI
Handles Feed for Rum. Animals?
Y
snip...end
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented.
http://www.fda.gov/cvm/CVM_Updates/BSE0108.htm
http://madcowfeed.blogspot.com/2008/06/texas-firm-recalls-cattle-heads-that.html
http://madcowfeed.blogspot.com/2008/05/fda-bseruminant-feed-inspections-firms.html
In 2007, in one weekly enforcement report, the fda recalled 10,000,000+ pounds of BANNED MAD COW FEED, 'in commerce', and i can tell you that most of it was fed out ;
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST 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
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
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
snip...
see listings and references of enormous amounts of banned mad cow protein 'in commerce' in 2006 and 2005 ;
see full text ;
Friday, April 25, 2008
Substances Prohibited From Use in Animal Food or Feed [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46
http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html
SPECIFIED RISK MATERIALS
http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html
SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS
http://cjdmadcowbaseoct2007.blogspot.com/2008/04/srm-mad-cow-recall-406-thousand-pounds.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
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3; Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique, France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious Disease control, Sweden; 5Georg August University, Germany; 6German Primate Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans. Secondly, we aimed at examining the course of the disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian v CJD as fast as intracerebrally inoculated animals.
The work referenced was performed in partial fulfillment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).
http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf
Calves were challenged by mouth with homogenised brain from confirmed cases of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were then left to develop BSE, but were not subjected to the normal stresses that they might have encountered in a dairy herd. Animals in all four groups developed BSE. There has been a considerable spread of incubation period in some of the groups, but it appears as if those in the 1 and 10g challenge groups most closely fit the picture of incubation periods seen in the epidemic. Experiments in progress indicate that oral infection can occur in some animals with doses as low as 0.01g and 0.001g. .........
http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose
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
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
http://www.gao.gov/new.items/d02183.pdf
http://www.gao.gov/new.items/d05101.pdf
GAO says US barriers to mad cow disease are full of holes Robert Roos News Editor
Note: This story was updated March 1, 2002, to include additional information about recent federal actions to prevent mad cow disease.
Feb 28, 2002 (CIDRAP News) - Congress's General Accounting Office (GAO) concludes in a new report that the United States remains vulnerable to bovine spongiform encephalopathy (BSE), or mad cow disease, because of inadequate import barriers and weak enforcement of rules to contain any BSE-contaminated products that might reach US shores.
http://www.cidrap.umn.edu/cidrap/content/other/bse/news/gaorept.html
##################### Bovine Spongiform Encephalopathy #####################
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; 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
______________________________
PRODUCT a) Dairy feed, custom, Recall # V-134-6; Custom Dairy Feed with Monensin, Recall # V-135-6. CODE None. Bulk product RECALLING FIRM/MANUFACTURER Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on June 28, 2006. Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated recall is complete. REASON Possible contamination of dairy feeds with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE 1,484 tons
DISTRIBUTION TN and WV
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
##################### Bovine Spongiform Encephalopathy #####################
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
______________________________
PRODUCT Bulk custom made dairy feed, Recall # V-115-6 CODE None RECALLING FIRM/MANUFACTURER Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or about July 14, 2006. FDA 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 Approximately 2,223 tons DISTRIBUTION KY
______________________________
PRODUCT Bulk custom made dairy feed, Recall # V-116-6 CODE None RECALLING FIRM/MANUFACTURER Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006. FDA 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 1,220 tons DISTRIBUTION KY
______________________________
PRODUCT Bulk custom made dairy feed, Recall # V-117-6 CODE None RECALLING FIRM/MANUFACTURER Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated recall is completed. REASON Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE 40 tons
DISTRIBUTION LA and MS
______________________________
PRODUCT Bulk Dairy Feed, Recall V-118-6 CODE None RECALLING FIRM/MANUFACTURER Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA initiated recall is complete. REASON Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE 7,150 tons
DISTRIBUTION MS
______________________________
PRODUCT Bulk custom dairy pre-mixes, Recall # V-119-6 CODE None RECALLING FIRM/MANUFACTURER Walthall County Co-op, Tylertown, MS, by telephone on June 26, 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 87 tons
DISTRIBUTION MS
______________________________
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; 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
###
http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.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
###
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; 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
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
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
CJD WATCH MESSAGE BOARD TSS
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; 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 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
Department of Health and Human Services Public Health Service Food and Drug Administration
Minneapolis District Office Central Region 212 Third Avenue South Minneapolis, MN 55401 Telephone: (612) 758-7119 FAX: (612) 334-4142
June 9, 2005
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Refer to MIN 05-15
Michael J. Langenhorst President Anamax Corporation P.O. Box 10067 Green Bay, WI 54307
Dear Mr. Langenhorst:
Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, 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). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].
Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:
1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.
2. 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 that may be used for ruminants.
Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S .C. 343(a)(1)).
The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.
Your response should be directed to Compliance Officer Jane E . Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.
Sincerely,
/S/
W. Charles Becoat Director Minneapolis District
http://www.fda.gov/foi/warning_letters/g5373d.pdf
2. WITH A RECENT NATION WIDE MAD COW FEED BAN RECALL in the past few months that consisted of some 10,878.06 TONS, then another Mad Cow feed ban warning letter in May, IT should seem prudent to ask why our feed bans continue to fail in 2006, and continue to fail today ? 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.
Page 2 of 98 8/3/2006
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
see full text ;
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
######## Bovine Spongiform Encephalopathy <BSE-L@UNI-KARLSRUHE.DE> #########
Public Health Service Food and Drug Administration
New Orleano District Nashville Branch Office Plus Park Blvd. Nashville, TN 37217 Tel: 615-781-6388 FAX: 615-781-6383
May 22, 2003
VIA FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. John F. Turner, Owner, Manager Millstone Agri Distributors 3721 E. Lamar Alexander Highway Maryville, TN 37804
Warning Letter No 03-NSV-16
Dear Mr. Turner:
An inspection of your animal feed manufacturing operation, located at Maryville, Tennessee conducted by a U.S. Food and Drug Administration investigator on February 13, 2003, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations (21 CFR.), Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow this rule, products you manufactured and distributed are adulterated within the meaning of Sections 402(a)(2)(C) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) since they contain an unsafe food additive and were prepared, packed, or held under insanitary conditions . . . whereby [they] may have been rendered injurious to health. Feed you manufactured also was misbranded within the meaning of Section 403(a)(1) of the Act because of your failure to follow this rule.
Our investigation found the following violations of 21 C.F.R. 589.2000:
1. Failure to separate the receipt, processing, and storage of products containing prohibited material from products not containing prohibited material [21 C.F.R. 589.2000(e)(1)(iv)];
2. Failure to establish written procedures, including clean-out and flushing procedures, to avoid commingling and cross-contamination of common equipment [21 C.F.R. 589.2000(e)(1)(iii)(B)];
3. Failure to maintain records sufficient to track prohibited materials throughout the receipt, processing, and distribution of your products [21 C.F.R. 589.2000(c)(1)(ii)];
4. Failure to provide for measures to avoid commingling or cross-contamination of feeds intended for ruminants and feeds intended for nonruminants that may contain prohibited materials [21 C.F.R. 589.2000(c)(1)(iii)]. Specifically, our investigation found that the ruminant product 10% Beef Conditioned was formulated primarily with screenings and fines derived from previously manufactured non-ruminant products, Premium Rooster Kicker in particular, that contain or may contain prohibited material. Such deviations cause the ruminant product 10% Beef Conditioner being manufactured at this facility to be adulterated within the meaning of Sections 402(a)(2)(C) and 402(a)(4) of the Act;
5. Failure to label your non-ruminant products with the required cautionary statement Do not Feed to Cattle or Other Ruminants [21 C.F.R. 589.2000(c)(1)(ii)]. Our investigation specifically found that dog food containing prohibited material was added as an ingredient to your product Premium Rooster Kicker. The failure of these feeds to bear the required BSE warning statement causes them to be misbranded within the meaning of Section 403(f) of the Act.
The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDAs Small Entity Compliance Guide to assist you with complying with the regulations.
You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. You should notify this office in writing within 15 working days of receipt of this letter of the steps you have taken to bring your iirm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 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 that corrections have been made.
Your reply should be directed to the attention of Joseph E. Hayes, Compliance Officer, U.S. Food and Drug Administration, 297 Plus Park Boulevard, Nashville, TN 37217.
Sincerely,
/s/ Carl E. Draper Director, New Orleans District Office
http://www.fda.gov/foi/warning_letters/g4056d.htm
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTERS JULY 20, 2004 USA
Date: Tue, 20 Jul 2004 09:14:11 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS
Public Health Service Food and Drug Administration
San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700
VIA HAND DELIVERY
Our Reference No. 1000123954
June 23, 2004
Ronald M. Foster, Manager Randall C. Boyce, Manager Trevor O. Foster, Manager George P. Foster, Manager Fresno Farming LLC P.O. Box 457 1000 Davis Street Livingston, California
WARNING LETTER
Dear Mssrs. Foster, Boyce, Foster, and Foster:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your medicated animal feed mill operation, Fresco Farming LLC, located in Traver, California from April 14, 2004 through May 6, 2004, and found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow this rule, products you manufactured and distributed are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Our inspection found the following violations of 21 C.F.R. 589.2000:
1. Failure to provide for measures to avoid commingling or cross-contamination of products that contain or may contain protein derived from mammalian tissues into animal protein or feeds that may be used for ruminants to comply with 21 C.F.R. 589.2000(e)(1)(iii).
* Your firm uses a vacuum system to clean up spilled product in the tunnel area. This tunnel area houses the two receiving conveyor systems and the elevators for the two conveyor systems. When product, including ruminant meat and bone meal, is spilled onto the floor of this area, the spilled product is vacuumed up by the vacuum system and, via a discharge hose, was placed into a conveyor system that your firm had designated as free of ruminant meat and bone meal. Your firm admitted that it was unaware of the vacuum system discharging into the conveyor systems designated as free of ruminant meat and bone meal and that this had been in place since April 2003. Your firm remedied this problem during FDAs April/May 2004 inspection by removing the discharge hose connection to the conveyer system that your firm had designated as free of ruminant meat and bone meal . * Your firm uses a dust collection system that pulls dust from systems that receive both ruminant meat and bone meal and feed ingredients intended for ruminants. This dust system then discharged collected product back into the two conveyor systems via a cross connection, thereby making it likely that ruminant meat and bone meal became commingled with ruminant feed ingredients. Your firm admitted that it was unaware of the cross connection and that it had been in place since April 2003. Your firm removed the cross connection during FDAs April/May 2004 inspection.
2. Failure to maintain written procedures specifying the clean-out procedure or other means, and specifying the procedures for separating products that contain or may contain protein derived from mammalian tissue from all other protein products from the time of receipt until the time of shipment, to comply with 21 C.F.R. 589.2000(e)(1)(iv). This observation was also noted during FDAs July/August 2003 inspection of your firm.
* There are no written procedures for separating products that contain prohibited material from ingredients used in ruminant feeds from the time of receipt until the time of shipment. * The written procedure for cleaning out or flushing equipment after mixing feeds containing prohibited material was not adequate to prevent contamination of ruminant feed with prohibited material.
3. Failure to maintain records sufficient to track materials that contain protein derived from mammalian tissues throughout their receipt, processing, and distribution to comply with 21 C.F.R. 589.2000(e)(1)(i). This observation was also noted during FDAs July/August 2003 inspection of your firm.
* Specifically, your firm has failed to develop and implement complete written procedures to separate ruminant meat and bone meal from feed ingredients intended for ruminants from the time of receipt until the time of distribution. The written procedures that do exist fail to address the use of equipment common to ruminant meat and bone meal and ruminant feed ingredients.
The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for use as animal feed, you are responsible for assuring that 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 such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations and prevent their recurrence. If corrective actions cannot be completed in fifteen (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 that corrections have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention: Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, California 94502-7070. If you have questions regarding this letter, please contact Ms. Kishida at (510) 337-6824.
Sincerely,
/s/
CD Moss, Acting DD for Barbara J. Cassens District Director San Francisco District
cc: VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED C. Michael Blasco, Feed Mill Manager Fresno Farming LLC P.O. Box 430 Traver, California 93673
http://www.fda.gov/foi/warning_letters/g4849d.htm
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863
July 12, 2004
WARNING LETTER CHI-16-04
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. Donald E. Hamilton, President/Owner Illini Feeds, Inc. P.O. Box 86, 1145 State Hwy. 94 Aledo, Illinois 61231
Dear Mr. Hamilton:
On February 19 and 20, 2004, the Food and Drug Administration (FDA) conducted an inspection of your animal feed handling facility located at 1145 State Highway 94, Aledo, Illinois. The inspection found 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). The deviations cause the swine feed manufactured by your facility to be misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found that salvaged pet food containing prohibited material was added as an ingredient to the swine products manufactured at your facility. During the inspection, our investigator found that you failed to label your non-ruminant products with the required caution statement - Do not feed to cattle or other ruminants. [21 CFR 589.2000(d)(1)]
The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for use in animal feed, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct this violation, and you should establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action without further notice, such as seizure and/or injunction.
During the inspection, you told the investigator that you would put the required cautionary statement on your products that contain prohibited material, and maintain tracking documents for all incoming ingredients, including animal proteins prohibited in ruminant feed. Please notify this office in writing within 15 working days of receiving this letter of any further steps you have taken to assure that your firm is in compliance with the law. Your response should also include an explanation of each step taken to correct the violations, and prevent their recurrence. Please include copies of any available documentation such as written procedures, corrected labeling, etc., demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the above address.
Sincerely,
/s/
Scott J. MacIntire District Director
http://www.fda.gov/foi/warning_letters/g4840d.htm
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863
June 15, 2004
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. David W. Bernauer CEO and Chairman of the Board Walgreen co. 200 Wilmot Rd. Deerfield, IL 60015
Dear Mr. Bernauer:
Inspection of your firms warehouse at 5100 Lake Terrace N.E., Mt. Vernon, Illinois, by the Illinois Department of Public Health and the U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and March 2, 2004, documented numerous insanitary conditions which caused the food and drug products stored there to become adulterated.
Our inspection showed that the food and drug products stored and held at your facility violated the Federal Food, Drug, and Cosmetic Act (the Act), rendering them adulterated. These adulterated fwd and drug products: a) consisted in whole or in part of filthy substances, including rodent fecal pellets, rodent hair, and insects, in violation of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had been held under insanitary conditions whereby they have become contaminated with rodent filth, in violation of Sections 402(a)(4) and 501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].
Evidence of rodent activity documented throughout the old and new warehouse included dead mice in traps, excreta pellets, and gnawed paper material observed in, on, and near food and drugs stored in the warehouse. Rodents gnaw holes were observed into several packaged food products with rodent hairs at gnaw holes into products. Many more fecal pellets were on food and drug packages and still more were found near the stored foods, drugs, and cosmetics in the warehouse.
Other conditions observed during the inspection that could be contributing factors to rodent infestation include damaged and/or poorly fitting rail and truck dock doors, gaps around a conduit entry into the building, and the structural condition of the concrete and expansion gaps at floor/wall/support beam junctions in various areas of the warehouse allowing the entry or harborage of pests. Additionally, the investigators observed cobwebs, dead insects, dust, debris, product spillage, and papers in the warehouse, indicating a general lack of good sanitation practices.
Also, products that contain or may contain animal protein prohibited ruminant feed (BSE material) failed to bear the caution statement, Do not feed to cattle or other ruminants. Specifically, pet food products were salvaged, repackaged, and donated to [redacted] and other similar organizations in the area, without the proper labeling and agreement that they would not be used for ruminants. Please refer to Title 21, Code of Federal Regulations, Section 589.2000, concerning these requirements.
Our laboratory confirmed the findings of rodent excreta, rodent hairs on product gnaw holes, and rodent gnawed fibers (packaging material) sampled from the warehouse during the inspection.
The above listed violations are not intended to be all-inclusive. It is your responsibility to assure adherence with each requirement of the Act and its implementing regulations. The investigators reported that you destroyed food products that showed evidence of contamination and began to take some steps to correct the insanitary conditions in your facility. We request that you take prompt action to correct all violations.
Please provide this office, within 15 working days of receipt of this letter, a detailed response stating the actions you plan to take and have taken to correct and prevent the recurrence of these objectionable conditions. Provide the time within which corrections will be completed, reasons why any corrective action cannot be completed, and documentation to show that corrections have been made. Failure to take prompt action to correct all violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the Chicago District Office.
Sincerely,
/s/
Scott J. MacIntire District Director
cc: Stephen J. Lawrence, Distribution Center Manager Walgreen Co. 5100 Lake Terrace NE Mount Vernon, IL 62864-9665
http://www.fda.gov/foi/warning_letters/g4853d.htm
USA BSE GBR SHOULD BE GBR III, but someone dropped the ball...
TSS
######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ##########
DEPARTMENT OF HEALTH & HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
April 9, 2001 WARNING LETTER
01-PHI-12 CERTIFIED MAIL RETURN RECEIPT REQUESTED
Brian J. Raymond, Owner Sandy Lake Mills 26 Mill Street P.O. Box 117 Sandy Lake, PA 16145 PHILADELPHIA DISTRICT
Tel: 215-597-4390
Dear Mr. Raymond:
Food and Drug Administration Investigator Gregory E. Beichner conducted an inspection of your animal feed manufacturing operation, located in Sandy Lake, Pennsylvania, on March 23, 2001, and determined that your firm manufactures animal feeds including feeds containing prohibited materials. The inspection found significant deviations from the requirements set forth in Title 21, code of Federal Regulations, part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) . Such deviations cause products being manufactured at this facility to be misbranded within the meaning of Section 403(f), of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found failure to label your swine feed with the required cautionary statement "Do Not Feed to cattle or other Ruminants" The FDA suggests that the statement be distinguished by different type-size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
In addition, we note that you are using approximately 140 pounds of cracked corn to flush your mixer used in the manufacture of animal feeds containing prohibited material. This flushed material is fed to wild game including deer, a ruminant animal. Feed material which may potentially contain prohibited material should not be fed to ruminant animals which may become part of the food chain.
The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of FDA's Small Entity Compliance Guide to assist you with complying with the regulation... blah, blah, blah...
http://www.fda.gov/foi/warning_letters/g1115d.pdf
DEPARTMENT OF HEALTH & HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
April 9, 2001 WARNING LETTER
01-PHI- 11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Eugene P. Yachere, Owner Yachere Feed, Inc. 200 Main Street Rockwood, PA 15557
Dear Mr. Yachere:
Food and Drug Administration Investigator Gregory E. Beichner conducted an inspection of your animal feed manufacturing operation, located in Rockwood, Pennsylvania, on March 14, 2001, and determined that your firm manufactures animal feeds including feeds containing prohibited materials. The inspection found significant deviations from the requirements set forth in Title 21, code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy {BSE). Such deviations cause products being manufactured at this facility to be misbranded and adulterated within the meaning of Section 403(f), 402(a) (2) (C), and 402(a) (4) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection found failure to label your poultry feed products with the required cautionary statement "Do Not Feed to Cattle or other Ruminants". The FDA suggests that the statement be distinguished by different type-size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
Our inspection also found that all animal feeds you manufacture may contain prohibited material since you failed to provide for measures to avoid commingling and cross-contamination of feeds containing prohibited materials with feeds containing no prohibited materials. Additionally, you were unable to provide any documentation including manufacturing/production records which would identify animal feeds processed on the same equipment directly after the manufacture of poultry feeds containing prohibited material.
The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring....
Blah, Blah, Blah, same old crap...
http://www.fda.gov/foi/warning_letters/g1114d.pdf
And now they are feeding ruminants to fish!
Subject: MAD FISH WARNING LETTERS (you 'veghead's just thought you were free of TSEs;-) Date: Tue, 3 Jul 2001 From Terry S. Singeltary Sr. <flounder@wt.net
Bovine Spongiform Encephalopathy (love them farm raised catfish)
WARNING LETTER
June 12, 2001
Mr. Scott Nelson, Owner Integral Fish Foods, Inc. 715 South 7th Street Grand Junction, CO 81501
Ref. #: DEN-01-35
Dear Mr. Nelson,
An inspection of your fish feed manufacturing operation located at Grand Junction, Colorado, conducted by a Colorado Department of Agriculture Inspector on March 20, 2001, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and/or distributed by your facility to be adulterated within the meaning of section 402(a)(4) and misbranded within the meaning of Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection found that your procedures to prevent cross-contamination are inadequate in that:
You do not have written procedures specifying the clean-out procedures for your feed mixer.
Our investigation also found that you fail to label your products, Fat Cat Catfish Fingerling Feed and Gold Nugget Trout Fry Feed #2 Crumble, each containing meat and bone meal, with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants". The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulations.
Page 2 - Integral Fish Foods, Inc. June 12, 2001
We find it quite disturbing that the above violations STILL EXIST CONSIDERING YOU HAVE BEEN ADVISED ON 2 PREVIOUS OCCASIONS OF THESE REQUIREMENTS, INCLUDING APRIL 7, 1999 and MARCH 6, 2000....
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237.3097 Telephone: (513) 679-2700
CERTIFIED MAIL RETURN RECEIPT REQUESTED
WARNING LETTER CIN-WL-6466-01
March 5, 2001
John T. Dunbar President Champaign Landmark, Inc. 304 Bloomfield Avenue Urbana, OH 43078
Dear Mr. Dunbar:
An inspection of your feed mill was conducted by a Food and Drug Administration (FDA) investigator on February 13-15, 2001. This inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and distributed by your facility to be misbranded within the meaning of Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act).
The investigator examined 30 Mixing and Delivery Tickets for products containing prohibited materials. 15 of those tickets lacked the required cautionary statement "Do not feed to Cattle or Other Ruminants". We suggest that you find a more reliable method than simply handwriting the statement on the back of the ticket. We also suggest the statement be distinguished by different type size, color, or other means of highlighting so it is easily noticed by the purchaser.
Other issues in addition to the deficiency noted above:
We question whether flushing with xxxxx of crushed corn is adequate to clean your mixer, especially for products containing dried molasses. If you haven't already done so, you should establish that the flush method you use cleans out the remainder of preceding batches containing prohibited materials.
During the inspection, our investigator verbally advised that your batch records should clearly document that the mixing system was cleaned or flushed in accordance with your approved procedures. It was not clear that writing "yes" on the mixing record meant the system should be flushed or that it had been done. The person conducting the clean-out or flush should document the procedure by initialing and dating the batch record immediately after the step is completed.
snip...
http://www.fda.gov/foi/warning_letters/m5239n.pdf
Mr. Terry D. Viktorin Co-Owner Z$W Mill, Inc. P.O. Box 236 Torrington, Wyoming 82240
http://www.fda.gov/foi/warning_letters/g1083d.pdf
Bryan Enterprises 29946 Route 30 West Hanoverton, Oh. 44423
cross contamination violations, no records, etc.
http://www.fda.gov/foi/warning_letters/m5227n.pdf
Hartville Elevator Company, Inc. cross contamination, no records etc.
http://www.fda.gov/foi/warning_letters/m5195n.pdf
DEPARTMENT OF HEALTH AND HUMAN SERVICE
April 4, 2001
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. Mat Geib Owner Greeley Elevator Company 700 6th Street Greeley, Colorado 80631
Ref. #: DEN-01-26
Dear Mr. Geib:
An inspection of your animal feed manufacturing operation located at Greeley, Colorado, conducted by Colorado Department of Agriculture Inspectors on February 20, 2001, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and/or distributed by your facility to be adulterated within the meaning of section 402(a)(4) and misbranded within the meaning of Section 403(F) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection found that your procedures to prevent cross-contamination are inadequate in that:
You do not have written procedures specifying the clean-out procedures for your feed mixer.
You do not maintain records sufficient to track materials containing meat and bone meal throughout their receipt, processing, and distribution.
Our investigation also found that you fail to label your product, Greeco Lay Mash with meat and bone meal, with the required cautionary statement 'Do Not Feed to Cattle or Other Ruminants".
The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulations.
Page 2 - Greeley Elevator Company March 27, 2001
We find it quite disturbing that the above violations still exist considering you have been advised on at least 2 occasions of these requirements. In fact, during the previous inspection of April, 2000, you advised the Inspector you no longer use meat and bone meal. At the beginning of the current inspection the Inspector was again told by the firm's agronomist that no meat and bone meal was being used. On inspection of the mixing area and the basement storage area, the Inspector found both labeled and unlabeled bags of meat and bone meat and was told by an employee that it was used in the Greeco Lay Mash formula.
You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to make immediate and lasting corrections will result in regulatory action without further notice including seizure, and/or injunction.
You should notify this office in writing within 15 working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, that has been taken, or will be 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 time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your response should be sent to Tom Warwick, Compliance Officer, Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. He may be reached at (303) 236-3054 if you have any questions about this matter.
Sincerely, Thomas A. Allison District Director
http://www.fda.gov/foi/warning_letters/g1126d.pdf
April 16, 2001
Richard A. Warren Manager Perry Coal and Feed Company 4204 Main Street Perry, Ohio 44081
[a summary of violations]
* no written procedures for cleaning out and flushing equipment after mixing feeds containing prohibited material.
* NO processing records or records documenting that the system was cleaned or flushed.
http://www.fda.gov/foi/warning_letters/g1140d.pdf
April 16, 2001 Alan R. Beckwith General Manager Jeffers
on Milling Company 168 East Jefferson Street Jefferson, Ohio 44047
[a summary of violations]
* no written procedures for cleaning out or flushing equipment after mixing feeds containing prohibited materials
* Your firm DOES NOT perform a flush out...
* NO records etc.
http://www.fda.gov/foi/warning_letters/g1141d.pdf
April 16, 2001 Gary E. Berrier Owner Dorset Milling P.O. Box 2 2358 State Route 193 Dorset, Ohio 44032
[summary of violations]
* no written procedures for cleaning and flushing
* firm does not always perform a flush out
* NO processing records
* firm has not been labeling feeds that may contain the cross contamination
* firm does also does not maintain records of sales of feed that contain, or may contain, prohibited protein materials
http://www.fda.gov/foi/warning_letters/g1142d.pdf
Subject: MORE AND MORE U.S.A. MAD COW FEED BAN VIOLATIONS OF THE INFAMOUS 8/4/97 FEED BAN 'THAT NEVER WAS'
Date: May 25, 2001 at 12:50 pm PST
Mr. Jerry M. Behimer, President Material Resources, LLC - Gateway Co-Packing Company 901 Kingshighway Washington, IL 62204
Dear Mr. Behimer;
snip;
Specifically, our investigator found the following violations during the inspection;
* Your firm does not provide adequate measures to avoid commingling or cross-contamination of prohibited and non-prohibited protein material.
* Your firm has no written procedures that document measures that have been adopted to prevent commingling or cross-contamination, between feeds that contain prohibited protein with feeds that contain non-prohibited materials.
* Your firm lacks adequate records to track products that contain, or may contain, prohibited material, prohibited material throughout their receipt and processing.
The above is not intended to be an all-inclusive list of violations...
snip...
http://www.fda.gov/foi/warning_letters/g1247d.pdf
==============
Reid Kooch, President Wallowa County Grain Growers, Inc. 911 S. River Enterprise, Oregon 97828
Dear Mr. Kooch:
snip...
Our Investigation found a failure to separate the receipt, processing and storage of the product containing prohibited material from non-prohibited material; failure to establish a written system, including clean-out, and flushing procedures, to avoid commingling and cross-contamination of common equipment; failure to maintain records sufficient to track the materials throughout the receipt, processing and distribution of your products.
The above is not intended to be an all-inclusive list of deviation from the regulations...
snip...
http://www.fda.gov/foi/warning_letters/g1265d.pdf
Subject: MORE SERIOUS BREACHES OF U.S.A. MAD COW 'PARTIAL' FEED BAN, that never was...
Date: May 16, 2001 at 12:07 pm PST
thought i would bring to your attention the fact that the FDA has again been issuing these same letters to feed manufacturers for years, to no avail, same as the infamous 'Dear Manufacturer' letters to the Nutritional Supplement manufacturers. Those letters have been circulating since the late 80s early 90s. AGAIN, to no avail, these manufacturers, as with the brain dead feed manufacturers, are laughing all the way to the bank, even though the risks of spreading these human/animal TSEs are very real. Apparently, the FDA has absolutely NO enforcement of regulations over them.
Terry S. Singeltary Sr., Bacliff, Texas USA
D.W. Knight President Farmers Mill & Elevator Company 265 Main Street Dexter, Georgia 31019
snip...
Of particular concern is that these same violations were pointed out during the previous inspection of this facility on October 21, 1998. That inspection was conducted by the Georgia Department of Agriculture. The two violations noted were the failure to establish flush procedures for the use of prohibited materials and feed labels not including the cautionary statement.
http://www.fda.gov/foi/warning_letters/g1197d.pdf
Kenneth H. Sherwood, President Alaska Garden and Pet Supply, Inc. 114 N. Orca Anchorage, Alaska 99501
http://www.fda.gov/foi/warning_letters/g1211d.pdf
'ANIMAL PROTEIN' SEARCH 9/9/02
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Darling International, Inc. 5/07/02 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF] [HTML] All American Feed & Tractor 4/01/02 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF] [HTML] Tyson Foods 2/12/02 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF] [HTML] The Feed Bucket 12/11/01 Atlanta District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF] [HTML] Finlayson Ag Center 11/08/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF] [HTML] Dixon Feeds, Inc. 10/24/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF] [HTML] Buckeye Feed Mills, Inc. 9/20/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF] [HTML] Wilcox Farms, Inc. 9/14/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF] [HTML]
http://www.accessdata.fda.gov/scripts/wlcfm/full_text.cfm?full_text=animal+protein&Search=Search
now, compare search on 8/8/01...tss
'ANIMAL PROTEIN' SEARCH 8/8/01
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Date: Tue, 28 Aug 2001 11:13:43 -0700
Reply-To: BSE-L Sender: Bovine Spongiform Encephalopathy BSE-L
From: "Terry S. Singeltary Sr."
Subject: MAD COW FEED BAN WARNING LETTERS U.S.A. AUGUST 8, 2001
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421
Telephone: 426-486-8788 FAX: 426-483-4996
August 8, 2001
VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 01-75
William W. Himmelspach, Owner 22195 S.W. 78th Tualatin, Oregon 97062
WARNING LETTER
Dear Mr. Himmelspach:
An investigation at your animal feed manufacturing operation located at 22195 S.W. 78th Tualatin, Oregon 97062, conducted by a Food and Drug Administration investigator on July 12, 2001, found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured at this facility to be adulterated within the meaning of Section 402(a)(2)(C), and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act).
Our investigation found a failure to separate the receipt, processing, and storage of the product containing prohibited material from non-prohibited material; failure to establish a written system, including clean-out and flushing procedures, to avoid commingling and cross-contamination of common equipment; and failure to maintain records sufficient to track the materials throughout the receipt, processing, and distribution of your products.
In addition, our investigation found a failure to label your products with the required cautionary, statement "Do Not Feed to Cattle or Other Ruminants," Your pig feeds, containing prohibited materials, were not labeled with the cautionary statement, and you reuse poly-tote bags for ruminant feed and pig feed, where the bags could become contaminated with prohibited material. The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser.
The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with
William W. Himmelspach Tualatin, Oregon Re: Warning Letter SEA 01-75 Page 2
your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulation.
You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 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 that corrections have been made.
Your reply should be directed to the Food and Drug Administration, Attention: Bruce Williamson, Compliance Officer. If you have any questions please contact Mr. Williamson at (425) 483-4976.
Sincerely,
Charles M. Breen District Director
Enclosure; Form FDA 483 Small Entity Compliance Guide
http://www.fda.gov/foi/warning_letters/g1619d.pdf
Warning Letters Index - Search Form Results Company Name Date Issued Issuing Office
Subject
File Adrian Elevator, Inc. 5/03/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Alaska Garden and Pet Supply, Inc. 4/27/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File Bryan Enterprises 2/20/01 Cincinnati District Office Feed Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Carrollton Farmers Exchange 7/12/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Centerburg Mill and General Store, Inc 3/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Centerburg Mill and General Store, Inc. 5/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Central Ohio Farmers Cooperative, Inc. 5/24/01 Cincinnati District Office Animal Protein Prohibited in Ruminant Feed
View File Champaign Landmark, Inc. 3/05/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded
View File Countryline Co-Op, Inc. 5/14/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Dorset Milling 4/16/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Earl B. Olson Feed Mill 4/23/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Faler Feed Store, Inc. 3/21/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Farmers Mill & Elevator Company 3/30/01 Atlanta District Office Animal Proteins Prohibited in Ruminant Feed
View File Farnam Companies, Inc. 7/20/01 Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Greeley Elevator Company 4/04/01 Denver District Office Animal Proteins Prohibited in Ruminant Feed
View File Hartville Elevator Company, Inc. 2/22/01 Cincinnati District Office Feed Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Himmelspach, William W. 8/08/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File Integral Fish Foods, Inc. 6/12/01 Denver District Office Animal Proteins Prohibited in Ruminant Feed
View File Jefferson Milling Company 4/16/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Lime Creek Ag Services, Inc. 4/25/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Material Resources LLC 5/04/01 Chicago District Office Animal Proteins Prohibited in Ruminant Feed
View File Material Resources, LLC 5/04/01 Chicago District Office Animal Protein Prohibited in Ruminant Feed
View File Medina Landmark, Inc. 3/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Minister Farmers Cooperative Exchange, Inc. 4/10/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Feed Mill
View File Peco Foods, Inc. 2/23/01 New Orleans District Office CGMP Requirements for Medicated Feeds/Animal Proteins Prohibited in Ruminant Feed
View File Perry Coal and Feed Company 4/16/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Rietdyk's Milling Company 3/05/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File River Valley Co-Op 3/22/01 Cincinnati District Office Animal Proteins Prohibeted in Ruminant Feed
View File River Valley Co-Op 5/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Round Lake Farmers Coop. 5/30/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Rudy, Inc. 3/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Rudy, Inc. 5/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Sandy Lake Mills 4/09/01 Philadelphia District Office Animal Proteins Prohibited in Ruminant Feed
View File Shields Feed and Supply Company 3/07/01 New Orleans District Office Animal Proteins Prohibited in Ruminant Feed
View File Stewart's Farm Supply 3/21/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Superior Feeds 6/06/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File The Scoular Company 5/30/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File University of Minnesota 5/10/01 Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed
View File Valley Feed Mill, Inc. 5/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
View File Wallowa County Grain Growers, Inc. 5/17/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File Wallowa County Grain Growers, Inc. 5/17/01 Seattle District Office Animal Proteins Prohibited in Ruminant Feed
View File Western Reserve Farm Cooperative 3/21/01 Cincinnati District Office Animal Protein Prohibited in Ruminant Feed
View File Yachere Feed, Inc. 4/09/01 Philadelphia District Office Animal Proteins Prohibited in Ruminant Feed
View File Z & W Mill, Inc. 3/27/01 Denver District Office Animal Proteins Prohibited in Ruminant Feed
View File
http://63.75.126.221/scripts/wlcfm/resultswl.cfm
(TYPE IN 'ANIMAL PROTEIN')
Food and Drug Administration
Cincinnati District Office Central Region 6T51 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700
CERTIFIED MAIL RETURN RECEIPT REQUESTED
WARNING LETTER CIN-WL-6934-01
March 23, 2001
Randall A. Hegenderfer President The Centerburg Mill and General Store, Inc 108 North Hartford Avenue, Box 207 Centerburg, OH 43011
Dear Mr. Hegenderfer:
An inspection of your feed mill was conducted by a Food and Drug Administration (FDA) investigator on March 1, 2001. This inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigator was verbally told that you have separate processing equipment for products containing prohibited materials, but the equipment is not identified, there are no written procedures to address separation of the products, and there are no processing records for products which contain, or may contain, prohibited material.
Your records must allow your firm to track products that contain, or may contain, prohibited material throughout their receipt, processing, and distribution. This includes records of cash sales.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulation.
You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 15 days, state the reason for the delay and the date by which the
Page -2-
corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Deborah Grelle, Director of Compliance, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Oh 45237, telephone (513) 679-2700 extension 160.
Sincerely yours,
Henry L. Fielden District Director
Enclosure: Small Entity Compliance Guide
Cc: David Schleich, Chief Plant Industry Division Ohio Department of Agriculture 8995 East Main Street Reynoldsburg, OH 43068-3399
===========================
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700
CERTIFIED MAIL RETURN RECEIPT REQUESTED
WARNING LETTER CIN-WL.-6916.-01
March 22, 2001
Michael S. McCandlish Branch Manager River Valley Co-Op 508 North Oak Street Baltimore, OH 43105
Dear Mr. McCandlish:
An inspection of your feed mill was conducted by a Food and Drug Administration (FDA) investigator on March 2, 2001. This inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) and misbranded within the meaning of Section 403(0 of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection found your firm fails to label feeds which contain, or may contain, prohibited materials with the required cautionary statement "Do not feed to Cattle or Other Ruminants". We suggest this statement be distinguished by different type size or color or other means of highlighting the statement so it is easily noticed by the purchaser.
Our investigation found your procedures to prevent cross contamination are inadequate in that:
· There are no written procedures for cleaning out or flushing equipment after mixing feeds containing prohibited material.
You should establish adequate procedures and verify that the flush/clean-out method you use cleans out the remainder of preceding batches containing prohibited materials. Note: If you flush with feed ingredients, or sequence with non-ruminant feed, you must label these products with the required cautionary statement "Do not feed to Cattle or Other Ruminants"
There are no processing records or records documenting that the system was cleaned or flushed in accordance with your approved procedures.
Customer records are not adequate to track products that contain, or may contain, prohibited material.
Page-2-
This letter is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA's Small Entity Compliance Guide to assist you with complying with the regulation.
You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective action cannot be completed in 15 days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Note: The need for clean-out procedures and the required cautionary statement was previously discussed with you on May 5, 1999 by Dennis Frayel, an investigator with the Ohio Department of Agriculture (ODA). At that time you verbally told the ODA representative that these deficiencies would be corrected. Please explain why corrections were not made following the ODA inspection.
Your reply should be directed to Deborah Grelle, Director of Compliance, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Oh 45237, telephone (513) 679-2700 extension 160.
Sincerely yours,
Henry L. Fielden District Director
Enclosure: Small Entity Compliance Guide
Cc: David Sehleich, Chief Plant Industry Division Ohio Department of Agriculture 8995 East Main Street Reynoldsburg, OH 43068-3399
Michael D. Wood River Valley Co-Op 254 West High Street London, OH 43140
==================
Centerburg Mill and General Store, Inc 3/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1049d.pdf
Medina Landmark, Inc. 3/23/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1048d.pdf
River Valley Co-Op 3/22/01 Cincinnati District Office Animal Proteins Prohibeted in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1045d.pdf
Rudy, Inc. 3/22/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1047d.pdf
Faler Feed Store, Inc. 3/21/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
url was not available, shows 'error'...tss
Stewart's Farm Supply 3/21/01 Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1043d.pdf
Western Reserve Farm Cooperative 3/21/01 Cincinnati District Office
Animal Protein Prohibited in Ruminant Feed
http://www.fda.gov/foi/warning_letters/g1038d.pdf
http://63.75.126.221/scripts/wlcfm/recentfiles.cfm
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER Animal Proteins Prohibited in Ruminant Feed/Misbranded DEC. 9, 2004
Date: Tue, 21 Dec 2004 16:04:44 -0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: cjdvoice@yahoogroups.com
Public Health Service Food and Drug Administration
New Orleans District Southeast Region 6600 Plaza Drive, Suite 400 New Orleans, Louisiana 70127 Telephone: 504-253-4519 Facsimile: 504-253-4520
December 9, 2004
WARNING LETTER NO. 2005-NOL-07
FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. Alan O. Bostick, President Sunshine Mills, Inc. 500 6th Street SW Red Bay, Alabama 35582
Dear Mr. Bostick:
On September 7 and 14, 2004, a United States Food and Drug Administration (FDA) investigator inspected your animal feed manufacturing facility, located at 2103 South Gloster Street, Tupelo, Mississippi. 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. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products you manufactured and/or distributed are misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection indicated you manufacture products containing beef meat and bone meal. Products that contain or may contain protein derived from mammalian tissues, as defined by 21 CFR 589.2000(a), and are intended for use in animal feed, must be labeled with the cautionary statement Do not feed to cattle or other ruminants. This is required by 21 CFR 589.2000(c)(1)(i). Your firm failed to label your non-ruminant products with this required cautionary statement. Specifically, the products that contained protein derived from mammalian tissues but lacked the required statement included your Happy Fisherman and Premier catfish feeds. Under 21 CFR 589.2000(g)(2), failure of these feeds to bear the required cautionary statement causes them to be misbranded under Section 403(a)(1) of the Act.
The above is not intended to be an all-inclusive list of deviations from regulations. As a manufacturer of materials intended for animal feed use, you are responsible for assuring your overall operation and products you manufacture and distribute are in compliance with the law. A copy of FDAs Small Entity Compliance Guide is enclosed to assist you in complying with the regulations.
You should take prompt action to correct these violations and establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.
We are aware you sent label corrections for the last shipment of each of the mislabeled products. You also stated you plan [redacted] However, you should notify this office in writing, within 15 working days of the receipt of this letter, of the 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 violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for delay and date by which corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at the above address. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (504) 253-4519.
Sincerely,
/s
H. Tyler Thornburg District Director New Orleans District
Enclosures: FDA Form 483 FDAs Small Entity Compliance Guide 21 CFR 589.2000
cc: [redacted] General Manager Sunshine Mills, Inc. 2103 South Gloster Street Tupelo, Mississippi 38801
http://www.fda.gov/foi/warning_letters/g5105d.htm
-------- Original Message --------
Subject: MAD DEER FEED BAN WARNING LETTER RECALL 6 TONS DISTRIBUTED USA Date: Wed, 20 Oct 2004 14:53:56 -0500
From: "Terry S. Singeltary Sr." <flounder@WT.NET>
Reply-To: Bovine Spongiform Encephalopathy <BSE-L@UNI-KARLSRUHE.DE>
To: BSE-L@UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy #####################
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
http://www.fda.gov/
################# BSE-L-subscribe-request@uni-karlsruhe.de #################
-------- Original Message --------
Subject: Re: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) !
Date: Tue, 24 Jun 2003 16:59:41 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
References: <3EE5D269.9040504@wt.net>
i hate to keep kicking a mad cow here, but i thought since the FDA et al still refuses to tell us about _all_ the ruminant-to-ruminant feed ban violations, i thought i would go over a few of the old ones i might have missed. BOY, did i miss one. has all this feed been confirmed to have been recalled? how much is still out there?
RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
________
PRODUCT & 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.
snip...
END OF ENFORCEMENT REPORT FOR June 6, 2001.
http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00696.html
wish someone would give us that update they were speaking of a year or so ago;
Database Change
IMPORTANT: After March 11, 2002, FDA discontinued the database that was used to compile these listings. The Agency started a new database on April 15, 2002, and future updates on BSE enforcement and inspectional findings will draw from it. The format of the information presented here may change, due to design changes of the new database. The site was to be updated after a period of time to allow for transition into the new database system. Please note that the information presently available below is outdated. This site will be updated very shortly.
http://www.fda.gov/cvm/efoi/InpectionListDescriptionforHP.htm
i guess figuring the time period on the reply from the FOIA request of being about a year or so, and still no results, why should this surprise me?
USA/CANADA/MEXICO BSE GBR SHOULD BE CHANGED TO BSE GBR III ASAP!
TSS
Date: Sun, 12 Jan 2003 12:56:44 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Re: USA ruminant-to-ruminant feed ban warning letters ???
######## Bovine Spongiform Encephalopathy #########
Greetings List Members,
as you know, i finally had to request to the FOIA for the USA madcow feed ban warning letters. so i thought some of you may be interested in an update on this matter.
so here it is;
Subject: Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed Ban Violations Jan. 2001 to Jan. 2003
Date: Mon, 6 Jan 2003 08:32:43 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L
Food and Drug Administration Office of Information Resources Management Division of Freedom of Information (HFI-35) 5600 Fishers Lane Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.
1/6/03
Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed Ban Violations Jan. 2001 to Jan. 2003
Greetings FDA and To Whom it may concern,
i wish to request all ruminant-to-ruminant feed ban violations from Jan. 2001 to Jan. 2003. it seems none has been posted since May 2001 on the FDA site. I also kindly request that all fees be wavered due to the fact this is public information, public health is at risk, and this will be distributed 'freely' to the public...
thank you, kind regards,
I am sincerely,
Terry S. Singeltary Sr. P.O. Box Bacliff, Texas USA 77518
CJD Watch
==========================================================
now since then, just this past Friday 1/10/03, i get this from FDA;
REPLY FROM DPH/FDA to TSS;
PLEASE note, my request was for all R-T-R feed ban violations from Jan. 2001 to Jan. 2003. BUT in the reply, they posted Jan. 2002 to Jan. 2003. i called and this is to be corrected. hopefully this FOIA request will ignite some enthusiasm from the FDA into posting to the public any R-T-R MAD COW FEED BAN violations, since GW et al new policy on secrecy took effect on this matter in May of 2002 (correcting my below 'since May 2001).
TSS
Department of Health & Human Services
Food and Drug Administration Rockville MD 20857
1/7/03
In reply refer to;
xxxxxxx
Dear Requester,
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding;
RUMINANT-TO-RUMINANT FEED - BAN VIOLATIONS 1/02 - 1/03
We will respond as soon as possible and may charge you a fee for processing your request. If you have any questions about your request, please call Edna G. Wilkerson, Information Technician, at 301-827-6564 or write to us at;
Food and Drug Administration Division of Freedom of Information 5600 Fishers Lance, HFI - 35 Rockville, MD 20857
If you call or write, use the reference number above which will help us to answer your questions more quickly...
===========================================================
now, Sunday, i read this in the Houston Chronicle 1/12/03;
SENATOR AIMS TO UPGRADE FREEDOM OF INFORMATION
TEXAS Sen. John Coprnyn says he wants to improve public access to government records in Washington, a position that appears to put him at odds with the Bush administration.
Cornyn, a moderate Republican who sits on the Senate Judiciary Committee, said he'll work on legislation in the coming weeks to improve the Freedom of Information Act.
"FOIA needs to be strenghened," he said, "We need to quicken the turnaround time and create a mechanism that allows an indepentent, third party to decide whether a record should be kept secret."
Echoing sentiments he expressed while serving as Texas attorney general, Cornyn added: "I believe in a system of governement that allows consent of the people. And people can't consent if they don't what their elected officials are doing."
Since taking office two years ago, the Bush Administration has taken steps to restrict access to governement information, an effort that was accelerated in the name of national security following the Sept. 11 terrorist attacks......
Greetings again BSE-L list members,
how would _USA_ ruminant-to-ruminant feed ban warning letters have anything to do with terrorism and National Security?
WE KNOW HOW THE FOIA WORKS DON'T WE ;
Monday, September 1, 2008 RE-FOIA OF DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [No. 00-072-1] September 1, 2008
http://foiamadsheepmadrivervalley.blogspot.com/2008/09/re-foia-of-declaration-of-extraordinary.html
WHO WOULD WANT A USDA CERTIFIED MAD COW BRAIN TO EAT ???
OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .
World 37,727 33 363,222 344
Mexico 37,727 33 338,475 326
Romania 0 0 24,747 19
0206290010: HEARTS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 581,872 418 7,564,955 5,685 Angola 0 0 211,527 46 Cambodia (Kampuchea) 0 0 22,682 60 China 0 0 49,887 36 Colombia 0 0 22,657 28 Gabon 0 0 24,947 11 Hong Kong 0 0 24,494 45 Indonesia 400,639 261 4,420,683 2,747 Italy 0 0 24,494 20 Korea 0 0 124,089 71 Mexico 181,233 157 2,494,078 2,517 Poland 0 0 47,359 20 Russia 0 0 98,058 85
0206290020: KIDNEYS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram)
December 2004 2004, through December Quantity Value Quantity Value .World 303,293 175 3,009,780 1,684 Angola 0 0 60,075 15 Bahamas 0 0 11,431 8 Cayman Islands 0 0 4,450 10 China 0 0 48,988 26 Gabon 48,200 15 489,329 206 Hong Kong 0 0 48,988 26 Indonesia 0 0 47,174 17 Ivory Coast 188,414 96 1,694,772 959 Jamaica 10,546 5 78,933 37 Mexico 56,133 59 203,788 204 Moldova 0 0 295,091 166 Romania 0 0 26,761 10
0206290040: SWEATBREADS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 0 0 95,209 83 Bulgaria 0 0 25,243 22 Ghana 0 0 0 0 Mexico 0 0 69,859 58 Netherlands 0 0 107 4
0206290050: LIPS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 1,389,825 2,709 7,355,294 13,917 Bahamas 0 0 40,000 5 Mexico 1,386,800 2,706 7,293,673 13,895 Montserrat 0 0 18,596 15 Namibia 3,025 3 3,025 3
0206290090: OFFAL OF BOVINE ANIMALS, EDIBLE, NESOI, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 2,386,597 2,913 22,701,393 25,320 Antigua Barbuda 2,141 6 3,162 11 Argentina 590 4 1,044 7 Aruba 1,000 4 1,476 10 Bahamas 0 0 117,929 184 Bulgaria 0 0 315,543 301 Canada 337,392 255 3,544,821 3,347 Cayman Islands 0 0 5,350 21 China 0 0 22,185 37 Colombia 0 0 24,127 36 Cyprus 0 0 25,052 20 Denmark 0 0 46,416 25 Dominican Republic 0 0 24,086 16 Egypt 0 0 145 3 Gabon 96,208 92 316,411 271 Germany 0 0 2,545,197 554 Greece 0 0 190,564 146 Guatemala 0 0 117,362 197 Haiti 0 0 13,125 25
Haiti 0 0 13,125 25 Honduras 23,940 34 23,940 34 Hong Kong 0 0 48,343 130 Indonesia 7,470 9 640,472 249 Italy 0 0 47,849 38 Ivory Coast 192,410 184 1,133,273 1,012 Jamaica 80,703 54 124,514 86 Japan 25,094 53 432,608 2,659 Korea 0 0 23,596 25 Malaysia 97,997 48 457,516 203 Mexico 1,376,419 1,977 9,425,957 13,261 Netherlands 20,229 20 245,555 129 New Zealand 0 0 0 0 Panama 23,399 44 161,425 117 Philippines 0 0 22,184 39 Poland 0 0 805,355 477 Romania 48,988 33 1,294,879 1,191 Senegal 0 0 52,909 103 Singapore 0 0 728 3 Spain 0 0 202 4 St Christopher-Nevis 0 0 1,020 3 St Lucia 0 0 5,313 8 Switzerland 0 0 6,506 35 Taiwan 46,920 86 97,268 127 Trinidad and Tobago 0 0 38,102 84 Turks and Caicos Islands 5,697 9 6,082 13 United Kingdom 0 0 291,303 76 Uruguay 0 0 499 4
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020629.html
0206100000: OFFAL OF BOVINE ANIMALS, EDIBLE, FRESH OR CHILLED
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 149,260 308 1,312,166 2,933 Bahamas 2,174 3 6,710 6 Canada 15,265 14 115,659 129 Cayman Islands 0 0 1,312 5 China 48,988 44 48,988 44 Egypt 0 0 27,654 81 Gabon 0 0 97,462 80 Hong Kong 0 0 48,988 30 Indonesia 0 0 38,000 33 Ivory Coast 0 0 127,000 108 Kuwait 0 0 12,487 36 Mexico 82,833 247 667,881 2,070 Philippines 0 0 26,797 88 Taiwan 0 0 43,544 30 Turks and Caicos Islands 0 0 1,907 3 United Arab Emirates 0 0 47,777 190
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020610.html
0206210000: TONGUES OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 432,185 755 3,479,807 6,127 Bangladesh 23,623 38 47,380 77 Honduras 15,163 28 17,105 31 Hong Kong 0 0 47,151 86 Indonesia 0 0 83,245 193 Japan 0 0 25,697 57 Kazakhstan 0 0 145,001 175 Mexico 368,562 638 3,046,441 5,384 Nicaragua 6,537 13 6,537 13 Philippines 18,300 38 61,250 111
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020621.html
0206220000: LIVERS OF BOVINE ANIMALS, EDIBLE, FROZEN
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 5,712,394 4,115 55,278,021 38,020 Albania 0 0 74,863 45 Angola 24,677 22 888,634 430 Antigua Barbuda 2,682 3 5,111 5 Azerbaijan 97,471 45 633,575 324 Bahamas 1,836 3 10,561 8 Belarus 0 0 355,818 130 Belgium 488,886 295 2,998,386 1,265 Bulgaria 0 0 355,234 310 Canada 18,416 49 372,057 910 Dominican Republic 0 0 13,599 7 Ecuador 0 0 8,378 5 France 0 0 92,361 29 Georgia 0 0 243,876 170 Germany 609,187 323 2,104,312 908 Greece 0 0 149,205 87 Guatemala 0 0 19,962 11 Honduras 65,432 30 196,264 104 India 0 0 67,491 55 Indonesia 769,971 1,139 4,495,414 7,077 Iraq 0 0 48,984 21 Italy 0 0 9,002 12 Ivory Coast 0 0 24,701 8 Jamaica 170,782 137 170,782 137 Kazakhstan 0 0 868,130 762 Korea 0 0 23,593 17 Kuwait 0 0 1,560 7 Latvia 0 0 577,885 166 Liberia 0 0 24,950 16 Liechtenstein 0 0 24,369 11 Lithuania 0 0 996,660 552 Madagascar 0 0 24,494 10 Mali 0 0 49,211 40 Mexico 264,561 131 5,094,330 5,868 Moldova 249,107 125 2,743,394 1,314 Mozambique 0 0 24,093 17 Netherlands 0 0 49,520 26 Nicaragua 31,131 19 48,335 25 Philippines 24,504 14 97,948 156 Poland 1,553,201 953 23,262,526 13,113 Romania 0 0 199,072 121 Russia 0 0 544,267 225 Saudi Arabia 70,805 88 243,230 381 Senegal 0 0 285,311 302 Turkey 884,029 496 1,733,636 881 Ukraine 0 0 244,559 132 United Kingdom 362,446 235 4,709,748 1,792 Venezuela 0 0 45,360 19 Zaire 23,270 9 23,270 9
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020622.html
0201203550: MEAT OF BOVINE ANIMALS, NESOI, CUTS WITH BONE IN, PROCESSED, FRESH OR CHILLED
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 293,718 1,252 703,296 2,552 Anguilla 0 0 11,482 35 Aruba 0 0 4,775 24 Bahamas 19,416 50 247,589 684 Barbados 0 0 14,377 33 Bermuda 0 0 1,361 3 Cayman Islands 0 0 13,502 48 Colombia 244,578 738 244,578 738 France 6,242 368 6,700 400 Germany 1,564 48 1,564 48 Guatemala 21,918 49 21,918 49 Honduras 0 0 19,051 24 Hong Kong 0 0 14,618 76 Indonesia 0 0 1,008 3 Italy 0 0 750 6 Korea 0 0 6,023 35 Marshall Islands 0 0 37,817 121 Mexico 0 0 20,347 21 Netherlands Antilles 0 0 449 8 St Lucia 0 0 436 4 Suriname 0 0 240 4 Switzerland 0 0 2,402 81 Trinidad and Tobago 0 0 6,047 18 Turks and Caicos Islands 0 0 26,262 90
0201206000: MEAT OF BOVINE ANIMALS, CUTS WITH BONE IN, EXCEPT PROCESSED, FRESH ORCHILLED
U.S. Domestic Exports: December 2004 and 2004 Year-to-Date, not Seasonally Adjusted
(FAS Value, in Thousands of Dollars) (Units of Quantity: Kilogram) December 2004 2004, through December Quantity Value Quantity Value .World 86,480 824 698,955 4,793 Antigua Barbuda 0 0 410 6 Bahamas 10,521 27 60,334 200 Bahrain 0 0 3,721 11 Canada 39,462 342 472,538 3,481 Chile 0 0 9,694 29 Dominican Republic 0 0 28,327 37 French Polynesia 0 0 1,596 10 Greece 0 0 2,825 16 Honduras 0 0 9,887 20 Japan 0 0 0 0 Mexico 0 0 9,189 28 Netherlands Antilles 478 8 4,250 44 Philippines 0 0 393 3 Saudi Arabia 1,053 15 22,470 102 St Lucia 0 0 372 3 Svalbard, Jan Mayen Island 34,064 430 57,812 715 Trinidad and Tobago 0 0 6,258 59 Turks and Caicos Islands 902 3 8,879 29
http://ita.doc.gov/ td/ industry/ otea/ Trade-Detail/ Latest-Month/ Exports/ 02/ 020120.html
Greetings,
IN 2009, it would be a miracle that every cow in the United States of America was not exposed to mad cow disease via feed, the number one firewall all the officials brag about all the time $$$
----- Original Message -----
From: "TERRY SINGELTARY" <flounder9@VERIZON.NET>
To: <BSE-L@LISTS.AEGEE.ORG>
Sent: Wednesday, March 18, 2009 4:25 PM
Subject: [BSE-L] HERE WE GO AGAIN, FDA TO DELAY ENHANCED MAD COW FEED BAN RULE
-------------------- BSE-L@LISTS.AEGEE.ORG --------------------
Industry News - PM FDA to delay enhanced feed ban rule
By Tom Johnston on 3/18/2009
The Food and Drug Administration will extend by 60 days the April 27 effective date of the agency's enhanced ban on high-risk cattle material in feed for all animals, according to industry sources.
The decision comes as the Obama administration reviews rules not yet in effect and considers extending the implementation dates by 60 days. In such cases, agencies also are directed to allow for an additional 30 days for public comment.
FDA will soon publish a notice in the Federal Register.
Packers and renderers, among others in the food chain, have been pressing FDA to delay implementing the enhanced feed ban and allow for additional public comment in light of hardships they already have begun to incur in the run-up to the rule's implementation. To view the final rule, click here.
Primary among the challenges, they say, is disposal of banned materials such as spinal cords and brains from cattle older than 30 months of age. Some renderers, for example, already have been refusing to take such materials or older dead stock off of packers' hands, forcing them to find other methods of disposal that can be costly and problematic.
Editor's Note: More details about the impacts of this rule will be included in a feature article in the May issue of Meatingplace magazine.
http://www.meatingplace.com/MembersOnly/webNews/details.aspx?item=11718
SIGH!
does this really surprise anyone $
i said it during the clinton era, i said for 8 years during the bush blunder, and i am saying now. it seems the industry i.e. has bought it's way deeply into the white house, no matter whom is in office. the people do not own it anymore.
there was nothing more to look at except $$$
there is nothing more to talk about.
the partial, and voluntary august 4, 1997 ruminant to ruminant feed ban was nothing more than ink on paper, and that's all it is today.
sadly, that's all this has ever been about, money. science, public health, nothing else matters. just ask old stan the man, the prion man ;
Tuesday, March 17, 2009
BSE Feed Ban Enhancement: Implementation Questions and Answers Updated March 10, 2009
http://madcowfeed.blogspot.com/2009/03/bse-feed-ban-enhancement-implementation.html
DAMNING TESTIMONY FROM STANLEY PRUSINER THE NOBEL PEACE PRIZE WINNER ON PRIONS SPEAKING ABOUT ANN VENEMAN
''they don't wanna know, the dont' care'' "they don't want our comments'' ''level of absolute ignorance'' ''beef export'' ''nothing else matters'' ''yes, i think prions are bad to eat, and you can die from them''
http://maddeer.org/video/embedded/prusinerclip.html
Saturday, February 21, 2009 Renderers say industry not prepared for FDA feed ban rule ??? WHAT, IT'S 2009 FOR PETE'S SAKE $$$ Two recent articles caught my eye ;
Renderers say industry not prepared for FDA feed ban rule
Food Chemical News
February 2, 2009
and
BSE, rendering relate to human safety
Emma Struve 02/17/2009
http://madcowfeed.blogspot.com/2009/02/renderers-say-industry-not-prepared-for.html
Risk of Introduction of BSE into Japan by the Historical Importation of Live Cattle from the United Kingdom (USA AND CANADA)
http://bseusa.blogspot.com/2009/03/risk-of-introduction-of-bse-into-japan.html
Wednesday, January 28, 2009
TAFS1 Position Paper on Specified Risk Materials (January, 2009)
TAFS INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation
(January 2009)
TAFS1 Position Paper on Specified Risk Materials
http://madcowspontaneousnot.blogspot.com/2009/01/tafs1-position-paper-on-specified-risk.html
TAFS1 Position Paper on Testing of Cattle for BSE (Revision January 2009)
http://madcowtesting.blogspot.com/2009/02/tafs1-position-paper-on-testing-of.html
Wednesday, February 11, 2009 Atypical BSE North America Update February 2009
http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html
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
___________________________________
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
___________________________________
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
Friday, November 21, 2008
Plasma & Serum Proteins Receive Continued FDA Approval
http://madcowfeed.blogspot.com/2008/11/plasma-serum-proteins-receive-continued.html
http://madcowfeed.blogspot.com/
Thursday, November 27, 2008 Prion diseases are efficiently transmitted by blood transfusion in sheep
http://vcjdblood.blogspot.com/2008/11/prion-diseases-are-efficiently.html
Scientists warn of first ever case of human mad cow disease from blood plasma
http://vcjdtransfusion.blogspot.com/2009/02/scientists-warn-of-first-ever-case-of.html
November 25, 2008
Update On Feed Enforcement Activities To Limit The Spread Of BSE
http://madcowfeed.blogspot.com/2008/11/november-2008-update-on-feed.html
Docket APHIS-2007-0033 Docket Title Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Docket Type Rulemaking Document APHIS-2007-0033-0001 Document Title Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Public Submission APHIS-2007-0033-0002.1 Public Submission Title Attachment to Singeltary comment
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648027c28e
Manuscript Draft Manuscript Number: Title: HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory Article Type: Personal View Corresponding Author: Mr. Terry S. Singeltary, Corresponding Author's Institution: na First Author: Terry S Singeltary, none Order of Authors: Terry S Singeltary, none; Terry S. Singeltary Abstract: TSEs have been rampant in the USA for decades in many species, and they all have been rendered and fed back to animals for human/animal consumption. I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2007.
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648027c28e&disposition=attachment&contentType=pdf
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 Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE
IS THERE A SCRAPIE-LIKE DISEASE IN CATTLE ?
In April of 1985, a mink rancher in Wisconsin reported a debilitating neurologic disease in his herd which we diagnosed as TME by histopathologic findings confirmed by experimental transmission to mink and squirrel monkeys. The rancher was a ''dead stock'' feeder using mostly (>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
http://downercattle.blogspot.com/
TSS
Saturday, March 14, 2009 Agriculture Secretary Tom Vilsack Announces Final Rule for Handling of Non-Ambulatory Cattle
Release No. 0060.09 Contact: Amanda Eamich (202) 720-9113
http://downercattle.blogspot.com/2009/03/agriculture-secretary-tom-vilsack.html
Friday, November 30, 2007
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION
http://cjdquestionnaire.blogspot.com/
FDA FAILED US
http://fdafailedus.blogspot.com/
SCIENCE BUSHWHACKED
http://sciencebushwhacked.blogspot.com/
Sunday, July 20, 2008 Red Cross told to fix blood collection or face charges 15 years after warnings issued, few changes made to ensure safety
http://vcjdblood.blogspot.com/2008/07/red-cross-told-to-fix-blood-collection.html
TSS
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