TAFS INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL
Foundation
(Revision January 2009)
TAFS1 Position Paper on Testing of Cattle for BSE – Purpose and Effectiveness © TAFS, Berne, 2009 Large scale testing of cattle for BSE has now been established in many countries, starting in Switzerland in 1999, and followed by the European Union in 2001. Similar programmes have subsequently been introduced in other countries. This position paper explains some of the background to such testing, especially in relation to its purpose and effectiveness, and possible future developments. It also emphasises the fact that the key measure to protect consumers is the removal of Specified Risk Materials, rather than testing. Further details of SRM controls and their background can be found in a separate TAFS position paper. For the purposes of this document, testing means the collection of a sample of brain tissue after death or slaughter, and its examination with a commercial “rapid test”.
Why are countries required to test cattle for BSE?
* The main purpose of testing is to identify whether BSE exists in a country, and if so, the likely numbers of infected cattle. This is to supplement compulsory reporting of clinically affected suspects, and is particularly important where farmers and veterinarians may have difficulty in recognising BSE. Diagnosis of BSE in the live animal requires experience, and early signs of abnormalities may either be missed, or their significance not recognised. Farmers may therefore slaughter or sell such animals without ever suspecting that they are affected with BSE. Testing has been effective in identifying the first case of BSE in several countries thought to be free of the disease. World-wide statistics arising from surveillance are available through the OIE or World Animal Health Organisation(16).
* By determining how much BSE exists, especially when monitored over a sufficiently long period of time, the testing can give an indication of the effectiveness of measures introduced to control BSE. In other words, a declining prevalence indicates that controls are working. If cases continue to occur for long periods after controls have been introduced, it may mean that controls are not totally effective.
1 TAFS is an international platform created by a group of scientists, food industry experts, animal health regulators, epidemiologists, diagnosticians, food producers, and consumers. Its purpose is to establish and maintain lines of communication for the dissemination of reliable information to the public that can maintain confidence in the safety of food with regard to Transmissible Animal Diseases (TAD).
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* The scale of testing has also enabled the detection of apparently new forms of BSE, in small numbers, colloquially referred to as “atypical BSE”. A separate TAFS position paper is available on “atypical BSE”
* In some countries testing of cattle at slaughter is also introduced to increase consumer confidence in the consumption of beef and other products produced from cattle. The removal of positive cattle from the human food chain is claimed to provide a degree of protection to consumers. Clinically suspect cattle are already excluded from the food chain.
Are all cattle tested?
* No. In Europe, the primary target for testing of cattle slaughtered for human consumption is cattle aged over 30 months at the time of slaughter. This age was chosen from experience in the British epidemic that the brain and spinal cord of infected cattle over 30 months are more likely to be infectious, and test positive, than in younger animals.
* Some countries (eg Germany, France, Italy, Spain) have at times included animals aged over 24 months in the testing programme, while Japan, tested all ages in the early days of its surveillance programme. From 2005 the Japanese government no longer required the testing of cattle under 21 months of age, but allowed local authorities to continue should they prefer to do so. That continues to be the position at the beginning of 2009.
* Two other categories of cattle are also targeted for testing. The first, called fallen stock, which are cattle that are sick and die or are culled on farm, do not enter the human food chain. They are normally destroyed by incineration or rendering, or occasionally buried on farm. Such animals over 30 months of age have been shown to have a higher probability of testing BSE positive than animals slaughtered for human consumption. Animals over 24 months in this group weretargeted for testing, but as discussed below, this can change.
* Secondly, a category of cattle called “casualties” are also considered to be a good target population for the detection of BSE. These animals may be suffering from some abnormality, but have been certified by a veterinary surgeon as being fit for human consumption. Cattle with broken legs are an example of such animals. Broken legs or other injuries can arise as a result of excessive kicking on the part of the cow due to infection with BSE. In the EU, casualties (defined as cattle subject to emergency slaughter or found sick at ante-mortem inspection) over 24 months of age were tested for BSE. Some countries ban the consumption of casualties, in which case they will then be destroyed and tested along with fallen stock.
* Testing of fallen stock and casualties is the most cost-effective approach of finding BSE infected animals in that fewer animals have to be tested for each positive detected. Together they are commonly referred to as “risk animals.” ? None of the categories and age-groups referred to above are absolute. It is essential that they are reviewed from time to time to consider whether they remain appropriate. (See below)
Is it necessary to test all ages of cattle?
* No. Some countries have at times introduced such a policy (eg Japan), but it is extremely expensive while doing little to increase the likelihood of finding positive cattle.
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* Experience in the United Kingdom suggests that most infected cattle die of BSE at between four and six years of age, with an average of 60 months(19) although some may be much older. Research on sheep naturally infected with a similar disease called scrapie, or mice experimentally infected with scrapie, suggested that the brain would be infected by approximately mid-way in the incubation(4, 7, 10, 14). Translated into cattle this would be approximately 30 months of age if it is assumed that calves become infected in the first few months of life. Small numbers would of course be positive before this age. Surveillance in Germany has shown this to be possible, and the age at testing in that country was reduced to 24 months as a result. Japan has had a similar experience. Indeed the youngest BSE case ever detected was clinically affected at 20 months of age in the United Kingdom, and may represent the extreme end of the age range of affected cattle.
* Brains of cattle experimentally infected with 100g of BSE-infected brain in two separate challenge studies in the United Kingdom have tested positive only at 32 and 30/33 months after infection(1,8,18,), although one of these studies also demonstrates that the brain is infectious shortly before it tests positive by rapid tests(8). A German study has confirmed however that there is considerable variation between animals challenged at the same age, and occasional animals may be positive before 30 months(11). In that study, the lower limit detected after an oral dose of 100g was 24 months post- infection. Perhaps more realistically, following a dose of 1g only, and more likely to represent natural exposure levels, brain was found to be positive at 44 months post-infection(1).
* Further research data from the United Kingdom on BSE-infected cattle suggests that the brain is actually not infectious until a much later stage of incubation than seen in sheep and mice with scrapie. It seems as if this may only be in the six to 12 months before the onset of clinical disease. This suggests that for the majority of infected cattle the selection of 30 months as the age above which cattle are tested is appropriate, and cautious. In other words, it should detect the vast majority of infected cattle that are approaching the onset of clinical disease (1, 3, 9, 18).
* Selection of just a proportion of cattle to test, such as fallen stock, casualties and healthy animals over 30 (or 24) months of age when killed, makes best use of limited resources in establishing a large testing programme, particularly in countries with low BSE risk. In other words, in order of probability of detecting positive cattle, testing could be focused on cattle exhibiting clinical signs compatible with BSE, fallen stock/casualties, or apparently healthy cattle over the age of 30 months when slaughtered. The ideal mix of cattle to be sampled will vary from country to country, but the testing of healthy cattle is not an appropriate substitute for the testing of the other categories.
What tissue is tested?
* Brain (particularly the part referred to as brain stem), or sometimes spinal cord, are the preferred tissues to test. This is because these tissues, along with the eye, are the only tissues found to be consistently positive in naturally infected cattle. The tests used have also been optimised to work on brain.
* In experimentally infected cattle, in addition to central nervous tissue, the lower small intestine is also infected, but it is inconsistently positive and it is not yet possible to perform tests with any confidence on this tissue. It has not proved possible to demonstrate this infectivity in the intestine of naturally infected cattle. Traces of infectivity have been detected in tonsil and bone marrow of experimentally infected
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cattle, but these results do not indicate that either tissue is an appropriate alternative for testing. ? More recently, tests carried out on peripheral nerves of cattle clinically affected with BSE(2,12,13,15) have confirmed that at late stages of incubation some nerves are positive, but much less so than brain. So again they do not represent optimal targets for testing.
Is this effective in detecting all infected cattle?
* No. Only a proportion of infected cattle will be detected by the testing of brain. As explained above in selecting the age of cattle to test, infectivity appears to reach the brain and spinal cord only relatively late in the incubation period. Consequently, an animal in the early stages of incubation will test negative despite being infected.
* This problem could be overcome if the intestine could be tested as described above, but that is not yet possible with current tests.
If all infected cattle cannot be detected by this means, why bother to test at all?
* Because the primary purpose of testing is to improve our understanding of how much BSE exists in the cattle population, the inefficiency of the testing approach is outweighed by the additional information gathered, over and above reliance on the detection of clinically affected cattle. Taken together they give a better indication of the scale of the problem, and whether or not measures introduced to control BSE are effective. Ideally surveillance results should indicate that cattle born after the introduction of control measures are either not infected or far less likely to be infected than cattle born before the measures.
If only a proportion of infected cattle can be detected, does testing provide significant consumer protection?
* The extent to which testing increases consumer protection is still open to question, especially if other protective measures are in place (see below).
* It is conceivable that tissues not previously recognised as infected may still be found as research continues. Infectivity levels are expected to be extremely low, and undetectable with the tools used so far. If these tissues were otherwise consumed then the destruction of the carcase would afford the consumer a greater degree of protection. If the tissues are not sufficiently infectious to pose a health risk, and/or are not consumed, then the additional protection provided may be nil.
* Recent results from Japan and Germany confirm this point(2,12,13,15), with positivity or infectivity being detected in some peripheral nerves that would not normally be removed as SRM. The amount of infectivity present is low, and considered be up to 1000-fold lower than the brain. Unpublished evidence suggests that these become positive only after the brain and spinal cord. This therefore confirms that testing and removal of positive animals does provide some additional, as yet unquantifiable, protection to consumers over and above that provided by removal of SRM. Given that detection of positivity or infectivity in some peripheral nerves coincides with the onset of clinical signs, it is probable that such animals would be detected before slaughter, and therefore excluded from the food chain.
What alternatives are there to testing of cattle slaughtered for human consumption?
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* In most countries, testing of cattle at slaughter is only one of several lines of defence to protect the consumer.
* The first critical step is the exclusion of all clinically affected cattle from the human food chain. These should be reported to the authorities, killed and destroyed. Inspection of animals as they enter the abattoir for slaughter will identify some affected cattle that may not have been detected on farm. Indeed, transportation to the abattoir often triggers more obvious clinical signs in affected animals. These will be destroyed.
* Finally, in most countries where BSE has been recognised, the key protective measure is the removal from the human food chain of tissues that are expected to contain the greatest amounts of infectivity. Such tissues are currently called Specified Risk Materials. These are described more fully in the TAFS position paper on SRM.
* When SRM are removed they are destroyed, and thereby also excluded from animal feed as well. This measure therefore protects both humans and animals.
What tests are used?
* Since 1999, when the European Commission first evaluated new rapid screening tests, there have been further rounds of evaluation and approval. In addition, the OIE has also started to offer evaluation of tests for more global use.
* All allow the completion of testing of cattle within a matter of hours from death, thus enabling abattoirs to await the results before carcases are released for human consumption. All parts of positive animals are then kept separate and destroyed.
* Although test manufacturers make claims about the relative merits of their tests, all are considered to be appropriate for the purpose. None have been shown to guarantee the detection of animals earlier in the incubation period than the others. Criteria for selection of tests for use in a particular country therefore take into account the skills and resources in that country for conducting testing, the volume of testing to be done, and test cost price.
* Because of the constantly evolving nature of this area, with approvals having taken place in the EU, Japan, USA and Canada, it is not possible to list all approvals in this document. Most of the tests used in N America and Japan are related to those approved in Europe, and are essentially identical. The OIE Reference Laboratory at the Veterinary Laboratories Agency(17), UK therefore maintains lists of approved tests, or links to approval sites in other countries where accessible, that will enable readers to further investigate what is available on the market.
* Any animals found positive by the use of such tests are subjected to further testing at National Reference Laboratories using internationally recognised confirmatory tests. Carcases will already have been removed from the food chain before this as a precautionary measure.
Will testing continue indefinitely?
* This is most unlikely as it is extremely expensive and complex to implement. In its discussion document entitled the “TSE Roadmap”(5), the European Commission estimated that between 2001 and 2004 it cost 1.56 million euros to detect each case by testing in the healthy slaughter population, but this rose to 64 million euros/case for animals aged under 48 months. As this is an average figure, for countries with very low incidence of BSE the cost was even higher.
* As control measures take effect, these costs will rise even in older testing groups, while in parallel the risk to consumers is falling towards zero.
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* The TSE Roadmap therefore began a public debate in Europe about planning a future strategy that will maintain protective measures for both consumers and animals, but at a cost that is proportionate to the risk.
* As anticipated by the TSE Roadmap, the review process was taken forward in 2008 when the European Commission consulted the European Food Safety Authority on options for alternative testing strategies. In recognition of the falling prevalence of BSE in EU countries where controls were tightened at the end of 2000, the Commission asked EFSA to consider the implications of raising the target age for testing in both healthy and risk categories of cattle. The EFSA Opinion offered estimates for the consequences of increasing the minimum age at testing by 12 month intervals to an upper limit of 60 months.
* In summary, the EFSA Opinion(6) considered options of raising the age at testing to 36, 48 or 60 months in healthy cattle, and 30, 36, 48 and 60 months for risk animals. As recognized earlier in this paper, falling prevalence of BSE in EU152 countries confirmed the effectiveness of measures introduced at the end of 2000 (newer Member States where control measures have not been in place for as long as in EU15 countries were excluded as further time was needed to provide evidence of effectiveness).
* For healthy cattle, the Opinion estimated that fewer than two cases would be missed in all EU15 countries if the age at testing was increased to 36 or 48 months, and fewer than three missed if the age was raised to 60 months.
* For risk animals, less than one positive animal would be missed by raising the age at testing to 30, 36 or 48 months, or fewer than three cases if raised to 60 months.
* As a result, the Commission recommended that EU15 countries could apply to increase the age at testing in both surveillance streams to 48 months in 2009. Following consultation with the European Parliament, and by national authorities, the age at testing in EU15 countries has been raised to 48 months in 2009. Some may decide not to apply this flexibility across all surveillance streams.
* In future, similar changes can be anticipated in the remaining EU countries, and the age limit may be raised further in the EU15 countries, but all changes will continue to be subject to ongoing review of surveillance and enforcement data throughout the EU.
2 EU15 countries – Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, United Kingdom.
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References:
1. Arnold, M.A., Ryan, J.B.M., Konold, T., Simmons, M.M., Spencer, Y.I., Wear, A., Chaplin, M., Stack, M., Czub, S., Mueller, R., Webb, P.R., Davis, A., Spiropoulos, J., Holdaway, J., Hawkins, S.A.C., Austin, A.R., and Wells, G.A.H. (2007) Estimating the temporal relationship between PrPSc detection and incubation period in experimental bovine spongiform encephalopathy (BSE) of cattle. J. Gen Virol. 88: 3198-3208. 2. Buschmann A., Groschup MH. Highly BSE-sensitive transgenic mice confirm the essential restriction of infectivity to the nervous system in clinically diseased cattle. J Infect Dis. 2005 Sep 1;192(5):934-42. 3. Deslys, J.P, Comoy, E, Hawkins, S, Simon, S, Schimmel, H, Wells, G, Grassi, J and Moynagh, J. (2001). Screening of slaughtered cattle for BSE. Nature. 409, 476-478. 4. Dickinson, A.G. and Outram, G. (1979). The scrapie replication-site hypothesis and its implications for pathogenesis. In: Slow Transmissible Diseases of the Nervous System. vol.2. S.B.Prusiner and W.J.Hadlow, eds. Academic Press, New York, pp 13-31. 5. EC. 2005. The TSE Roadmap – available at
http://ec.europa.eu/food/food/biosafety/bse/roadmap_en.pdf
6. EFSA (2008). Scientific Opinion of the Panel on Biological Hazards on a request from the European Commission on the Risk for Human and Animal Health related to the revision of the BSE monitoring regime in some Member States. The EFSA Journal. 762:1-47.
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/biohaz_op_ej762_bse_monitoring_en,2.pdf?ssbinary=true
7. Eklund, C.M, Kennedy, R.C. and Hadlow, W.J. (1967). Pathogenesis of scrapie virus infection in the mouse. J. Infect Dis. 117. 15-22. 8. Espinosa, J-C., Morales, ,M., Castilla, J., Rogers, M. and Torres, J.M. (2007) Progression of prion infectivity in asymptomatic cattle after oral bovine spongiform encephalopathy challenge. J. Gen. Virol. 88. 1379-1383 9. Grassi, J, Comoy, E, Simon, S, Creminon, C, Frobert, Y, Trapmann, S, Schimmel, H, Hawkins, S.A.C, Moynagh, J, Deslys, J.P and Wells, G.A.H. (2001). Rapid test for the preclinical postmortem diagnosis of BSE in central nervous system tissue. Vet Rec. 149, 577-582. 10. Hadlow, W.J, Kennedy, R.C. and Race, R.E. (1982). Natural infection of Suffolk sheep with scrapie virus. J Infect Dis. 146, 657-664. 11. Hoffmann, C., Ziegler, U., Buschmann, A., Weber, A., Kupfer, L., Oelschlegel, A., Hammerschmidt, B. and Groschup, M.J. (2007) Prions spread via the autonomic nervous system in cattle incubating bovine spongiform encephalopathy. J. Gen. Virol. 88. 1048-1055. TAFS 8 12. Iwamaru Y, Okubo Y, Ikeda T, Hayashi H, Imamura M, Yokoyama T, Shinagawa M. (2005) PrPSc distribution of a natural case of bovine spongiform encephalopathy. In: Kitamoto T, ed. Prions. Food and Drug Safety. Springer Verlag, New York. 13. Iwata, N., Sato, Y. Higuchi, Y. Nohtomi, K. Nagata, N. Hasegawa, H. Tobiume, M. Nakamura, Y., Hagiwara, K., Furuoka, H, Horiuchi, M. Yamakawa, Y & Sata.T (2006). Distribution of PrP(Sc) in Cattle with Bovine Spongiform Encephalopathy Slaughtered at Abattoirs in Japan. Jpn J Infect Dis. 59:100-7. 14. Kimberlin, R.H. and Walker, C.A. (1988). Pathogenesis of experimental scrapie. In: Novel Infectious Agents and the Central Nervous System. Ciba Foundation Symposium. 135. G.Boack and J. Marsh, Eds. Wiley, Chichester.pp 37-62. 15. Masujin, K., Matthews, D., Wells, G.A.H., Mohri, S and Yokoyama, T. (2007). Prions in the peripheral nerves of bovine spongiform encephalopathy (BSE) affected cattle. J. Gen. Virol. 88: 1850-1858. 16. OIE, World Animal Health Organisation, BSE statistics: available at :-
http://www.oie.int/eng/info/en_esb.htm
17. Veterinary Laboratories Agency (VLA) – TSE science home page for references on approved rapid tests, available at:-
http://www.defra.gov.uk/corporate/vla/science/science-tse-rl-intro.htm
18. Wells, G.A.H, Hawkins, S.A.C, Green, R.B, Austin, A.R, Dexter, I, Spencer, Y.I, Chaplin, M.J, Stack, M.J, and Dawson, M. (1998). Preliminary observations on the pathogenesis of experimental bovine spongiform encephalopathy (BSE):an update. Vet Rec. 142, 103-106. 19. Wilesmith, J.W. (1998). Manual on Bovine Spongiform Encephalopathy. FAO. Rome.
http://www.tafsforum.org/position_papers/TAFS_POSITION_PAPER_ON_TESTING_OF_CATTLE_FOR_BSE_2009.pdf
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
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
Research Project: Detection of Prp**d in Tissue Samples and Bodily Fluids of Cattle from the German Bse Pathogenesis Study Location: Virus and Prion Diseases of Livestock
2008 Annual Report
1a.Objectives (from AD-416) The overall objective of this cooperative project is to evaluate PrP**D tissue distribution and migration in cattle orally infected with BSE of British origin. To achieve this objective, the following specific approaches will be conducted: (1) the protein misfolding cyclic amplification (PMCA) assay will be used on blinded replicate aliquots of tissue from animals in the BSE study to independently confirm whether PrP**D can be detected in the tissue samples. The Cooperator will function as lead investigator and ARS will confirm test results for the presence or absence of PrP**D in any given sample. (2) The Cooperator will analyze the proteome in tissue samples by two dimensional SDS PAGE. (3) NADC will evaluate microscopic pathology and visual function of the retina of available animals and tissues to assess PrP**D accumulation and visual function effects.
1b.Approach (from AD-416) The German BSE oral pathogenesis study involves 56 beef cattle orally dosed with BSE containing brain tissue obtained from British cattle. The animal study is managed by the cooperator and various tissues are collected at prescribed times and at necropsy. These tissues will enable the cooperating parties to perform independent confirmation on the presence or absence of PrP**D for verification of PrP**D distribution in tissues. In addition, retinal samples will be analyzed to assess the extent of retinal pathology in infected cattle and visual system function in available remaining live cattle will be tested using electroretinography.
3.Progress Report The overall objective of this cooperative project is to evaluate PrP**d tissue distribution and migration in cattle orally infected with Bovine spongiform encephalopathy (BSE) of British origin. The live-animal phase of this work was completed this year. Samples from this experiment will be brought to the USDA, ARS, National Animal Disease Center for further characterization in the upcoming year. Methods used for monitoring included phone contact, e-mail, and site visits. This project addresses NP 103, component 8.
http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=411017&fy=2008
Research Project: Study of Atypical Bse Location: Virus and Prion Diseases of Livestock
Project Number: 3625-32000-086-05 Project Type: Specific Cooperative Agreement
Start Date: Sep 15, 2004 End Date: Sep 14, 2009
Objective: The objective of this cooperative research project with Dr. Maria Caramelli from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct comparative studies with the U.S. bovine spongiform encephalopathy (BSE) isolate and the atypical BSE isolates identified in Italy. The studies will cover the following areas: 1. Evaluation of present diagnostics tools used in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison of the U.S. BSE isolate and other typical BSE isolates with atypical BSE cases. 3. Studies on transmissibility and tissue distribution of atypical BSE isolates in cattle and other species.
Approach: This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate. Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal.
http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490
CHAPTER 3 Animal Disease Eradication Programs and Control and Certification Programs
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In FY 2007, two field cases, one validation study case, and two RSSS cases were consistent with a variant of the disease known as Nor98 scrapie.1 These five cases originated from flocks in California, Minnesota, Colorado, Wyoming, and Indiana, respectively.
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http://www.aphis.usda.gov/publications/animal_health/content/printable_version/AHR_Web_PDF_07/D_Chapter_3.pdf
NOR-98 Scrapie FY 2008 to date 1
http://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/monthly_scrapie_rpt.pps
ATYPICAL TSEs in USA CATTLE AND SHEEP ?
http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf
Monday, December 1, 2008
When Atypical Scrapie cross species barriers
http://nor-98.blogspot.com/2008/12/when-atypical-scrapie-cross-species.html
Tuesday, January 06, 2009
CWD Update 93 December 29, 2008
http://chronic-wasting-disease.blogspot.com/2009/01/cwd-update-93-december-29-2008.html
Sunday, December 28, 2008
MAD COW DISEASE USA DECEMBER 28, 2008 an 8 year review of a failed and flawed policy
http://bse-atypical.blogspot.com/2008/12/mad-cow-disease-usa-december-28-2008-8.html
[Docket No. FDA-2008-D-0597] Draft Guidance for Industry: Small Entities Compliance Guide for Renderers-Substances Prohibited From Use in Animal Food or Feed; Availability AGENCY: Food and Drug Administration, HHS. ACTION:
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http://edocket.access.gpo.gov/2008/pdf/E8-28189.pdf
Greetings,
I kindly wish to submit the following to [Docket No. FDA-2008-D-0597] ;
I would kindly like to once again comment on the failed attempts of the FDA et al to stop the spread of animal TSEs, including BSE, through the legal, and illegal feeding practices, of feeding animal protein to livestock for human and animal consumption. Since the terribly flawed, partial, and voluntary August 4, 1997 ruminant to ruminant feed ban was put into place, literally 100s of thousands of tons of banned animal protein has been fed out into commerce, even as late as 2007, when some 10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. 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. NOW, how much of that product that went out into commerce was fed out to cattle, and how much was ever recovered ? AND to think that feeding blood to livestock producing animals is still legal, when scientific study after study shows that TSEs are easily transmitted via blood. IT is absolutely unacceptable that still in 2008, the USA is still feeding highly suspect mad cow feed to USA cattle, and other livestock producing animals. Especially when the last two cases of BSE that were allowed to be tested and reported were of the atypical BSE category, of which we now know the atypical BSE is more virulent than that of the typical BSE, and when ARS research on the atypical BSE said long ago the SRM rules may need to be changed, IF the atypical BSE were to be proven to be more virulent. Why do we continue to flounder? I have submitted to these BSE feed dockets until I am blue in the face, and still to date, they still debate an issue that should have been settled long ago. IT's a fine example of how big ag, big industry, have a stranglehold on sound science and policy making thereof. How many millions of animals and humans have been needlessly exposed to this TSE agent, due to nothing more than ignorance and greed, simply because of a disease that is 100% fatal, but one that has such a long incubation period. For the government and industry as a whole, to continue to flagrantly violate said rules and regulations, in my opinion, should be regarded as criminal, and treated as such. People are dying. ...
Please see references ;
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http://madcowfeed.blogspot.com/2008/12/docket-no-fda2008d0597-draft-guidance.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
http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html
http://madcowspontaneousnot.blogspot.com/
USDA CERTIFIED SRM BRAINS FOR EXPORT (not tested for TSE). ...TSS
0206290030: BRAINS 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
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 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
2006
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV
Date: September 6, 2006 at 7:58 am PST
PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6; b) Performance Chick Starter, Recall # V-131-6; c) Performance Quail Grower, Recall # V-132-6; d) Performance Pheasant Finisher, Recall # V-133-6.
CODE None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL ______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6; b) 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
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; b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet, 50 lb. bags, Recall # V-122-6; c) Tucker Milling, LLC #31232 Game Bird Grower, 50 lb. bags, Recall # V-123-6; d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD Medicated, 50 lb bags, Recall # V-124-6; e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags, Recall # V-125-6; f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags, Recall # V-126-6; g) Tucker Milling, LLC #30116, TM Broiler Finisher, 50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit on June 20, 2006, and by letter on June 23, 2006. Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN
END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006
###
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; b) Performance Sheep Pell W/Decox/A/N, medicated, net wt. 50 lbs, Recall # V-101-6; c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6; d) CO-OP 32% Sinking Catfish Food Medicated, Recall # V-103-6; e) "Big Jim's" BBB Deer Ration, Big Buck Blend, Recall # V-104-6; f) CO-OP 40% Hog Supplement Medicated Pelleted, Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6; g) Pig Starter Pell II, 18% W/MCDX Medicated 282020, Carbadox -- 0.0055%, Recall # V-106-6; h) CO-OP STARTER-GROWER CRUMBLES, Complete Feed for Chickens from Hatch to 20 Weeks, Medicated, Bacitracin Methylene Disalicylate, 25 and 50 Lbs, Recall # V-107-6; i) CO-OP LAYING PELLETS, Complete Feed for Laying Chickens, Recall # 108-6; j) CO-OP LAYING CRUMBLES, Recall # V-109-6; k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED, net wt 50 Lbs, Recall # V-110-6; l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs, Recall # V-111-6; m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs, Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
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; b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg), Recall # V-080-6; c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL FEED, Recall # V-081-6; d) Feather Meal, Recall # V-082-6 CODE a) Bulk b) None c) Bulk d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration
New Orleans District 297 Plus Park Blvd. Nashville, TN 37217
Telephone: 615-781-5380 Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner Louisiana.DBA Riegel By-Products 2621 State Street Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.
This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.
You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez Acting District Director New Orleans District
http://www.fda.gov/foi/warning_letters/g5883d.htm
see full text ;
http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html
OIE amending the Annex to Decision 2007/453/EC establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk
snip...
IN A NUT SHELL ; $$$
(Adopted by the International Committee of the OIE on 23 May 2006)
11. Information published by the OIE is derived from appropriate declarations made by the official Veterinary Services of Member Countries.The OIE is not responsible for inaccurate publication of country disease status based on inaccurate information or changes in epidemiological status or other significant events that were not promptly reported to then Central Bureau............
http://www.oie.int/eng/Session2007/RF2006.pdf
full text ;
http://madcowtesting.blogspot.com/2007/10/bse-base-mad-cow-testing-texas-usa-and.html
TSS
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