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From: TSS ()
BSE declining in most Countries that have gone by BSE GBR (excluding and not including USA, Canada, and Mexico), there not looking to find, quite the opposite. ... EFSA concludes that the current GBR level of USA, CANADA, AND MEXICO is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases. that is why GW et al changed the rules to the legal trading of all strains of TSE, i.e. BSE MRR policy, and from the recent USDA/FDA mad cow feed violations, there are literally hundreds of thousands of tons and tons out there in commerce, and it is still being funneled out there today. ...TSS Adopted July 2004 (Question N° EFSA-Q-2003-083) Adopted July 2004 (Question N° EFSA-Q-2003-083) EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Adopted July 2004 (Question N° EFSA-Q-2003-083) Subject: MAD COW FDA FEED WARNING LETTER NO. 2007-NOL-01 October 26, 2006 H.J. Baker & Bro., Inc. New Orleans District 404 BNA Drive, Building 200, Suite 500 Nashville, TN 37217 Telephone: 615-366-7801 Facsimile: 615-366-7802 October 26, 2006 WARNING LETTER NO. 2007-NOL-01 FEDERAL EXPRESS OVERNIGHT DELIVERY Mr. Christopher V. B. Smith Corporate President, CEO H. J. Baker & Bro., Inc. 228 Saugatuck Avenue Westport, Connecticut 06880 Dear Mr. Smith: On June 6, 8, 12-15, and 23, 2006, a U.S . Food and Drug Administration (FDA) investigator inspected your animal feed protein supplement manufacturing facility, located at 603 Railroad Avenue, Albertville, Alabama. The inspection revealed significant deviations from the requirements set forth in Title 21, Code ofFederal 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, resulting in products being manufactured and distributed by your facility because they are adulterated within the meaning of Section 402(a)(4) [21 USC 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) and misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Act. Our investigation determined adulteration resulted from the failure of your firm to establish and implement measures sufficient to prevent commingling or cross-contamination . The adulterated feed was subsequently misbranded because it was not properly labeled. Specifically, we found : " Your firm failed to establish and use cleanout procedures or other means to prevent carry-over of products which contain or may contain protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants, as required by 21 CFR 589.2000(e)(1)(iii)(B) . Specifically, you failed to establish and use such measures for a screw auger installed in February 2005 . This auger is used to convey both prohibited and non-prohibited material to bulk storage bins. In addition, you failed to follow the cleanout procedure your firm had developed for the receiving systems. Your feed is, therefore, adulterated under Section 402(a)(4) [21 USC 342(a)(4)] of the Act. " You failed to label all products which contained or may have contained prohibited materials with the BSE cautionary statement, "Do not feed to cattle or other ruminants," as required by 21 CFR 589.2000(e)(1)(i) . Such products are misbranded under Section 403(3) [21 USC 343(a)(1)] of the Act. These misbranded products include the three Pro-Pak products mentioned below, as well as Page 2 - H. J . Baker & Bro., Inc., Albertville, Alabama Warning Letter No. 2007-NOL-O 1 those bulk loads of individual feed ingredients processed through this common screw auger and distributed between the time it was installed in February 2005, and June 9, 2006 . This letter is not intended to serve 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. We acknowledge your June 16, 2006, voluntary recall of three products you manufactured from February 2005 to June 2006. The three products recalled were: Pro-Lak Protein Concentrate for Lactating Dairy Animals; Pro-Amino II for PreFresh and Lactating Cows; and, Pro-Pak Marine & Animal Protein Concentrate for Use in Animal Feed. Recall effectiveness checks and other measures will determine the merit of this recall . We recognize you now label all products with the required BSE cautionary statement and we also acknowledge your intent, given verbally to New Orleans District management of the FDA, to discontinue the production of supplements which do not contain prohibited materials. In your written response to this letter, please confirm in writing you have taken these steps. 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, including the steps we acknowledge above and any additional steps you have taken. 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 Kari L. Batey, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Ms. Batey at (615) 366-7808. Sincerely, , Carol S . Sanchez Acting District Director New Orleans District Enclosure: Form FDA 483 cc: Craig R. Waterhouse Plant Manager H.J. Baker & Bros., Inc. 603 Railroad Avenue Albertville, Alabama 35951-3419 PRODUCT RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II ______________________________ ______________________________ ______________________________ ______________________________ ______________________________ ______________________________ END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006 ### ### ### ### END OF ENFORCEMENT REPORT FOR July 12, 2006 ### New Orleans District Telephone: 615-781-5380 WARNING LETTER NO. 2006-NOL-06 FEDERAL EXPRESS Mr. William Shirley, Jr., Owner Dear Mr. Shirley: On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration Our investigation found you failed to provide measures, including sufficient You failed to use clean-out procedures or other means adequate to prevent You failed to maintain written procedures specifying the clean-out As a result . the poultry meal you manufacture may contain protein derived This letter is not intended as an all-inclusive list of violations at your You should notify this office in writing within 15 working days of receiving Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Sincerely, /S Carol S. Sanchez Subject: EXPORTATION AND IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: BSE; MRR AND IMPORTATION OF COMMODITIES, 65758-65759 [E6-19042] Service 9 CFR Parts 93, 94, and 95 [Docket No. APHIS–2006–0026] Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule; reopening of comment period. SUMMARY: We are reopening the comment period for our proposed rule that would remove several restrictions regarding the identification of animals and the processing of ruminant materials from BSE minimal-risk regions, as well as BSE-based restrictions on gelatin derived from bovine hides. This action will allow interested persons additional time to prepare and submit comments. DATES: We will consider all comments that we receive on or before November 24, 2006. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov, select ‘‘Animal and Plant Health Inspection Service’’ from the agency drop-down menu, then click ‘‘Submit.’’ In the Docket ID column, select APHIS–2006– 0026 to submit or view public VerDate Aug<31>2005 14:28 Nov 08, 2006 Jkt 211001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\09NOP1.SGM 09NOP1 rmajette on PROD1PC67 with PROPOSALS1 65759 Federal Register / Vol. 71, No. 217 / Thursday, November 9, 2006 / Proposed Rules comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site’s ‘‘User Tips’’ link. • Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS–2006–0026, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Please state that your comment refers to Docket No. APHIS– 2006–0026. Reading Room: You may read any comments that we receive on Docket No. APHIS–2006–0026 in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690–2817 before coming. Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: For information regarding ruminant products, contact Dr. Karen James- Preston, Director, Technical Trade Services, Animal Products, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737–1231; (301) 734– 4356. For information concerning live ruminants, contact Dr. Lee Ann Thomas, Director, Technical Trade Services, Animals, Organisms and Vectors, and Select Agents, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737–1231; (301) 734–4356. SUPPLEMENTARY INFORMATION: On August 9, 2006, we published in the Federal Register (71 FR 45439–45444, Docket No. APHIS–2006–0026) a proposal to remove several restrictions regarding the identification of animals and the processing of ruminant materials from BSE minimal-risk regions, as well as BSE-based restrictions on gelatin derived from bovine hides. Comments on the proposed rule were required to be received on or before October 10, 2006. We are reopening the comment period on Docket No. APHIS– 2006–0026 for an additional 14 days. This action will allow interested persons additional time to prepare and submit comments. We will also consider all comments received between October 11, 2006, and the date of this notice. Authority: 7 U.S.C. 450, 1622, 7701–7772, 7781–7786, and 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. Done in Washington, DC, this 3rd of November 2006. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E6–19042 Filed 11–8–06; 8:45 am] BILLING CODE 3410–34–P Bovine spongiform encephalopathy; minimal-risk regions and importation of commodities, IN a time when FSIS/APHIS/USDA/FDA et al should be strengthening the TSE regulations, it seems corporate interest has won out again over sound science and consumer protection from an agent that is 100% fatal for the ones that go clinical. With the many different atypical TSEs showing up in different parts of the world, and with GWs BSE MRR policy (the legal policy of trading all strains of TSEs), the battle that has waged for the last 25 years to eradicate this agent from this planet will be set back decades, if not lost for good. ... http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf On the Question of Sporadic or Atypical Bovine Spongiform Encephalopathy and Creutzfeldt-Jakob Disease Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§ Strategies to investigate the possible existence of sporadic bovine spongiform encephalopathy (BSE) require systematic testing programs to identify cases in countries considered to have little or no risk for orally acquired disease, or to detect a stable occurrence of atypical cases in countries in which orally acquired disease is disappearing. To achieve 95% statistical confidence that the prevalence of sporadic BSE is no greater than 1 per million (i.e., the annual incidence of sporadic Creutzfeldt-Jakob disease [CJD] in humans) would require negative tests in 3 million randomly selected older cattle. A link between BSE and sporadic CJD has been suggested on the basis of laboratory studies but is unsupported by epidemiologic observation. Such a link might yet be established by the discovery of a specific molecular marker or of particular combinations of trends over time of typical and atypical BSE and various subtypes of sporadic CJD, as their numbers are influenced by a continuation of current public health measures that exclude high-risk bovine tissues from the animal and human food chains. Recognition of the different forms of BSE and CJD depends upon continuing systematic testing for both bovines and humans, but bovine testing will be vulnerable of bovine spongiform encephalopathy (BSE) and Creutzfeld-Jakob disease (CJD). The left panel shows the likely trends of typical BSE and variant CJD (vCJD). The right upper panel shows 1 possible pair of trends of atypical BSE and sporadic CJD (sCJD) that might occur in conjunction with the typical BSE/vCJD trends, and would be consistent with the interpretation that atypical BSE is not sporadic and not related to sCJD. The right lower panel shows a second possible associated pair of trends consistent with the interpretation that atypical BSE is sporadic and might also be related to the type 2 M/V subset of apparently sCJD. 1820 Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 12, No. 12, December 2006 as the commercial impact of declining BSE cases ceases to be an issue. Industry should be aware, however, of the implications of sporadic BSE. Its occurrence would necessitate the indefinite retention of all of the public health measures that exclude high-risk bovine tissues from the animal and human food chains, whereas its nonoccurrence would permit tissues that are now destroyed to be used as before, once orally acquired BSE has disappeared. SNIP...END Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 12, No. 12, December 2006 what the OIE BSE testing protocol calls for. ALL one has to do is look at the countries above that all went down with BSE, that all went by the infamous OIE BSE testing protocols. THEN and only then, after the USA finally fumbled the 'BSE FREE' golden egg and accidently had to document a case or two of mad cow, low and behold, what next? yep, you guessed it, time to move the goal post in the middle of the football game, GWs and his sleeping partners at the OIE, gave birth to the BSE MRR policy, the legal trading of all strains of TSE globally was born. ... DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 93, 94, 95, and 96 [Docket No. 03-080-3] RIN 0579-AB73 Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. Page 82 of 98 8/3/2006 SUMMARY: We are amending the regulations regarding the importation of animals and animal products to establish a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States via live ruminants and ruminant products and byproducts, and we are adding Canada to this category. We are also establishing conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. These actions will continue to protect against the introduction of BSE into the United States while removing unnecessary prohibitions on the importation of certain commodities from minimal-risk regions for BSE, currently only Canada. EFFECTIVE DATE: [Insert date 60 days after date of publication in the Federal Register]. FOR FURTHER INFORMATION CONTACT: For information concerning ruminant products, contact Dr. Karen James-Preston, Director, Technical Trade Services, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356. For information concerning live ruminants, contact Lee Ann Thomas, Director, Technical Trade Services, Animals, Organisms and Vectors, and Select Agents, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356. http://www.aphis.usda.gov/lpa/issues/bse/03-080-3_final_rule.pdf [Federal Register: November 4, 2003 (Volume 68, Number 213)] [Proposed Rules] [Page 62386-62405] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr04no03-5] ======================================================================== Proposed Rules Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. Page 83 of 98 8/3/2006 ======================================================================== [[Page 62386]] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 93, 94, and 95 [Docket No. 03-080-1] RIN 0579-AB73 Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: We are proposing to amend the regulations regarding the importation of animals and animal products to recognize a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States via live ruminants and ruminant products, and are proposing to add Canada to this category. We are also proposing to allow the importation of certain live ruminants and ruminant products and byproducts from such regions under certain conditions. We believe this action is warranted because it would continue to protect against the introduction of BSE into the United States while removing unnecessary prohibitions on certain commodities from Canada and other regions that qualify as BSE minimal-risk regions. DATES: We will consider all comments that we receive on or before January 5, 2004. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2003_register&docid=fr04no03-5 [Federal Register: April 8, 2005 (Volume 70, Number 67)] [Rules and Regulations] [Page 18251-18262] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr08ap05-11] Page 84 of 98 8/3/2006 [[Page 18251]] ----------------------------------------------------------------------- Part VII Department of Agriculture ----------------------------------------------------------------------- Animal and Plant Health Inspection Service ----------------------------------------------------------------------- 9 CFR Part 93, et al. Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Finding of No Significant Impact and Affirmation of Final Rule; Final Rule [[Page 18252]] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 93, 94, 95, and 98 [Docket No. 03-080-7] RIN 0579-AB73 Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Finding of No Significant Impact and Affirmation of Final Rule AGENCY: Animal and Plant Health Inspection Service, USDA. Page 85 of 98 8/3/2006 ACTION: Affirmation of final rule. ----------------------------------------------------------------------- SUMMARY: We are publishing a finding of no significant impact for a final rule concerning bovine spongiform encephalopathy minimal risk regions published January 4, 2005, and, based on that finding, we are affirming the provisions of the final rule. The finding of no significant impact is based on an environmental assessment that documented our review and analysis of potential environmental impacts associated with the final rule and our review of issues raised by the public regarding the environmental assessment. Together, the environmental assessment and our review of the issues raised provide a basis for our conclusion that the provisions of the final rule will not have a significant impact on the quality of the human environment and support our affirmation of the final rule. DATES: The final rule published January 4, 2005 (70 FR 460), with a partial delay of applicability published March 11, 2005 (70 FR 12112), was effective March 7, 2005. This affirmation of the final rule is effective April 8, 2005. http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/05-7141.htm World Animal Health Body Changes Mad Cow Risk Definitions WASHINGTON, DC, May 31, 2006 (ENS) - Member countries of the World Organization for Animal Health (OIE) last week voted unanimously to revise the three definitions of risk categories for countries affected by mad cow disease, formally known as bovine spongiform encephalopathy (BSE). The three definitions are - negligible risk, controlled risk, and undetermined risk of cattle being infected with the fatal brain-wasting disease. Previously, a country that discovered a case of BSE had to wait seven years from the date of its latest discovery before being eligible to be classified as a “negligible risk” country, the category for countries with the least amount of risk from the disease. Under these guidelines, the United States would have had to wait until the year 2013 to be classified as a negligible risk country after a veterinarian discovered a cow infected with the disease in Alabama in March, the third infected U.S. cow to be found. Now, as a result of OIE’s decision, countries work from the date of birth of the animal discovered to be infected with the BSE agent – misfolded proteins called prions. The decision was made at the OIE's Annual General Session held in Paris from May 21 to 26. Page 86 of 98 8/3/2006 The General Session notably brings together representatives appointed by the governments of the 167 OIE member countries. Some 600 participants representing member countries and intergovernmental organizations such as the UN Food and Agriculture Organization, the World Health Organization, the World Bank and the World Trade Organization took part in the event. Many U.S. cattlemen support the change because it more accurately reflects the scientific knowledge surrounding the disease. “Scientists have determined that BSE is caused by feeding contaminated animal-based feed to cattle, and that cattle are most likely to become infected with BSE during the first year of their lives, so using the infected animal’s birth date as a reference point allows countries to determine how recently contaminated feed may have been circulating within their feed system,” said Bill Bullard, CEO of R-CALF USA, a cattle industry association. A ban on feeding animal tissues to cattle was imposed in the United States and Canada in 1997. snip... http://www.ens-newswire.com/ens/may2006/2006-05-31-02.asp Research article Prion gene haplotypes of U.S. cattle Michael L Clawson , Michael P Heaton , John W Keele , Timothy PL Smith , Gregory P Harhay and William W Laegreid BMC Genetics 2006, 7:51 doi:10.1186/1471-2156-7-51 Published 8 November 2006 Abstract (provisional) Bovine spongiform encephalopathy (BSE) is a fatal neurological disorder characterized by abnormal deposits of a protease-resistant isoform of the prion protein. Characterizing linkage disequilibrium (LD) and haplotype networks within the bovine prion gene (PRNP) is important for 1) testing rare or common PRNP variation for an association with BSE and 2) interpreting any association of PRNP alleles with BSE susceptibility. The objective of this study was to identify polymorphisms and haplotypes within PRNP from the promoter region through the 3UTR in a diverse sample of U.S. cattle genomes. Results A 25.2-kb genomic region containing PRNP was sequenced from 192 diverse U.S. beef and dairy cattle. Sequence analyses identified 388 total polymorphisms, of which 287 have not previously been reported. The polymorphism alleles define PRNP by regions of high and low LD. High LD is present between alleles in the promoter region through exon 2 (6.7 kb). PRNP alleles within the majority of intron 2, the entire coding sequence and the untranslated region of exon 3 are in low LD (18.0 kb). Two haplotype networks, one representing the region of high LD and the other the region of low LD yielded nineteen different combinations that represent haplotypes spanning PRNP. The haplotype combinations are tagged by 19 polymorphisms (htSNPS) which characterize variation within and across PRNP. Conclusion The number of polymorphisms in the prion gene region of U.S. cattle is nearly four times greater than previously described. These polymorphisms define PRNP haplotypes that may influence BSE susceptibility in cattle. http://www.biomedcentral.com/content/pdf/1471-2156-7-51.pdf
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