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From: TSS ()
DEPARTMENT OF AGRICULTURE 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 http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-19042.pdf Exportation and importation of animals and animal products: IN REALITY, WHAT THIS MEANS IS IN ADDITION TO IMPORTATION OF COMMODITIES, YOU WILL BE IMPORTING FROM A COUNTRY THAT HAS THE MOST DOCUMENTED TSE THAN ANY OTHER NATION IN THE WORLD DUE TO NON-COMPLIANCE OF RUMINANT FEED BAN FOR ONE THING, AND OUTRIGHT DECEIT AND CORRUPTION FOR ANOTHER. DO YOU WANT TO EXPOSE YOUR PEOPLE TO THIS ALL FOR A BUCK $$$ THE USDA DOES. ...TSS 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 TO REDUCE TESTING OF BSE IN THE USA TO ONLY 40,000 A YEAR, is simply not scientific regardless of 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. ... BILLING CODE: 3410-34-P 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 FEED BAN, what feed ban ??? 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*** Page 87 of 98 8/3/2006 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 Page 88 of 98 8/3/2006 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 WHY still now only partial ruminant feed ban, with the fact that now we seem to have 3 cases of nvCJD to humans i.e. humanbovineTSE that were responsible from blood, and the fact the last 2 mad cows documented in the USA were that of an Atypical strain, would it not seem prudent to remove blood as well from ruminant feed ? WOULD it not seem prudent to improve and expand the SRM list now? as per your own thinking ; > If transmission occurs, tissue distribution comparisons will be made between cattle Page 89 of 98 8/3/2006 > 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. FULL text ; Research Project: Study of Atypical Bse Location: Virus and Prion Diseases of Livestock Project Number: 3625-32000-073-07 Project Type: Specific C/A Start Date: Sep 15, 2004 End Date: Sep 14, 2007 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 HOWEVER, JAPAN has already shown infectivity in tissues other than CNS in there atypical TSE in cattle, so why should we wait, and expose many to this agent needlessly, since the last two mad cows in the USA were also atypical TSE ? Page 90 of 98 8/3/2006 PrPSc distribution of a natural case of bovine spongiform encephalopathy Yoshifumi Iwamaru, Yuka Okubo, Tamako Ikeda, Hiroko Hayashi, Mori- kazu Imamura, Takashi Yokoyama and Morikazu Shinagawa Priori Disease Research Center, National Institute of Animal Health, 3-1-5 Kannondai, Tsukuba 305-0856 Japan gan@affrc.go.jp Abstract Bovine spongiform encephalopathy (BSE) is a disease of cattle that causes progressive neurodegeneration of the central nervous system. Infectivity of BSE agent is accompanied with an abnormal isoform of prion protein (PrPSc). The specified risk materials (SRM) are tissues potentially carrying BSE infectivity. The following tissues are designated as SRM in Japan: the skull including the brain and eyes but excluding the glossa and the masse- ter muscle, the vertebral column excluding the vertebrae of the tail, spinal cord, distal illeum. For a risk management step, the use of SRM in both animal feed or human food has been prohibited. However, detailed PrPSc distribution remains obscure in BSE cattle and it has caused controversies about definitions of SRM. Therefore we have examined PrPSc distribution in a BSE cattle by Western blotting to reassess definitions of SRM. The 11th BSE case in Japan was detected in fallen stock surveillance. The carcass was stocked in the refrigerator. For the detection of PrPSc, 200 mg of tissue samples were homogenized. Following collagenase treatment, samples were digested with proteinase K. After digestion, PrPSc was precipitated by sodium phosphotungstate (PTA). The pellets were subjected to Western blotting using the standard procedure. Anti-prion protein monoclonal antibody (mAb) T2 conjugated horseradish peroxidase was used for the detection of PrPSc. PrPSc was detected in brain, spinal cord, dorsal root ganglia, trigeminal ganglia, sublingual ganglion, retina. In addition, PrPSc was also detected in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve). Our results suggest that the currently accepted definitions of SRM in BSE cattle may need to be reexamined. T. Kitamoto (Ed.)PRIONSFood and Drug Safety================ ALSO from the International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004; Bovine spongiform encephalopathy (BSE) in Japan snip... "Furthermore, current studies into transmission of cases of BSE that are atypical or that develop in young cattle are expected to amplify the BSE prion" NO. Date conf. Farm Birth place and Date Age at diagnosis 8. 2003.10.6. Fukushima Tochigi 2001.10.13. 23 9. 2003.11.4. Hiroshima Hyogo 2002.1.13. 21 Test results # 8b, 9c cows Elisa Positive, WB Positive, IHC negative, histopathology negative b = atypical BSE case Page 91 of 98 8/3/2006 c = case of BSE in a young animal b,c, No PrPSc on IHC, and no spongiform change on histology International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004. Tetsuyuki Kitamoto Professor and Chairman Department of Prion Research Tohoku University School of Medicine 2-1 SeiryoAoba-ku, Sendai 980-8575, JAPAN TEL +81-22-717-8147 FAX +81-22-717-8148 e-mail; kitamoto@mail.tains.tohoku.ac.jp Symposium Secretariat Kyomi Sasaki TEL +81-22-717-8233 FAX +81-22-717-7656 e-mail: kvomi-sasaki@mail.tains.tohoku.ac.ip ================================= Atypical Proteinase K-Resistant Prion Protein (PrPres) observed in an Apparently Healthy 23-Month-Old Holstein Steer Jpn. J. Infect. Dis., 56, 221-222, 2003 Laboratory and Epidemiology Communications Atypical Proteinase K-Resistant Prion Protein (PrPres) Observed in an Apparently Healthy 23-Month-Old Holstein Steer Yoshio Yamakawa*, KenÕichi Hagiwara, Kyoko Nohtomi, Yuko Nakamura, Masahiro Nishizima ,Yoshimi Higuchi1, Yuko Sato1, Tetsutaro Sata1 and the Expert Committee for BSE Diagnosis, Ministry of Health, Labour and Welfare of Japan2 Department of Biochemistry & Cell Biology and 1Department of Pathology, National Institute of Infectious Diseases, Tokyo 162-8640 and 2Miistry of Health, Labour and Welfare, Tokyo 100-8916 Communicated by Tetsutaro Sata (Accepted December 2, 2003) *Corresponding author: Mailing address: Department of Biochemistry and Cell Biology, National Institute of Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 1628640, Japan. Tel: +81-3-5285-1111, Fax: +81-3-5285- 1157, E-mail: yamakawa@nih.go.jp Since October 18, 2001, 'bovine spongiform encephalopathy (BSE) examination for all cattle slaughtered at abattoirs in the country' has been mandated in Japan by the Ministry of Health, Labour and Welfare (MHLW). 'Plateria' ELISA-kit (Bio-Rad Laboratories, Hercules, Calif., USA) is routinely used at abattoirs for detecting proteinase K (PK)-resistant prion protein (PrPSc) in the obex region. Samples positive according to the ELISA screening are further subjected to Western blot (WB) and histologic and immunohistochemical examination (IHC) at the National Institute of Infectious Diseases (NIID) or Obihiro University. If PrPSc is detected either by WB or by IHC, the cattle are diagnosed as BSE. The diagnosis is approved by the Expert Committee for BSE Diagnosis, MHLW. From October 18, 2001 to September 30, 2003, approximately 2.5 million cattle were screened at abattoirs. A hundred and ten specimens positive according to ELISA were subjected to WB/IHC. Seven showed positive by both WB and IHC, all exhibiting the typical electrophoretic profile of a high content of the di-glycosylated molecular form of PrPSc (1-3) and the distinctive granular deposition of PrPSc in neuronal cells and neuropil of the dorsal nucleus of vagus. An ELISA-positive specimen from a 23 month-old Holstein steer slaughtered on September 29, 2003, in Ibaraki Page 92 of 98 8/3/2006 Prefecture (Ibaraki case) was sent to the NIID for confirmation. The animal was reportedly healthy before slaughter. The OD titer in ELISA was slightly higher than the 'cut-off' level given by the manufacturer. The histology showed no spongiform changes and IHC revealed no signal of PrPSc accumulation typical for BSE. However, WB analysis of the homogenate that was prepared from the obex region and used for ELISA revealed a small amount of PrPSc with an electrophoretic profile different from that of typical BSE-associated PrPSc (1-3). The characteristics were (i) low content of the di-glycosylated molecular form of PrPSc, (ii) a faster migration of the non-glycosylated form of PrPSc on SDS-PAGE, and (iii) less resistance against PK digestion as compared with an authentic PrPSc specimen derived from an 83-month-old Holstein (Wakayama case) (Fig. 1). Table 1 summarizes the relative amounts of three distinctive glycoforms (di-, mono, non-glycosylated) of PrPSc calculated by densitometric analysis of the blot shown in Fig. 1. As 2.5 mg wet weight obex-equivalent homogenate of the Ibaraki case (Fig. 1, lane 4) gave slightly stronger band intensities of PrPSc than an 8 mg wet weight obex-equivqlent homogenate of a typical BSE-affected Wakayama case (Fig. 1, lane 2), the amount of PrPSc accumulated in the Ibaraki case was calculated to be 1/500 - 1/1000 of the Wakayama case. In the Ibaraki case, the PrPSc bands were not detectable in the homogenates of the proximal surrounding region of the obex. These findings were consistent with the low OD value in ELISA, i.e., 0.2 -0.3 for the Ibaraki case versus over 3.0 for the Wakayama case. The DNA sequence of the PrP coding region of the Ibaraki case was the same as that appearing in the database (GenBank accession number: AJ298878). More recently, we encountered another case that resembled the Ibaraki case. It was a 21-monthold Holstein steer from Hiroshima Prefecture. WB showed typical BSE-specific PrPSc deposition though IHC did not detect positive signals of PrPSc (data not shown). Though the clinical onset of BSE is usually at around 5 years of age or later, a 20-month-old case showing the clinical signs has been reported (4). Variant forms of BSE similar to our cases, i.e., with atypical histopathological and/or biochemical phenotype, have been recently reported in Italy (5) and in France (6). Such variant BSE was not associated with mutations in the prion protein (PrP) coding region as in our case (5,6). The Ministry of Agriculture, Forestry and Fisheries of Japan (MAFF) announced a ban of feeding ruminants with meat bone meal (MBM) on September 18, 2001, and a complete ban was made on October 15 of the same year. According to the recent MAFF report, the previous seven cases of BSE in Japan were cattle born in 1995 - 1996 and possibly fed with cross-contaminated feed. However, the two cattle in this report were born after the complete ban. Whether contaminated MBM was implicated in the present cases remains to be investigated. REFERENCES Collinge, J., Sidle, K. C. L., Meads, J., Ironside, J. and Hill, A. F. (1996): Molecular analysis of prion strain variation and the aetiology of 'new variant' CJD. Nature, 383, 685 690. Bruce, M. E., Will, R. G., Ironside, J. W., McConnell, I., Drummond, D., Suttie, A., McCardle, L., Chree, A., Hope, J., Birkett, C., Cousens, S., Fraser, H. and Bostock, C. J. (1997): Transmissions to mice indicate that 'new variant' CJD is caused by the BSE agent. Nature, 389, 498-501. Hill, A. F., Desbruslais, M., Joiner, S., Sidle, K. C. L., Gowland, I. and Collinge, J. (1997): The same prion strain causes vCJD and BSE. Nature, 389, 448-450. Matravers, W., Bridgeman, J. and Smith, M.-F. (ed.)(2000): The BSE Inquiry. p. 37. vol. 16. The Stationery Office Ltd., Norwich, UK. Casalone, C., Zanusso, G., Acutis, P. L., Crescio, M. I., Corona, C., Ferrari, S., Capobianco, R., Tagliavini, F., Monaco, S. and Caramelli, M. (2003): Identification of a novel molecular and neuropathological BSE phenotype in Italy. International Conference on Prion Disease: from basic research to intervention concepts. Gasreig, Munhen, October 8-10. Bicaba, A. G., Laplanche, J. L., Ryder, S. and Baron, T. (2003): A molecular variant of bovine spongiform encephalopatie. International Conference on Prion Disease: from basic research to intervention concepts. Gasreig, Munhen, October 8-10. Asante, E. A., Linehan, J. M., Desbruslais, M., Joiner, S., Gowland, I., Wood, A. L., Welch, J., Hill, A. F., Lloyd, S. E., Wadsworth, J. D. F. and Collinge, J. (2002). BSE prions propagate as either variant CJD-like or sporadic CJD-like prion strains in transgenic mice expressing human prion protein. EMBO J., 21, 6358- 6366. Page 93 of 98 8/3/2006 9/13/2005 Page 12 of 17 SEE SLIDES IN PDF FILE; http://www.nih.go.jp/JJID/56/221.pdf http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf 4. WHAT does USDA/FDA ET AL intend to do about the risks of atypical BSE/TSE in cattle now that infectivity shows in tissue samples other than CNS in Japan, the fact now that the last Texas mad cow and that last mad cow in Alabama were indeed of the atypical strain, the fact that the studies long ago in Mission, Texas of USA sheep scrapie transmission to the USA bovine, which proved an 'atypical tse' in the USA bovine, the fact also that USDA/FDA are still floundering on the last SRM regulations, but with the BASE strain now in cattle that is not similar to nvCJD, but very similar to the sporadic CJD, and sporadic CJD has tripled in the last few years in the USA. WHAT do you plan to do to protect human health from these atypical strains of TSE, in relations to SRMs ? 5. THE 2004 Enhanced BSE surveillance program, that tested all those cows, but then we found just how terribly flawed the program was, from testing protocols, to testing the most likely to have BSE i.e. high risk, to the geographical distribution of the testing and high risk areas, to letting the tissue samples of one mad cow sit on a shelf for 7+ months and then having to have an act of Congress to ever get that cow finally confirmed, to that other Texas mad cow they decided to not even bother testing at all, just rendered that very suspect cow, to suspect to test evidently, back to that Alabama mad cow that they could only give a guess as to age with dentition where we all know that the age of that cow was so close to 10 years it could have been 9 years 7 months to 10 years 3 months, thus possibly being an BAPB i.e. USA 'born after partial ban', to all those rabies suspect cows that did not have rabies, and DID NOT get tested for BSE/TSE in that June 2004 enhanced surveillance program, even though the common lay person knows the suspect rabies negative cows are suppose to be BSE/TSE tested, how does one correct all these blatant failures and will they be corrected? IT never was about human/animal health, but all about commodities and futures. ... MISSION ACCOMPLISHED $$$ ENFAMOUS NON-SPECIES CODING SYSTEM BY FDA ET AL, another handy tool for importing/exporting all strains of TSE ; Docket Management Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305 Comment Number: EC -254 Accepted - Volume 11 Page 94 of 98 8/3/2006 http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/02n0276/02N-0276-EC-254.htm ONE FINAL THOUGHT ; OPINION http://www.efsa.eu.int/science/biohaz/biohaz_opinions/1540/biohaz_op_ej359_qra_vertebral_column_en1.pdf >>>New methodology, under the auspices of the OIE, is under construction within the EU and EFSA and the Panel recommended that once these classifications had been finalised they should harmonised with those used in the EFSA BSE QRA guidance document. The Panel anticipated that this harmonisation may have a knock-on impact on the QRA calculations, conclusions and recommendations and that, again, future Panel members should review this, and other, inputs of the QRA and address this impact using their “self-tasking mandate” option.<<< GOD HELP US! sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken. MOST countries that went by these OIE guidelines all eventually went down with BSE. ...TSS http://www.oie.int/downld/SC/2005/bse_2005.pdf THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE. AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they should do everyone a favor and dissolve there organization. ... Page 95 of 98 8/3/2006 WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ??? a.. BSE OIE see full text ; http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence of these agencies are so inept, either through ignorance and or just too overweight with industry reps., they then should be all done away with and a single agency brought forth, and if not, how will you correct this ongoing problem ? Thank you, I am sincerely disgusted, Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf EVERYONE OUT THERE THAT IS READING THIS SHOULD SUBMIT TO THIS DOCKET. ...TSS CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006 The U.S. Department of Agriculture was quick to assure the public earlier this week that the third case of mad cow disease did not pose a risk to them, but what federal officials have not acknowledged is that this latest case indicates the deadly disease has been circulating in U.S. herds for at least a decade. The second case, which was detected last year in a Texas cow and which USDA officials were reluctant to verify, was approximately 12 years old. These two cases (the latest was detected in an Alabama cow) present a picture of the disease having been here for 10 years or so, since it is thought that cows usually contract the disease from contaminated feed they consume as calves. The concern is that humans can contract a fatal, incurable, brain-wasting illness from consuming beef products contaminated with the mad cow pathogen. "The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that." Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive. USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general. "Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r *** Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain http://www.usda.gov/oig/webdocs/50601-10-KC.pdf [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk 03-025IFA http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf THE SEVEN SCIENTIST REPORT *** http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins. http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm Full Text Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama http://www.neurology.org/cgi/eletters/60/2/176#535 BRITISH MEDICAL JOURNAL BMJ http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2 BMJ http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1 Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
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