UPDATE MAY 5, 2009 CORRECTION
[Federal Register: May 5, 2009 (Volume 74, Number 85)] [Rules and Regulations] [Page 20583] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr05my09-6]
[[Page 20583]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 589
[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46
Substances Prohibited From Use in Animal Food or Feed; Confirmation of Effective Date of Final Rule; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; confirmation of effective date; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule; confirmation of effective date, that appeared in the Federal Register of Friday, April 24, 2009 (74 FR 18626) (the April 24, 2009, final rule; confirmation of effective date). That document had confirmed the effective date of April 27, 2009, for a final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ``Substances Prohibited From Use in Animal Food or Feed.'' In the April 24, 2009, final rule; confirmation of effective date, the agency also established a compliance date of October 26, 2009, in order to allow additional time for renderers to comply with the new requirements. The April 24, 2009, final rule; confirmation of effective date was published with an inadvertent error in the ``Background'' section. This document corrects that error.
DATES: This correction is effective: May 5, 2009.
FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy, Planning, and Preparedness (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.
SUPPLEMENTARY INFORMATION: In FR Doc. E9-9466, appearing on page 18626 in the Federal Register of Friday, April 24, 2009, the following correction is made: On page 18626, in the third column, under ``I. Background,'' in the first paragraph, the first sentence ``In the Federal Register of April 25, 2008, FDA published a final rule entitled ``Substances Prohibited From Use in Animal Food or Feed)'' (referred to herein as the April 25, 2008, final rule), that would become effective 1 year after the April 27, 2009, date of publication.'' is corrected to read ``In the Federal Register of April 25, 2008, FDA published a final rule entitled ``Substances Prohibited From Use in Animal Food or Feed'' (referred to herein as the April 25, 2008, final rule), that would become effective 1 year after that publication.''
Dated: April 28, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9-10138 Filed 5-4-09; 8:45 am]
BILLING CODE 4160-01-S
http://edocket.access.gpo.gov/2009/E9-10138.htm
TSS
=================================END
CVM Update Back April 30, 2009
FDA Issues Final Guidance for Renderers on Substances Prohibited From Use in Animal Food or Feed
The Food and Drug Administration (FDA) today issued a final guidance document, “Small Entities Compliance Guide for Renderers – Substances Prohibited from use in Animal Food or Feed,” to provide guidance on the requirements of the final rule published in the Federal Register of April 25, 2008. This rule will further protect consumers against bovine spongiform encephalopathy (BSE), otherwise known as ‘mad cow disease.’
The purpose of the guidance document is to help rendering firms comply with the rule that became effective April 27, 2009. The guidance should also help slaughter facilities and farms supplying offal and dead livestock to the renderers understand their obligations under the rule. A copy of the final guidance can be found at
http://www.fda.gov/cvm/Guidance/guide195.pdf.
The added measure of excluding high-risk materials from all animal feeds addresses risks associated with accidental feeding of such material to cattle, which could occur through cross-contamination of ruminant feed with non-ruminant feed or feed ingredients during manufacture and transport, or through misfeeding of non-ruminant feed to ruminants on the farm.
Comments on this guidance may be submitted any time to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically at
http://www.regulations.gov/.
All written comments should be identified with Docket No. FDA-2008-D-0597.
For additional information on BSE and the final rule, please see:
http://www.fda.gov/cvm/bsetoc.html.
For questions regarding this final document, please contact Shannon Jordre at FDA’s Center for Veterinary Medicine, 240-276-9229, mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000110/!x-usc:mailto:shannon.jordre@fda.hhs.gov.
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Issued by: FDA, Center for Veterinary Medicine, Communications Staff, HFV-12 7519 Standish Place, Rockville, MD 20855 Telephone: (240) 276-9300 FAX: (240) 276-9115 Internet Web Site: http://www.fda.gov/cvm
http://www.fda.gov/cvm/CVM_Updates/BSEUpdate043009.htm
#195
GUIDANCE FOR INDUSTRY
SMALL ENTITIES COMPLIANCE GUIDE
FOR RENDERERS—SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
Submit comments on this guidance at any time. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at
http://www.regulations.gov/.
All written comments should be identified with Docket No. FDA-2008-D-0597.
For questions regarding this guidance document, contact Shannon Jordre, Division of Compliance (HFV-230), U.S. Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Place, MPN-4, Rockville, MD 20855, (240) 276-9229.
Additional copies of this guidance document may be requested from the Communications Staff, HFV-12, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at
http://www.fda.gov/cvm.
U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine April 30, 2009
CONTAINS NON-BINDING RECOMMENDATIONS
Page 2
TABLE OF CONTENTS
I. BACKGROUND.......................................................................................................................3
II. PURPOSE.................................................................................................................................3
III. AGING CATTLE.....................................................................................................................6
IV. BRAIN AND SPINAL CORD REMOVAL............................................................................7
V. RECORDKEEPING..................................................................................................................8
VI. MARKING REQUIREMENTS.............................................................................................10
VII. WASTEWATER FROM RENDERING...............................................................................11
VIII. TALLOW............................................................................................................................12
IX. ENFORCEMENT...................................................................................................................14
CONTAINS NON-BINDING RECOMMENDATIONS
Page 3
GUIDANCE FOR INDUSTRY
SMALL ENTITIES COMPLIANCE GUIDE
FOR RENDERERS—SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED1
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
I. BACKGROUND
On April 25, 2008, FDA published a final rule in the Federal Register, entitled “Substances Prohibited from Use in Animal Food or Feed” (73 FR 22719). See also 74 FR 18626; April 24, 2009. This final rule established a new regulation at 21 CFR 589.2001 entitled, “Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy” and, amended the previously existing ruminant feed regulation at 21 CFR 589.2000 entitled, “Animal proteins prohibited in animal feed.” FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121). This document is intended to provide guidance on the requirements of Title 21, Code of Federal Regulations, new Section 589.2001, and amended Section 589.2000.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.
II. PURPOSE
WHAT IS THE PURPOSE OF REGULATION 589.2001?
1 This guidance has been prepared by the Office of Surveillance and Compliance in the Center for Veterinary Medicine at the Food and Drug Administration.
CONTAINS NON-BINDING RECOMMENDATIONS
Page 4
This regulation is designed to further strengthen existing safeguards against the establishment and amplification of Bovine Spongiform Encephalopathy (BSE), sometimes referred to as “Mad Cow Disease,” through animal feed. The regulation prohibits the use of certain cattle origin materials in the food or feed of all animals.
The following materials are prohibited in all animal feed by the new rule:
* The entire carcass of BSE-positive cattle;
* The brains and spinal cords from cattle 30 months of age and older;
*The entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not effectively removed or otherwise effectively excluded;
*Tallow that is derived from other materials prohibited by this rule that contain more than 0.15 percent insoluble impurities;
and
*Mechanically separated beef that is derived from the materials prohibited by this rule. Throughout the regulation, these materials are referred to as “cattle materials prohibited in animal feed” or CMPAF. If you (i.e., renderers) receive, manufacture, blend, process, or distribute any of these materials, you must comply with the provisions of this regulation (21 CFR 589.2001(c)(2)).
ARE THERE ANY CATTLE MATERIALS SPECIFICALLY EXEMPTED FROM THIS REGULATION?
Yes. The following materials do not fall under the definition of CMPAF:
*Tallow derivatives (as defined in the regulation (See 21 CFR 589.2001(b)(6)).
*Tallow that is derived from material containing the brains and spinal cords of cattle 30 months of age and older if such tallow contains no more than 0.15 percent insoluble impurities.
*Cattle materials (as defined in the regulation (See 21 CFR 589.2001(b)(vi)(C))) from a foreign country that has received designation by FDA as not being subject to the new regulation.
CONTAINS NON-BINDING RECOMMENDATIONS
Page 5
WHAT IS THE DIFFERENCE BETWEEN CATTLE MATERIAL PROHIBITED IN ANIMAL FEED (CMPAF) AND SPECIFIED RISK MATERIAL (SRM)?
SNIP...PLEASE SEE FULL TEXT HERE ;
http://www.fda.gov/cvm/Guidance/guide195.pdf
Saturday, February 21, 2009
Renderers say industry not prepared for FDA feed ban rule ??? WHAT, IT'S 2009 FOR PETE'S SAKE $$$
http://madcowfeed.blogspot.com/2009/02/renderers-say-industry-not-prepared-for.html
Saturday, March 14, 2009 Agriculture Secretary Tom Vilsack Announces Final Rule for Handling of Non-Ambulatory Cattle
http://www.usda.gov/2009/03/0060.xml
THANK GOD ! after years and years of exposing, especially our children with dead stock downer cows, from the USDA et al dead stock downer cow school lunch program, finally, some common sense comes forth. ...TSS
DEADSTOCK DOWNER CATTLE THE MOST HIGH RISK FOR MAD COW DISEASE, and the USDA et al have been force feeding your children this for years. who will monitor our children in the years, decades to come for CJD aka mad cow disease ???
SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE
IS THERE A SCRAPIE-LIKE DISEASE IN CATTLE ?
In April of 1985, a mink rancher in Wisconsin reported a debilitating neurologic disease in his herd which we diagnosed as TME by histopathologic findings confirmed by experimental transmission to mink and squirrel monkeys. The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle and a few horses. She had never been fed.
We believe that these findings may indicate the presence of a previously unrecognized scrapie-like disease in cattle and wish to alert dairy practitioners to this possibility.
snip...
PROCEEDINGS OF THE SEVENTH ANNUAL WESTERN CONFERENCE FOR FOOD ANIMAL VETERINARY MEDICINE, University of Arizona, March 17-19, 1986
http://www.bseinquiry.gov.uk/files/mb/m09a/tab01.pdf
http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf
IS THERE A SCRAPIE-LIKE DISEASE IN CATTLE ?
YOU BET THERE IS, AND HAS BEEN, AND WE BEEN FEEDING THE MOST HIGH RISK I.E. DEAD STOCK DOWNER COWS TO OUR CHILDREN FOR DECADES, who will follow these children for human TSE from mad cow disease here in the USA in the years, decades to come, and how many will they expose from the 'pass it forward' friendly fire modes ???
http://downercattle.blogspot.com/2008/12/evaluation-of-fsis-management-controls.html
http://downercattle.blogspot.com/
April 20, 2009
National Prion Disease Pathology Surveillance Center Cases Examined1 (December 31, 2008)
National Prion Disease Pathology Surveillance Center Cases Examined1
(December 31, 2008)
Year Total Referrals2 Prion Disease Sporadic Familial Iatrogenic vCJD
1996 & earlier 42 32 28 4 0 0
1997 115 68 59 9 0 0
1998 93 53 45 7 1 0
1999 115 69 61 8 0 0
2000 151 103 89 14 0 0
2001 210 118 108 9 0 0
2002 258 147 123 22 2 0
2003 273 176 135 41 0 0
2004 335 184 162 21 0 13
2005 346 193 154 38 1 0
2006 380 192 159 32 0 14
2007 370 212 185 26 0 0
2008 383 228 182 23 0 0
TOTAL 30715 17756 1490 254 4 2
1 Listed based on the year of death or, if not available, on year of referral; 2 Cases with suspected prion disease for which brain tissue and/or blood (in familial cases) were submitted; 3 Disease acquired in the United Kingdom; 4 Disease acquired in Saudi Arabia; 5 Includes 20 cases in which the diagnosis is pending, and 17 inconclusive cases; 6 Includes 25 cases with type determination pending in which the diagnosis of vCJD has been excluded.
Rev 2/13/09 National
http://www.cjdsurveillance.com/pdf/case-table.pdf
http://www.cjdsurveillance.com/resources-casereport.html
http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45
*5 Includes 20 cases in which the diagnosis is pending, and 17 inconclusive cases; *6 Includes 25 cases with type determination pending in which the diagnosis of vCJD has been excluded.
Greetings,
it would be interesting to know what year these atypical cases occurred, as opposed to lumping them in with the totals only.
are they accumulating ?
did they occur in one year, two years, same state, same city ?
location would be very interesting ?
age group ?
sex ?
how was it determined that nvCJD was ruled out ?
from 1997, the year i started dealing with this nightmare, there were 28 cases (per this report), up until 2007 where the total was 185 cases (per this report), and to date 2008 is at 182. a staggering increase in my opinion, for something that just happens spontaneously as some would have us believe. i don't believe it, not in 85%+ of all sporadic CJD cases. actually, i do not believe yet that anyone has proven that any of the sporadic CJD cases have been proven to be a spontaneous misfolding of a protein. there are many potential routes and sources for the sporadic CJD's. ...TSS
Sunday, April 12, 2009
r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
snip...
SEE FULL TEXT BELOW !
Monday, April 20, 2009
National Prion Disease Pathology Surveillance Center Cases Examined1 (December 31, 2008)
http://prionunitusaupdate2008.blogspot.com/2009/04/national-prion-disease-pathology.html
http://madcowtesting.blogspot.com/2008/04/mbm-greaves-meat-offal-live-cattle.html
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments
Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments
Wednesday, April 22, 2009
FDA Announces Confirmation of the Effective Date of the BSE Final Rule of October 26, 2009
http://madcowfeed.blogspot.com/2009/04/fda-announces-confirmation-of-effective.html
P26
TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN HUMANIZED MOUSE MODELS
Liuting Qing1, Fusong Chen1, Michael Payne1, Wenquan Zou1, Cristina Casalone2, Martin Groschup3, Miroslaw Polak4, Maria Caramelli2, Pierluigi Gambetti1, Juergen Richt5*, and Qingzhong Kong1 1Department of Pathology, Case Western Reserve University, Cleveland, OH 44106, USA; 2CEA, Istituto Zooprofilattico Sperimentale, Italy; 3Friedrich-Loeffler-Institut, Germany; 4National Veterinary Research Institute, Poland; 5Kansas State University, Diagnostic Medicine/Pathobiology Department, Manhattan, KS 66506, USA. *Previous address: USDA National Animal Disease Center, Ames, IA 50010, USA
Classical BSE is a world-wide prion disease in cattle, and the classical BSE strain (BSE-C) has led to over 200 cases of clinical human infection (variant CJD). Two atypical BSE strains, BSE-L (also named BASE) and BSE-H, have been discovered in three continents since 2004. The first case of naturally occurring BSE with mutated bovine PrP gene (termed BSE-M) was also found in 2006 in the USA. The transmissibility and phenotypes of these atypical BSE strains/isolates in humans were unknown. We have inoculated humanized transgenic mice with classical and atypical BSE strains (BSE-C, BSE-L, BSE-H) and the BSE-M isolate. We have found that the atypical BSE-L strain is much more virulent than the classical BSE-C. The atypical BSE-H strain is also transmissible in the humanized transgenic mice with distinct phenotype, but no transmission has been observed for the BSE-M isolate so far.
III International Symposium on THE NEW PRION BIOLOGY: BASIC SCIENCE, DIAGNOSIS AND THERAPY 2 - 4 APRIL 2009, VENEZIA (ITALY)
http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf
Research Project: GENETIC AND BIOLOGICAL DETERMINANTS OF RESPIRATORY DISEASE SUSCEPTIBILITY Location: Animal Health Systems Research
Title: Association of a bovine prion gene haplotype with atypical BSE
Author
Clawson, Michael
Submitted to: Meeting Abstract Publication Type: Abstract Publication Acceptance Date: December 2, 2008 Publication Date: January 1, 2009 Citation: Clawson, M.L. 2009. Association of a bovine prion gene haplotype with atypical BSE [abstract]. Plant and Animal Genomes XVII Conference. Abstract No. W091. Available:
http://www.intl-pag.org/17/abstracts/
Technical Abstract: Transmissible spongiform encephalopathies (TSEs), also known as prion diseases, are a class of fatal neurodegenerative disorders that occur in humans, ruminants, cats, and mink. Three distinct TSEs afflict cattle: classical bovine spongiform encephalopathy (BSE), atypical H-type BSE, and atypical L-type BSE. Classical BSE was identified in the 1980s and is acquired by cattle through the consumption of feed contaminated with the infectious prion agent. Atypical BSEs have only recently been recognized as distinct cattle prion diseases and are extremely rare. The full extent of genetic susceptibilities to atypical BSEs is unknown; however, one atypical H-type case identified in the United States (2006) was most likely caused by a genetic mutation in the prion gene, E211K. We have identified an association of a bovine prion DNA haplotype with atypical BSE that is independent of E211K. The haplotype spans a portion of the prion gene that includes part of intron 2, the entire coding region of exon 3, and part of the three prime untranslated region of exon 3 (13 kb). Despite the low frequency of this haplotype among general cattle populations, it was present in a majority of H- and L-type atypical BSE cases from Canada, France, and the United States. This result indicates that there is a genetic component to atypical BSE susceptibility in addition to E211K.
http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=234699
I ask Professor Kong ;
Thursday, December 04, 2008 3:37 PM Subject: RE: re--Chronic Wating Disease (CWD) and Bovine Spongiform Encephalopathies (BSE): Public Health Risk Assessment
''IS the h-BSE more virulent than typical BSE as well, or the same as cBSE, or less virulent than cBSE? just curious.....''
Professor Kong reply ;
.....snip
''As to the H-BSE, we do not have sufficient data to say one way or another, but we have found that H-BSE can infect humans. I hope we could publish these data once the study is complete. Thanks for your interest.''
Best regards, Qingzhong Kong, PhD Associate Professor Department of Pathology Case Western Reserve University Cleveland, OH 44106 USA
END...TSS
I look forward to further transmission studies, and a true ENHANCED BSE/atypical BSE surveillance program put forth testing all cattle for human and animal consumption for 5 years. a surveillance program that uses the most sensitive TSE testing, and has the personnel that knows how to use them, and can be trusted. I look forward to a stringent mad cow feed ban being put forth, and then strictly enforced. we need a forced, not voluntary feed ban, an enhanced feed ban at that, especially excluding blood. we need some sort of animal traceability. no more excuses about privacy. if somebody is putting out a product that is killing folks and or has the potential to kill you, then everybody needs to know who they are, and where that product came from. same with hospitals, i think medical incidents in all states should be recorded, and made public, when it comes to something like a potential accidental transmission exposure event. so if someone is out there looking at a place to go have surgery done, if you have several hospitals having these type 'accidental exposure events', than you can go some place else. it only makes sense. somewhere along the road, the consumer lost control, and just had to take whatever they were given, and then charged these astronomical prices. some where along the line the consumer just lost interest, especially on a long incubating disease such as mad cow disease i.e. Transmissible Spongiform Encephalopathy. like i said before, there is much more to the mad cow story than bovines and eating a hamburger, we must start focusing on all TSE in all species. ...TSS
Month Number of Tests
Feb 2009 -- 1,891
Jan 2009 -- 4,620
http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml
P02.35
Molecular Features of the Protease-resistant Prion Protein (PrPres) in H-type BSE
Biacabe, A-G1; Jacobs, JG2; Gavier-Widén, D3; Vulin, J1; Langeveld, JPM2; Baron, TGM1 1AFSSA, France; 2CIDC-Lelystad, Netherlands; 3SVA, Sweden
Western blot analyses of PrPres accumulating in the brain of BSE-infected cattle have demonstrated 3 different molecular phenotypes regarding to the apparent molecular masses and glycoform ratios of PrPres bands. We initially described isolates (H-type BSE) essentially characterized by higher PrPres molecular mass and decreased levels of the diglycosylated PrPres band, in contrast to the classical type of BSE. This type is also distinct from another BSE phenotype named L-type BSE, or also BASE (for Bovine Amyloid Spongiform Encephalopathy), mainly characterized by a low representation of the diglycosylated PrPres band as well as a lower PrPres molecular mass. Retrospective molecular studies in France of all available BSE cases older than 8 years old and of part of the other cases identified since the beginning of the exhaustive surveillance of the disease in 20001 allowed to identify 7 H-type BSE cases, among 594 BSE cases that could be classified as classical, L- or H-type BSE. By Western blot analysis of H-type PrPres, we described a remarkable specific feature with antibodies raised against the C-terminal region of PrP that demonstrated the existence of a more C-terminal cleaved form of PrPres (named PrPres#2 ), in addition to the usual PrPres form (PrPres #1). In the unglycosylated form, PrPres #2 migrates at about 14 kDa, compared to 20 kDa for PrPres #1. The proportion of the PrPres#2 in cattle seems to by higher compared to the PrPres#1. Furthermore another PK-resistant fragment at about 7 kDa was detected by some more N-terminal antibodies and presumed to be the result of cleavages of both N- and C-terminal parts of PrP. These singular features were maintained after transmission of the disease to C57Bl/6 mice. The identification of these two additional PrPres fragments (PrPres #2 and 7kDa band) reminds features reported respectively in sporadic Creutzfeldt-Jakob disease and in Gerstmann-Sträussler-Scheinker (GSS) syndrome in humans.
http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf
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
Wednesday, February 11, 2009
Atypical BSE North America Update February 2009
Both of the BSE cases ascertained in the US native-born cattle were atypical cases (H-type), which contributed to the initial ambiguity of the diagnosis. 174, 185 In Canada, there have been 2 atypical BSE cases in addition to the 14 cases of the classic UK strain of BSE2: one was the H-type, and the other was of the L-type.198
snip...end
source :
Enhanced Abstract Journal of the American Veterinary Medical Association January 1, 2009, Vol. 234, No. 1, Pages 59-72
Bovine spongiform encephalopathy
Jane L. Harman, DVM, PhD; Christopher J. Silva, PhD
http://avmajournals.avma.org/doi/ref/10.2460/javma.234.1.59
Atypical BSE North America Update February 2009
http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
full text ;
Sunday, April 12, 2009 TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN HUMANIZED MOUSE MODELS
http://bse-atypical.blogspot.com/2009/04/transmission-of-atypical-bovine.html
HUMAN AND ANIMAL TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY, the silent pandemic
April 28, 2009 11:13 AM
the mad cow feed ban i.e. ruminant to ruminant feed ban was a long time over due. since august 4, 1997, since the inception of the PARTIAL and VOLUNTARY ban, the ban has been flouted, and thought of as nothing more than a joke. the feed ban of august 4, 1997 was nothing more than ink on paper. in 2007 alone, in one weekly enforcement letter, 10 MILLION PLUS POUNDS OF BANNED, BLOOD LACED MEAT AND BONE MEAL went out in commerce, to be fed out from state to state. there were many more since the infamous fda mad cow feed ban that never was. the industry need not look any further than the mirror to find the one to blame. they have had 12 years to get their house in order, but they chose to ignore the ban, the science, and to conduct business as usual i.e. feeding SRMs to human and livestock producing animals. no good, prions kill. this is not rocket science. all one has to do is look at the transmission studies. it's what i call the 'silent pandemic'. most all of us have been exposed, some are dying, but it is the friendly fire, and the very long incubation period that is fooling everyone. sporadic CJDs are on the rise, and the UKBSEnvCJD hamburger eating adolescents only theory was nothing more than a pipe dream. it's wrong, and for those that continue to follow this bogus theory will only enhance and spread all TSEs globally in doing so. North America has documented not only the typical cBSE, but also the h-BSE, and the l-BSE atypicals have been documented. CWD rampant in deer and elk, Scrapie, and the Nor-98 atypical scrapie in sheep and goats, with the latest scrapie case documented in a goat in March 2009 in the USA. North America is awash in animal TSEs, and again, sporadic CJD is rising, with atypical cases of CJD in young in the USA, what's that ??? rest asure, the cdc/USDA et al will assure, it's nothing. i don't believe them. ...TSS
National Prion Disease Pathology Surveillance Center Cases Examined1 (December 31, 2008)
http://prionunitusaupdate2008.blogspot.com/2009/04/national-prion-disease-pathology.html
Terry S. Singeltary Sr.
http://www.bizlex.com/Articles-c-2009-04-28-86561.113117_FDA_ruling_hits_area_animal_agriculture.html
Tuesday, April 28, 2009
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY UPDATE (the silent pandemic) AND Agricultural Bioterrorism
http://madcowusda.blogspot.com/2009/04/transmissible-spongiform-encephalopathy.html
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
Thursday, April 30, 2009
Wednesday, April 22, 2009
FDA Announces Confirmation of the Effective Date of the BSE Final Rule of October 26, 2009
----- Original Message ----- From: "TERRY SINGELTARY" <flounder9@verizon.net> To: "Bovine Spongiform Encephalopathy" <BSE-L@LISTS.AEGEE.ORG>; <burt.pritchett@fda.hhs.gov> Cc: <cjdvoice@yahoogroups.com>; <BLOODCJD@YAHOOGROUPS.COM>; <MADcow@lists.iatp.org>; <CJD-L@LISTS.AEGEE.ORG>; <burt.pritchett@fda.hhs.gov> Sent: Wednesday, April 22, 2009 8:30 PM Subject: Re: [BSE-L] FDA-2002-N-0031-0132 Document Title Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date
CVM Update <
FDA Announces Confirmation of the Effective Date of the BSE Final RuleThe Food and Drug Administration today announced that the final rule entitled ''Substances Prohibited From Use in Animal Food or Feed,'' will become effective on April 27, 2009. However, to allow renderers additional time to comply with the new requirements, the Agency has established a compliance date of October 26, 2009. The additional 6 months will provide time for those affected to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule. FDA is encouraging affected parties who are able to begin complying with the rule to do so as soon as possible.In the April 9, 2009, Federal Register FDA proposed to delay the effective date of the final rule for 60 days and provided a period of 7 days for public comment. The agency received over 400 comments from state and national cattle producer organizations, individual cattle producers, renderers, meat processors, dairy organizations, State agriculture agencies, and consumers.Many of the comments indicated that certain entities were not adequately prepared to comply with the final rule and that adequate alternative carcass disposal methods had not been developed. However, a significant number of comments received opposed delaying the effective date of the final rule due to public and animal health concerns.In consideration of all comments received, FDA believes the most appropriate action is to confirm the April 27, 2009, effective date, and establish a compliance date of October 26, 2009, for those who need additional time to address compliance and implementation concerns.FDA will conduct outreach to affected stakeholders to help them comply with the rule. The Agency will hold a 50-state call to discuss the disposal issues in various states or regions and will engage others affected by the rule to assist as much as possible with meeting challenging carcass disposal issues by the October 26, 2009 compliance date. FDA also plans on finalizing the Small Entities Compliance Guide #195 for Renderers to provide additional information specific to the concerns of the rendering industry. Questions may be directed to Burt Pritchett, Center for Veterinary Medicine (HFV-22), FDA, 7519 Standish Place, Rockville, MD 20855, 240-453-6860, burt.pritchett@fda.hhs.gov.
For additional information, please see
http://www.federalregister.gov/OFRUpload/OFRData/2009-09466_PI.pdf
and
http://www.fda.gov/cvm/bsetoc.html.http://www.fda.gov/cvm/CVM_Updates/BSEFinalRule042209.htm
and
http://www.fda.gov/cvm/bsetoc.html
http://www.fda.gov/cvm/CVM_Updates/BSEFinalRule042209.htm
Tuesday, April 21, 2009
Docket No. FDA-2002-N-0031 CACTUS FEEDER INC.
http://madcowfeed.blogspot.com/2009/04/docket-no-fda-2002-n-0031-cactus-feeder.html
Monday, April 20, 2009
National Prion Disease Pathology Surveillance Center Cases Examined1 (December 31, 2008)
http://prionunitusaupdate2008.blogspot.com/2009/04/national-prion-disease-pathology.html
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments
Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments
TSS
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Tue, 9 Jan 2001 16:49:00 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
Greetings List Members,
I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.
I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.
"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."
and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick.
(understand, these are taken from my notes for now. the spelling of names and such could be off.)
[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.
[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]
[host Richard] could you repeat the question?
[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[not sure whom ask this] what group are you with?
[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.
[not sure who is speaking] could you please disconnect Mr. Singeltary
[TSS] you are not going to answer my question?
[not sure whom speaking] NO
from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;
[unknown woman] what group are you with?
[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?
at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.
IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from;
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:RBARNS@ORA.FDA.GOV 301-827-6906
he would be glad to give you one ;-)
Rockville Maryland, Richard Barns Host
BSE issues in the U.S., How they were labelling ruminant feed? Revising issues.
The conference opened up with the explaining of the U.K. BSE epidemic winding down with about 30 cases a week.
although new cases in other countries were now appearing.
Look at Germany whom said NO BSE and now have BSE.
BSE increasing across Europe.
Because of Temporary Ban on certain rendered product, heightened interest in U.S.
A recent statement in Washington Post, said the New Administration (old GW) has a list of issues. BSE is one of the issues.
BSE Risk is still low, minimal in U.S. with a greater interest in MBM not to enter U.S.
HOWEVER, if BSE were to enter the U.S. it would be economically disastrous to the render, feed, cattle, industries, and for human health.
(human health-they just threw that in cause i was listening. I will now jot down some figures in which they told you, 'no need to write them down'. just hope i have them correct. hmmm, maybe i hope i don't ???)
80% inspection of rendering
*Problem-Complete coverage of rendering HAS NOT occurred.
sizeable number of 1st time FAILED INITIAL INSPECTION, have not been reinspected (70% to 80%).
Compliance critical, Compliance poor in U.K. and other European Firms.
Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_ occur. Mixed level of compliance, depending on firm.
Rendering FDA license and NON FDA license
system in place for home rendering & feed 76% in compliance 79% cross contamination 21% DID NOT have system 92% record keeping less than 60% total compliance
279 inspectors 185 handling prohibited materials
Renderer at top of pyramid, significant part of compliance. 84% compliance
failed to have caution statement render 72% compliance & cross contamination caution statement on feed, 'DO NOT FEED TO CATTLE'
56 FIRMS NEVER INSPECTED
1240 FDA license feed mills 846 inspected
"close to 400 feed mills have not been inspected"
80% compliance for feed.
10% don't have system.
NON-FDA licensed mills There is NO inventory on non licensed mills. approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a lot of experience with"
40% do NOT have caution statement 'DO NOT FEED'.
74% Commingling compliance
"This industry needs a lot of work and only half gotten to"
"700 Firms that were falitive, and need to be re-inspected, in addition to the 8,000 Firms."
Quote to do BSE inspection in 19 states by end of January or 30 days, and other states 60 days. to change feed status??? Contract check and ask questions and pass info.
At this time, we will take questions.
[I was about the third or fourth to ask question. then all B.S.eee broke loose, and i lost my train of thought for a few minutes. picked back up here]
someone asking about nutritional supplements and sourcing, did not get name. something about inspectors not knowing of BSE risk??? the conference person assuring that Steve Follum? and the TSE advisory Committee were handling that.
Some other Dr. Vet, whom were asking questions that did not know what to do???
[Dennis Wilson] California Food Agr. Imports, are they looking at imports?
[Conference person] they are looking at imports, FDA issued imports Bulletin.
[Linda Singeltary ??? this was a another phone in question, not related i don't think] Why do we have non-licensed facilities?
(conference person) other feed mills do not handle as potent drugs???
Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of 6000 to 8000,
(they really don't know how many non licensed Firms in U.S. they guess 6000 to 8000??? TSS)
Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not'
Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned of Firms that have changed owners.
THE END
TSS
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Wed, 10 Jan 2001 14:04:21 -0500 From: "Gomez, Thomas M." Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
USDA/APHIS would like to provide clarification on the following point from Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.
[Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not']
Dr. Detwiler was responding to an announcement made during the call to use the FDA emergency number if anyone wanted to report a cow with signs suspect for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants to use the FDA emergency number as a last resort to report cattle suspect for BSE. What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement. Surveillance for BSE in the United States is a cooperative effort between states, producers, private veterinarians, veterinary hospitals and the USDA. The system has been in place for over 10 years. Each state has a system in place wherein cases are reported to either the State Veterinarian, the federal Veterinarian in Charge or through the veterinary diagnostic laboratory system. The states also have provisions with emergency numbers. Dr. Detwiler asked participants to use the systems currently in place to avoid the possibility of a BSE-suspect report falling through the cracks. Use of the FDA emergency number has not been established as a means to report diseased cattle of any nature.
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
Subject: Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan.9, 2001 Date: Wed, 10 Jan 2001 13:44:49 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:BSE-L@uni-karlsruhe.de References: 1
######### Bovine Spongiform Encephalopathy #########
Hello Mr. Thomas,
What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement.
would you and the USDA/APHIS be so kind as to supply this list with a full text version of the conference call and or post on your web-site? if so when, and thank you. if not, why not?
The system has been in place for over 10 years.
that seems to be a very long time for a system to be in place, and only test 10,700 cattle from some 1.5 BILLION head (including calf crop). Especially since French are testing some 20,000 weekly and the E.U. as a whole, are testing many many more than the U.S., with less cattle, same risk of BSE/TSEs.
Why does the U.S. insist on not doing massive testing with the tests which the E.U. are using? Why is this, please explain?
Please tell me why my question was not answered?
U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
It was a very simple question, a very important question, one that pertained to the topic of BSE/feed, and asked in a very diplomatic way. why was it not answered?
If all these years, we have been hearing that pharmaceutical grade bovines were raised for pharmaceuticals vaccines etc. But yet the USA cannot comply with feed regulations of the ruminant feed ban, PLUS cannot even comply with the proper labelling of the feed, cross contamination etc. Then how in the world can you Guarantee the feed fed to pharmaceutical grade bovine, were actually non ruminant feed?
Before i was ask to be 'disconnected', i did hear someone in the background say 'we can't'-- have him ask the question again.
could you please be so kind, as to answer these questions?
thank you, Terry S. Singeltary Sr. Bacliff, Texas USA
P.S. if you will also notice, i did not post that emergency phone number and do not intend on passing it on to anyone. I was joking when i said i should call and report the whole damn U.S. Herd. So please pass that on to Dr. Detwiler, so she can rest easily.
BUT, they should be reported, some are infected with TSE. The U.S. is just acting as stupid as Germany and other Countries that insist they are free of BSE.
TSS
Subject: Report on the assessment of the Georgraphical BSE-risk of the USA July 2000 (not good) Date: Wed, 17 Jan 2001 21:23:51 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
Greetings List Members and ALL EU Countries,
Because of this report, and the recent findings of the 50-state BSE Conference call, I respectfully seriously suggest that these Countries and the SSC re-evaluate the U.S.A. G.B.R. to a risk factor of #3.
I attempted to post this to list in full text, but would not accept...
thank you, kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA
Report on the assessment of the Geographical BSE-risk of the USA July 2000
PART II
REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE RISK OF THE UNITED STATES OF AMERICA
- 29 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
EXECUTIVE SUMMARY
OVERALL ASSESSMENT
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
Stability: Before 1990 the system was extremely unstable because feeding of MBM to cattle happened, rendering was inappropriate with regard to deactivation of the BSE-agent and SRM and fallen stock were rendered for feed. From 1990 to 1997 it improved to very unstable, thanks to efforts undertaken to trace imported animals and exclude them from the feed chain and intensive surveillance. In 1998 the system became neutrally stable after the RMBM-ban of 1997.
External challenges: A moderate external challenge occurred in the period before 1990 because of importation of live animals from BSE-affected countries, in particular from the UK and Ireland. It cannot be excluded that some BSE-infected animals have been imported by this route and did enter the US rendering and feed production system. The efforts undertaken since 1990 to trace back UK-imported cattle and to exclude them from the feed chain reduced the impact of the external challenge significantly.
Interaction of external challenges and stability: While extremely unstable, the US system was exposed to a moderate external challenge, mainly resulting from cattle imports from the UK. It can not be excluded that BSE-infectivity entered the country by this route and has been recycled to domestic cattle. The resulting domestic cases would have been processed while the system was still very unstable or unstable and would hence have initiated a number of second or third generation cases. However, the level of the possible domestic prevalence must be below the low detection level of the surveillance in place.
As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent will remain at the current level.
JUSTIFICATION
1. DATA
The available information was suitable to carry out the GBR risk assessment.
- 30 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
2. STABILITY
2.1 Overall appreciation of the ability to identify BSE-cases and to eliminate animals at risk of being infected before they are processed
· Before 1989, the ability of the system to identify (and eliminate) BSE cases was limited. · Since 1990 this ability is significantly improved, thanks to a good BSE-surveillance and culling system (contingency plan). · Today the surveillance should be able to detect clinical BSE-cases within the limits set by an essential passive surveillance system, i.e. some cases might remain undetected.
2.2 Overall appreciation of the ability to avoid recycling BSE-infectivity, should it enter processing
· Before 1997 the US rendering and feed producing system would not have been able to avoid recycling of the BSE agent to any measurable extent. If the BSE-agent was introduced the feed chain, it could probably have reached cattle. · After the introduction of the RMBM-to-ruminants-ban in August 1997 the ability of the system to avoid recycling of BSE-infectivity was somewhat increased. It is still rather low due to the rendering system of ruminant material (including SRM and fallen stock) and the persisting potential for cross-contamination of cattle feed with other feeds and hence RMBM.
2.3 Overall assessment of the Stability
· Until 1990 the US BSE/cattle system was extremely unstable as RMBM was commonly fed to cattle, the rendering system was not able to reduce BSE-infectivity and SRM were rendered. This means that incoming BSE infectivity would have been most probably recycled to cattle and amplified and the disease propagated. · Between 1990 and 1995 improvements in the BSE surveillance and the efforts to trace back and remove imported cattle gradually improved the stability but the system remained very unstable. In 1998 the system became unstable because of an RMBM-ban introduced in 1997. After 1998 the ban was fully implemented and the system is regarded to be neutrally stable since 1998. The US system is therefore seen to neither be able to amplify nor to reduce circulating or incoming BSE-infectivity.
3. CHALLENGES
A moderate external challenge occurred in the period 1980-1989 because of importation of live animals from the UK. imports from other countries are regarded to have been negligible challenges. · As a consequence of this external challenge, infectivity could have entered the feed cycle and domestic animals could have been exposed to the agent. These domestic BSE-incubating animals might have again entered processing, leading to an internal challenge since 1991. · This internal challenge could have produced domestic cases of BSE, yet prevalence levels could have been below the detection limits of the surveillance system until now. (According to US calculations, the current surveillance
-31 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
system could detect clinical incidence of 1-3 cases per year per million adult cattle, i.e. in absolute numbers 43-129 cases per year). Between 1990 und 1995, with the exclusion of the imported animals from Europe from the feed chain, the effect of the external challenges decreased.
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenqe
· In the late 80s, early 90s a moderate external challenges met an extremely unstable system. This would have amplified the incoming BSE-infectivity and propagated the disease. · With the exclusion of the imported animals from Europe from the feed chain between 1990 and 1995 the effect of the external challenge decreased. · Before 1998 an internal challenge, if it developed, would have met a still unstable system (inappropriate rendering, no SRM ban, RMBM ban only after 1997) and the BSE-infectivity could have been recycled and amplified. · After 1998 the neutrally stable system could still recycle the BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity circulating in the system would probably not be amplified.
4.2 Risk that BSE-infectivity enters processing
· A very low processing risk developed in the late 80s when the UK-imports were slaughtered or died. It increased until 1990 because of the higher risk to be infected with BSE of cattle imported from the UK in 1988/89, as these animals could have been processed prior to the back-tracing of the UK-imports in 1990. · From 1990 to 1995 a combination of surviving non-traced UK imports and some domestic (pre-)clinical cases could have arrived at processing resulting in an assumed constant low but non-negligible processing risk. · After 1995 any processing risk relates to assumed domestic cases arriving at processing. · The fact that no domestic cases have been shown-up in the BSE-surveillance is reassuring - it indicates that BSE is in fact not present in the country at levels above the detection limits of the country's surveillance system. This detection level has been calculated according to US-experts to be between 1 & 3 clinical cases per million adult cattle per year.
Note: The high turnover in parts of the dairy cattle population with a young age at slaughter makes it unlikely that fully developed clinical cases would occur (and could be detected) or enter processing. However, the theoretical infective load of the pre-clinical BSE-cases that under this scenario could be processed, can be assumed to remain relatively low.
4.3 Risk that BSE-infectivity is recycled and propagated
· During the period covered by this assessment (1980-1999) the US-system was not able to prevent propagation of BSE should it have entered, even if this ability was significantly improved with the MBM-ban of 1997. · However, since the likelihood that BSE-infectivity entered the system is regarded to be small but non-negligible, the risk that propagation of the disease took place is also small but not negligible.
- 32 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK
5.1 The current GBR
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
5.2 The expected development of the GBR
As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent remains at the current level.
5.3 Recommendations for influencin.q the future GBR
· As long as the stability of the US system is not significantly enbanced above neutral levels it remains critically important to avoid any new external challenges. · All measures that would improve the stability of the system, in particular with regard to its ability to avoid recycling of the BSE-agent should it be present in the cattle population, would reduce, over time, the probability that cattle could be infected with the BSE-agent. Possible actions include: removal of SRMs and/or fallen stock from rendering, better rendering processes, improved compliance with the MBM-ban including control and reduction of cross-contamination. · Results from an improved intensive surveillance programme, targeting at risk sub-populations such as adult cattle in fallen stock or in emergency slaughter, could verify the current assessment.
snip... end...TSS
From: Terry S. Singeltary Sr. [flounder@wt.net] Sent: Tuesday, July 29, 2003 1:03 PM To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:fdadockets@oc.fda.gov Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:ggraber@cvm.fda.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:Linda.Grassie@fda.gov; BSE-L Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION TO DOCKET 2003N-0312]
Greetings FDA,
snip...
PLUS, if the USA continues to flagrantly ignore the _documented_ science to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle), it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion as well. NOT to leave out the OIE and it's terribly flawed system of disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment on this as a threat to human health. the OIE should also change the mathematical formula for testing of disease. this (in my opinion and others) is terribly flawed as well. to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2 years ago that they were concerned with CWD, but said any changes might take years. well, two years have come and gone, and no change in relations with CWD as a human health risk. if we wait for politics and science to finally make this connection, we very well may die before any decisions or changes are made. this is not acceptable. we must take the politics and the industry out of any final decisions of the Scientific community. this has been the problem from day one with this environmental man made death sentence. some of you may think i am exaggerating, but you only have to see it once, you only have to watch a loved one die from this one time, and you will never forget, OR forgive...yes, i am still very angry... but the transmission studies DO NOT lie, only the politicians and the industry do... and they are still lying to this day...TSS
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Last updated: 19 July 2005 Adopted July 2004 (Question N° EFSA-Q-2003-083)
Report Summary Summary of the Scientific Report
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.
A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.
EFSA concludes that the current GBR level of USA 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.
Publication date: 20 August 2004
USA BSE GBR
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620779461.htm
http://www.efsa.europa.eu/EFSA/Scientific_Document/sr03_biohaz02_usa_report_annex_en1.pdf?ssbinary=true
http://www.efsa.europa.eu/EFSA/Scientific_Document/sr03_biohaz02_usa_report_v2_en1.pdf?ssbinary=true
2005-2006
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT October 1, 2005 through December 31, 2005
snip....
CARGILL MEAT SOLUTIONS 00086K M DODGE CITY, KS X X On 10/11/05, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.
EXCEL CORP 00086R M FORT MORGAN, CO 2/22/05 X X On 8/11/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8. On 12/22/04, plant appealed the withholding action. Appeal was denied on 1/25/05.
00245L M LEXINGTON, NE 3/12/04 3/18/04 X 5/4/05 X X On 3/10/05, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.
9/16/05 9/29/05 X X TYSON FRESH MEATS INC. 09268 M PASCO, WA X X On 7/28/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.
TYSON FRESH MEATS INC. X X 00245D M EMPORIA, KS On 12/23/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.
DESERET MEAT 04852 M SPANISH FORK, UT 7/20/05 8/1/05 X X 12/29/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
NORTHERN PACKING COMPANY INC. 00571 M BRIAR HILL, NY 12/9/05 12/23/05 X X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
A.J. CEKAK'S MEAT MARKET 9/1/05 9/20/05 X X X On 9/1/05, an enforcement action 21562 M concerning failure to meet regulatory ORD, NE requirements for Escherichia coli Biotype 1 (E. coli) was taken. The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
ALTA VISTA LOCKER 10/5/05 10/26/05 X X The enforcement action included, as a 31931 M basis, failure of the establishment toALTA VISTA, KS comply with Agency requirements concerning specified risk material.
BROWN'S PROCESSING 13100 M13100 P ELSBERRY, MO 8/8/05 8/16/05 X X X 11/16/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
CHAMPLAIN BEEF INC 2/28/05 3/4/05 3/8/05 X X X 08547 M WHITEHALL, NY 10/17/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
FIVE STAR PACK INC. 9/1/05 9/9/05 X X 12/29/05 On 9/1/05, an enforcement action 08725 M08725 P concerning failure to meet regulatory GOLDEN CITY, MO requirements for Escherichia coli Biotype 1 (E. coli) was taken. The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material. FRESH FARMS BEEF 12/16/05 12/28/05 X X X The enforcement action included, as a 18579 M basis, failure of the establishment toRUTLAND, VT comply with Agency requirements concerning specified risk material.
GOETZ AND SONS WESTERN 11/15/05 11/23/05 12/1/05 X X MEATS INC 06245 M06245 P EVERETT, WA 12/17/05 12/28/05 X X X On 12/17/05, firm violated a regulatory control action by selling U.S.D.A retained product.
H AND P MEATS 21352 M SOUTH PITTSBURG, TN 7/28/05 8/8/05 8/17/05 8/19/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
HOPKINS PACKING COMPANY 11069 M BLACKFOOT, ID 7/28/05 8/1/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
NORTHWEST PREMIUM MEATS LLC 11032 M11032 P NAMPA, ID 7/26/05 7/29/05 X X 11/15/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
PARADISE LOCKER MEATS 31865 M31865 P TRIMBLE, MO 9/21/05 10/7/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material. PARAGON SPRAY DRYING, LLC 31762 M31762 P WAUKON, IA 9/6/05 9/12/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
RANDALL MEAT COMPANY 10669 M HOT SPRINGS, AR 7/1/05 7/28/05 10/12/05 10/24/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
S & S MEAT COMPANY 01046 M01046 P KANSAS CITY, MO 8/4/05 8/19/05 X X 11/16/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
STEAK MASTER 21159 M21159 P ELWOOD, NE 11/4/05 11/17/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
THE MEAT SHOP 31561 M BENSON, VT 8/18/05 9/6/05 9/9/05 X X X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
THEURER'S QUALITY MEATS, INC 31647 M31647 P LEWISTON, UT 7/27/05 7/29/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
TOOELE VALLEY MEATS 20594 M20594 P GRANTSVILLE, UT 7/25/05 8/1/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
WALNUT VALLEY PACKING LLC 32007 M32007 P EL DORADO, KS 12/15/05 12/30/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
YODER BROTHERS MEAT PROCESSING 17301 M PARIS, TN 10/3/05 10/12/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
full text 54 pages ;
http://www.fsis.usda.gov/PDF/QER_Q1_FY2006.pdf
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT July 1, 2005 through September 30, 2005
snip...
52 pages
http://www.fsis.usda.gov/PDF/QER_Q4_FY2005.pdf
TSS
----- Original Message ----- From: "TERRY SINGELTARY" <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:flounder9@VERIZON.NET> To: <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:BSE-L@LISTS.AEGEE.ORG> Sent: Thursday, April 16, 2009 3:20 PM Subject: [BSE-L] FDA-2002-N-0031-0132 Document Title Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date
-------------------- mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:BSE-L@LISTS.AEGEE.ORG --------------------
TSS COMMENT SUBMISSION # 5
Docket ID FDA-2002-N-0031 Docket Title Animal Proteins Prohibited in Ruminant Feed Document ID FDA-2002-N-0031-0132 Document Title Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date
Completely Edited Version
PRION ROUNDTABLE
2003
page 29
Dr. Linda Detwiler
The UK imports into the US.
There were 496 total, and 173 of the UK imports could have entered the US feed system. People don't like to hear this, but it's possible that one of the UK imports in the US entered the animal feed system and was exported to Canada. That's a possibility, because they import 50% of their feed from the US.
From 1994, we imported 11 million head of cattle from Canada. Most of these were feedlot animals for slaughter, but there were about 500,000 breeding animals. A number of Canada's cull cows were slaughtered here and could have introduced infectivity into our system. Even today we have Canadian imports in the country, breeding animals that were brought in prior to the ban and reside here.
We have feed ban exemptions: plate waste, poultry litter. We still allow that if it comes off a human plate, or if it's trimmings, it can be palletized and fed to ruminants. That might be a small amount, but it could allow spinal cord in certain cuts to be fed back to ruminants. Poultry litter or feather meal could be significant. Poultry is getting quite a bit of ruminant material in the US because it cannot go back to ruminants. Poultry and pigs are getting a substantial amount. Poultry litter is not only what passes through the chicken, but think about how chickens eat. They spill a lot on the floor. That stuff is still allowed to be fed back to cattle. That's a direct break in the ban, except that it's legal. Ruminants are getting ruminant material.
Unfiltered tallow: tallow is a lipid material. However, if it's not filtered, there are protein residues. That's meat and bone meal. That's allowed to be fed, so that's another legal exception where you can feed ruminant meat and bone meal through unfiltered tallow. We don't have an SRM ban and the 40 animals are the ones that if you have the agent, they introduce the most infectivity back into the animal food chain when they're rendered.
What's our on-farm compliance? We really don't know. ...snip...end...Dr. Linda Detwiler
UK EXPORTS OF MBM TO WORLD
http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf
OTHERS
BEEF AND VEAL
http://www.bseinquiry.gov.uk/files/mb/m11f/tab08.pdf
http://www.bseinquiry.gov.uk/files/mb/m11f/tab09.pdf
http://www.bseinquiry.gov.uk/files/mb/m11f/tab10.pdf
LIVE CATTLE
http://www.bseinquiry.gov.uk/files/mb/m11f/tab11.pdf
FATS
http://www.bseinquiry.gov.uk/files/mb/m11g/tab01.pdf
EMBRYOS
http://www.bseinquiry.gov.uk/files/mb/m11g/tab03.pdf
GELATIN ETC
http://www.bseinquiry.gov.uk/files/mb/m11g/tab02.pdf
SEMEN
http://www.bseinquiry.gov.uk/files/mb/m11g/tab04.pdf
MEAT
http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf
CANADA
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf
USA
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf
MEXICO
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf
Wednesday, April 16, 2008 MBM, greaves, meat offal, live cattle, imports from UK to USA vs Canada "Three of four possible manufacturers supplying a protein supplement likely fed to the animal could have included meat and bone meal (MBM) as an ingredient in its formulation. One of these manufacturers was able to confirm usage of meat and bone meal in supplements and confirm a source of MBM to be one common to previous BSE investigations."
USA AND CANADA IMPORTS OF UK CATTLE BETWEEN 1981 - 1989
USA = 496
CANADA = 198
*add 14 to 198 as last UK import to Canada, 14 in 1990
http://www.inspection.gc.ca/english/sci/ahra/bseris/bserise.pdf
HERE is another look at all the imports for both the USA and Canada of UK live cattle and greaves exports ;
UK Exports of Live Cattle by Value 1986-96
USA 697 LIVE CATTLE
CANADA 299 LIVE CATTLE
http://www.bseinquiry.gov.uk/files/mb/m11f/tab11.pdf
UK TABLE of Exports of meal of meat and meat offal; greaves 1979 - 1995
USA 24 TONS
CANADA 83 TONS
http://www.bseinquiry.gov.uk/files/mb/m12/tab12.pdf
HOWEVER, my files show 44 tons of greaves for USA. ...TSS
Subject: Re: exports from the U.K. of it's MBM to U.S.??? From: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:S.J.Pearsall@esg.maff.gsi.gov.uk Date: Tue, 8 Feb 2000 14:03:16 +0000 To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:flounder@wt.net (Receipt Notification Requested) (Non Receipt Notification Requested)
Terry
Meat and bonemeal is not specifically classified for overseas trade purposes. The nearest equivalent is listed as flours and meals of meat or offals (including tankage), unfit for human consumption; greaves. UK exports of this to the US are listed below:
Country Tonnes
1980 1981 12 1982 1983 1984 10 1985 2 1986 1987 1988 1989 20 1990
Data for exports between 1975 and 1979 are not readily available. These can be obtained (at a charge) from data retailers appointed by HM Customs and Excise: BTSL (Tel: 01372 463121) or Abacus (01245 252222). Best wishes Simon Pearsall Overseas trade statistics Stats (C&F)C
============ END...TSS...2008============
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3; Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique, France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious Disease control, Sweden; 5Georg August University, Germany; 6German Primate Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans. Secondly, we aimed at examining the course of the disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian vCJD as fast as intracerebrally inoculated animals.
The work referenced was performed in partial fulfilment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).
http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley's surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
6. It also appears to me that Mr Bradley's answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate"
experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley's surprise at the results because all the dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
TSS
http://madcowtesting.blogspot.com/2008/04/mbm-greaves-meat-offal-live-cattle.html
Thursday, April 09, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:burt.pritchett@fda.hhs.gov
Greetings FDA et al,
I lost my Mother to the Heidenhain Variant Creutzfeldt Jakob disease (confirmed see autopsy below).
I kindly wish to comment on the following ;
[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46
[Federal Register: April 9, 2009 (Volume 74, Number 67)] [Proposed Rules] [Page 16160-16161] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap09-18]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 589
[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46 TSS SUBMISSION # 5
Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed delay of effective date.
http://edocket.access.gpo.gov/2009/E9-8127.htm
MY COMMENT AS FOLLOWS ;
I find it deeply disturbing, that with the science to date, especially with the science to date, transmission studies, the more virulent atypical strains of the BSE i.e. h-BSE and l-BSE, both of which have now been documented in North America, that we are even still discussing this most important topic. The industry involved has beat this mad cow feed ban to death, and still refuse to comply. IF they would have adhered to policy, rules and regulations put forth August 4th, 1997, when the partial, and voluntary ruminant to ruminant feed ban was first put in place, they would not still be crying the same tune. WE need not only to enforce the present ban, but strengthen it, especially to include blood in the ban. WE (the consumer), was promised this would happen years ago. For Pete's sake, this will be the third president to have to address these same questions, and I pray that this one has the guts to finally do something. We need NOT discuss this for one more second. We had 8 years that President Bush literally covered up mad cow disease, and let literally millions and millions of pounds of mad cow feed into commerce to be fed out. IN one feed ban recall alone in 2007, 10 MILLION PLUS POUNDS was fed out into commerce. and under this same President, we now millions of kids across our Nation that have been needlessly exposed to the mad cow agent via the infamous USDA CERTIFIED DOWNER COW DEAD STOCK SCHOOL LUNCH PROGRAM. if you think for one moment that the largest meat recall in the history of the USA was because a few animals were filmed being abused, your only kidding yourself. that meat was recalled because dead stock downer cows are at the highest risk to carry mad cow disease, and they had been feeding our children this stuff for years. AND then had the nerve to lie to us about THE GREAT BSE FIREWALL IN THE USA THAT WOULD PROTECT THE CONSUMER I.E. THE BSE FEED BAN, that never was nothing more than ink on paper. who will monitor these children in the years and decades to come for a human form of Transmissible Spongiform Encephalopathy? who can with a CJD/TSE surveillance system and CJD Questionnaire set up the way it is now? you can't.
R-CALF and the CJD Foundation, seem oblivious to the fact that the USA has a mad cow problem. THIS IS NOT ABOUT THE CANADIAN BORDER. this is about feeding cows to cows in the USA, USA RUMINANT MAD COW FEED IN COMMERCE, and the fact the USA has had a mad cow problem for years.
all R-CALF wants to do is blame it on Canada, close the border, and then continue to feed ruminant feed to USA cattle, and ignore the TSE problem in the USA bovine, read closely what Bullard says from R-CALF ;
"We either implement this feed ban without any further delay or we stop the source of this problem by removing and reversing the Canadian cattle that continues to enter this country" said Bullard
http://www.montanasnewsstation.com/Global/story.asp?S=10171123
ENOUGH already $ NO MORE DISCUSSION PLEASE, WE NEED ACTION !
STOP ALL MAD COW FEED REGARDLESS !!!
I strenuously urge President Obama to NOT discuss this for one more moment, actions must be put forth now, and enforce such actions.
I strenuously urge President Obama to ENHANCE the feed ban to include blood, and enforce said regulations, based on sound science.
I strenuously urge President Obama to ban the use of "poultry litter" and the use of all mammalian and poultry protein in ruminant feed,as a feed ingredient for ruminant animals, and enforce said regulations, based on sound science.
I strenuously urge President Obama to ban the use of "plate waste" as a feed ingredient for ruminants, and enforce said regulations, based on sound science.
I strenuously urge President Obama to ban from human food (including dietary supplements please see latest May 2009 CDC warning on these type supplements, CWD, and Elk Antler Velvet), and cosmetics a wide range of bovine- derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates, and enforce such actions, based on sound science.
I strenuously urge President Obama to further minimize the possibility of cross- contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination, and enforce said regulations, based on sound science.
Sunday, April 12, 2009
BSE MAD COW TESTING USA 2009 FIGURES
Month Number of Tests
Feb 2009 -- 1,891
Jan 2009 -- 4,620
http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml
http://madcowtesting.blogspot.com/2009/04/bse-mad-cow-testing-usa-2009-figures.html
PLEASE SEE MY FULL COMMENT SUBMISSION IN THE PDF ATTACHMENT, OR GO HERE
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments
Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments
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CVM Update <
FDA Announces Confirmation of the Effective Date of the BSE Final RuleThe Food and Drug Administration today announced that the final rule entitled ''Substances Prohibited From Use in Animal Food or Feed,'' will become effective on April 27, 2009. However, to allow renderers additional time to comply with the new requirements, the Agency has established a compliance date of October 26, 2009. The additional 6 months will provide time for those affected to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule. FDA is encouraging affected parties who are able to begin complying with the rule to do so as soon as possible.In the April 9, 2009, Federal Register FDA proposed to delay the effective date of the final rule for 60 days and provided a period of 7 days for public comment. The agency received over 400 comments from state and national cattle producer organizations, individual cattle producers, renderers, meat processors, dairy organizations, State agriculture agencies, and consumers.Many of the comments indicated that certain entities were not adequately prepared to comply with the final rule and that adequate alternative carcass disposal methods had not been developed. However, a significant number of comments received opposed delaying the effective date of the final rule due to public and animal health concerns.In consideration of all comments received, FDA believes the most appropriate action is to confirm the April 27, 2009, effective date, and establish a compliance date of October 26, 2009, for those who need additional time to address compliance and implementation concerns.FDA will conduct outreach to affected stakeholders to help them comply with the rule. The Agency will hold a 50-state call to discuss the disposal issues in various states or regions and will engage others affected by the rule to assist as much as possible with meeting challenging carcass disposal issues by the October 26, 2009 compliance date. FDA also plans on finalizing the Small Entities Compliance Guide #195 for Renderers to provide additional information specific to the concerns of the rendering industry. Questions may be directed to Burt Pritchett, Center for Veterinary Medicine (HFV-22), FDA, 7519 Standish Place, Rockville, MD 20855, 240-453-6860, burt.pritchett@fda.hhs.gov.
For additional information, please see
http://www.federalregister.gov/OFRUpload/OFRData/2009-09466_PI.pdf
and
http://www.fda.gov/cvm/bsetoc.html.http://www.fda.gov/cvm/CVM_Updates/BSEFinalRule042209.htm
and
http://www.fda.gov/cvm/bsetoc.html
http://www.fda.gov/cvm/CVM_Updates/BSEFinalRule042209.htm
Tuesday, April 21, 2009
Docket No. FDA-2002-N-0031 CACTUS FEEDER INC.
http://madcowfeed.blogspot.com/2009/04/docket-no-fda-2002-n-0031-cactus-feeder.html
Monday, April 20, 2009
National Prion Disease Pathology Surveillance Center Cases Examined1 (December 31, 2008)
http://prionunitusaupdate2008.blogspot.com/2009/04/national-prion-disease-pathology.html
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments
Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments
TSS
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Tue, 9 Jan 2001 16:49:00 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
Greetings List Members,
I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.
I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.
"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."
and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick.
(understand, these are taken from my notes for now. the spelling of names and such could be off.)
[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.
[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]
[host Richard] could you repeat the question?
[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[not sure whom ask this] what group are you with?
[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.
[not sure who is speaking] could you please disconnect Mr. Singeltary
[TSS] you are not going to answer my question?
[not sure whom speaking] NO
from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;
[unknown woman] what group are you with?
[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?
at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.
IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from;
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:RBARNS@ORA.FDA.GOV 301-827-6906
he would be glad to give you one ;-)
Rockville Maryland, Richard Barns Host
BSE issues in the U.S., How they were labelling ruminant feed? Revising issues.
The conference opened up with the explaining of the U.K. BSE epidemic winding down with about 30 cases a week.
although new cases in other countries were now appearing.
Look at Germany whom said NO BSE and now have BSE.
BSE increasing across Europe.
Because of Temporary Ban on certain rendered product, heightened interest in U.S.
A recent statement in Washington Post, said the New Administration (old GW) has a list of issues. BSE is one of the issues.
BSE Risk is still low, minimal in U.S. with a greater interest in MBM not to enter U.S.
HOWEVER, if BSE were to enter the U.S. it would be economically disastrous to the render, feed, cattle, industries, and for human health.
(human health-they just threw that in cause i was listening. I will now jot down some figures in which they told you, 'no need to write them down'. just hope i have them correct. hmmm, maybe i hope i don't ???)
80% inspection of rendering
*Problem-Complete coverage of rendering HAS NOT occurred.
sizeable number of 1st time FAILED INITIAL INSPECTION, have not been reinspected (70% to 80%).
Compliance critical, Compliance poor in U.K. and other European Firms.
Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_ occur. Mixed level of compliance, depending on firm.
Rendering FDA license and NON FDA license
system in place for home rendering & feed 76% in compliance 79% cross contamination 21% DID NOT have system 92% record keeping less than 60% total compliance
279 inspectors 185 handling prohibited materials
Renderer at top of pyramid, significant part of compliance. 84% compliance
failed to have caution statement render 72% compliance & cross contamination caution statement on feed, 'DO NOT FEED TO CATTLE'
56 FIRMS NEVER INSPECTED
1240 FDA license feed mills 846 inspected
"close to 400 feed mills have not been inspected"
80% compliance for feed.
10% don't have system.
NON-FDA licensed mills There is NO inventory on non licensed mills. approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a lot of experience with"
40% do NOT have caution statement 'DO NOT FEED'.
74% Commingling compliance
"This industry needs a lot of work and only half gotten to"
"700 Firms that were falitive, and need to be re-inspected, in addition to the 8,000 Firms."
Quote to do BSE inspection in 19 states by end of January or 30 days, and other states 60 days. to change feed status??? Contract check and ask questions and pass info.
At this time, we will take questions.
[I was about the third or fourth to ask question. then all B.S.eee broke loose, and i lost my train of thought for a few minutes. picked back up here]
someone asking about nutritional supplements and sourcing, did not get name. something about inspectors not knowing of BSE risk??? the conference person assuring that Steve Follum? and the TSE advisory Committee were handling that.
Some other Dr. Vet, whom were asking questions that did not know what to do???
[Dennis Wilson] California Food Agr. Imports, are they looking at imports?
[Conference person] they are looking at imports, FDA issued imports Bulletin.
[Linda Singeltary ??? this was a another phone in question, not related i don't think] Why do we have non-licensed facilities?
(conference person) other feed mills do not handle as potent drugs???
Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of 6000 to 8000,
(they really don't know how many non licensed Firms in U.S. they guess 6000 to 8000??? TSS)
Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not'
Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned of Firms that have changed owners.
THE END
TSS
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Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Wed, 10 Jan 2001 14:04:21 -0500 From: "Gomez, Thomas M." Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
USDA/APHIS would like to provide clarification on the following point from Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.
[Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not']
Dr. Detwiler was responding to an announcement made during the call to use the FDA emergency number if anyone wanted to report a cow with signs suspect for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants to use the FDA emergency number as a last resort to report cattle suspect for BSE. What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement. Surveillance for BSE in the United States is a cooperative effort between states, producers, private veterinarians, veterinary hospitals and the USDA. The system has been in place for over 10 years. Each state has a system in place wherein cases are reported to either the State Veterinarian, the federal Veterinarian in Charge or through the veterinary diagnostic laboratory system. The states also have provisions with emergency numbers. Dr. Detwiler asked participants to use the systems currently in place to avoid the possibility of a BSE-suspect report falling through the cracks. Use of the FDA emergency number has not been established as a means to report diseased cattle of any nature.
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
Subject: Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan.9, 2001 Date: Wed, 10 Jan 2001 13:44:49 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:BSE-L@uni-karlsruhe.de References: 1
######### Bovine Spongiform Encephalopathy #########
Hello Mr. Thomas,
What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement.
would you and the USDA/APHIS be so kind as to supply this list with a full text version of the conference call and or post on your web-site? if so when, and thank you. if not, why not?
The system has been in place for over 10 years.
that seems to be a very long time for a system to be in place, and only test 10,700 cattle from some 1.5 BILLION head (including calf crop). Especially since French are testing some 20,000 weekly and the E.U. as a whole, are testing many many more than the U.S., with less cattle, same risk of BSE/TSEs.
Why does the U.S. insist on not doing massive testing with the tests which the E.U. are using? Why is this, please explain?
Please tell me why my question was not answered?
U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
It was a very simple question, a very important question, one that pertained to the topic of BSE/feed, and asked in a very diplomatic way. why was it not answered?
If all these years, we have been hearing that pharmaceutical grade bovines were raised for pharmaceuticals vaccines etc. But yet the USA cannot comply with feed regulations of the ruminant feed ban, PLUS cannot even comply with the proper labelling of the feed, cross contamination etc. Then how in the world can you Guarantee the feed fed to pharmaceutical grade bovine, were actually non ruminant feed?
Before i was ask to be 'disconnected', i did hear someone in the background say 'we can't'-- have him ask the question again.
could you please be so kind, as to answer these questions?
thank you, Terry S. Singeltary Sr. Bacliff, Texas USA
P.S. if you will also notice, i did not post that emergency phone number and do not intend on passing it on to anyone. I was joking when i said i should call and report the whole damn U.S. Herd. So please pass that on to Dr. Detwiler, so she can rest easily.
BUT, they should be reported, some are infected with TSE. The U.S. is just acting as stupid as Germany and other Countries that insist they are free of BSE.
TSS
Subject: Report on the assessment of the Georgraphical BSE-risk of the USA July 2000 (not good) Date: Wed, 17 Jan 2001 21:23:51 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
Greetings List Members and ALL EU Countries,
Because of this report, and the recent findings of the 50-state BSE Conference call, I respectfully seriously suggest that these Countries and the SSC re-evaluate the U.S.A. G.B.R. to a risk factor of #3.
I attempted to post this to list in full text, but would not accept...
thank you, kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA
Report on the assessment of the Geographical BSE-risk of the USA July 2000
PART II
REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE RISK OF THE UNITED STATES OF AMERICA
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Report on the assessment of the Geographical BSE-risk of the USA July 2000
EXECUTIVE SUMMARY
OVERALL ASSESSMENT
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
Stability: Before 1990 the system was extremely unstable because feeding of MBM to cattle happened, rendering was inappropriate with regard to deactivation of the BSE-agent and SRM and fallen stock were rendered for feed. From 1990 to 1997 it improved to very unstable, thanks to efforts undertaken to trace imported animals and exclude them from the feed chain and intensive surveillance. In 1998 the system became neutrally stable after the RMBM-ban of 1997.
External challenges: A moderate external challenge occurred in the period before 1990 because of importation of live animals from BSE-affected countries, in particular from the UK and Ireland. It cannot be excluded that some BSE-infected animals have been imported by this route and did enter the US rendering and feed production system. The efforts undertaken since 1990 to trace back UK-imported cattle and to exclude them from the feed chain reduced the impact of the external challenge significantly.
Interaction of external challenges and stability: While extremely unstable, the US system was exposed to a moderate external challenge, mainly resulting from cattle imports from the UK. It can not be excluded that BSE-infectivity entered the country by this route and has been recycled to domestic cattle. The resulting domestic cases would have been processed while the system was still very unstable or unstable and would hence have initiated a number of second or third generation cases. However, the level of the possible domestic prevalence must be below the low detection level of the surveillance in place.
As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent will remain at the current level.
JUSTIFICATION
1. DATA
The available information was suitable to carry out the GBR risk assessment.
- 30 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
2. STABILITY
2.1 Overall appreciation of the ability to identify BSE-cases and to eliminate animals at risk of being infected before they are processed
· Before 1989, the ability of the system to identify (and eliminate) BSE cases was limited. · Since 1990 this ability is significantly improved, thanks to a good BSE-surveillance and culling system (contingency plan). · Today the surveillance should be able to detect clinical BSE-cases within the limits set by an essential passive surveillance system, i.e. some cases might remain undetected.
2.2 Overall appreciation of the ability to avoid recycling BSE-infectivity, should it enter processing
· Before 1997 the US rendering and feed producing system would not have been able to avoid recycling of the BSE agent to any measurable extent. If the BSE-agent was introduced the feed chain, it could probably have reached cattle. · After the introduction of the RMBM-to-ruminants-ban in August 1997 the ability of the system to avoid recycling of BSE-infectivity was somewhat increased. It is still rather low due to the rendering system of ruminant material (including SRM and fallen stock) and the persisting potential for cross-contamination of cattle feed with other feeds and hence RMBM.
2.3 Overall assessment of the Stability
· Until 1990 the US BSE/cattle system was extremely unstable as RMBM was commonly fed to cattle, the rendering system was not able to reduce BSE-infectivity and SRM were rendered. This means that incoming BSE infectivity would have been most probably recycled to cattle and amplified and the disease propagated. · Between 1990 and 1995 improvements in the BSE surveillance and the efforts to trace back and remove imported cattle gradually improved the stability but the system remained very unstable. In 1998 the system became unstable because of an RMBM-ban introduced in 1997. After 1998 the ban was fully implemented and the system is regarded to be neutrally stable since 1998. The US system is therefore seen to neither be able to amplify nor to reduce circulating or incoming BSE-infectivity.
3. CHALLENGES
A moderate external challenge occurred in the period 1980-1989 because of importation of live animals from the UK. imports from other countries are regarded to have been negligible challenges. · As a consequence of this external challenge, infectivity could have entered the feed cycle and domestic animals could have been exposed to the agent. These domestic BSE-incubating animals might have again entered processing, leading to an internal challenge since 1991. · This internal challenge could have produced domestic cases of BSE, yet prevalence levels could have been below the detection limits of the surveillance system until now. (According to US calculations, the current surveillance
-31 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
system could detect clinical incidence of 1-3 cases per year per million adult cattle, i.e. in absolute numbers 43-129 cases per year). Between 1990 und 1995, with the exclusion of the imported animals from Europe from the feed chain, the effect of the external challenges decreased.
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenqe
· In the late 80s, early 90s a moderate external challenges met an extremely unstable system. This would have amplified the incoming BSE-infectivity and propagated the disease. · With the exclusion of the imported animals from Europe from the feed chain between 1990 and 1995 the effect of the external challenge decreased. · Before 1998 an internal challenge, if it developed, would have met a still unstable system (inappropriate rendering, no SRM ban, RMBM ban only after 1997) and the BSE-infectivity could have been recycled and amplified. · After 1998 the neutrally stable system could still recycle the BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity circulating in the system would probably not be amplified.
4.2 Risk that BSE-infectivity enters processing
· A very low processing risk developed in the late 80s when the UK-imports were slaughtered or died. It increased until 1990 because of the higher risk to be infected with BSE of cattle imported from the UK in 1988/89, as these animals could have been processed prior to the back-tracing of the UK-imports in 1990. · From 1990 to 1995 a combination of surviving non-traced UK imports and some domestic (pre-)clinical cases could have arrived at processing resulting in an assumed constant low but non-negligible processing risk. · After 1995 any processing risk relates to assumed domestic cases arriving at processing. · The fact that no domestic cases have been shown-up in the BSE-surveillance is reassuring - it indicates that BSE is in fact not present in the country at levels above the detection limits of the country's surveillance system. This detection level has been calculated according to US-experts to be between 1 & 3 clinical cases per million adult cattle per year.
Note: The high turnover in parts of the dairy cattle population with a young age at slaughter makes it unlikely that fully developed clinical cases would occur (and could be detected) or enter processing. However, the theoretical infective load of the pre-clinical BSE-cases that under this scenario could be processed, can be assumed to remain relatively low.
4.3 Risk that BSE-infectivity is recycled and propagated
· During the period covered by this assessment (1980-1999) the US-system was not able to prevent propagation of BSE should it have entered, even if this ability was significantly improved with the MBM-ban of 1997. · However, since the likelihood that BSE-infectivity entered the system is regarded to be small but non-negligible, the risk that propagation of the disease took place is also small but not negligible.
- 32 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK
5.1 The current GBR
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
5.2 The expected development of the GBR
As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent remains at the current level.
5.3 Recommendations for influencin.q the future GBR
· As long as the stability of the US system is not significantly enbanced above neutral levels it remains critically important to avoid any new external challenges. · All measures that would improve the stability of the system, in particular with regard to its ability to avoid recycling of the BSE-agent should it be present in the cattle population, would reduce, over time, the probability that cattle could be infected with the BSE-agent. Possible actions include: removal of SRMs and/or fallen stock from rendering, better rendering processes, improved compliance with the MBM-ban including control and reduction of cross-contamination. · Results from an improved intensive surveillance programme, targeting at risk sub-populations such as adult cattle in fallen stock or in emergency slaughter, could verify the current assessment.
snip... end...TSS
From: Terry S. Singeltary Sr. [flounder@wt.net] Sent: Tuesday, July 29, 2003 1:03 PM To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:fdadockets@oc.fda.gov Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:ggraber@cvm.fda.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000161/!x-usc:mailto:Linda.Grassie@fda.gov; BSE-L Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION TO DOCKET 2003N-0312]
Greetings FDA,
snip...
PLUS, if the USA continues to flagrantly ignore the _documented_ science to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle), it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion as well. NOT to leave out the OIE and it's terribly flawed system of disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment on this as a threat to human health. the OIE should also change the mathematical formula for testing of disease. this (in my opinion and others) is terribly flawed as well. to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2 years ago that they were concerned with CWD, but said any changes might take years. well, two years have come and gone, and no change in relations with CWD as a human health risk. if we wait for politics and science to finally make this connection, we very well may die before any decisions or changes are made. this is not acceptable. we must take the politics and the industry out of any final decisions of the Scientific community. this has been the problem from day one with this environmental man made death sentence. some of you may think i am exaggerating, but you only have to see it once, you only have to watch a loved one die from this one time, and you will never forget, OR forgive...yes, i am still very angry... but the transmission studies DO NOT lie, only the politicians and the industry do... and they are still lying to this day...TSS
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Last updated: 19 July 2005 Adopted July 2004 (Question N° EFSA-Q-2003-083)
Report Summary Summary of the Scientific Report
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.
A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.
EFSA concludes that the current GBR level of USA 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.
Publication date: 20 August 2004
USA BSE GBR
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620779461.htm
http://www.efsa.europa.eu/EFSA/Scientific_Document/sr03_biohaz02_usa_report_annex_en1.pdf?ssbinary=true
http://www.efsa.europa.eu/EFSA/Scientific_Document/sr03_biohaz02_usa_report_v2_en1.pdf?ssbinary=true
2005-2006
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT October 1, 2005 through December 31, 2005
snip....
CARGILL MEAT SOLUTIONS 00086K M DODGE CITY, KS X X On 10/11/05, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.
EXCEL CORP 00086R M FORT MORGAN, CO 2/22/05 X X On 8/11/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8. On 12/22/04, plant appealed the withholding action. Appeal was denied on 1/25/05.
00245L M LEXINGTON, NE 3/12/04 3/18/04 X 5/4/05 X X On 3/10/05, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.
9/16/05 9/29/05 X X TYSON FRESH MEATS INC. 09268 M PASCO, WA X X On 7/28/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.
TYSON FRESH MEATS INC. X X 00245D M EMPORIA, KS On 12/23/04, a withholding action concerning labels for Advanced Meat Recovery System product was taken in accordance with 9 CFR Part 500.8.
DESERET MEAT 04852 M SPANISH FORK, UT 7/20/05 8/1/05 X X 12/29/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
NORTHERN PACKING COMPANY INC. 00571 M BRIAR HILL, NY 12/9/05 12/23/05 X X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
A.J. CEKAK'S MEAT MARKET 9/1/05 9/20/05 X X X On 9/1/05, an enforcement action 21562 M concerning failure to meet regulatory ORD, NE requirements for Escherichia coli Biotype 1 (E. coli) was taken. The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
ALTA VISTA LOCKER 10/5/05 10/26/05 X X The enforcement action included, as a 31931 M basis, failure of the establishment toALTA VISTA, KS comply with Agency requirements concerning specified risk material.
BROWN'S PROCESSING 13100 M13100 P ELSBERRY, MO 8/8/05 8/16/05 X X X 11/16/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
CHAMPLAIN BEEF INC 2/28/05 3/4/05 3/8/05 X X X 08547 M WHITEHALL, NY 10/17/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
FIVE STAR PACK INC. 9/1/05 9/9/05 X X 12/29/05 On 9/1/05, an enforcement action 08725 M08725 P concerning failure to meet regulatory GOLDEN CITY, MO requirements for Escherichia coli Biotype 1 (E. coli) was taken. The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material. FRESH FARMS BEEF 12/16/05 12/28/05 X X X The enforcement action included, as a 18579 M basis, failure of the establishment toRUTLAND, VT comply with Agency requirements concerning specified risk material.
GOETZ AND SONS WESTERN 11/15/05 11/23/05 12/1/05 X X MEATS INC 06245 M06245 P EVERETT, WA 12/17/05 12/28/05 X X X On 12/17/05, firm violated a regulatory control action by selling U.S.D.A retained product.
H AND P MEATS 21352 M SOUTH PITTSBURG, TN 7/28/05 8/8/05 8/17/05 8/19/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
HOPKINS PACKING COMPANY 11069 M BLACKFOOT, ID 7/28/05 8/1/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
NORTHWEST PREMIUM MEATS LLC 11032 M11032 P NAMPA, ID 7/26/05 7/29/05 X X 11/15/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
PARADISE LOCKER MEATS 31865 M31865 P TRIMBLE, MO 9/21/05 10/7/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material. PARAGON SPRAY DRYING, LLC 31762 M31762 P WAUKON, IA 9/6/05 9/12/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
RANDALL MEAT COMPANY 10669 M HOT SPRINGS, AR 7/1/05 7/28/05 10/12/05 10/24/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
S & S MEAT COMPANY 01046 M01046 P KANSAS CITY, MO 8/4/05 8/19/05 X X 11/16/05 The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
STEAK MASTER 21159 M21159 P ELWOOD, NE 11/4/05 11/17/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
THE MEAT SHOP 31561 M BENSON, VT 8/18/05 9/6/05 9/9/05 X X X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
THEURER'S QUALITY MEATS, INC 31647 M31647 P LEWISTON, UT 7/27/05 7/29/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
TOOELE VALLEY MEATS 20594 M20594 P GRANTSVILLE, UT 7/25/05 8/1/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
WALNUT VALLEY PACKING LLC 32007 M32007 P EL DORADO, KS 12/15/05 12/30/05 X X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
YODER BROTHERS MEAT PROCESSING 17301 M PARIS, TN 10/3/05 10/12/05 X X The enforcement action included, as a basis, failure of the establishment to comply with Agency requirements concerning specified risk material.
full text 54 pages ;
http://www.fsis.usda.gov/PDF/QER_Q1_FY2006.pdf
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT July 1, 2005 through September 30, 2005
snip...
52 pages
http://www.fsis.usda.gov/PDF/QER_Q4_FY2005.pdf
TSS
----- Original Message ----- From: "TERRY SINGELTARY" <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:flounder9@VERIZON.NET> To: <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:BSE-L@LISTS.AEGEE.ORG> Sent: Thursday, April 16, 2009 3:20 PM Subject: [BSE-L] FDA-2002-N-0031-0132 Document Title Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date
-------------------- mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:BSE-L@LISTS.AEGEE.ORG --------------------
TSS COMMENT SUBMISSION # 5
Docket ID FDA-2002-N-0031 Docket Title Animal Proteins Prohibited in Ruminant Feed Document ID FDA-2002-N-0031-0132 Document Title Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date
Completely Edited Version
PRION ROUNDTABLE
2003
page 29
Dr. Linda Detwiler
The UK imports into the US.
There were 496 total, and 173 of the UK imports could have entered the US feed system. People don't like to hear this, but it's possible that one of the UK imports in the US entered the animal feed system and was exported to Canada. That's a possibility, because they import 50% of their feed from the US.
From 1994, we imported 11 million head of cattle from Canada. Most of these were feedlot animals for slaughter, but there were about 500,000 breeding animals. A number of Canada's cull cows were slaughtered here and could have introduced infectivity into our system. Even today we have Canadian imports in the country, breeding animals that were brought in prior to the ban and reside here.
We have feed ban exemptions: plate waste, poultry litter. We still allow that if it comes off a human plate, or if it's trimmings, it can be palletized and fed to ruminants. That might be a small amount, but it could allow spinal cord in certain cuts to be fed back to ruminants. Poultry litter or feather meal could be significant. Poultry is getting quite a bit of ruminant material in the US because it cannot go back to ruminants. Poultry and pigs are getting a substantial amount. Poultry litter is not only what passes through the chicken, but think about how chickens eat. They spill a lot on the floor. That stuff is still allowed to be fed back to cattle. That's a direct break in the ban, except that it's legal. Ruminants are getting ruminant material.
Unfiltered tallow: tallow is a lipid material. However, if it's not filtered, there are protein residues. That's meat and bone meal. That's allowed to be fed, so that's another legal exception where you can feed ruminant meat and bone meal through unfiltered tallow. We don't have an SRM ban and the 40 animals are the ones that if you have the agent, they introduce the most infectivity back into the animal food chain when they're rendered.
What's our on-farm compliance? We really don't know. ...snip...end...Dr. Linda Detwiler
UK EXPORTS OF MBM TO WORLD
http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf
OTHERS
BEEF AND VEAL
http://www.bseinquiry.gov.uk/files/mb/m11f/tab08.pdf
http://www.bseinquiry.gov.uk/files/mb/m11f/tab09.pdf
http://www.bseinquiry.gov.uk/files/mb/m11f/tab10.pdf
LIVE CATTLE
http://www.bseinquiry.gov.uk/files/mb/m11f/tab11.pdf
FATS
http://www.bseinquiry.gov.uk/files/mb/m11g/tab01.pdf
EMBRYOS
http://www.bseinquiry.gov.uk/files/mb/m11g/tab03.pdf
GELATIN ETC
http://www.bseinquiry.gov.uk/files/mb/m11g/tab02.pdf
SEMEN
http://www.bseinquiry.gov.uk/files/mb/m11g/tab04.pdf
MEAT
http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf
CANADA
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf
USA
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf
MEXICO
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf
Wednesday, April 16, 2008 MBM, greaves, meat offal, live cattle, imports from UK to USA vs Canada "Three of four possible manufacturers supplying a protein supplement likely fed to the animal could have included meat and bone meal (MBM) as an ingredient in its formulation. One of these manufacturers was able to confirm usage of meat and bone meal in supplements and confirm a source of MBM to be one common to previous BSE investigations."
USA AND CANADA IMPORTS OF UK CATTLE BETWEEN 1981 - 1989
USA = 496
CANADA = 198
*add 14 to 198 as last UK import to Canada, 14 in 1990
http://www.inspection.gc.ca/english/sci/ahra/bseris/bserise.pdf
HERE is another look at all the imports for both the USA and Canada of UK live cattle and greaves exports ;
UK Exports of Live Cattle by Value 1986-96
USA 697 LIVE CATTLE
CANADA 299 LIVE CATTLE
http://www.bseinquiry.gov.uk/files/mb/m11f/tab11.pdf
UK TABLE of Exports of meal of meat and meat offal; greaves 1979 - 1995
USA 24 TONS
CANADA 83 TONS
http://www.bseinquiry.gov.uk/files/mb/m12/tab12.pdf
HOWEVER, my files show 44 tons of greaves for USA. ...TSS
Subject: Re: exports from the U.K. of it's MBM to U.S.??? From: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:S.J.Pearsall@esg.maff.gsi.gov.uk Date: Tue, 8 Feb 2000 14:03:16 +0000 To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:flounder@wt.net (Receipt Notification Requested) (Non Receipt Notification Requested)
Terry
Meat and bonemeal is not specifically classified for overseas trade purposes. The nearest equivalent is listed as flours and meals of meat or offals (including tankage), unfit for human consumption; greaves. UK exports of this to the US are listed below:
Country Tonnes
1980 1981 12 1982 1983 1984 10 1985 2 1986 1987 1988 1989 20 1990
Data for exports between 1975 and 1979 are not readily available. These can be obtained (at a charge) from data retailers appointed by HM Customs and Excise: BTSL (Tel: 01372 463121) or Abacus (01245 252222). Best wishes Simon Pearsall Overseas trade statistics Stats (C&F)C
============ END...TSS...2008============
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3; Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique, France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious Disease control, Sweden; 5Georg August University, Germany; 6German Primate Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans. Secondly, we aimed at examining the course of the disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian vCJD as fast as intracerebrally inoculated animals.
The work referenced was performed in partial fulfilment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).
http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley's surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
6. It also appears to me that Mr Bradley's answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate"
experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley's surprise at the results because all the dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
TSS
http://madcowtesting.blogspot.com/2008/04/mbm-greaves-meat-offal-live-cattle.html
Thursday, April 09, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000149/!x-usc:mailto:burt.pritchett@fda.hhs.gov
Greetings FDA et al,
I lost my Mother to the Heidenhain Variant Creutzfeldt Jakob disease (confirmed see autopsy below).
I kindly wish to comment on the following ;
[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46
[Federal Register: April 9, 2009 (Volume 74, Number 67)] [Proposed Rules] [Page 16160-16161] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap09-18]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 589
[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46 TSS SUBMISSION # 5
Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed delay of effective date.
http://edocket.access.gpo.gov/2009/E9-8127.htm
MY COMMENT AS FOLLOWS ;
I find it deeply disturbing, that with the science to date, especially with the science to date, transmission studies, the more virulent atypical strains of the BSE i.e. h-BSE and l-BSE, both of which have now been documented in North America, that we are even still discussing this most important topic. The industry involved has beat this mad cow feed ban to death, and still refuse to comply. IF they would have adhered to policy, rules and regulations put forth August 4th, 1997, when the partial, and voluntary ruminant to ruminant feed ban was first put in place, they would not still be crying the same tune. WE need not only to enforce the present ban, but strengthen it, especially to include blood in the ban. WE (the consumer), was promised this would happen years ago. For Pete's sake, this will be the third president to have to address these same questions, and I pray that this one has the guts to finally do something. We need NOT discuss this for one more second. We had 8 years that President Bush literally covered up mad cow disease, and let literally millions and millions of pounds of mad cow feed into commerce to be fed out. IN one feed ban recall alone in 2007, 10 MILLION PLUS POUNDS was fed out into commerce. and under this same President, we now millions of kids across our Nation that have been needlessly exposed to the mad cow agent via the infamous USDA CERTIFIED DOWNER COW DEAD STOCK SCHOOL LUNCH PROGRAM. if you think for one moment that the largest meat recall in the history of the USA was because a few animals were filmed being abused, your only kidding yourself. that meat was recalled because dead stock downer cows are at the highest risk to carry mad cow disease, and they had been feeding our children this stuff for years. AND then had the nerve to lie to us about THE GREAT BSE FIREWALL IN THE USA THAT WOULD PROTECT THE CONSUMER I.E. THE BSE FEED BAN, that never was nothing more than ink on paper. who will monitor these children in the years and decades to come for a human form of Transmissible Spongiform Encephalopathy? who can with a CJD/TSE surveillance system and CJD Questionnaire set up the way it is now? you can't.
R-CALF and the CJD Foundation, seem oblivious to the fact that the USA has a mad cow problem. THIS IS NOT ABOUT THE CANADIAN BORDER. this is about feeding cows to cows in the USA, USA RUMINANT MAD COW FEED IN COMMERCE, and the fact the USA has had a mad cow problem for years.
all R-CALF wants to do is blame it on Canada, close the border, and then continue to feed ruminant feed to USA cattle, and ignore the TSE problem in the USA bovine, read closely what Bullard says from R-CALF ;
"We either implement this feed ban without any further delay or we stop the source of this problem by removing and reversing the Canadian cattle that continues to enter this country" said Bullard
http://www.montanasnewsstation.com/Global/story.asp?S=10171123
ENOUGH already $ NO MORE DISCUSSION PLEASE, WE NEED ACTION !
STOP ALL MAD COW FEED REGARDLESS !!!
I strenuously urge President Obama to NOT discuss this for one more moment, actions must be put forth now, and enforce such actions.
I strenuously urge President Obama to ENHANCE the feed ban to include blood, and enforce said regulations, based on sound science.
I strenuously urge President Obama to ban the use of "poultry litter" and the use of all mammalian and poultry protein in ruminant feed,as a feed ingredient for ruminant animals, and enforce said regulations, based on sound science.
I strenuously urge President Obama to ban the use of "plate waste" as a feed ingredient for ruminants, and enforce said regulations, based on sound science.
I strenuously urge President Obama to ban from human food (including dietary supplements please see latest May 2009 CDC warning on these type supplements, CWD, and Elk Antler Velvet), and cosmetics a wide range of bovine- derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates, and enforce such actions, based on sound science.
I strenuously urge President Obama to further minimize the possibility of cross- contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination, and enforce said regulations, based on sound science.
Sunday, April 12, 2009
BSE MAD COW TESTING USA 2009 FIGURES
Month Number of Tests
Feb 2009 -- 1,891
Jan 2009 -- 4,620
http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml
http://madcowtesting.blogspot.com/2009/04/bse-mad-cow-testing-usa-2009-figures.html
PLEASE SEE MY FULL COMMENT SUBMISSION IN THE PDF ATTACHMENT, OR GO HERE
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments
Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments
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