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FDA Issues Final Guidance for Renderers on Substances Prohibited From Use in Animal Food or Feed

Posted Apr 30 2009 11:41pm
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.
-----------------------------------------------------------------------
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 .

--------------------------------------------------------------------------------

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
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