SAMPLE COLLECTION FROM CATTLE UNDER THE BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) ONGOING SURVEILLANCE PROGRAM 2/14/12

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC FSIS NOTICE

13-12

2/14/12

DISTRIBUTION: Electronic NOTICE EXPIRES: 3/1/13 OPI: OPPD

SAMPLE COLLECTION FROM CATTLE UNDER THE BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) ONGOING SURVEILLANCE PROGRAM

I. PURPOSE

This notice provides Food Safety and Inspection Service (FSIS) inspection program personnel (IPP) with instructions regarding the collection of brain samples for the Animal and Plant Health Inspection Service’s (APHIS) Bovine Spongiform Encephalopathy (BSE) ongoing surveillance program. The contents in this notice were last issued in FSIS Notice 05-10.

II. DEFINITION OF COLLECTION PROCEDURES

A. At federally-inspected slaughter establishments that have approved alternative off-site sample collection arrangements with APHIS:

1. APHIS will provide for the collection of brain (obex) samples from an allocated number of cattle 30 months and older condemned for any reason on ante-mortem inspection and from cattle of any age displaying Central Nervous System (CNS) symptoms.

2. At such establishments, FSIS IPP will provide the following to plant management, to the APHIS Area Veterinarian in Charge (AVIC), and to sample collecting contractors:

a. Condemn tag (Z-tag) numbers (not the Z-tag itself); and

b. Disposition information (i.e., the reason for condemnation under 9 CFR Part 309), including history, clinical signs and the condemnation code assigned.

B. At federally-inspected establishments that do not have approved alternative off-site sample collection arrangements with APHIS, FSIS Public Health Veterinarians (PHVs) are to:

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1. Notify the APHIS AVIC when an animal has been condemned for CNS reasons and provide the information outlined in II.A.2.

2. If arrangements with the APHIS AVIC cannot be made, collect appropriate BSE samples from cattle of all ages that display CNS symptoms.

NOTE: Certain Alternative Off-Site Agreements that were in place during Enhanced Surveillance may no longer be in effect. Therefore, IPP may need to advise the establishment that they need to establish new agreements with APHIS and potential collectors.

III. FSIS PERSONNEL RESPONSIBILITIES

A. Upon receipt of this notice, the FSIS PHV is to ask establishment management whether:

1. It has an approved alternative off-site sample collection arrangement with APHIS for collecting allocated samples (as per paragraph II. A.); or

2. It is not an establishment that has an alternative off-site sample collection arrangement with APHIS. If the establishment does not have such an arrangement, then FSIS is to follow the directions in paragraph II.B.

B. If during the meeting establishment management states that it has submitted an application to APHIS to begin off-site sampling, until APHIS approves that arrangement, FSIS PHVs are to:

1. Identify all CNS animals condemned on ante-mortem with a "U. S. Condemned” tag;

2. If an animal is condemned for this reason, contact the APHIS AVIC and follow the directions in paragraph II.B.;

3. Ensure that the animals are humanely euthanized, unless APHIS requests that the animal not be euthanized; and

4. Not allow any CNS animal condemned on ante-mortem to move off the premises of the establishment until APHIS collects the sample or APHIS requests otherwise.

C. In a memorandum of interview (MOI), the FSIS PHV is to document who was present at the meeting with establishment management, the date and time of the meeting, how the establishment plans to proceed based on the choices set out in A. above, and any documents shared with management.

D. If the establishment states that it has submitted a request to APHIS to begin off-site sampling, the FSIS PHV is to update the MOI as to whether the establishment reached an agreement, and in general, what the agreement was.

E. The FSIS PHV is to maintain a copy of the MOI in the official government file, provide a copy to the plant management, and e-mail a copy to the APHIS AVIC. Any

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changes in the agreement with APHIS for off-site sample collection are to be reflected in an updated MOI, which is then distributed as above.

IV. FSIS RESPONSIBILITIES RELATED TO APPROVED ALTERNATIVE OFF-SITE SAMPLE COLLECTION

A. The FSIS PHV is to complete the condemnation form, FSIS Form 6000-13 (Certification of Ante-mortem or Post-mortem Disposition of Tagged Animals), and FSIS Form 6150-1 (Identification Tag – Ante-mortem). The FSIS PHV is to pay special attention when providing a full description of the reason for the condemnation on FSIS Form 6000-13 and fill out fully FSIS Form 6150-1.

B. Incoming animal identification, except the Z-tag, is to be left on these animals to provide needed identifying information on collection forms at the approved alternative off-site collection location. IPP are, or someone under their supervision is to remove Z-tags before any carcasses leave the official establishment.

NOTE: Information supplied to plant management to take to the approved alternative off-site collection locations needs to be complete and accurate. FSIS PHVs need to provide a full description of the reason for the condemnation on FSIS Form 6000-13. APHIS will use this information to triage which condemned animals are sampled.

V. FSIS SAMPLE COLLECTION FOR CATTLE DISPLAYING CNS SYMPTOMS

A. If the establishment does not have an arrangement with APHIS for off-site sampling of cattle with CNS symptoms, the FSIS PHV is to follow the directions in paragraph II.B. The FSIS PHV is to make all final disposition decisions regarding whether to condemn cattle in accordance with 9 CFR part 309.

NOTE: FSIS PHVs can find information regarding BSE sampling (e.g., forms, sampling supply information) on the FSIS intranet under Public Folders, OPPD, PDD, BSE, at:

http://collaboration/sites/InfoExch/OPPD/default.aspx?RootFolder=%2fsites%2fInfoExch%2fOPPD%2fOPPD%2fPDD%2fBSE%20Training%20Info&FolderCTID=&View=%7b6F518F12%2d11E4%2d4A8C%2dB891%2dAACB8FDD96BD%7d



Additional BSE sampling information is provided on the APHIS website at:

http://www.aphis.usda.gov/animal_health/lab_info_services/downloads/BSE_Procedures_Manual.pdf



B. If the responsibility to collect the BSE sample falls to the FSIS PHV, the FSIS PHV, or the establishment under the supervision of the FSIS PHV, is to promptly remove the head in order to collect the brain sample. If the establishment does not arrange to remove the head, the FSIS PHV may need to collect the brain sample as a priority over other ante-mortem or post-mortem procedures.

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C. The FSIS PHV, being mindful of other potential CNS disease conditions of public health significance that may be present, is to collect the brain sample either in the inedible area of the establishment or in an isolated area set aside for such collection to prevent human exposure or the creation of insanitary conditions. Establishment personnel and FSIS IPP are to take proper sanitary measures before returning to edible areas of the establishment after brain sample collection, in accordance with 9 CFR 416.5.

D. In situations where the FSIS PHV has missed the last UPS pick-up for the day, or the FSIS PHV collected the sample on a day when UPS does not pick up, the PHV is to refrigerate the samples until the next available UPS pick-up day. Remember, the sample is not to pass through or to be stored in areas of the establishment where the establishment produces edible product. The FSIS PHV is to maintain the sample’s chain-of-custody.

E. The FSIS PHV is to verify the collection, documentation, and control of all animal identification associated with cattle condemned during ante-mortem inspection that are to be sampled by FSIS. The FSIS PHV is to attach the “U. S. Condemned” tag to cattle condemned during ante-mortem inspection in accordance with 9 CFR 309.13. This documentation will facilitate traceback in the event that the sample result is positive for BSE. The FSIS PHV is to include in the documentation all pertinent information to facilitate trace back of the animal in question in accordance with 9 CFR 320.1.

F. The FSIS PHV is to verify that the presence of condemned cattle or parts does not create insanitary conditions (9 CFR Part 416). The establishment is responsible for the disposal of the condemned cattle in accordance with 9 CFR part 314. The FSIS PHV also is to verify that the establishment maintains records regarding the disposal of the condemned cattle in accordance with 9 CFR 320.1.

G. IPP may inform the establishment that it may choose to hold the carcass and parts until testing results are available. If the establishment chooses to dispose of any carcass or parts before it receives test results, IPP are to advise the establishment that it must dispose of the carcass in one of the following ways:

1. Render it at a facility for non-animal feed use (e.g., biofuel or cement);

2. Alkaline digestion;

3. Incineration; or

4. Lined landfills.

H. Documentation for Cattle Showing Signs of CNS Symptoms

1. For locations without high-speed internet connections, the FSIS PHV is to forward the completed BSE Veterinary Services Laboratory Submissions (BSE-VSLS) sample collection sheets to the corresponding APHIS,VS area office by FAX or by e-mail. The following site lists the VS office FAX numbers and e-mail where available:

http://www.aphis.usda.gov/import_export/downloads/vsavic.pdf



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NOTE: The FSIS PHV can get copies of BSE-VSLS forms by contacting the local APHIS office. The APHIS AVIC in each area office may assist with sample delivery verification and troubleshooting.

2. For locations with high-speed connections, the FSIS PHV is to enter the relevant information into the BSE-VSLS.

NOTE: FSIS PHVs can refer to the BSE-VSLS training for assistance getting access to BSE-VSLS and inputting information. The FSIS PHV may contact the District Office (DO) if he or she needs a copy of the training CD.

VI. TEST RESULTS FOR FSIS SAMPLING FROM CATTLE SHOWING CNS SYMPTOMS

A. The FSIS PHV will receive, by e-mail, a report from the AVIC on the BSE test results. The AVIC will also send copies of the results to the DO.

B. If the test on the carcass condemned for CNS conditions is negative (reported as “not detected”), then any carcasses and parts the establishment has held may be released for rendering or other disposal in accordance with 9 CFR 314. C. If the test is inconclusive, the FSIS PHV will receive supervisory instruction on further actions.

D. For any sample confirmed positive for BSE, the FSIS PHV is to verify that the establishment disposes of the carcasses and parts in the proper manner as set out in paragraph V. G.

VII. PHIS PROCEDURES FOR BSE SAMPLING FROM CATTLE SHOWING CNS SIGNS

A. Enter disposition information into PHIS in ADR.

B. Enter BSE sampling information into the ADR APHIS Lab Sampling page in ADR.

VIII. RABIES

A. When an animal is condemned by the FSIS PHV on ante-mortem for rabies, the FSIS PHV is to contact the DO, which will advise APHIS. In these cases, APHIS will see that the animal is tested for rabies. APHIS will work with the laboratory to get appropriate samples forwarded for BSE surveillance from rabies negative animals.

B. Rabies booster vaccination for PHVs collecting BSE samples is still highly recommended. PHVs can be reimbursed for rabies vaccinations or boosters. Rabies vaccinations are voluntary. Only PHVs who are actually involved with BSE sample collection will be eligible for reimbursement on the vaccination series. PHVs are to make

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arrangements for the vaccinations with their private physician. PHVs are to contact their Front-line supervisor for approval on reimbursement prior to beginning the three shot vaccination series. Refer questions regarding this notice to the Policy Development Division through askFSIS at http://askfsis.custhelp.com or by telephone at 1-800-233-3935.

Assistant Administrator

Office of Policy and Program Development

http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/13-12.pdf




Tuesday, November 02, 2010

IN CONFIDENCE

The information contained herein should not be disseminated further except on the basis of "NEED TO KNOW".

BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992

http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html




2009 UPDATE ON ALABAMA AND TEXAS MAD COWS 2005 and 2006

http://bse-atypical.blogspot.com/2006/08/bse-atypical-texas-and-alabama-update.html




U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001

http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html





Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 INTRODUCTION The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) held a public meeting on July 25, 2006 in Washington, D.C. to present findings from the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 (report and model located on the FSIS website:




http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp).



Comments on technical aspects of the risk assessment were then submitted to FSIS.




Comments were received from Food and Water Watch, Food Animal Concerns Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S. Singeltary.




This document provides itemized replies to the public comments received on the 2005 updated Harvard BSE risk assessment. Please bear the following points in mind:




http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf



Owens, Julie From: Terry S. Singeltary Sr. [flounder9@verizon.net]


Sent: Monday, July 24, 2006 1:09 PM

To: FSIS RegulationsComments

Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Page 1 of 98

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf



FSIS, USDA, REPLY TO SINGELTARY

http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf





Monday, October 10, 2011



EFSA Journal 2011 The European Response to BSE: A Success Story



snip...



EFSA and the European Centre for Disease Prevention and Control (ECDC) recently delivered a scientific opinion on any possible epidemiological or molecular association between TSEs in animals and humans (EFSA Panel on Biological Hazards (BIOHAZ) and ECDC, 2011). This opinion confirmed Classical BSE prions as the only TSE agents demonstrated to be zoonotic so far but the possibility that a small proportion of human cases so far classified as "sporadic" CJD are of zoonotic origin could not be excluded. Moreover, transmission experiments to non-human primates suggest that some TSE agents in addition to Classical BSE prions in cattle (namely L-type Atypical BSE, Classical BSE in sheep, transmissible mink encephalopathy (TME) and chronic wasting disease (CWD) agents) might have zoonotic potential.



snip...



http://www.efsa.europa.eu/en/efsajournal/pub/e991.htm?emt=1






http://www.efsa.europa.eu/en/efsajournal/doc/e991.pdf





see follow-up here about North America BSE Mad Cow TSE prion risk factors, and the ever emerging strains of Transmissible Spongiform Encephalopathy in many species here in the USA, including humans ;



http://transmissiblespongiformencephalopathy.blogspot.com/2011/10/efsa-journal-2011-european-response-to.html





Thursday, August 12, 2010



Seven main threats for the future linked to prions

First threat

The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed.



***Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.



Second threat



snip...



http://www.neuroprion.org/en/np-neuroprion.html







Sunday, November 13, 2011

California BSE mad cow beef recall, QFC, CJD, and dead stock downer livestock

http://transmissiblespongiformencephalopathy.blogspot.com/2011/11/california-bse-mad-cow-beef-recall-qfc.html





Terry S. Singeltary Sr. on the Creutzfeldt-Jakob Disease Public Health Crisis



http://www.youtube.com/watch?v=zf3lfz9NrT4





http://www.youtube.com/watch?v=c0tWkNvhO4g





http://www.youtube.com/watch?v=zf3lfz9NrT4&feature=results_main&playnext=1&list=PL780BE2AF0B62A944





full text with source references ;



http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/terry-singeltary-sr-on-creutzfeldt.html







Friday, February 10, 2012



Creutzfeldt-Jakob disease (CJD) biannual update (2012/1) potential iatrogenic (healthcare-acquired) exposure to CJD, and on the National Anonymous Tonsil Archive



http://creutzfeldt-jakob-disease.blogspot.com/2012/02/creutzfeldt-jakob-disease-cjd-biannual.html





Sunday, February 12, 2012



National Prion Disease Pathology Surveillance Center Cases Examined1 (August 19, 2011) including Texas



http://transmissiblespongiformencephalopathy.blogspot.com/2012/02/national-prion-disease-pathology.html





Saturday, June 25, 2011

Transmissibility of BSE-L and Cattle-Adapted TME Prion Strain to Cynomolgus Macaque




"BSE-L in North America may have existed for decades"




http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/transmissibility-of-bse-l-and-cattle.html





Sunday, June 26, 2011

Risk Analysis of Low-Dose Prion Exposures in Cynomolgus Macaque

http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/risk-analysis-of-low-dose-prion.html





Friday, December 23, 2011

Oral Transmission of L-type Bovine Spongiform Encephalopathy in Primate Model

Volume 18, Number 1—January 2012 Dispatch

http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/oral-transmission-of-l-type-bovine.html







TSS