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From: TSS ()
Subject: INSTRUCTIONS FOR VERIFYING THE PROPER REMOVAL OF VISIBLE BEEF TONSILLAR MATERIAL FROM TONGUES BY USE OF SKINNING MACHINES
Date: February 9, 2007 at 11:30 am PST

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC FSIS NOTICE 10-07 2/9/07 DISTRIBUTION: Inspection Offices; T/A Inspectors; TSC; Import Offices NOTICE EXPIRES: 2/1/08 OPI: OPPED

INSTRUCTIONS FOR VERIFYING THE PROPER REMOVAL OF VISIBLE BEEF TONSILLAR MATERIAL FROM TONGUES BY USE OF SKINNING MACHINES

I. PURPOSE

This notice instructs inspection program personnel on how to verify that establishments that choose to use skinning machines for beef tongues are properly removing tonsillar material. Complete removal of the visible tonsillar material is necessary because this material is a Specified Risk Material (SRM) in cattle of any age. This notice provides a picture of what the tongue looks like when the tonsillar material has been properly removed, as well as a link to other photographs that depict proper removal of the tonsillar material.

NOTE: This notice only addresses the removal of tonsillar material by means of skinning machines. Inspection program personnel are to continue to follow the current instructions for the removal, segregation, and disposition of tonsillar material by all other means.

II. BACKGROUND

Under 9 CFR 310.22, the tonsillar material from cattle of all ages is designated as an SRM, and establishments that slaughter or process cattle are required to develop, implement, and maintain written procedures in their food safety system for the removal, segregation, and disposition of all SRMs. If an establishment uses a skinning machine to remove tonsillar material, it needs to address in its HACCP plan, Sanitation SOP, or other prerequisite program the implication of this use on its ability to produce safe product. Significantly, FSIS has recently become aware that for tonsillar material to be completely removed from beef tongues by the use of a skinning machine, no less than 5 mm (3/16" equals 4.8 mm and 1/4" equals 6.3 mm) needs to be removed from the affected portions of the tongue (see Attachment 1).

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III. INSPECTION PROGRAM PERSONNEL VERIFICATION RESPONSIBILITIES

A. Upon receipt of this notice, inspection program personnel are to have an awareness meeting at establishments that may choose to use skinning machines to remove tonsillar material from beef tongues. Inspection program personnel are to inform the establishment that if it decides to use a skinning machine, it will need to

reassess its HACCP system as set out in 9 CFR 417.4(a)(3), because the depth of the cut necessary to ensure the production of safe product is a new issue for its slaughter or processing system and likely represents a change at the establishment that may affect the HACCP system.

B. In a memorandum of interview, inspection program personnel are to document who was present at the initial awareness meeting, the date and time of the meeting, what was discussed, and any documents that were shared with management. Inspection program personnel are to maintain a copy of the memorandum in the official government file and provide a copy to the establishment management.

C. After the establishment has performed its reassessment, inspection program personnel are to verify into which program (i.e., HACCP plan, Sanitation SOP, or other prerequisite program) the establishment incorporates any procedures it adopts because of its reassessment. PHVs are to verify that the establishment has appropriately addressed in its food safety system the use of the skinning machine to remove tonsillar material and, in particular, to implement procedures to ensure that:

1. when the tonsillar material is removed, no less than 5 mm (3/16" equals 4.8 mm and 1/4" equals 6.3 mm) from the surface of the tongue is removed from the affected portions of the tongue; and

2. tonsillar material (i.e., the SRM) does not remain on the blade or any part of the skinning machine in a manner that may cross-contaminate product with SRM material.

D. If an establishment does not address the use of skinning machines as set out in III. A. and C. above, or fails to execute such procedures as described in III. A. and C. above, FSIS inspection program personnel are to take the appropriate action as set out in FSIS Notice 9-04 and FSIS Directive 5000.1, Revision 2, Amendment 1.

NOTE: Inspection program personnel can find additional information and diagrams on the location of the tonsillar material on the FSIS Technical Service Center web page under SRM Guidance Material at: http://www.fsis.usda.gov/About_FSIS/Technical_Service_Center/index.asp.

FSIS Notice 10-07

FSIS has issued a training course entitled FSIS- 808 Beef Tonsil Material Removal and Non-Compliance Documentation on AgLearn. The course is mandatory for all inspection program personnel assigned to beef slaughter establishments. Inspection program personnel are to complete this training within 30 days after receipt of this notification. Inspection program personnel are allotted official time to complete the course. Estimated time for completion is one (1) hour.

For technical questions, contact the Technical Service Center at (800) 233-3935.

Assistant Administrator

Office of Policy, Program, and Employee Development

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Attachment 1

Picture shows 5 mm of tonsillar material skinned from the tongue.

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http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/10-07.pdf

http://www.fsis.usda.gov/regulations_&_policies/Notice_Images/index.asp

TALK ABOUT FSIS CLOSING THE BARN DOOR AFTER THE MAD COWS GOT LOOSE. ...TSS

Short Communication
Shortening of the Bovine Tongue According to Regulation (EC) 999/2001 is not Complying with the Current Legal Definition of Specified Risk Material – a Macroscopical and Histological Preliminary Study
M. Kühne1,21Institute for Food Quality and Safety, Institute for Anatomy, University of Veterinary Medicine, Bischofsholer Damm 15, D-30173 Hannover, Germany2Corresponding author: E-mail: michael.kuehne@tiho-hannover.de,
G. Klein11Institute for Food Quality and Safety, Institute for Anatomy, University of Veterinary Medicine, Bischofsholer Damm 15, D-30173 Hannover, Germany and
H. Gasse11Institute for Food Quality and Safety, Institute for Anatomy, University of Veterinary Medicine, Bischofsholer Damm 15, D-30173 Hannover, Germany
Address of authors: 1Institute for Food Quality and Safety, Institute for Anatomy, University of Veterinary Medicine, Bischofsholer Damm 15, D-30173 Hannover, Germany; 2Corresponding author: E-mail: michael.kuehne@tiho-hannover.de
Institute for Food Quality and Safety, Institute for Anatomy, University of Veterinary Medicine, Bischofsholer Damm, Hannover, Germany
Summary

The full elimination of all specified risk material (SRM) in food of animal origin is crucial for consumer protection and is of high priority in inner EU trade. Among other tissues, the tonsils of cattle are considered as SRM. The aim of this study was to evaluate whether the 'cut at the back of the tongue just before the tongue bones' required by EC regulation is sufficient to remove tonsils and lymphatic tissue completely. Eight skulls from cattle were collected for the simulation of a vertical cut according to the EC regulation and the detection of the target at the back of the tongue. Further, specimens of the lingual mucosa were cut out from two tongues and examined microscopically. The most caudal of these specimens was from the macroscopically visible part of the lingual tonsil. The most rostral specimen contained the most caudal Papilla vallata. Simulation of the obligatory ventro-dorsal cut yielded hits at varying locations on the dorsal surface of the tongue, sometimes including tissue of the lingual tonsil. Histological examination of the lingual mucosa gave clear evidence that lymphatic tissue resembling the tissue of a tonsil in terms of its histological organization and infiltration of the mucosal epithelium could even be found in areas with no macroscopically visible lingual tonsils.

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1439-0450.2005.00826.x?journalCode=jvb

Opinion of the Scientific Panel on Biological Hazards of the

European Food Safety Authority on BSE risk from bovine tonsil

and consumption of bovine tongue

(Question N° EFSA-Q-2003-095)

Adopted on 4 March 2004

SUMMARY OF OPINION

The European Commission requested the European Food Safety Authority (EFSA) and its Scientific

Panel on Biological Hazards to consider an update of the Scientific Steering Committee (SSC) opinion

(7-8 November 2002) on TSE infectivity distribution in ruminant tissues as pertaining to BSE risk

from bovine tonsil and the consumption of bovine tongue in view of results revealing possible rapid

prion neuroinvasion following tongue infection.

The re-assessment of tonsil infectivity, considering already established precautionary measures, very

low oral tonsil infectivity titre and absence of new positive findings in tonsil infectivity from the ongoing

cattle bioassay study, does not suggest the necessity of an update of the SSC opinion on TSE

infectivity distribution in ruminant tissues. In the case of the detection of PrPSc in tongue following

direct tongue or intra cerebral infection as recently observed in one specific animal model, a

quantitative risk analysis appears currently not to be possible in view of the total absence of data for

other strains and species. Research into this field is recommended.

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/243.Par.0001.File.dat/opinion_biohaz_06_en1.pdf

The Spongiform Encephalopathy Advisory Committee (SEAC) held its 78th meeting in London on 24 June 2003, when it discussed the following matters:

Risk Assessment on Ox Tongue and Associate Tonsil Tissue
At an earlier meeting SEAC considered a new finding of BSE infectivity in bovine tonsil and its possible association with ox tongue.
SEAC recommended that a risk assessment be conducted and this was commissioned by the Food Standards Agency, and presented at the June 2003 meeting. The risk assessment considered the possible range of human exposure to BSE infectivity from the consumption of ox tongue. The Committee concluded that it was not possible to advise the FSA precisely on the magnitude of the risk due to the substantial scientific uncertainty inherent in the risk assessment. However, the Committee agreed that the scientific evidence indicated that the potential risk of infectivity from eating tongue was likely to be very small. The Committee identified further scientific work that would help to refine the risk estimates.

http://www.seac.gov.uk/summaries/summ_0603.htm

Assessment of potential public health implications

The risk assessment considered the possible range of human exposure to BSE infectivity

from the consumption of bovine tonsil present on ox tongue.

As the amount of tonsil that might be consumed with tongue was not defined, one

exposure estimate in the risk assessment was based on the assumption that 100% of the

tonsil tissue, estimated to be 50g, is present on every tongue consumed. The Committee

agreed this was a precautionary estimate. It was likely that tongue would be peeled

before consumption. This would remove the superficial layer, reducing the amount of any

adherent tonsil tissue and thus the exposure. Also, tongue meat is usually served sliced

making it unlikely that one person would consume all the lymphoid tissue remaining on

any one tongue.

The risk assessment also considered a more plausible scenario in which 10% of tonsil

tissue was present on the tongue when consumed.

Estimates of infectivity of tonsil tissue

For the purposes of the risk assessment, the total infectivity of a tonsil was estimated as

0.25 bovine oral ID50 units in an infected animal. It was assumed that infectivity was

present in the tonsil tissue at a similar level over the entire incubation period of the

disease. The quantitative estimate of worst-case exposure to infectivity for a population

(assuming all tonsil was included with the tongue) was calculated as 90 bovine oral ID50

units per year, distributed over the tongue-eating population.

http://www.seac.gov.uk/statements/Bovine_Tonsil.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

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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

2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)


http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml

TSS




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