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From: TSS ()
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). 2 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 3 Attachment 1 Picture shows 5 mm of tonsillar material skinned from the tongue. 4 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 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 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; 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 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 http://www.thelancet.com/journal/journal.isa also have shared Mr Bradley’s surprise at the results because all the dose levels right down to 1 gram triggered infection. 2 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. 2) Infectious dose: To cattle: 1 gram of infected brain material (by oral ingestion) TSS
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