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From: TSS ()
Summary of Opinion www.efsa.eu.int 1 Opinion of the Scientific Panel on Biological Hazards of the European Food Safety Authority on the “Quantitative assessment of the Human BSE risk posed by Bovine Vertebral Column including Dorsal Root Ganglia with respect to residual BSE risk”1 (Question N° EFSA-Q-2003-099) Adopted on 18 May 2006 SUMMARY 1.1. Residual BSE risk due to Bovine Vertebral Column The European Food Safety Authority (EFSA) quantitative risk assessment (QRA) guidance document gives residual Bovine Spongiform Encephalopathy (BSE) risk assessments for byproducts – tallow, gelatine and calcium phosphates – used in human food obtained from cattle fit for human consumption (EFSA QRA report, 2004). The effect of including vertebral column in the batch of raw materials used for the production of the by-products was calculated as part of separate risk assessments for these materials. The Commission Mandate to EFSA asked the Panel to review the “Opinion and report, assessment of the human BSE risk posed by bovine vertebral column including dorsal root ganglia (adopted on 16 May 2002)” in the light of their QRA on residual BSE risk and, if appropriate, revise the 2002 Opinion accordingly. This revision covers the by-products, tallow and gelatine, but does not consider the human risk from consumption of meat on the bone or the inclusion of bovinederived phosphates as food additives, or the effect of changing the age limit for regarding vertebral column as specified risk material. The EFSA Opinions on tallow and gelatine give descriptions of manufacturing processes, the various assumptions relating to their QRA and the background considerations relating to the interpretation of the output values. In this document we simply reproduce the relevant conclusions and recommendations of those opinions relating to the inclusion of vertebral column and the production of these by-products. 1 For citation purposes: Opinion of the Scientific panel on Biological Hazards on “Quantitative assessment of the Human BSE risk posed by Bovine Vertebral Column including Dorsal Root Ganglia with respect to residual BSE risk”, The EFSA Journal (2006), 359, 1-3 Summary of Opinion www.efsa.eu.int 2 Some illustrative data is shown below for the range of median (P50) exposure estimates (units, Cattle oral infectious dose 50%, CoID50/person/week)2. For detailed results see table 1 further in this document. GBR II† GBR III GBR IV Tallow De-Greasing bones * * 10-12 to 10-11 Mixture of tissues * * 10-12 to 10-10 Gelatine Acid & Alkaline * * 10-9 to 10-8 Heat & Pressure * * 10-11 to 10- 10 The logic of interpreting the CoID50 units of exposure in terms of human risk is essentially that assuming a species barrier of 1, and all the other assumptions, an exposure value > 10-8 per time period may result in one or more cases of vCJD per time period. The only scenario in which the P50 values approach the 10-8 level is in the production of gelatine from bovine bones by the acid and alkaline method. Referring back to the gelatine opinion, this is a worst case consumption scenario where all the daily human dose of gelatine is assumed to be bovine bone derived (when it is more likely to be 1-5%). Similarly, for more realistic sourcing scenarios such as a GBR III country with reliable surveillance, even the P97.5 values only approach 10-8 for gelatine produced from bovine bones by the acid and alkaline method (and a worst case consumption input). 1.2. Conclusion of this revision • Inclusion of vertebral column in the raw materials used to produce tallow and gelatine from bones or a mixture of tissues increases the level of human exposure by ~ 3-10 fold. However, the levels of residual BSE risk for these products calculated in the QRA are low and the increased risk factor due to inclusion of vertebral column is unlikely to translate into further cases of vCJD in the population. Therefore, in the case of tallow and gelatine, there appears to be no rationale for imposing an age-limit above which to exclude vertebral column from the batches of raw materials used to produce these by-products. • The human risk from consumption of meat on the bone or the inclusion of bovine-derived phosphates as food additives could be estimated using the QRA model if the appropriate input data for human consumption were available. 1.3. Further recommendations of the BIOHAZ Panel during the adoption of this report at their Plenary Meeting, 17-18th May, 2006 • This is the final Report to be revised in the light of the EFSA BSE QRA guidance document (EFSA QRA report, 2004), and joins a series covering a range of residual BSE risk assessments on the cattle by-products : tallow, gelatin, and calcium phosphates. Each revision considers the separate effects of the QRA on the risk of exposure to human and/or cattle population for each by-product. The Panel recognised the need to evaluate the cumulative effect of each incremental change in exposure to the populations calculated in 2 * in this Table is defined as an exposure level of < 10-13 CoID50 units/person/per week. † GBR: Geographical BSE Risk Summary of Opinion www.efsa.eu.int 3 these revisions, and recommended that this “total” exposure assessment be carried out in the near future. • “Gaps” in these residual risk assessments were inevitable due to the restricted scope of the original EFSA BSE QRA guidance document, and the Panel recommended that these gaps should be addressed by future Panel members using their “self-tasking mandate” option. For example, in the context of this vertebral column document, the QRA model could be used to estimate the human risk from consumption of meat on the bone or the inclusion of bovine-derived phosphates as food additives. • The EFSA BSE QRA guidance document was written almost four years ago, and although some parts have been revised since then to accommodate new research findings, the methodology and nomenclature for defining the geographical BSE risk (GBR) input to the model is no longer appropriate. New methodology, under the auspices of the OIE, is under construction within the EU and EFSA and the Panel recommended that once these classifications had been finalised they should harmonised with those used in the EFSA BSE QRA guidance document. The Panel anticipated that this harmonisation may have a knock-on impact on the QRA calculations, conclusions and recommendations and that, again, future Panel members should review this, and other, inputs of the QRA and address this impact using their “self-tasking mandate” option. http://www.efsa.eu.int/science/biohaz/biohaz_opinions/1540/biohaz_op_ej359_qra_vertebral_column_summary_en1.pdf OPINION http://www.efsa.eu.int/science/biohaz/biohaz_opinions/1540/biohaz_op_ej359_qra_vertebral_column_en1.pdf >>>New methodology, under the auspices of the OIE, is under construction within the EU and EFSA and the Panel recommended that once these classifications had been finalised they should harmonised with those used in the EFSA BSE QRA guidance document. The Panel anticipated that this harmonisation may have a knock-on impact on the QRA calculations, conclusions and recommendations and that, again, future Panel members should review this, and other, inputs of the QRA and address this impact using their “self-tasking mandate” option.<<< GOD HELP US! sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken. MOST countries that went by these OIE guidelines all eventually went down with BSE. ...TSS THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE. WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ??? see full text ; http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic
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