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From: TSS ()
Subject: EFSA RISK ASSESSMENT FOR ONLY BSE by Bovine Vertebral Column including Dorsal Root Ganglia to humans
Date: June 16, 2006 at 8:54 am PST

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


http://www.oie.int/downld/SC/2005/bse_2005.pdf

THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they should do everyone a favor and dissolve there organization. ...

WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ???


Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA


a.. BSE OIE

see full text ;

http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic


TSS






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