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From: TSS ()
Subject: Draft position of the Community on the report of the meeting of the OIE (BSE 2005)
Date: May 25, 2005 at 2:09 pm PST

##################### Bovine Spongiform Encephalopathy #####################

Draft position of the Community on the report of the meeting of the OIE Terrestrial Animal Health Standards Commission [Paris January 2005] to be submitted for consideration and possible adoption in the 73rd General Session to be held in May 2005 in Paris

2

COMMISSION STAFF WORKING DOCUMENT

Draft position of the Community on the report of the meeting of the OIE Terrestrial

Animal Health Standards Commission [Paris January 2005] to be submitted for

consideration and possible adoption in the 73rd General Session to be held in May 2005

in Paris

UNION EUROPEENNE

Bruxelles, le

D(2005) 520441 HLB

Subject : General session of the OIE

Dear Director General,

Please find attached as Annex I the position of the Community concerning the report of the

Terrestrial Animal Health Standards Commission in view of the preparation of the General

Session to be held in May 2005 in Paris. In addition the Community positions on revisions to

the OIE diagnostic manual are included as Annex II and the Community has also attached a

list of BSE tests which it would like included in the OIE Diagnostic Manual at Annex III.

Relating to the proposed amendments to the BSE chapter and the Appendix on surveillance

the Member States expressed unanimously the position that any amendment of the three key

topics i.e. list of tradeable products, number of categories and surveillance is seen as a

package. Therefore the endorsement of the list of tradeable products will only be possible if

the proposed amendments on the BSE chapter and the Appendix on surveillance can be

supported by the Member States

Furthermore the Community supports the new designations of (1) Switzerland as a country

free from CBPP without vaccination, (2)a zone in Peru free from FMD without vaccination,

(3) a zone and certain municipalities in Brazil free from FMD with vaccination, (4) certain

zones of Colombia free from FMD with vaccination, (5)Lebanon, Nigeria and Tanzania as

free from rinderpest disease, (6) Benin, Bhutan, Eritrea, Mongolia, Senegal, Togo and Turkey

free from rinderpest infection, (7) a described zone in Ethiopia and one in Sudan free from

rinderpest disease.

I trust you will take the Community points on board prior to or during the meeting

Thank you for your continued cooperation

Kind regards

Dr. Arthur Besch Jaana Husu-Kallio

Directeur Deputy Director General

Administration des Services Vétérinaires

Luxembourg

Enclosures: 2

Copy: CVOs all Member States

CVOs Andorra, Bulgaria, Iceland, Norway, Romania and Switzerland

Dr. B. Vallat

Directeur général OIE

12 rue de Prony

F-75017 Paris

4

Original: English

January 2005

PRELIMINARY VERSION OF THE REPORT OF THE MEETING OF THE

OIE TERRESTRIAL ANIMAL HEALTH STANDARDS COMMISSION

Paris, 17-28 January 2005

______

The OIE Terrestrial Animal Health Standards Commission (hereafter referred to as the

Terrestrial Code Commission) met at the OIE Headquarters in Paris from 17-28 January 2005,

and discussed some common issues with the Scientific Commission for Animal Diseases

(hereafter referred to as the Scientific Commission) on 18 January 2005. The President of the

Terrestrial Code Commission also met with the Aquatic Animal Health Standards

Commission (hereafter referred to as the Aquatic Animals Commission).

The members of the Terrestrial Code Commission are listed in Appendix I. The agenda

adopted is given in Appendix II.

The Director General of the OIE, Dr B. Vallat, welcomed the members and thanked them all

for their willingness to participate in this important OIE work. He emphasised his strong

commitment towards progress on some important texts, especially those concerning bovine

spongiform encephalopathy (BSE) and avian influenza, as a result of the discussions at the

72nd General Session:

- regarding BSE, Dr Vallat was confident that the Member Countries would support a three

category approach but the level of surveillance required remained an issue for many

Member Countries; he supported the Terrestrial Code Commission's emphasis on safe

commodities and considered that 'boneless skeletal muscle meat' was an important

commodity which needed to be discussed in this regard;

- Dr Vallat considered that it was important for the Terrestrial Code Commission to

harmonise the work done by experts and the Scientific Commission in revising the

chapters and in drafting surveillance appendices for foot and mouth disease (FMD), BSE

and avian influenza; .....

snip...

12

9. Bovine spongiform encephalopathy (Chapter 2.3.13. and Appendix 3.8.4.)

Community position:

The Community welcomes the action taken by the OIE Terrestrial Animal Health

Standards Commission to draft a new text reflecting a simplified categorisation system for

BSE but would like the detailed comments made in the Appendices taken on board.

13

a) Chapter 2.3.13.

The report of the April 2004 meeting of the ad hoc Group on the BSE chapter (which

was included in the report of the July 2004 meeting of the Bureau) is attached for

completeness (Appendix XXIV).

The Terrestrial Code Commission was very appreciative of the detailed submissions

received in support of its work on the proposed three category system, from the

USA, the EU, Australia, New Zealand, Japan and Chile. The OIE Regional

Commissions for Europe and the Americas also supported this approach. In addition,

other Member Countries made comment on specific articles in this version (Peru, the

Southern Cone countries of South America, Norway and Switzerland). An invited

submission was also received from the gelatin manufacturing industries in Europe,

South America, and Asia and the Pacific. Invited OIE experts also provided

comments.

As a result of the outcome of the discussion on BSE at the 72nd General Session, the

universal support in comments received and the endorsement from the Scientific

Commission, the Terrestrial Code Commission decided to prepare for adoption a

revised BSE chapter based on the three category system. Because of the significant

time spent on BSE during its meeting (on the chapter and surveillance appendix), the

Terrestrial Code Commission did no further work on the five category chapter which

was an alternative proposal in the July report.

Within this support for a three category system, while Japan preferred a prevalencebased

approach, most countries explicitly or implicitly supported a risk-based

approach. The latter approach formed the basis for the changes proposed below by

the Terrestrial Code Commission.

14

The Terrestrial Code Commission was of the view that the concern over hides and

skins from the head has arisen from a potential for surface contamination of the hide

by brain material following penetrative stunning methods. However, it believed that

there were many conditions which would have to be met before the hypothetical

likelihood of contamination translated into an actual risk to human health. Surface

contamination of the hide would be eliminated through the routine industry processes

of soaking of the hides for hair removal and subsequent washing. In addition, further

processing steps, e.g. for extraction and conversion into gelatin, would help ensure

the safety of the final product. The Terrestrial Code Commission has proposed that

the exception for hides and skins from the head be removed.

With regard to blood and blood products, the Terrestrial Code Commission recalled

the views of the BSE ad hoc Group which met in April 2004, that the information

available indicated that bovine blood and blood by-products would be safe, subject to

stunning having been carried out in accordance with Article 2.3.13.15. Accordingly,

it has recommended that blood and blood products be placed in the first list of

commodities (those which require no BSE-specific risk mitigation measures). (See

Article 1, paragraph 1.)

The Terrestrial Code Commission was of the view that there was no scientific basis

for considering that boneless skeletal muscle meat (excluding mechanically derived

meat) was likely to contain BSE infectivity. Mouse and calf bioassays conducted on

muscle tissue collected from clinical cases had not detected BSE infectivity. The

Terrestrial Code Commission recommended that boneless skeletal muscle meat also

be placed in the first list of commodities.

The Terrestrial Code Commission did not make changes to the factors to be

considered in a risk assessment. The Terrestrial Code Commission followed the

views of the BSE ad hoc Group in considering that the changes proposed by

Australia and New Zealand (replacing TSEs with BSE) would have unnecessarily

narrowed the scope of the risk assessment.

The Terrestrial Code Commission discussed the criteria listed in Article 2 for the

determination of the BSE risk status of a country, zone or compartment. After

considering submissions from several Member Countries that the surveillance

burdens be commensurate with the BSE risk determined through a structured, formal

science-based risk assessment, the Terrestrial Code Commission proposed that the

formal surveillance requirements specified in Appendix 3.8.4. should not apply to

those Member Countries where the BSE risk has been assessed as negligible.

However, criteria 2, 3 and 4 of Article 2 would still apply, in particular the

compulsory notification and investigation of all cattle showing clinical signs

consistent with BSE. This is consistent with requirements for many other OIE listed

diseases. The paragraphs in Article 2 on release and exposure assessments were

modified at the recommendation of an OIE expert.

Several Member Countries requested that the text on the feed ban be strengthened

and this was done in Articles 3 and 4. In addition, in Articles 3 and 4, the Terrestrial

Code Commission has placed more emphasis on the risk assessment and less on

prevalence. In Article 4, it could not identify any significant difference in final risk

presented regarding whether indigenous BSE had occurred more or less than 7 years

ago; accordingly, it has deleted paragraph 3) of Article 4 and reworded paragraph 2)

to cover all circumstances in which there had been an indigenous case. The

15

Terrestrial Code Commission considered that the significant difference between the

requirements of Articles 3 and 4 was whether a Member Country could demonstrate

that the appropriate generic measures had been in place for the relevant period of

time.

The Terrestrial Code Commission recalled that the reason for the inclusion of a

requirement for post mortem inspection was to ensure a minimum standard of

professional involvement, particularly in countries where the removal of specified

risk materials (SRMs) was required.

Comments from Member Countries which were essential to the revision of the three

category approach were addressed by the Terrestrial Code Commission and have

been included in the revised chapter; matters requiring consideration by BSE experts

will be addressed after the 73rd General Session.

16

The articles in the proposed three category chapter have been temporarily numbered

from 1 to 16 for ease of reference. The chapter (Appendix XI) is proposed for

adoption.

b) Appendix 3.8.4.

The report of the ad hoc Group on surveillance for BSE is at Appendix XXIV for the

information of Member Countries.

The Terrestrial Code Commission examined the appendix proposed by the experts

and made some changes in line with the explanations below. The Appendix on

surveillance for BSE (Appendix XII) is proposed for adoption.

A commonality among submissions received was that the current surveillance

requirements should be modified. However, there were also significant differences

among submissions. Some Member Countries recommended that high levels of

surveillance and risk mitigation measures be applied in all countries while others

recommended a more balanced approach between the level of risk identified through

the process described in Article 2 of the proposed chapter, and the severity of

mitigating measures and the intensity of surveillance. In this latter category were

Member Countries (New Zealand, Chile and the Southern Cone countries of South

America) recommending a significant reduction in surveillance burdens in countries

which had already demonstrated negligible risk.

The Terrestrial Code Commission thanked Japan for its detailed submission. The

calculations provided showed that, to prove a prevalence of less than one case in

one million adult cattle, a greatly increased test load would need to be implemented.

The EU also provided a detailed submission in which it reiterated its support for the

BSurvE computer model. The Terrestrial Code Commission noted that the ad hoc

Group had been reluctant to recommend the use, without adaptation, of this model by

Member Countries. The Terrestrial Code Commission also noted that the EU had

requested that the OIE assist the EU to undertake a peer-review of the model.

The Terrestrial Code Commission noted that the 'point values' used in the approach

recommended by the ad hoc Group had not been selected arbitrarily but were derived

from an in-depth statistical analysis of all EU (other than the United Kingdom [UK])

data on BSE cases detected by all methods of surveillance. The detailed submission

received from the USA and comments from Norway supported this approach.

The Terrestrial Code Commission noted that the ad hoc Group on BSE surveillance

would need to meet again after the 73rd General Session to further consider

'maintenance surveillance'.

10. Transmissible spongiform encephalopathy agents inactivation procedures

(Appendix 3.6.3.)

Community position:

The Community can support the amendments proposed in Appendix XIII.

The revised text circulated for Member Countries' comment in July 2004

(Appendix XIII) is proposed for adoption.

snip... FULL TEXT SOME 594 PAGES...TSS

http://europa.eu.int/comm/food/international/organisations/ah_pcad_oie17_en.pdf

http://europa.eu.int/comm/food/international/organisations/ah_pcad_oie17_en.pdf

Greetings list members,

LIKE i said, they should hang up there jock strap, they have caved in to industry demands over public health. I cannot stand to read anymore of this crap now. i was in too good a mood before coming back to this machine to read junk science. they threw some 2+ decades of trying to erradicate a disease out the window if they adopt these standards and the TSE agent will spread, ALL STRAINS. some 20+ strains of sheep scrapie, with new atypical strains like the NOR98 emerging. BSE came from one of those strains (which one?), NOW we have BSE back to goat documented in natural field conditions, and BSE to sheep in the lab. THE old theory that BSE would not transmit to man was a joke, it did as nvCJD. THEN we have the old theory that blood would not transmit to man, that was a joke to, because it did transmit to man. NOW we are hearing that blood from a BSE infected cow is O.K.? there kidding right? hmm, what about the new strain of TSE in cattle 'BaSE'? what about that blood? this TSE in cattle NOT similar to nvCJD in humans but very similar to sporadic CJD. too early to tell exactly which one of the 6 documented phenotypes of sporadic CJD. WHAT about the atypical TSE cow in Japan that showed the TSE agent in the peripheral nerve (11th BSE case of Japan)? what about that?


THEN, we have the USA in a very unique situation with all kinds of human/animal TSEs. WE have plenty of CJD/TSE in humans, TME in mink, CWD in deer and elk, Scrapie in sheep and goat, BSE in VERMONT sheep imported from BELGUIM i will probably not live long enough to know the final out come of that DECLARATION OF EMERGENCY FOR AN ATYPICAL TSE IN THOSE SHEEP, that was declared here in the USA. WHAT about all those imported UK sheep and goat that were imported here to the USA, wonder if any BSE or BaSE was in any of those imports to the USA? most all this rendered and fed back to animals for human consumption and has been for decades here in the USA. the mink that were fed 95%+ dead stock downer cattle that came down with TME meant nothing?

all this and the USA has no home grown TSE in there cattle and no CJD from any of the above?

all this will be exported throughout the globe?

the TSE agent continues to amplify and spread, while more humans and animals become exposed and die.

good luck.

the BSE GBR RISK ASSESSMENTS should NOT be abandoned for GWs BSE MRR policy or this OIE policy.

the BSE GBR RISK ASSESSMENTS should be changed to the GLOBAL TSE GBR RISK ASSESSMENTS and this policy should be strengthened even more than the old BSE GBR risk assessments. ...

still very disgusted in Bacliff, Texas USA

Terry S. Singeltary Sr.

#################### https://lists.aegee.org/bse-l.html ####################





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