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From: TSS (216-119-144-71.ipset24.wt.net)
Subject: Brussels, 22.10.2004 -- OIE Terrestrial Animal Health Standards Commission Paris, 28 June to 2 July 2004 written comments (BSE)
Date: October 27, 2004 at 1:38 pm PST
-------- Original Message --------
Subject: Brussels, 22.10.2004 -- OIE Terrestrial Animal Health Standards Commission Paris, 28 June to 2 July 2004 written comments (BSE)
Date: Wed, 27 Oct 2004 15:41:02 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy #####################
EN EN
COMMISSION OF THE EUROPEAN COMMUNITIES
Brussels, 22.10.2004
SEC(2004) 1344
COMMISSION STAFF WORKING DOCUMENT
Written comments of the Community on the report of the meeting of the
Bureau of the
OIE Terrestrial Animal Health Standards Commission
held in Paris, 28 June to 2 July 2004
EN 2 EN
COMMISSION STAFF WORKING DOCUMENT
Written comments of the Community on the report of the meeting of the
Bureau of the
OIE Terrestrial Animal Health Standards Commission
held in Paris, 28 June to 2 July 2004
EXPLANATORY MEMORANDUM
The Bureau of the OIE Terrestrial Animal Health Standards Commission
(Code Commission)
met at OIE Headquarters from 28 June to 2 July 2004. A report has been
drafted which has
proposed certain modifications to the Code.
The report has been circulated to member countries with requests for
comments. The
comments will be reviewed by the Code Commission in January 2005 but
comments from
member countries must reach the OIE by 26 November 2004. In view of the
status of these
Health Codes, in particular in making recommendations for international
trade in animals,
their products and for the categorisation of diseases, it is necessary
for the Community to take
a common position on this matter.
In addition the Community has attached information on bluetongue from
the Community
Reference Laboratory for bluetongue which it would like the OIE to
examine with a view to
reviewing the Code Chapter on bluetongue.
The Commission therefore proposes to the Council to authorise the
Commission to present to
the OIE, as since 1995, the following written comments in the Annex
before the 26 November
2004 for the meeting referred to above. This is in order to allow the
Code Commission to take
the Community comments into account during their meetings, prior to
submission of revised
versions for further comments to member countries or the final versions
to the General
Session in May 2005. The cover letter to be sent with our response is
attached at Annex A
(Doc D(2004) 521598).
In order to facilitate the examination of the comments of the Community,
they have been
incorporated in boxes into the OIE reports. In this context, the
Community thanks the OIE for
providing the electronic version of the Reports.
EN 3 EN
ANNEX A
UNION EUROPEENNE
Bruxelles, le
D(2004) 521598 HLB
Objet: Réunion du Code zoosanitaire Janvier 2004
Monsieur le Directeur général,
Nous vous prions de bien vouloir trouver en annexe les commentaires de
l'Union Européenne
sur le rapport du bureau de la Commission du Code zoosanitaire
international de lOffice
International des Epizooties, en vue de la préparation de la Session
générale de 2005 (en
annexe I).
En complément, la Commission, par un courrier du 1er Juillet vous avait
fait part de ses
commentaires sur le projet de réécriture du Chapitre bluetongue du Code
actuellement en
discussion et faisant suite au Symposium de Taormina.
Il lui avait été répondu par un courrier du 13 août que, dans ses
commentaires, la Commission
napportait aucune information susceptible damener le bureau à modifier
son projet.
Sur le sujet particulièrement sensible de la durée de la virémie, qui
est un élément déterminant
dans larchitecture générale du chapitre, une évaluation du risque en
matière de bluetongue
(en annexe II) récemment conduite par le laboratoire de Pirbright
(laboratoire communautaire
de référence pour la bluetongue) conclue que les 60 jours retenus lors
du symposium de
Taormina ne sont pas suffisants. Les publications qui ont été étudiées
dans cette évaluation
ont amené lauteur à conclure à une probabilité non négligeable
danimaux dont la virémie
dépasse 60 jours, en particulier chez les bovins.
Ceci remet en cause la sécurité du dispositif proposé dans le nouveau
chapitre puisque la
« quarantaine » de 60 jours ne permettrait pas de prévenir les
mouvements danimaux
virémiques.
Ces conclusions sont en contradiction avec celles du symposium de
Taormina et ceci nest pas
sans soulever un véritable problème sagissant de la position de la
Commission sur ce point et
ses implications dans la rédaction du chapitre du code
Sagissant davis scientifique divergents sur lesquels la Commission
nest pas à ce stade en
mesure de se prononcer, je vous propose de soumettre ces nouvelles
données à un groupe
dexperts internationaux afin quune nouvelle évaluation de cette durée
maximale de la
virémie soit conduite et que les différents avis sur le sujet soit
valablement confrontés afin de
parvenir à une conclusion définitive.
EN 4 EN
Nous tenons également à vous remercier pour l'excellente collaboration
entre nos services et
vous prions d'agréer, Monsieur le Directeur général, l'expression de nos
sentiments distingués.
Dr. Jaana Husu-Kallio
Directeur Général Adjointe
Peices jointes: 2
Copie: Tous les directeurs/chefs de service vétérinaire de la
Communauté/chefs de service vétérinaire de lAndorra, Bulgarie, Islande,
Norvège, Roumanie et Suisse
Dr. B. Vallat
Directeur général OIE
12 rue de Prony
F-75017 Paris
FRANCE
EN 5 EN
ANNEX I
Original: English
July 2004
REPORT OF THE MEETING OF THE BUREAU OF THE
OIE TERRESTRIAL ANIMAL HEALTH STANDARDS COMMISSION
Paris, 28 June to 2 July 2004
______
The Bureau of the OIE Terrestrial Animal Health Standards Commission
(hereafter referred to as the Bureau)
met at the OIE Headquarters from 28 June to 2 July 2004.
The members of the Bureau and other participants are listed in Appendix
I. The Agenda adopted is given in
Appendix II.
Dr D. Wilson, Head of the International Trade Department, welcomed the
members of the Bureau on behalf of
the Director General, Dr B. Vallat, and recalled the extensive work
programme for the Code Commission
resulting from discussions at the 72nd General Session, particularly on
foot and mouth disease (FMD), avian
influenza and a simplified categorisation system for bovine spongiform
encephalopathy (BSE).
The Bureau took the opportunity to review the currency of all chapters
and appendices in the OIE Terrestrial
Animal Health Code (hereafter referred to as the Terrestrial Code), and
the texts which remained under study
from previous discussions. Topics which the Bureau considered should be
updated as a priority were listed in the
future work programme. After cross-checking against the 2004 edition of
the OIE Manual of Diagnostic Tests
and Vaccines for Terrestrial Animals (hereafter referred to as the
Terrestrial Manual), the Bureau removed the
term (under study) from texts for enzootic bovine leucosis, equine viral
arteritis and small ruminant semen.
The Bureau examined various draft and revised Terrestrial Code chapters
and appendices, and comments
received on them. The outcome of this part of the Bureaus work is
presented as appendices to this report, with
insertions and amendments to existing Terrestrial Code text and
previously circulated drafts being shown as
double underlined text, and with text proposed for deletion in strikeout. Member Countries are strongly encouraged to comment on all aspects of
the report. Comments need to reach the
OIE Headquarters by 26 November 2004 in order to be considered at the
next Code Commission meeting in
January 2005 A. TEXTS FOR MEMBER COUNTRY COMMENT
1. Chapter 1.1.1. General definitions
The Bureau did not revise the definition for emerging disease because
it considered that the proposal
received from the United States of America (USA) did not significantly
improve the current text.
A revised definition for buffer zone is at Appendix III.
The Bureau decided not to develop a definition for fallen stock but to
explain more clearly the use of the
term in the BSE surveillance Appendix.
The Bureau recommended that the Central Bureau revise, without changing
the scientific content or intent,
the Terrestrial Code text as necessary to introduce the latest
approaches to zone/region and compartment,
and OIE listed diseases, as determined by the OIE International Committee. Community comments:
The Community supports this proposal provided the changes proposed in
Appendix III are
taken on board as the proposed wording is not compatible with the
current definition for
surveillance. 2. Section 1.2. Obligations and ethics in international trade
The Bureau decided not to include the comments from the USA in
paragraphs 5) and 6) of Article 1.1.1.2
because some of the comments reflected Member Countries existing SPS
obligations, and others did not
take account of the need in some circumstances to act urgently on
unverified reports. snip... EN 8 EN
9. Chapter 2.3.13. Bovine spongiform encephalopathy
EN 9 EN
For this chapter, the Bureau of the Code Commission produced two
alternative versions, taking into
account comments received from Member Countries. Part a) contains a
proposed new chapter with a
simplified categorisation system while Part b) proposes a revised
current chapter.
The Bureau urges Member Countries to examine these two approaches and to
send comments to the Central
Bureau.
a) New BSE chapter with a simplified categorisation system
Community position:
The Community welcomes the action taken by the Bureau of the Code
Commission to draft
a new text reflecting a simplified categorisation system for BSE but
would like the detailed
comments made on the individual Article taken on board.
Recalling the support from the OIE International Committee at the 72nd
General Session for a
simplified categorisation system for BSE, the Bureau of the Code
Commission drafted a new text
reflecting this approach. The new text (Appendix VI) is submitted to
Member Countries for comment.
The following criteria were the basis for formulating the new text:
i) the recommendations from the ad hoc Group meeting of April 2004 for a
three category
approach; the report of the meeting is at Appendix VII;
ii) proposals from Member Countries the EU, the USA, Australia, New
Zealand, Japan, South
Africa, Korea and Argentina for a new approach;
iii) the shift in emphasis agreed by the OIE International Committee
towards commodity-specific
recommendations;
iv) the linkage between risk assessment outcomes and surveillance, and
the ability to be categorised
as negligible BSE risk with or without mitigating measures; and
v) the recommendations of the ad hoc Group regarding the factors
relevant to a risk assessment and
the safety of certain commodities.
Articles were consolidated as necessary to address a three category
approach but changes to existing
recommendations were minimised. In the explanation below, current
Article refers to the
2004 edition of the Terrestrial Code.
Article 1 was not modified with regard to specific commodities because
of the absence of any new
scientific information on the risks presented. With the respect to
tallow, this approach reflects the
position of the BSE ad hoc Group. The Bureau understands that the
results of an investigation into
whether or not the BSE agent may be present in tallow will soon be
released. In addition, while the ad
hoc Group believed that the information available indicated that bovine
blood and blood by-products
would be safe (subject to stunning being carried out in accordance with
the current Article 2.3.13.14),
EN 10 EN
the Bureau awaits further concrete scientific information before making
recommendations on their
use.
Article 2 was modified, taking into consideration the recommendations of
the ad hoc Group on the
factors important to release and exposure assessments.
A new Article 3 addressing a category named negligible BSE risk without
mitigating measures was
drafted by merging current Articles 2.3.13.3 and 2.3.13.4 describing
free and provisionally-free
categories, and taking into consideration the recommendations of the ad
hoc Group and comments
received from Member Countries. Recommendations regarding the
destruction of progeny were
retained for a country or zone/compartment which had reported a case of
BSE more than 7 years ago;
however, the Bureau was of the view that, in the light of the lack of
evidence for vertical transmission,
these recommendations should be dispensed with from this article and the
new Article 4.
The new Article 4 addressing a category named negligible BSE risk with
mitigating measures
incorporates the current Articles 2.3.13.5 and 2.3.13.6 describing
minimal and moderate risk
categories, and includes the concept of high BSE risk in its
recommendations. In this exercise, the
Bureau took into consideration the recommendations of the ad hoc Group
and comments received
from Member Countries.
In order to have a single middle category, the Bureau considered it
necessary not to differentiate risk
levels for commodities on the basis of BSE incidence rate. In this
regard, the Bureau agreed with the
ad hoc Groups proposal that because of the difficulty of estimating
accurately the prevalence of BSE
infection and the relative lack of importance of prevalence in relation
to rendering commodities safe, a
broad second category be created with no arbitrary distinctions.
Australia recommended an emphasis
on risk assessment and disease management rather than on disease
incidence in drawing up new
categories. The USA also supported a risk-based rather than
prevalence-based approach to
categorisation. The Bureau considered that this approach did not reduce
the importance of surveillance
in categorising countries or zones/compartments.
A new Article 5 undetermined BSE risk was created for those countries
or zones/compartments
which, by not conducting a risk assessment or surveillance, could not be
categorised in either of the
above categories but which could still trade safely in certain
commodities under specified conditions.
Community position:
The Community fully supports the risk-based approach on which the simplified
categorisation system will be based upon i.e. an initial risk assessment
and the
implementation of a surveillance programme. However the EU does not
support to make a
link to the current Appendix when evaluating the implementation of the
surveillance
programme in the framework of the categorisation of the country. The EU
re-iterates
comments made on Appendix 3.8.4. on surveillance and monitoring systems
for bovine
spongiform encephalopathy.
The Community would like the OIE to take on board the detailed comments
in Appendix
VI.
EN 11 EN
In accordance with the proposed three category system, the articles
dealing with commodities have
been redrafted to address the risk posed by the combination of the
commodity and the source country
or zone/compartment.
A new Article 6 is essentially unchanged from the current Article
2.3.13.8 which dealt with imports
from free countries or zones.
A new Article 7 dealing with cattle from a country or zone/compartment
posing a negligible BSE risk
with mitigating measures resulted from a merger of the existing
recommendations in current
Articles 2.3.13.10 and 2.3.13.11.
The existing recommendations for the import of cattle from a country or
zone with a high BSE risk
were incorporated unchanged in new Article 8 addressing cattle from a
country or zone/compartment
with an undetermined BSE risk.
On the recommendation of the ad hoc Group, recommendations for
post-mortem inspection were
added to new Articles 9, 10 and 11 to address the need to certify to
certain tissues having been
removed in a manner to avoid contamination.
The new Article 10 is a combination of current Articles 2.3.13.14 and
2.3.13.15. The
recommendations regarding the age for the removal of specified risk
materials were based on expert
advice regarding pathogenesis studies and epidemiological analysis.
The new Article 11 was modified from the current Article 2.3.13.16,
taking into account the
recommendations of the ad hoc Group, and in order to adapt it for Member
Countries in which animal
identification and traceability are not required. The Bureau did not
believe that such systems would
play a significant role in further mitigating any BSE risk posed by the
exported commodity.
The recommendation for the removal of the entire intestine was
reconsidered, and in view of
comments from the USA, Thailand, Taiwan, Korea, Canada and Japan and
advice from an expert, the
Bureau now proposes that the current Article 2.3.13.18 (new Article 13)
be modified to require the
exclusion from trade of the distal ileum only.
The substance of the remainder of the articles is unchanged. The Bureau
considered that the
recommendations in the current Article 2.3.13.22 are substantially
incorporated into new Article 2 and
proposes deletion of this article.
b) Proposed revision of the current BSE chapter
The Bureau took Member Countries comments into account in revising the
current BSE chapter.
In the absence of new scientific information on the risks presented,
Article 2.3.13.1 was not modified
with respect to specific commodities. This approach on tallow reflects
the position of the BSE ad hoc
Group. The Bureau understands that the results of an investigation into
whether or not the BSE agent
may be present in tallow will soon be released. In addition, while the
ad hoc Group believed that the
information available indicated that bovine blood and blood
by-products would be safe (subject to
stunning being carried out in accordance with Article 2.3.13.14), the
Bureau awaits further concrete
scientific information before making recommendations on their use.
Article 2.3.13.2 was modified, taking into consideration the
recommendations of the ad hoc Group on
the factors important to release and exposure assessments.
Revised text submitted by the EU and Canada on Article 2.3.13.3 (and on
Articles 2.3.13.4, 2.3.13.5,
2.3.13.12 and 2.3.13.16 for Canada) was not adopted as it was not
considered to significantly improve
the existing risk mitigation.
A comment from Australia and Canada regarding the age cut-off in
Articles 2.3.13.5 and 2.3.13.6 was
not adopted as the ad hoc Group believed that an age of 24 months was
the usual cut off point for
animal census data; if the ages were aligned at 24 months, the ad hoc
Group considered that the
prevalence cut-off limits for the categories would need to be adjusted.
The wording of paragraph 2) c) of Article 2.3.13.6 was clarified.
On the recommendation of the ad hoc Group and in light of comments from
Canada,
recommendations for post-mortem inspection were added to Articles
2.3.13.13, 2.3.13.14, 2.3.13.15
and 2.3.13.20 to address the need to certify to certain tissues having
been removed in a manner to
avoid contamination.
A Japanese recommendation that meat-and-bone meal be banned even from
BSE-free countries was
not adopted as it was considered to be excessive for exporting countries
not affected by BSE.
The age cut-off for mechanically separated meat from skull and vertebral
column in Article 2.3.13.16
was changed from 6 to 12 months on the recommendation of the ad hoc
Group and for consistency
with Article 2.3.13.18.
The current recommendation to remove the entire intestine was
reconsidered by the Bureau, and in
view of comments from the USA, Thailand, Taiwan, Korea, Canada and Japan
and advice from an
expert, the Bureau now proposes that Article 2.3.13.18 be modified to
require the exclusion from trade
of the distal ileum only.
The Bureau considered that the recommendations in Article 2.3.13.22 are
substantially incorporated
into Article 2.3.13.2 and proposes deletion of this Article.
The proposed modifications (Appendix VIII) are submitted to Member
Countries for comment.
c) Appendix 3.8.4 on surveillance and monitoring systems for BSE
The Bureau noted that the ad hoc Group had examined comments on the
appendix submitted by
Member Countries in making its recommendations. The Bureau endorsed the
comments of the ad hoc
Group regarding the BSE surveillance appendix and is submitting revised
text for the comment of
Member Countries (Appendix IX).
d Appendix 3.6.3 on transmissible spongiform encephalopathy agents
inactivation procedures
The Bureau modified Appendix 3.6.3 in accordance (Appendix X). snip... FULL TEXT 202 PAGES ...TSS International Affairs - Organisations - OIE
Draft written comments of the Community on the report of the meeting of the Bureau of the OIE Terrestrial Animal Health Standards Commission held in Paris, 28 June to 2 July 2004 http://europa.eu.int/comm/food/international/organisations/ah_pcad_oie10_en.pdf TSS ################# BSE-L-subscribe-request@uni-karlsruhe.de #################
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