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From: Terry S. Singeltary Sr. (216-119-144-41.ipset24.wt.net)
Subject: OIE Terrestrial Animal Health Standards Commission held in Paris, 28 June to 2 July 2004 (BSE)
Date: December 14, 2004 at 9:18 am PST

-------- Original Message --------
Subject: OIE Terrestrial Animal Health Standards Commission held in Paris, 28 June to 2 July 2004 (BSE)
Date: Tue, 14 Dec 2004 11:17:16 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


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

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

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.
EN 12
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 (takes a while to load) ;

http://europa.eu.int/comm/food/international/organisations/ah_pcad_oie10_en.pdf

* Written comments of the Community

on the Report of the meeting of the Bureau of the OIE Terrestrial
Animal Health Standards Commission.
Submitted by the European Union to the OIE on 13/12/2004 (6,20MB)
* 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 (1,03MB)
Submitted by the Commission to the Council on 22/10/2004
(SEC/2004/1344)
* Written comments of the Community

on the OIE Fourth Strategic Plan 2005-2010 (1,5MB)
Submitted by the European Union to the OIE on 24/09/2004
* Written comments of the Community

on (1) a draft report of the meeting of an ad hoc group to revise
the bluetongue Chapter in the OIE Terrestrial Animal Health Code
and (2) on a review of the new Avian Influenza Code Chapter to be
submitted for adoption and consideration in the 73rd General
Session to be held in May 2005 (122KB)
Submitted by the European Union to the OIE on 01/07/2004
* Written comments of the Community

on the OIE Aquatic Animal Health Standards Commission [Parois, 5-9
January 2004] (1,5MB)
Submitted by the European Union to the OIE on 25/05/2004
* Written comments of the Community

on the report of the meeting of the Bureau of the OIE terrestrial
animal health code [Paris December 2003] to be submitted for
consideration and possible adoption in the 72nd General Session to
be held in May 2004 in Paris (1,5MB)
Submitted by the European Union to the OIE on 03/03/2004
* Draft written comments of the Community

on the report of the meeting of the Bureau of the OIE terrestrial
animal health code [Paris December 2003] to be submitted for
consideration and possible adoption in the 72nd General Session to
be held in May 2004 in Paris (1,5MB)
Submitted by the Commission to the Council on 17/02/2004
(SEC/2004/209)
* Written comments of the Community

on the Draft report of the meeting of the Bureau of the OIE
[Office International des Epizooties] Aquatic Animal Health
Standards Commission [Paris October 2003] (1,5MB)
Submitted by the European Union to the OIE on 18/12/2003
* Written comments of the Community

on the report of the meeting of the Bureau of the OIE [Office
International des Epizooties] International Animal Health Code
Commission [Paris July 2003] and the Scientific Commission [Paris
August 2003] to be submitted for adoption and consideration in the
72nd General Session to be held in May 2004 (6MB)
Submitted by the European Union to the OIE on 19/11/2003
* Draft written comments of the Community

on the report of the meeting of the Bureau of the OIE [Office
International des Epizooties] Aquatic Animals Health Code
Commission [Paris July 2003] and the Scientific Commission [Paris
August 2003] to be submitted for adoption and consideration in the
72nd General Session to be held in May 2004 (705KB)
Submitted by the Commission to the Council on 23/10/2003
(SEC/2003/1177)
* Draft written comments of the Community

on the report of the meeting of the Bureau of the OIE [Office
International des Epizooties] Aquatic Animals Health Standards
Commission [Paris June 2003] to be submitted for adoption and
consideration in the 72nd General Session to be held in May 2004
(354KB)
Submitted by the Commission to the Council on 29/09/2003
(SEC/2003/1065)

From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science
to date about the known TSEs in the USA (let alone the undocumented TSEs
in cattle), it is my opinion, every other Country that is dealing with
BSE/TSE should boycott the USA and demand that the SSC reclassify the
USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the
SSC to _flounder_ any longer on this issue, should also be regarded with
great suspicion as well. NOT to leave out the OIE and it's terribly
flawed system of disease surveillance. the OIE should make a move on CWD
in the USA, and make a risk assessment on this as a threat to human
health. the OIE should also change the mathematical formula for testing
of disease. this (in my opinion and others) is terribly flawed as well.
to think that a sample survey of 400 or so cattle in a population of 100
million, to think this will find anything, especially after seeing how
many TSE tests it took Italy and other Countries to find 1 case of BSE
(1 million rapid TSE test in less than 2 years, to find 102 BSE cases),
should be proof enough to make drastic changes of this system. the OIE
criteria for BSE Country classification and it's interpretation is very
problematic. a text that is suppose to give guidelines, but is not
understandable, cannot be considered satisfactory. the OIE told me 2
years ago that they were concerned with CWD, but said any changes might
take years. well, two years have come and gone, and no change in
relations with CWD as a human health risk. if we wait for politics and
science to finally make this connection, we very well may die before any
decisions
or changes are made. this is not acceptable. we must take the politics
and the industry out of any final decisions of the Scientific community.
this has been the problem from day one with this environmental man made
death sentence. some of you may think i am exaggerating, but you only
have to see it once, you only have to watch a loved one die from this
one time, and you will never forget, OR forgive...yes, i am still very
angry... but the transmission studies DO NOT lie, only the politicians
and the industry do... and they are still lying to this day...TSS


http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

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


############## BSE-L-subscribe-request@kaliv.uni-karlsruhe.de ##############





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