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From: TSS (216-119-144-39.ipset24.wt.net)
Subject: Re: USDA document cites young mad cow cases and concerns for TSE in young bovine
Date: August 23, 2004 at 10:06 am PST

In Reply to: USDA document cites young mad cow cases and concerns for TSE in young bovine posted by TSS on August 23, 2004 at 9:52 am:

Canada and the United States have been raised to level III (presence of
BSE likely but not confirmed, or confirmed at a lower level) following a
new assessment taking into account the most recent evidence. EFSAs
Scientific Expert Working Group on geographic BSE risk assessment also
evaluated the status of Mexico and South Africa which were classified as
level III.

http://www.efsa.eu.int/press_room/press_release/575_en.html

European Food Safety Authority
20 August 2004
PRESS RELEASE
EFSA publishes Geographical BSE-Risk (GBR) assessments for
Australia, Canada, Mexico, Norway, South Africa, Sweden
and the United States of America
The European Food Safety Authority (EFSA) has issued today seven up-to-date
scientific reports on the Geographical Bovine Spongiform Encephalopathy
(BSE)
Risk (GBR) assessments for Australia, Canada, Mexico, Norway, South Africa
Sweden and the United States of America. While Australias GBR level I
(i.e.
presence of BSE in domestic cattle is highly unlikely) is maintained,
that of Norway
has been raised to level II (presence of BSE unlikely but not excluded),
Sweden
remains at GBR level II and those of Canada and the United States have
been raised
to level III (presence of BSE likely but not confirmed, or confirmed at
a lower level)
following a new assessment taking into account the most recent
evidence. EFSAs
Scientific Expert Working Group on geographic BSE risk assessment also
evaluated
the status of Mexico and South Africa which were classified as level III.
In 2003 EFSA was requested by the European Commission (EC) to re-assess the
Geographical Bovine Spongiform Encephalopathy (BSE) risk (GBR) for 13
countries:
Australia, Botswana, Canada, Costa Rica, El Salvador, Nicaragua,
Namibia, Norway,
Mexico, Panama, Swaziland, Sweden and the United States. Although the
European
Commission did not specifically seek advice from EFSA relating to the
appearance of
BSE in South Africa, the working group decided to carry out a risk
assessment for this
country under a self-tasking mandate in order to allow for a meaningful
evaluation of the
three other countries in the Southern African Region for which a GBR
assessment was
requested (i.e. Botswana, Namibia, Swaziland). EFSAs Scientific Expert
Working
Group on the Assessment of the GBR has completed to date those
assessments relating to
Australia, Canada, Mexico, Norway, South Africa, Sweden and the United
States of
America. The GBR assessments for the remaining countries will be
finalized by the end
of 2004.
In conducting the GBR assessments, EFSAs GBR working group followed the
methodology developed by the former Scientific Steering Committee of DG
Health and
Consumer Safety (DG SANCO) of the European Commission which is described
in its
final opinion on GBR assessment1. The risk assessments published today
are based on
up-to-date data provided by the countries concerned as well as other
sources of data (i.e.
Eurostat and country export data) covering the period of 1980 to 2003.
A detailed analysis for each country is presented in the Scientific
Reports which can be
found at:
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/catindex_en.html

For media enquiries, please contact:
Carola Sondermann, Senior Press Officer
Tel: +32 2 337 2294
Carola.Sondermann@efsa.eu.int
Or EFSA Communications Director, Anne-Laure Gassin
Tel: +32 2 337 2248
Anne-Laure.Gassin@efsa.eu.int
For more background information about the European Food Safety
Authority, go to:
http://www.efsa.eu.int/
Notes to editors
1. The Geographical BSE-Risk (GBR) is a qualitative indicator of the
likelihood of the
presence of one or more cattle being infected with BSE, pre-clinically
as well as
1 Final opinion on the Geographical Risk of Bovine Spongiform
Encephalopathy (GBR) (Adopted on 6
July 2000). http://europa.eu.int/comm/food/fs/sc/ssc/out113_en.pdf
Updated opinion on the Geographical Risk of Bovine Spongiform
Encephalopathy (GBR) (adopted on 11
January 2002). http://europa.eu.int/comm/food/fs/sc/ssc/out243_en.pdf
clinically, at a given point in time, in a country. Where its presence
is confirmed, the
GBR gives an indication of the level of infection.
2. The GBR assessments are based on information submitted by countries
concerned in
response to a European Commission recommendation in 1998 setting out the
information
requirements for such an assessment.2 The information concerns in
particular imports of
bovines and meat and bone meal (MBM) from the United Kingdom and other
BSE-risk
countries, rendering standards for animal by-products, use of so called
Specified Risk
Materials (SRMs), feeding of MBM to ruminants etcetera.
3. The table below shows the current GBR levels of the seven countries
assessed by
EFSA so far, as well as their former classification where available.
GBR
level
Presence of one or more cattle clinically or
pre-clinically infected with the BSE agent in
a geographical region/country
GBR of the country/Region
Current status
(status before)
I Highly unlikely
Australia (I)
II Unlikely but not excluded
Norway (I), Sweden (II)
III Likely but not confirmed or confirmed at a
lower level
Canada (II), Mexico (N/A),
South Africa (N/A), USA (II)
IV Confirmed at a higher level
N/A= not applicable, i.e. not assessed before
2 Preliminary-opinion on a method to assess the geographical BSE-Risk of
Countries or Regions (adopted
on 10 December 1998).
http://europa.eu.int/comm/food/fs/sc/ssc/out35_en.html

http://www.efsa.eu.int/press_room/press_release/575/pr_biohaz02_gbr_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)

Adopted July 2004 (Question N° EFSA-Q-2003-083)
[20 August 2004]

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)
Publication date: 20 August 2004

Adopted July 2004 (Question N° EFSA-Q-2003-083)

* 167 kB Report


* 105 kB Summary

Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working
Group on the Assessment of the Geographical Bovine Spongiform
Encephalopathy (BSE) Risk (GBR) were asked by the European Commission
(EC) to provide an up-to-date scientific report on the GBR in the United
States of America, i.e. the likelihood of the presence of one or more
cattle being infected with BSE, pre-clinically as well as clinically, in
USA. This scientific report addresses the GBR of USA as assessed in 2004
based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached
domestic cattle in the middle of the eighties. These cattle imported in
the mid eighties could have been rendered in the late eighties and
therefore led to an internal challenge in the early nineties. It is
possible that imported meat and bone meal (MBM) into the USA reached
domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle
imports from BSE risk countries were slaughtered or died and were
processed (partly) into feed, together with some imports of MBM. This
risk continued to exist, and grew significantly in the mid 90s when
domestic cattle, infected by imported MBM, reached processing. Given the
low stability of the system, the risk increased over the years with
continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is
likely but not confirmed that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent. As long as there are no
significant changes in rendering or feeding, the stability remains
extremely/very unstable. Thus, the probability of cattle to be
(pre-clinically or clinically) infected with the BSE-agent persistently
increases.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html


SUMMARY

javascript:popwindow('http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf',750,480,1,0,1,0,0,1,1,0)


REPORT USA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Australia

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Canada

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Mexico

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Norway

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of South Africa

Adopted July 2004 (Question N° EFSA-Q-2003-074)

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Sweden

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[20 August 2004]

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[20 August 2004]


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/catindex_en.html


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




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