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From: Terry S. Singeltary Sr. (216-119-144-36.ipset24.wt.net)
Subject: EFSA ASSESSES GEOGRAPHICAL BSE RISK
Date: October 1, 2004 at 2:18 pm PST

-------- Original Message --------
Subject: EFSA ASSESSES GEOGRAPHICAL BSE RISK
Date: Fri, 1 Oct 2004 15:56:26 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE


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

EFSA ASSESSES GEOGRAPHICAL BSE RISK

BSE/TSE: A Degenerating Brain Disease
According to the World Health Organization
(WHO), transmissible spongiform
encephalopathies, known as TSEs, are a
family of diseases in humans and animals
characterised by spongy degeneration of
the brain.
Different strains of TSE affect different animals.
Scrapie is common in sheep and
goats. White tail and mule deer as well as
Editorial by Herman KoŽter
EFSA
news 1
p1 Editorial by Herman KoŽter
p1-3 Feature Story: EFSA assesses
Geographical BSE Risk
p3 Brown Bag Lunch Meetings
p3-5 Scientific News
" Appointment of new Panel Members
" NDA Panel : Trans Fatty Acids
Press Briefing
" Report on EFSAs first Scientific
Colloquium
p5 Introduction to EFSAs Legal
Affairs Department
p6 Announcements
" Management Board: Re-election of
Chair and Vice-Chairs
" Advisory Forum Event
" 2nd EFSA Scientific Colloquium
Contents
In the late 1990s, Bovine Spongiform
Encephalopathy (BSE), or mad cow disease,
made the headlines daily as scientists,
health authorities, legislators, farmers and
consumers tried to cope with one of the
most significant food scares to impact
Europe in the last decade. The BSE crisis
and other food scares undermined consumer
confidence and triggered the
complete overhaul of EU food safety policy.
A new comprehensive and integrated
approach to food safety was laid down in
the White Paper on food safety. This new
policy called for the separation of risk
assessment from risk management through
the creation of a new scientific body
charged with providing independent and
objective advice concerning risks associated
with the food chain, paving the way for the
establishment of the European Food Safety
Authority in January 2002. In order to manage
risks more effectively and ensure the
highest level of consumer protection, over
80 different legislative measures were proposed
based on a farm to fork approach.
In order to address the emergence of mad
cow disease, the European Commission
introduced a comprehensive set of stringent
Community measures to prevent, control and
eradicate transmissible spongiform
encephalopathies (TSEs) including BSE.
Regulation Number 999/2001 establishes
measures to limit the spread of the disease
and monitor the trade of live animals and
animal products.
Annex II of the Regulation describes a
process for determining a countrys BSE status.
The first step involves the initial risk
analysis, called Geographical Bovine
Spongiform Encephalopathy Risk or GBR.
In addition, criteria such as: training of veterinarians
and personnel involved in animal
trade and slaughter; reporting and examination
of animals showing signs of BSE; level
of BSE surveillance and monitoring; and
laboratory analysis of samples collected are
utilised to determine the BSE status of a
given country.
Herman KoŽter
EFSAs Deputy Executive Director
and Director of Science
BSE/TSE Assessment Team
continued on page 2
EFSA
news 2
Rocky Mountain elk can contract chronic
wasting disease. Bovine spongiform
encephalopathy (BSE) is a disease of the
brain in cattle. It is now generally assumed
that its human equivalent, variant
Creutzfeldt-Jacob Disease (vCJD), is caused
by transmission of BSE to humans.
BSE is a fatal disease which has an average
incubation period of four to five years. The
cause of the disease is still being debated;
however strong evidence supports the theory
that the agent causing the disease is
composed largely, if not entirely, of an
abnormally folded protein, called a prion,
which converts the normal form of the host
protein into the pathological form. It is transmitted
to cattle through feeding of
BSE-contaminated meat and bone meal
supplements.
EFSAs BSE/TSE Assessment Team
In 2003, the European Commission (EC)
asked the European Food Safety Authority
(EFSA) to reassess the Geographical Bovine
Spongiform Encephalopathy Risk (GBR) for
13 different countries: Australia, Botswana,
Canada, Costa Rica, El Salvador, Nicaragua,
Namibia, Norway, Mexico, Panama,
Swaziland, Sweden and the United States.
GBR is a qualitative indicator of the likelihood
that one or more cattle are infected
with BSE, pre-clinically as well as clinically,
at a given point in time, in a specific coun-
EFSA assesses Geographical BSE Risk (continued from page 1)
try. Where the presence of BSE is confirmed,
the GBR gives an indication of the
level of infection.
To carry out this task, EFSAs Scientific
Expert Working Group on the assessment of
GBR analyses the most up-to-date scientific
data. The TSE/BSE unit at EFSA assists, provides
scientific support and co-ordinates
the GBR evaluations carried out by external
scientific experts. The EFSA team is led by
veterinarian, Dr. Bart Goossens. Ir. Rozenn
Saunier (microbiologist) and Dr. Wolfgang
Gelbmann (veterinarian) provide further scientific
support to the expert working group.
Administrative assistance is ensured by
Angela Cohen and Radika Potier.
GBR Assessment
The first priority of EFSAs Scientific Expert
Working Group was to assess countries with
no TSE-related import restrictions to the EU,
ie the GBR I countries. The second priority
was to determine the GBR of major EU trading
partners classified as GBR II. Although
the European Commission did not specifically
request a GBR assessment for South
Africa, the working group decided to do so
as it was required in order to carry out
those requested for three other countries in
the Southern African Region: Botswana,
Namibia, Swaziland.
BSE Risk Re-assessed for Seven
Countries
In August, EFSAs Scientific Expert Working
Group on Geographic BSE risk assessment
issued seven scientific reports for Australia,
Canada, Mexico, Norway, South Africa,
Sweden and the United States of America.
These assessments, which are based on the
most recent scientific evidence, have concluded
that Australia remains at GBR level I,
meaning that the presence of BSE in
domestic cattle is highly unlikely.
Norway has been raised to level II, which
means that the presence of BSE is unlikely,
but not excluded. Sweden is unchanged at
level II, while Canada and the United States
have been raised to level III, which means
the presence of BSE is likely, but not confirmed,
or confirmed at a lower level. The
group also evaluated the status of Mexico
and South Africa, both classified as level III.
The GBR assessments for the remaining
countries will be finalised by the end of
2004.
Presence of one or more cattle clinically
or pre-clinically infected with the BSE agent in a
geographical region/country
Highly unlikely
Unlikely but not excluded
Likely but not confirmed or confirmed at a lower level
Confirmed at a higher level
GBR of the Country/Region
Current status (status before)
Australia (I)
Norway (I), Sweden (II)
Canada (II), Mexico (N/A), South
Africa (N/A), USA (II)
GBR level
I
II
III
IV
The full reports of the GBR assessments conducted to date can be found
in the Science section of the EFSA website,
under Scientific Reports at:
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/catindex_en.html
Additional information on GBR can be found at:
http://www.efsa.eu.int/press_room/press_release/575_en.html
continued on page 3
EFSA assesses Geographical BSE Risk (continued from page 2)
BSE/TSE Testing
The testing of animals for BSE using a post
mortem laboratory test is required to obtain
a complete picture of the epidemiological
situation of the disease in cattle. Apart from
the removal of specified risk materials
(SRMs like spinal cord, brain, eyes, parts of
the intestines&) from cattle, sheep and
goats - a measure which reduces up to
99% of TSE infectivity - TSE testing in animals
is another important means of
preventing entry of TSEs into the human
food chain. Following a mandate from the
European Commission, EFSA has set up a
Scientific Expert Working Group on TSE
testing which is evaluating new, rapid TSE
post mortem tests for cattle and sheep as
well as proposals for TSE tests on live animals.
The availability of a rapid and
accurate diagnostic ante mortem test would
be a major advance in dealing with the
problem of BSE and TSEs in general. With
regard to epidemiological screening, it
might in the future offer the possibility of
reducing the number of animals to be culled
(ie killed and destroyed so as to remove
them from the food chain) after detection of
one BSE-positive animal in the herd.
However, in order to ensure consumer protection,
any BSE test performed on live
animals should be as reliable as the currently
approved post mortem tests.
EFSAs Scientific Expert Working Group on
TSE testing has recently published two
opinions on the design of a field trial protocol
for the evaluation of new rapid BSE post
mortem tests and for BSE testing in live animals.
?
Both of these reports are published on the EFSA website at:
http://www.efsa.eu.int/science/efsa_scientific_reports/bse_t
se/catindex_en.html

http://www.efsa.eu.int/press_room/efsa_journal_2004/efsa_news_september2004/636/efsanews-09en1.pdf

TSS

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


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 Nį 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 90ís 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

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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