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From: TSS ()
Subject: Japan finds a new possible case of mad cow disease
Date: May 11, 2005 at 9:26 am PST

-------- Original Message --------
Subject: Japan finds a new possible case of mad cow disease
Date: Wed, 11 May 2005 11:36:16 -0500
From: "Terry S. Singeltary Sr."
To: BSE-L


Japan finds a new possible case of mad cow disease


12:13 2005-05-11

you must applaud Japan for it's BSE/TSE surveillance.

they seem to be trying to find BSE/TSE in there cattle,

a far cry from what the USA is doing (just the opposite)...


TSS


Japan finds a new possible case of mad cow disease


12:13 2005-05-11

A cow in northern Japan has tested positive for mad cow disease in a
preliminary test, and its samples are being sent to university
laboratories to try to confirm the infection, a state official said
Wednesday.

If confirmed, it would be the nation's 18th case of the fatal
brain-wasting disease, said Toshinobu Tanabe, an official in Hokkaido
prefecture in charge of dairy industry.

Preliminary tests on the cow turned up positive on Tuesday at a
slaughter house in Hokkaido, an island in Japan's far north, Tanabe
said. But the animal's age and other details were not immediately known,
he said.

Samples taken from the cow were sent Wednesday to two university
laboratories in Hokkaido for more precise testing, he said. Final
results from the secondary test are expected within several days.

Japan confirmed its first human case of mad cow disease in February
after a man with symptoms of the illness died.

Tokyo has checked every slaughtered cow before it enters the food supply
since 2001, after its first discovery of mad cow disease, known formally
as bovine spongiform encephalopathy.

Japan banned U.S. beef imports after the first case of mad cow was
confirmed there last December.

Under pressure from Washington, Japan's Food Safety Commission recently
backed moved to relax domestic safety standards and exclude tests on
cattle younger than 21 months, a step that could lead to a partial
lifting of the ban. Officials still have to examine the safety of U.S.
beef imports before making a final decision.

Eating beef from an infected cattle is thought to cause the fatal human
variant Creutzfeldt-Jakob disease.

AP

http://newsfromrussia.com/science/2005/05/11/59683.html


Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 13 -
On the basis of the available information, it has to be concluded that the country's
BSE/cattle system was extremely unstable until today, i.e., it would have recycled and
amplified BSE-infectivity very fast, should it have entered the system. The stability of the
BSE/cattle system in Canada overtime is as given in table 5 above.
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenges
In conclusion, the stability of the Canada BSE/cattle system in the past and the external
challenges the system has coped with are summarised in the table 6.
INTERACTION OF STABILITY AND EXTERNAL CHALLENGE IN CANADA
Period Stability External Challenge Internal challenge
1980 to 1990 Low Unlikely but not excluded
1991 to 1995 High
1996 to 2000 Extremely high
Likely and rapidly growing
2001 to 2003
Extremely
unstable
Very high Confirmed at a lower level
Table 6: Internal challenge resulting from the interaction of the external challenge and stability. The
internal challenge level is determined according to guidance given in the SSC-opinion on the GBR of
July 2000 (as updated in 2002).
From the interaction of the two parameters stability and external challenge a
conclusion is drawn on the level of internal challenge that emerged and had to be met
by the system, in addition to external challenges that occurred.
An external challenge resulting from cattle import could only lead to an internal
challenge once imported infected cattle were rendered for feed and this contaminated
feed reached domestic cattle. Cattle imported for slaughter would normally be
slaughtered at an age too young to harbour plenty of BSE infectivity or to show signs,
even if infected prior to import. Breeding cattle, however, would normally live much
longer and only animals having problems would be slaughtered younger. If being 4-6
years old when slaughtered, they could suffer from early signs of BSE, being
approaching the end of the BSE-incubation period. In that case, they would harbour,
while being pre-clinical, as much infectivity as a clinical BSE case. Hence cattle imports
could have led to an internal challenge about 3 years after the import of breeding cattle
(that are normally imported at 20-24 months of age) that could have been infected prior
to import. In case of Canada this implies that cattle imported in the mid eighties could
have been rendered in the late eighties and therefore led to an internal challenge in the
early 90s.
On the other hand imports of contaminated MBM would lead to an internal challenge in
the year of import, if fed to cattle. The feeding system is of utmost importance in this
context. If it could be excluded that imported, potentially contaminated feed stuffs
reached cattle, such imports might not lead to an internal challenge at all. In case of
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 14 -
Canada this implies that it was possible that imported MBM reached domestic cattle and
lead to an internal challenge in the early 90s.
4.2 Risk that BSE infectivity entered processing
A certain risk that BSE-infected cattle entered processing in Canada, and were at least
partly rendered for feed, occurred in the early 1990s when cattle imported from UK in
the mid 80s could have been slaughtered. 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.
4.3 Risk that BSE infectivity was recycled and propagated
A risk that BSE-infectivity was recycled and propagated exists since a processing risk
first appeared; i.e. in the early 90s. Until today this risk persists and increases fast
because of the extremely unstable BSE/cattle system in Canada.
5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK
5.1 The current GBR as function of the past stability and challenge
The current geographical BSE-risk (GBR) level is III, i.e. it is confirmed at a lower level
that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
This assessment deviates from the previous assessment (SSC opinion, 2000) because at
that time several exporting countries were not considered a potential risk.
5.2 The expected development of the GBR as a function of the past and
present stability and challenge
" As long as the system remains unstable, it is expected that the GBR continues to
grow, even if no additional external challenges occur.
" Since recent improvements in the safety of MBM production in many countries or
significant recent reductions in the incidence of BSE are not taken into account for
the assessment of the external challenge, the external challenge assessed after 2001
could be overestimated and is the worst case assumption. However all current GBR
conclusions are not dependent on these assumptions in any of the countries assessed.
For future assessments and when the impact of the production, surveillance and true
incidence changes has been fully quantified, these developments should be taken
into account.
5.3 Recommendations for influencing the future GBR
" Enhancing the stability of the system, in particular by ensuring that cattle have no
access to mammalian MBM in combination with appropriate rendering and exclusion of
SRM and fallen stock from any feed chain could lead, over time, to a reduction of the
GBR.
" Improved passive and active surveillance, i.e. sampling of animals not showing
signs compatible with BSE from at-risk cattle populations, such as adult cattle in fallen stock and emergency slaughter, by means of rapid screening, would allow
monitoring the efficiency of stability enhancing measures.... snip...end

CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf


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


What GAO Found
United States Government Accountability Office
Why GAO Did This Study
Highlights
Accountability Integrity Reliability
www.gao.gov/cgi-bin/getrpt?GAO-05-101.
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact Robert A.
Robinson at (202) 512-3841 or
robinsonr@gao.gov.
Highlights of GAO-05-101, a report to
congressional requesters
February 2005
MAD COW DISEASE
FDA"s Management of the Feed Ban Has
Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness
FDA has made needed improvements to its management and oversight of the
feed-ban rule in response to GAO"s 2002 report, but program weaknesses
continue to limit the effectiveness of the ban and place U.S. cattle at risk of
spreading BSE. Improvements made include FDA establishing a uniform
method of conducting compliance inspections and training FDA inspectors,
as well as state inspectors who carry out inspections under agreements with
FDA, on the new method. FDA also implemented new data-entry procedures
that are designed to more reliably track feed-ban inspection results.
Consequently, FDA has a better management tool for overseeing compliance
with the feed-ban rule and a data system that better conforms to standard
database management practices. However, various program weaknesses
continue to undermine the nation"s firewall against BSE. For example:
⬢ FDA acknowledges that there are more feed manufacturers and
transporters, on-farm mixers, and other feed industry businesses that are
subject to the feed ban than the approximately 14,800 firms inspected to
date; however, it has no uniform approach for identifying additional
firms.
⬢ FDA has not reinspected approximately 2,800, or about 19 percent, of
those businesses, in 5 or more years; several hundred are potentially
high risk. FDA does not know whether those businesses now use
prohibited material in their feed.
⬢ FDA"s feed-ban inspection guidance does not include instructions to
routinely sample cattle feed to test for potentially prohibited material as
part of the compliance inspection. Instead, it includes guidance for
inspectors to visually examine facilities and equipment and review
invoices and other documents.
⬢ Feed intended for export is not required to carry a caution label SDo not
feed to cattle or other ruminants,⬝ when the label would be required if
the feed were sold domestically. Without that statement, feed containing
prohibited material could be inadvertently or intentionally diverted back
to U.S. cattle or given to foreign cattle.
⬢ FDA has not always alerted USDA and states when it learned that cattle
may have been given feed that contained prohibited material. This lapse
has been occurring even though FDA"s guidance calls for such
communication.
⬢ Although research suggests that cattle can get BSE from ingesting even a
small amount of infected material, inspectors do not routinely inspect or
review cleanout procedures for vehicles used to haul cattle feed.
More than 5 million cattle across
Europe have been killed to stop the
spread of bovine spongiform
encephalopathy (BSE), commonly
called mad cow disease. Found in
26 countries, including Canada and
the United States, BSE is believed
to spread through animal feed that
contains protein from BSE-infected
animals. Consuming meat from
infected cattle has also been linked
to the deaths of about 150 people
worldwide. In 1997, the Food and
Drug Administration (FDA) issued
a feed-ban rule prohibiting certain
animal protein (prohibited
material) in feed for cattle and
other ruminant animals. FDA and
38 states inspect firms in the feed
industry to enforce this critical
firewall against BSE. In 2002, GAO
reported a number of weaknesses
in FDA"s enforcement of the feed
ban and recommended corrective
actions. This report looks at FDA"s
efforts since 2002 to ensure
industry compliance with the feed
ban and protect U.S. cattle.
What GAO Recommends
GAO recommends FDA, among
other things, develop procedures
for finding additional firms subject
to the feed-ban and using tests to
augment inspections. FDA said the
study was thorough but disagreed
on four of nine recommendations.
GAO continues to believe that,
given the discovery of BSE in North
America and the oversight gaps
described in the report, the
recommended actions are needed
to protect U.S. cattle from BSE.


3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,
but Oversight Weaknesses Continue to Limit Program Effectiveness.
GAO-05-101, Feb. 25.
http://www.gao.gov/cgi-bin/getrpt?GAO-05-101
Highlights - http://www.gao.gov/highlights/d05101high.pdf

Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

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

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.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 77518




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