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From: TSS ()
Subject: Follow up on the result of the audit of the FSIS to the Mexican system of inspection
Date: March 16, 2005 at 12:46 pm PST

-------- Original Message --------
Subject: Follow up on the result of the audit of the FSIS to the Mexican system of inspection
Date: Wed, 16 Mar 2005 13:02:31 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@KALIV.UNI-KARLSRUHE.DE


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

Greetings list members,

WHY is it that of all the submissions by Countries of there potential
risk of BSE/TSE, MEXICO DID NOT SUBMIT there BSE
GBR risk assessment ???

COULD it be that there system is even worse than that of
USA or CANADA ???

ONE would have to wonder why MEXICO REFUSED to submit
material for a BSE GBR risk assessment and wonder just what MEXICO
is trying to hide by NOT submitting this information.

FINALLY THE EFSA HAD TO asked the European Commission (EC) to provide an
up-to-date scientific report on the GBR in Mexico.

JAPAN did not submit data either (or at least i have found no BSE GBR
risk assessment for JAPAN OR MEXICO), and we see what happened
with JAPAN, there country was indeed infected with BSE. ...TSS


Tuesday March 15 2005

Follow up on the result of the audit of the FSIS to the Mexican system
of inspection


The 18 of January of 2005, the Food Safety and Inspection Services
(FSIS) notified the National Service of Health, Inocuidad and Calidad
Agroalimentaria (SENASICA) that as result of the carried out audit has
recovered the confidence in the equivalence of the inspection systems,
giving like consequence the rise of the suspension on the elegibilidad
of México to consider and to enlist establishments that wish to export
beef products to the United States of America. At the moment the FSIS
has lapsed the re-inspection to the 100% in the entry points of
originating Mexican beef products of the establishments that at this
moment are approved to export to the United States of America.During
January of 2005, one transmitted to establishments TIF the requirements
that are needed to be able to reenlist to the establishments that wish
to export beef products to the United States of America.To the date they
have been begun to receive the plans of Anélisis de Peligros and
Critical Puntos of Control (HACCP) and Operational Procedure Esténdar de
Sanitización (POES) of some of the interested companies, which take
different degrees from advance. It is possible to mention that the
SENASICA I will only enlist establishments that fulfill the norms
exactly. This it was the profit of an arduous work of almost two years
continuous, that must be maintained and be improved, being a joint
responsibility of the beef industry and the Federal Government.In the
same way it is necessary to stand out that of the 28 of February to the
15 of March of the present year, personnel of the FSIS I will make a new
audit to verify that fulfillment to the made observations has occurred
to the audited establishments, as well as verifying the possible new
establishments that are enlisted.

http://web2.senasica.sagarpa.gob.mx/xportal/sen/qesen/Doc1647/

> At the moment the FSIS has lapsed the re-inspection to the 100% in the
> entry points of originating Mexican beef products of the
> establishments that at this moment are approved to export to the
> United States of America.

SOME FACTS this and other reports by the FSIS fail to mention ;

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Mexico
Last updated: 08 September 2004

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

* 169 kB Report


* 109 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 Mexico,
i.e. the likelihood of the presence of one or more cattle being infected
with BSE, pre-clinically as well as clinically, in Mexico. This
scientific report addresses the GBR of Mexico as assessed in 2004 based
on data covering the period 1980-2003.

The BSE agent was probably imported into Mexico and could have reached
domestic cattle. These cattle imported could have been rendered and
therefore led to an internal challenge in the mid to late 1990s. It is
possible that imported meat and bone meal (MBM) into Mexico reached
domestic cattle and leads to an internal challenge around 1993.

It is likely that BSE infectivity entered processing at the time of
imported at - risk MBM (1993) and at the time of slaughter of imported
live at - risk cattle (mid to late 1990s). The high level of external
challenge is maintained throughout the reference period, and the system
has not been made stable. Thus it is likely that BSE infectivity was
recycled and propagated from approximately 1993. The risk has since
grown consistently due to a maintained internal and external challenge
and lack of a stable system.

EFSA concludes that the current geographical BSE risk (GBR) level is
III, i.e. it is likely but not confirmed that domestic cattle are
(clinically or pre-clinically) infected with the BSE-agent. The GBR is
likely to increase due to continued internal and external challenge,
coupled with a very unstable system.

Publication date: 20 August 2004

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/565_en.html

Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 1 -
European Food Safety Authority
Scientific Expert Working Group on GBR
Working Group Report on
the Assessment of the Geographical BSE-Risk (GBR) of
MEXICO
2004
NOTE TO THE READER
Independent experts of the EFSA Scientific Expert Working Group on
GBR have produced this report, applying an innovative methodology
by a complex process to data that were supplied by the responsible
country authorities. Both, the methodology and the process are
described in detail in the final opinion of the Scientific Steering
Committee (SSC) on "the Geographical Risk of Bovine Spongiform
Encephalopathy (GBR)" of 6 July 2000 and its update of 11 January
2002. These opinions are available at the following Internet address:

Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 2 -
1. DATA
" The available information was sufficient to carry out the qualitative
assessment of
the GBR.
" Reasonable worst case assumptions have been used in cases were the
available
information was not complete.
Sources of data
" Country dossier (CD) consisting of information provided from the countrys
authorities in 2001  2004.
Other sources:
" EUROSTAT data on export of "live bovine animals" and on "flour, meal and
pellets of meat or offal, unfit for human consumption; greaves" (customs
code
230110), covering the period 1980 - 2003.
" United Kingdom - export data (UK) on "live bovine animals" and on
"Mammalian
Flours, Meals and Pellets" (MBM1), 1980 - 1996.
" Available export data from BSE - risk countries.
" FAO Expert Consultation Mission, May 2003 (FAO TCP/RLA/0177): Evaluation
and reinforcement of the Prevention System for the Bovine Spongiform
Encephalopathy (BSE) and the Animal Feed Control System.
2. EXTERNAL CHALLENGES
2.1 Import of cattle from BSE - Risk2 countries
An overview of the data on live cattle imports is presented in table 1
and is based on
data as provided in the country dossier (CD) and corresponding data on
relevant
exports as available from BSE risk countries that exported to Mexico.
Only data from
risk periods are indicated, i.e. those periods when exports from a BSE
risk country
already represented an external challenge, according to the SSC opinion
on the GBR
(SSC July 2000 and updated January 2002).
The CD notes that imports of 70 dairy cattle from UK were planned in
1984, but these
animals were not imported because of Foot and Mouth Disease (FMD)
regulations.
Neither Eurostat nor UK export data indicate that these exports actually
took place,
and therefore they are not included in the final assessment.
1 For the purpose of the GBR assessment the abbreviation MBM refers to
rendering products, in
particular the commodities Meat and Bone Meal as such; Meat Meal; Bone
Meal; and Greaves. With
regard to imports it refers to the customs code 230110 flours, meals
and pellets, made from meat or
offal, not fit for human consumption; greaves.
2 BSE-risk countries are all countries already assessed as GBR III or IV
or with at least one confirmed
domestic BSE case.
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 3 -
Eurostat records show that Mexico imported 995 cattle from other
European BSE risk
countries, mostly from Spain (823). There was reasonable agreement between
Eurostat and the CD, which records 1182 imports. The CD provides
information on
the fate of some imports from Spain, which would not have posed a
challenge. These
were bullfighting breeds and all but 152 animals could be traced (the
majority still
being alive). The CD also considers the few imports from Germany and the
Netherlands unlikely to have taken place due to FMD in Europe, but
documentation to
support this is not provided, hence they are not excluded from the
possible challenge.
Additionally, cattle imported from Denmark, France and Switzerland were
assessed as
possible risk.
The CD indicates large numbers of cattle imported from USA (~ 2.3
million since the
beginning of the risk period in 1993) and Canada (~ 125,000 since the
beginning of
the risk period in 1993).
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of
the Geographical BSE Risk of Mexico
- 4 -
Country: Live cattle imports, raw data
MEXICO Data 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99
0 1 2 3
TOTALS
(R1&R2)
Canada CD 1532 104 5547 8241 404 534 426 1515 7762 16665 3139 8687 26538
18560 17226 14576 11718 5678 3228 136656
other 110 149 432 114 167 972
Denmark CD 209 55 264
other 0
France CD 0
other 9 9
Germany CD 0
other 136 136
Netherlands CD 0
other 27 27
Spain CD 91 804 895
other 91 732 823
Switzerland CD 23 23
other 0
USA CD 46401 7532 136155 102273 54945 38054 18234 32204 330761 163 214
40041 12306 427268 510242 342081 301095 297089 248254 69932 25508 2748391
other 64226 210344 251237 76854 128636 14641 115289 236392 159081 100481
126873 143769 1627823
UK CD
other
TOTALS
non UK CD 0 0 47933 7636 141702 110514 55372 38588 18660 33719 338523
163 214 0 56706 15445 436046 537793 360696 318321 311665 259972 75610
28736 3194014
other 0 0 0 0 0 9 0 0 0 0 64226 210344 251237 76854 128799 14641 115380
237124 159081 100591 127022 144201 114 167 1629790
UK CD 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
other 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Table 1: Live cattle imports into Mexico (CD) and corresponding exports
from BSE - risk countries. Source for export data: Eurostat and UK
export statistics and,
where available, export statistics from other BSE - risk countries.
Note: Only imports in risk periods (shaded) are taken into account for
assessing the external challenge. Risk
periods are defined according to the SSC opinion of January 2002. The
numbers shown in the table are the raw import figures and are not
reflecting the adjusted imports for the
assessment of the external challenge.
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 5 -
2.2 Import of MBM or MBM - containing feedstuffs from BSE - Risk
countries
An overview of the data on MBM imports is presented in table 2 and is
based on data
provided in the country dossier (CD) and corresponding data on relevant
exports as
available from BSE risk countries that exported to Mexico. Only data
from risk
periods are indicated, i.e. those periods when exports from a BSE risk
country already
represented an external challenge, according to the SSC opinion on the
GBR (SSC,
July 2000 and updated January 2002).
The CD only provides import information on MBM since 1996. According to the
CD, Eurostat and UK export statistics, no imports of MBM have taken
place from
UK. From other European countries, the CD records 1 ton from NL, 1707 tons
from Denmark (1996 - 1999) and Eurostat records 0.4 tons from France.
Large amounts of MBM were imported from USA {according to the CD: ~ 670,000
tons since the beginning of the risk period in 1993; according to USA
export data:
690,000 between 1993 and 2001 only (2002 and 2003 data unavailable)} and
Canada
(~ 153,000 tons according to the CD since the beginning of the risk
period in 1993).
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of
the Geographical BSE Risk of Mexico
- 6 -
Table 2: MBM imports into Mexico (CD) and corresponding exports from BSE
- risk countries. Source for export data: Eurostat and UK export
statistics and, where
available, export statistics from other BSE - risk countries. Note: Only
imports in risk periods (shaded) are taken into account for assessing
the external challenge. Risk periods
are defined according to the SSC opinion of January 2002. The numbers
shown in the table are the raw import figures and are not reflecting the
adjusted imports for the assessment
of the external challenge
Country: MBM imports, raw data
MEXICO Data 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99
0 1 2 3
TOTALS
(R1 & R2)
Canada CD 111 53 250 2689 5762 5033 59519 79825 153242
other 0
Denmark CD 34 1284 239 150 1707
other 0
France CD 0
other 0,2 0,2 0,4
Netherlands CD 1 1
other 0
USA CD 18339 26577 5287 47253 44104 30368 283728 215530 671186
other 40263 51863 52189 81200 65063 67193 66183 77614 65653 98136 94106
80851 78830 919144
UK CD
other
TOTALS
non UK CD 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 18484 27914 5776 50092 49866
35402 343247 295355 826136
other 0 0 0 0 0 0 0 0 0 40263 51863 52189 81200 65063 67193 66183 77614
65653 98136 94106 80851 78830 0 0 919144
UK CD 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
other 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 7 -
2.3 Overall assessment of the external challenge
The level of the external challenge that has to be met by the BSE/cattle
system is
estimated according to the guidance given by the SSC in its final
opinion on the GBR
of July 2000 (as updated in January 2002).
Live cattle imports:
According to the CD the country imported in total over the period 1980
to 2003,
approximately 3.2 million live cattle from BSE - risk countries, of
which conclusively
none came from the UK. The numbers shown in table 1 are the raw import
figures
and are not reflecting the adjusted imports for the assessment of the
external
challenge. Broken down to 5 - years periods the resulting external
challenge is as
given in table 3. This assessment takes into account the evidence that
certain
imported cattle did not enter the domestic BSE/cattle system, i.e. were
not rendered
into feed. In the case of Mexico, it is assumed that cattle still
alive (imports from
Spain) did not enter the rendering system.
MBM imports:
According to the CD the country imported in total over the period 1980 -
2003
approximately 826,000 tons MBM from BSE - risk countries (according to
other
data: ~ 919,000 tons), of which none came from the UK. The numbers shown in
table 2 are the raw import figures and are not reflecting the adjusted
imports for the
assessment of the external challenge. Broken down to 5 - years periods
the resulting
external challenge is as given in table 3. This assessment takes into
account the
evidence that certain imported MBM did not enter the domestic BSE/cattle
system or
did not represent an external challenge for other reasons. However, in
the case of
Mexico, there was not sufficient evidence to remove any quantities of
MBM from the
external challenge.
External Challenge experienced by MEXICO
External challenge Reason for this external challenge
Period Overall Level Cattle imports MBM imports Comment
1980 to 1985
1986 to 1990
Negligible
Negligible
Negligible
1991 to 1995 Very high
High Very high
Due to MBM imports
from USA since 1993
and cattle imports
from USA/Canada
since 1994
1996 to 2000 Extremely high Due to imports from
USA / Canada
2001 to 2003
Extremely high
Very high
Extremely high Due to imports from
USA / Canada
Table 3: External challenge resulting from live cattle and/or MBM
imports from the UK and other
BSE - risk countries. The challenge level is determined according to the
SSC - opinion on the GBR of
July 2000 (as updated in January 2002).
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 8 -
On the basis of the available information, the overall assessment of the
external
challenge is as given in the table above.
3. STABILITY
3.1 Overall appreciation of the ability to avoid recycling of BSE
infectivity, should it enter processing
Feeding
Use of MBM in cattle feed
Until 11th October 2000, MBM could and was legally included in cattle feed.
Feed bans
The law prohibiting the use of ruminant MBM in ruminant feed was
published on 11th
October 2000. According to the FAO mission, implementation of the ban
began in
2002.
Potential for cross - contamination and measures taken against
In feed mills, lines are not always separated. According to the CD
flushing is used to
clean in - between lines, and feed mills carry out in - house controls.
According to the
CD, controls during transport and on farms are not regularly carried
out, but
inspections may occur on the farm. No details are provided on the kind
or frequency
of these control measures, the dates checking of cross contamination
began, or on the
results of these inspections.
Control of feed bans and cross - contamination
According to the CD, checks occur to ensure that plants do not use
ruminant MBM in
feed stuff production for ruminants. This may have been helped by
regulations
defined in 1999 that allowed ruminant feed production to use MBM only from
rendering plants that do not process ruminant material. However,
detailed outcomes of
control procedures, tests carried out or quality control are not provided.
It is concluded that cross contamination is possible.
Rendering
" A rendering industry exists in Mexico and raw bovine materials are
normally
rendered. This includes fat tissue, bones, horns and hooves but not
usually viscera,
eyes, brains or spinal cords. About 90 % of the rendered material is of
bovine
origin and the rest consists mainly of pork material. 58 plants produce
MBM, with
an annual production of between 150,000 and 250,000 tons per year. It is
estimated that about 6 % was destined for bovines in 2000.
" The rendering process standard (133° C/20min/3bar) is not applied.
According to the
CD, there are guidelines in place so that the standard process will be
used in the
event that a BSE case is discovered.
" According to the CD, regulations were introduced in 1999 to ensure
that the
processing of animal offal and its employment in animal food took place
in two
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 9 -
plant types: 1). plants processing material of ruminant origin plus
other species
(such as pig) and 2). plants processing only non-ruminant material. Plants
corresponding to the first category are prohibited from the preparation of
foodstuffs intended for ruminants. The fulfillment of this procedure is
checked
annually through veterinarians. Specific results of checking procedures
are not
supplied in the CD.
Specified Risk Material (SRM) and fallen stock
There is no SRM-ban. SRM is normally destined for human consumption.
According
to the CD, fallen stock from pasture and diseased animals are
incinerated and not
rendered.
Conclusion on the ability to avoid recycling
In light of the above information, it has to be assumed that the BSE
agent, should it
have entered Mexico, could have been recycled and potentially amplified.
3.2 Overall appreciation of the ability to identify BSE - cases and to
eliminate animals at risk of being infected before they are
processed
Cattle population structure
Detailed information is provided in the CD on the cattle population and
their
husbandry system. Approximately 30 million cattle is the national
population of
which the majority is for beef production, and approximately 6 % dairy.
Approximately 34 % of animals are over 24 months old. In dairy cattle,
59 % of the
milk production is derived from intensive production.
The average age and weight at slaughter varies according to rearing
system. Slaughter
tends to occur at approximately 3 years on extensive pasture, 2 years on
semiintensive,
1.3 years on intensive fattening, 6 - 7 years for dairy cows and 10
years for
breeding cows.
BSE surveillance
Notification of BSE is compulsory since 21 September 1994.
Awareness/training
measures were initially put in place in 1994 and increased in intensity
since 1997
(leaflets, training scheme on BSE - related issues, sampling manual).
Laboratory
personnel have been trained since 1997 in surveillance, diagnostic
techniques and risk
management in Mexico but also in Canada and USA. Since November 1998 a
trilateral agreement (Mexico - USA - Canada) on an exchange program in
relation to
BSE has been set up, that focuses on diagnostics and surveillance.
The methods used for BSE suspects are described. Since the end of 1996,
histopathology has been used. Together with Canada and USA, a project on
immunohistochemistry as a diagnostic technique has been jointly set up,
and the same
monoclonal commercial antibodies will be used in the three countries.
In the years 1996 to 2003, a total of 2047 animals have been tested for
BSE (1726 >
29 months of age), with active surveillance in place since 1997. Since
2000, some
fallen stock has also been targeted. No positive test results have occurred.
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 10 -
The CD describes a program for increased BSE surveillance beginning in 2004
(Program of Epidemiological Vigilance and Prevention of BSE for 2004).
This is a
programme developed in conjunction with the Commission of Mexico to the
United
States for the Prevention of Foot and Mouth Disease and other Exotic
Illnesses of
Animals.
3.3 Overall assessment of the stability
For the overall assessment of the stability, the impact of the three
main stability
factors (i.e. feeding, rendering and SRM - removal) and of the
additional stability
factor, BSE-surveillance, has to be estimated. The guidance provided by
the SSC in
its opinion on the GBR of July 2000 (as updated in 2002) is applied.
Feeding:
Feeding MBM to cattle was legally possible until October 2000 and the
information
provided indicates that it was common practice for both dairy and beef
cattle.
Therefore feeding was assumed to be not OK for the period 1980-2000.
The feed
ban is of ruminant MBM only and good evidence of its effectiveness is
not provided.
Therefore feeding remains not OK also for the period 2000-2003.
Rendering:
Rendering is and was common practice in Mexico. Ruminant material is
included,
excluding most SRM and most fallen stock. The process used was and is
not adequate
for reducing BSE - infectivity. Therefore rendering is assessed as
having been "not
OK" throughout the reference period (i.e. 1980-2003).
SRM-removal:
There is no SRM ban. However, SRM is consumed by humans and it does not
tend to
enter the feed chain and fallen stock and diseased animals are
incinerated. Hence
SRM-removal it is assessed as "reasonably OK" throughout the reference
period
(i.e. 1980-2003).
BSE surveillance
There is some passive and active BSE surveillance. However, given the
large cattle
population size, the BSE surveillance system in Mexico is insufficient.
Recent plans
have been introduced to increase surveillance efforts since 2004.
On the basis of the available information it has to be concluded that
the countrys
BSE/cattle system was and is very unstable. Incoming BSE - infectivity
would have
been recycled and quickly amplified. The stability of the BSE/cattle
system in Mexico
overtime is as given in table 4.
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 11 -
Stability of the BSE/cattle system in MEXICO over time
Stability Reasons
Period Level Feeding Rendering SRM removal
BSE
surveillance
1980 to 2003 Very unstable
Not OK
Not OK
Reasonably OK
1996  2003:
passive and
some active
surveillance
Table 4: Stability resulting from the interaction of the three main
stability factors and the BSE
surveillance. The stability level is determined according to the SSC -
opinion on the GBR of July
2000 (as updated in 2002).
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenges
In conclusion, the stability of the Mexico BSE/cattle system in the past
and the
external challenges the system has coped with are summarized in the
table 5 below.
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.
INTERACTION OF STABILITY AND EXTERNAL CHALLENGE IN MEXICO
Period Stability External Challenge Internal challenge
1980 to 1985
1986 to 1990
Negligible Highly unlikely
1991 to 1995 Very high
1996 to 2000
2001 to 2003
Very unstable
Extremely high
Likely to be present and growing
since 1993
Table 5: 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).
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 large amounts 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
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 12 -
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 Mexico this implies
that an
internal challenge caused by live cattle imports (predominantly from USA
or Canada)
first occurred in the mid to late 1990s and continued to the present.
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
Mexico this implies that an internal challenge caused by MBM imports
(predominantly from USA or Canada) first occurred around 1993 and
continued to the
present.
In view of the above - described consideration the combination of the
very / extremely
high external challenges with a very unstable system makes the
occurrence of an
internal challenge likely in Mexico from approximately 1993 onwards.
4.2 Risk that BSE infectivity entered processing
It is likely that BSE infectivity entered processing at the time of
imported at - risk
MBM (1993) and at the time of slaughter of imported live at - risk
cattle (mid to late
1990s). The high level of external challenge is maintained throughout
the reference
period, and the system has not been made stable, leading to increased
internal
challenge.
4.3 Risk that BSE infectivity was recycled and propagated
It is likely that BSE infectivity was recycled and propagated from
approximately
1993. The risk has since grown consistently due to a maintained internal
and external
challenge and lack of a stable system.
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 likely
but not confirmed
that domestic cattle are (clinically or pre-clinically) infected with
the BSE-agent.
5.2 The expected development of the GBR as a function of the past
and present stability and challenge
" The GBR is likely to increase due to continued internal and external
challenge,
coupled with a very unstable system.
" 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
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 13 -
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
" Measures that improve the stability of the system, will, over time,
reduce the
probability that cattle get infected with the BSE-agent. Possible
actions include
- strict removal of SRM and/or fallen stock from rendering,
- pressurized rendering processes,
- significant improvement of ban on use of ruminant MBM in cattle feed,
supported by regular sampling of such feed for the non-occurrence of MBM.
" 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 the stability enhancing measures.
Documentation provided to EFSA
" Letter with the ref D(2003)KVD/ip/420722 from the European
Commission requesting a geographical risk assessment for the
appearance of BSE in a country.
" Country Dossier as prepared by the country in response to the EC and
EFSA data collection request.
" Other sources of data information i.e. exports from third countries and
Eurostat data.
" SSC, July 2000. Final opinion on the Geographical Risk of Bovine
Spongiform Encephalopathy (GBR).
" SSC, January 2002. Updated opinion on the Geographical Risk of
Bovine Spongiform Encephalopathy (GBR).
Acknowledgment
Members of the EFSA Scientific Expert Working Group on GBR are acknowledged
for their valuable contribution to this mandate. The members are: Didier
Calavas,
Aline De Koeijer, Michael Gravenor, John Griffin, Dagmar Heim, Matthias
Kramer,
Riitta Maijala, Mo Salman, Vittorio Silano, Emmanuel Vanopdenbosch, and Stig
Widell.


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


Canadian Animal Health Consultative Committee Meetings
November 30 to December 4, 2003


Transmissible Spongiform Encephalopathies (TSEs):
Policy, Politics and Philosophy


Linda A. Detwiler, DVM
Adjunct Professor
University of Maryland
Animal Health Consultant

------------------------------------------------------------------------


Surveillance: Why do it?

* Is the disease present?
* Will tell you if prevention is successful
* Will tell you if control is working
* Buyer confidence
* Trade confidence

------------------------------------------------------------------------


BSE Surveillance

* Older animals (over 24 months)
* High risk - exposed to contaminated feed
* Neurologically ill cattle
* Fallen stock and emergency slaughter
* Dead of unknown cause
* herdmates of positive cases

------------------------------------------------------------------------


BSE Surveillance in the EU

* CNS cases
* Risk populations (fallen stock, emergency slaughter)
* Normal slaughter populations - average positive 005%
* Cost to find a postive in the normal slaughter population > $1 million

------------------------------------------------------------------------


UK Infection Rates

* Total animals affected - 182,346 (as of 10-31-03)
* Proportion of cattle herds affected - 38.3 %
* Proportion of dairy herds affected - 61.9%
* Proportion of beef herds affected - 17.4%
* Great Britain: 171.4 cases per million (Oct 02-Sept 03)
* NI: 94.2 cases per million (Oct 02-Sept 03)

------------------------------------------------------------------------
UK
Year Expected cases Range (passive) Actual (passive)
To end 1987 675
1988 2184
1992 36682
1993 34370
2001 504 353-655 781 (332 active)
2002 183 93-273 445 (594 A)
2003 (10-17) 57 7-107 129 (281 A)

------------------------------------------------------------------------
Country Size of adult herd (mill) Total cases since 86 Total in 2003
(10-31)
Austria 1.0 1 0
Belgium 1.5 115 12
Czech Republic 7 3
Denmark .9 13 2
Finland .4 1 0
France 11.1 875 120
Germany 6.3 285 42
Greece .3 1 0

------------------------------------------------------------------------
Country Size of adult herd (mill) Total cases since 86 Total in 2003
(10-31)
Ireland 3.2 1325 150
Israel 1 0
Italy 3.2 115 27
Japan 8 3
Netherlands 1.8 66 14
Poland 8 4
Portugal .8 823 98
Switzerland 449 18

* Sweden no cases found

------------------------------------------------------------------------
Country Adult cattle population Tests on at risk (CNS) Positives Jan-Aug 03
Austria 1.0 11,283 (2) 0 (0)
Belgium 1.5 25,182 4
Denmark .9 21,445 (32) 0 (1)
Finland .4 16,495 (5) 0 (0)
Germany 6.3 172,094 (521) 12 (6)
Greece .3 1557 (0) 0 (0)
France 11.1 189,131 (393) 60 (7)

------------------------------------------------------------------------
Country Adult cattle population Tests on healthy sltr Positives Jan-July 03
Austria 1.0 105,147 0
Belgium 1.5 203,297 7
Denmark .9 132,934 1
Finland .4 57,774 0
Germany 6.3 1,314,599 25
Greece .3 14,572 0
France 11.1 1,705,534 25

------------------------------------------------------------------------


That eighth case of BSE in Japan!

* 23 month Holstein steer (born Oct 2001)
* No overt clinical signs
* Slightly positive screening test (ELISA)
* Negative immunohistochemistry
* Positve western blot - banding pattern different
* Atypical?

------------------------------------------------------------------------


That ninth case of BSE in Japan!

* 21 month Holstein steer (born Jan 2001)
* No overt clinical signs
* Slightly positive screening test (ELISA) - repeated positive
* Negative immunohistochemistry
* Positive western blot - banding pattern same and first seven cases

------------------------------------------------------------------------


That eighth case of BSE in Japan!

* Explanation of the Diagnosis - location is critical
* Born at implementation of the ban
* Feeding history?
* Italy has 2 cases with different banding patterns

------------------------------------------------------------------------


The eighth and ninth cases of BSE in Japan!

We need more information

------------------------------------------------------------------------


BSE youngest animals detected in months (UK)

Year Age Year Age
1986 30,33 1995 24,32
1987 30,31 1996 29,30
1988 24,27 1997 37,37
1989 21,24 1998 34,36
1990 24,24 1999 39,39
1991 24,26 2000 40,42
1992 20,26 2001 48,48
1993 29,30 2002 51,52
1994 30,30 2003 50,62

------------------------------------------------------------------------


Actions in the EU and Japan

*

SRM ban from human food and animal feed

* Surveillance of healthy sltr and at risk
o EU mandatory : healthy sltr >30months (some countries 24
months); at risk 24 months
o Japan: all ages healthy sltr
o Prohibition on feeding animal MBM to food producing animals
(some exceptions)  taken because of cross contamination

------------------------------------------------------------------------


EU Geographical BSE Risk (GBR)

* I - highly unlikely to have BSE
* II - unlikley to have BSE but not totally excluded
* III - likely to have BSE but not yet detected OR BSE at low level
* IV - BSE at high level
* EFSA will take over classifications - near future

------------------------------------------------------------------------


OIE Code: Chapter on BSE (2.3.13)

Provides:

* Criteria to classify
* Status of countries (5 categories)
* Unrestricted products
* Recommendations to import live animals and products with restrictions
* Surveillance guidelines (Appendix 3.8.4)

------------------------------------------------------------------------


OIE Code: Chapter on BSE (2.3.13)

Criteria to classify:

Conduct risk assessment

* Potential for intro and recycling of MBM
* Potential for importation of contaminated MBM
* Potential for importation of infected animals
* Epidemiological situation concerning all animal TSEs
* Extent of knowledge of population structure
* origin and use of ruminant carcasses (including fallen stock),
by-products and slaughterhouse waste, the parameters of the
rendering processes and the methods of animal feed manufacture;

------------------------------------------------------------------------


OIE Code: Chapter on BSE (2.3.13)

Criteria to classify:

* Ongoing awareness program for industry to report disease
* Compulsory reporting of suspect BSE cases
* BSE surveillance program in accordance with Appendix for 7 years
* Actual examination of brain tissue in accordance with Manual

------------------------------------------------------------------------


OIE Code: Chapter on BSE (2.3.13)

* BSE status for a country:
* Free - no or all imported cases; criteria for 7 yrs
* Provisionally free - no or all imported cases; criteria not for 7 yrs
* Minimal Risk - last indigenous case more than 7 yrs; criteria not
for 7 yrs, MBM not for 8 yrs OR
last case less 7 yrs; less than 1 case/million last 4 years;
criteria for 7 yrs, MBM ban for 8 yrs

Progeny 2 yrs prior and after/cattle reared first yr with positive -
depopulated

------------------------------------------------------------------------


OIE Code: Chapter on BSE (2.3.13)

* Moderate - cases more than 1 per million and less than 100 cases
per million (cattle population over 2 and survives CNS) OR
Cases more than 1/million and less than 200 cases/million(cattle
population over 2 and survives CNS, at risk and healthy sltr)
Less than 1 case per million for less than 4 consecutive months OR
* High - not meet requirements of other categories

------------------------------------------------------------------------


OIE Code: Products Unrestricted trade

* Milk and milk products
* Semen and embryos (collected per IETS)
* Protein free tallow and derivatives
* Dicalcium phosphate
* Hides and skins
* Gelatin and collagen from hides and skins

------------------------------------------------------------------------


OIE Code: Other products

* Can be traded with restrictions:
* Live animals regardless of age
* Meat
* Tallow with protein
* Gelatin from bones
* Other bovine tissues
* Removal of SRMs
* Prohibited - ruminant MBM and SRMs from countries with BSE

------------------------------------------------------------------------


BSE in Canada: Lessons learned thus far

* It doesn't take much to introduce BSE into a country
* Identification is important
* Disposal issues can pose emergencies - need infrastructure

------------------------------------------------------------------------


BSE: Can it Happen in the US?

------------------------------------------------------------------------


And would it be found????

------------------------------------------------------------------------


A Warning shot by way of Canada

* Re-evaluation of risk
* Lessons learned
* Chance for further safety measures

------------------------------------------------------------------------


Formal Risk Assessments

USDA : Veterinary Services - 1991

Harvard School of Public Health
Tuskegee University - 1998

------------------------------------------------------------------------


Harvard / Tuskegee
Risk Assessment

* Describe potential pathways of BSE infectivity into national herd
or food supply
* Characterize and quantify steps in pathways
* Identify key steps for research or risk management
* Computer simulation model to predict spread if BSE entered USA

------------------------------------------------------------------------


Harvard / Tuskegee
Risk Assessment - Outcomes

* US is resistant to BSE
* Low human exposure potential - BUT some through SRMs and AMR
* Feed ban is key to protection - leaks will amplify

------------------------------------------------------------------------


How and Why can we say the Risk is Low

------------------------------------------------------------------------


Import Regulations

* Import Restrictions - countries with BSE
o July 1989 - live ruminants
o November 1989 - ruminant products
o 1991 - formal regulations

* Import Restrictions - Europe
o December 1997
o all live ruminants and most ruminant products

------------------------------------------------------------------------


Import Policies and Regulations

North American Policy

------------------------------------------------------------------------


Surveillance

* Field CNS Cases
* Veterinary Diagnostic Laboratory data
* Public health laboratories
* CNS condemns at slaughter
* "Downers"

------------------------------------------------------------------------


Feed Ban

*

FDA Authority - 1997

*

Prohibited to feed most mammalian proteins to ruminants

* Exceptions:
o milk
o blood
o gelatin
o plate waste
o pure equine/pure porcine

------------------------------------------------------------------------


Why the risk is not zero!!!

* Science
* Trade
* Existing regulations
* Human Error

------------------------------------------------------------------------


Why the risk is not zero!!!

* Science
o Attack rate study - .01 gr
o Distribution of infectivity

* Trade
o UK Imports - 496 total (173 into system)
o Feed
o Canadian Imports - 11 million hd

------------------------------------------------------------------------


Why the risk is not zero!!!

* Regulations
o feed ban exemptions
o plate waste
o poultry litter
o unfiltered tallow
o SRM bans?????
o 4 D animals?

* Human Error

------------------------------------------------------------------------


BSE: NEVER SAY NEVER

* UK - 1996 link to human disease
* Germany
* Japan

------------------------------------------------------------------------


BSE: Lessons Learned

"Absence of evidence is not evidence of absence" - "There is absolutely
no scientific evidence of..."

------------------------------------------------------------------------


BSE: Lessons Learned

* All TSEs are not created equal!
* Predictions can be dangerous - prepare for the unexpected
* Long incubation diseases with no preclinical test are like wolves
in sheep's clothing

------------------------------------------------------------------------


BSE: Lessons Learned

* Prevention which has adverse actions or significant cost may be
difficult to sell
* Failure to prevent is an easy target
* How do you measure the success of prevention?

------------------------------------------------------------------------


BSE: Lessons Learned

* Regulations are only as good as&&.

------------------------------------------------------------------------


BSE: Lessons Learned

* Positive solutions for one problem may create more extensive problems

------------------------------------------------------------------------


BSE: Lessons Learned

* Regaining scientific credibility and public confidence may require
extreme measures

------------------------------------------------------------------------


BSE: Will it happen in the US or will there be a 2nd case in Canada???

------------------------------------------------------------------------


NEVER SAY NEVER

------------------------------------------------------------------------

[an error occurred while processing this directive]

http://64.233.187.104/search?q=cache:IqG-jA1w0NwJ:www.inspection.gc.ca/english/anima/heasan/cancom/2003/tseeste.shtml+BSE+GBR+JAPAN+EFSA&hl=en

http://www.inspection.gc.ca/english/anima/heasan/cancom/2003/tseeste.shtml

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

ONE YEAR PREVIOUSLY ;

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

######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########





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