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From: TSS (216-119-143-168.ipset23.wt.net)
Subject: EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of Geographical BSE Risk of United States of America (USA)
Date: August 24, 2004 at 11:15 am PST

EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of
United States of America (USA).
http://www.efsa.eu.int
1 of 6
Scientific Report of the European Food Safety Authority
on the Assessment of the Geographical BSE-Risk (GBR) of
United States of America (USA).
Question N° EFSA-Q-2003-083
Adopted July 2004
Summary
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 90’s 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.
Key words: BSE, geographical risk assessment, GBR, USA, third countries
EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of
United States of America (USA).
http://www.efsa.eu.int
2 of 6
Background
History
In 1998, the EC asked the Scientific Steering Committee (SSC) to perform a risk assessment
in order to establish the GBR of a country. In July 2000 the SSC adopted its final opinion on
"The Geographical Risk of Bovine Spongiform Encephalopathy (GBR)" (as updated in
January 2002). It describes a method and a process for the assessment of the GBR and
summarises the outcome of its application. Detailed reports on the GBR-assessments were
published on the Internet for each of these countries.
Determination of BSE status
In 2001, Regulation (EC) No 999/20011 established the rules for the determination of BSE
status of a country. It determines certain measures concerning the control of BSE and
concerning trade and importation of certain live animals and animal products.
Annex II of this Regulation lays down the method for the determination of BSE status. This
includes two steps: an initial risk assessment, and the evaluation of additional criteria. The
method is similar to that laid down in the International Animal Health Code of the
International Animal Health Organisation (OIE).
The categorisation of countries has been deferred until July 2005 awaiting a review of the OIE
categorisation system. In the meantime a number of transitional measures are in place, in
particular concerning specified risk material and import conditions.
State of play
The Scientific Steering Committee issued an opinion on GBR (using the methodology
established by the SSC in June 2000 and updated January 2002) for one third of the countries
requesting the determination of their BSE status.
Prioritisation
The first priority is the re-assessment of GBR I countries, as currently no TSE related import
restrictions (certification of absence of specific risk material (SRM)) apply to GBR I
countries.
If the preliminary re-assessment indicates that the current GBR I will not be confirmed, any
delay might have negative consequences on consumer health protection. Furthermore, the
GBR assessment of neighbouring countries with intensive trade contacts should be dealt with
at the same time, because the outcomes are interdependent.
The major trading partners with a GBR II classification should be dealt with as second
priority, in view of the SSC opinion on tallow derivatives and the draft guidance note of
EMEA.
Terms of reference
In view of the above, the European Commission asks the EFSA to advice on the risk
assessment for the appearance of BSE in USA.
1 Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the
prevention, control and eradication of certain transmissible spongiform encephalopathies OJ L 147, 31.5.2001
and updates.
EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of
United States of America (USA).
http://www.efsa.eu.int
3 of 6
Assessment
EFSA refers to the Working Group Report (annex) prepared by the EFSA Scientific Expert
Working Group on GBR for full details on the assessment.
External Challenge
USA was exposed to a moderate external challenge for the period 1980-1990, a very high
external challenge for the period 1991-1995, and an extremely high external challenge for
period 1996-2003.
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 surveillance has to
be estimated. Again, the guidance provided by the SSC in its opinion on the GBR of July
2000 (as updated in 2002) is applied. 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.
Feeding
Until August 1997, ruminant meat and bone meal (RMBM) was legally fed to cattle. Feeding
was therefore "not OK". In August 1997, an RMBM-ban was introduced but feeding of nonruminant
MBM to cattle remained legal as well as feeding of RMBM to non-ruminant
animals (farm animals and pets). An RMBM ban is difficult to maintain, as only labels can
distinguish the various MMBMs. This makes control of the feed ban very difficult because
analytical differentiation between ruminant and non-ruminant MBM is difficult. Due to the
highly specialized production system in the USA, various mammalian MBM streams can be
separated. Such a feed ban would therefore be assessed as "reasonably OK", for all regions
where this highly specialized system exists. However, several areas in the USA do have
mixed farming and mixed feed mills, and in such regions an RMBM ban would not suffice.
Additionally, official controls for cattle feeds to control for compliance with the ban started in
2002. Thus, for the whole country, the assessment of the feeding after 1997 remains "not
OK", but improving.
Rendering
The rendering industry is operating with processes that are not known to reduce infectivity. It
is therefore concluded that rendering was and is "not OK".
SRM-removal
SRM were and are still rendered for feed, as are (parts of) the fallen stock. SRM-removal is
therefore regarded as "not OK".
BSE surveillance
Before 1989, the ability of the system to identify (and eliminate) BSE-cases was limited.
Since 1990 this ability is improved, thanks to a specific (passive) BSE surveillance. The
initiated introduction of active surveillance in risk populations should improve the system
significantly.
EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of
United States of America (USA).
http://www.efsa.eu.int
4 of 6
Conclusions
The European Food Safety Authority concludes:
1. The BSE agent was probably imported into USA and could have reached domestic
cattle in the middle of the eighties. This 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 meat and bone meal (MBM) imported into the USA
reached domestic cattle and lead to an internal challenge in the early nineties.
2. 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 90’s 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.
3. 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.
4. This assessment deviates from the previous assessment (SSC opinion, 2000) because
at that time several exporting countries were not considered a potential risk.
5. It is also worth noting that the current GBR conclusions are not dependent on the large
exchange of imports between USA and Canada. External challenge due to exports to
the USA from European countries varied from moderate to high. These challenges
indicate that it was likely that BSE infectivity was introduced into the North American
continent.
6. EFSA and its Scientific Expert Working group on GBR are concerned that the
available information was not confirmed by inspection missions as performed by the
Food and Veterinary office (FVO – DG SANCO) in Member States and other third
countries. They recommend including, as far as feasible, BSE-related aspects in
future inspection missions.
Expected development of the GBR
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.
A table summarising the reasons for the current assessment is given in the table below
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.
EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of
United States of America (USA).
http://www.efsa.eu.int
5 of 6
• 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 Working Group 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.
Annex
Details of the assessment are presented in the report as prepared by the EFSA Scientific
Expert Working Group on GBR:
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574_en.html
EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of United States of America (USA).
http://www.efsa.eu.int
6 of 6
USA, Summary of the GBR Assessment, July 2004 GBR Level : III**
EXTERNAL CHALLENGE STABILITY INTERACTION of EXTERNAL
CHALLENGE and STABILITY
1980-1990: Moderate
1991-1995: Very High
1996-2003: Extremely high
1980-2003: Extremely unstable
Live Cattle imports MBM imports Feeding Rendering SRM-removal BSE surveillance
Any external challenge would have met the
extremely unstable system and infectivity
would have been recycled.
INTERNAL CHALLENGE
An internal challenge was possibly present
from 1980 to 1990 and was likely to be present
and growing from 1991 to 2003
EXPECTED DEVELOPMENT OF THE
GBR
From UK:
323 (CD*)
or
327 (other sources of
data)
From other BSE risk
countries:
16.656.490 (CD)
or
15.496.449 (other
sources of data).
*CD: country dossier
From UK:
5 tons (CD)
or
101 tons (other
sources of data)
From other BSE risk
countries:
406.547 tons (CD)
or
229.701 tons (other
sources of data)
1980-2003:
Not OK.
Feeding of
ruminant MBM to
cattle legally
possible until
August 1997.
1980-2003:
Not OK.
No proof of an
effective process in
reducing BSEinfectivity
is given.
1980-2003:
Not OK.
SRM are still
rendered for feed.
Passive but
improving with
some testing of risk
groups.
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.
** GBR level III: ‘it is likely but not confirmed’ that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.

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

TSS




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