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From: TSS ()
Subject: Transmissible Spongiform Encephalopaties August 31, 2005 GAIN REPORT...TSS
Date: September 1, 2005 at 1:49 pm PST

FOREIGN AGRICULTURAL SERVICE
U.S. MISSION TO THE EUROPEAN UNION
Last update: August 31, 2005

Transmissible Spongiform Encephalopaties
Introduction
Impact on U.S. Trade
EU Legislation
Background
Reports
Links

Introduction
In response to the public health threats resulting from transmissible spongiform encephalopaties (TSEs), such as BSE (mad cow disease) which is linked to new variant Creutzfeldt-Jakob disease in humans, the European Commission issued legislation to ban Specified Risk Materials (SRM) to guarantee the safety of the food chain. The ban prohibited the use of SRMs (defined as the skull, tonsils, ileum and spinal cord of cattle, sheep and goats aged over one year, and spleens of sheep and goats) in any products sold in the EU. A comprehensive chronological list of BSE/TSE legislation in the EU is available on the European Commission's website.

In May 2001, Regulation 999/2001, the centerpiece of the EU TSE legislation intended to supersede all existing TSE legislation, was adopted. Among other things, it established criteria to classify the BSE status of member states and third countries into one of five classification categories. Certain requirements, including removal of SRM's, would then be applied to a country depending on the classification. On June 28, 2003, the European Parliament and the Council adopted Regulation 1128/2003 prolonging transitional measures with two years, until July 1, 2005, for countries whose BSE status has not been determined yet. The extension maintains the present level of public health protection as the transitional measures on SRM's and slaughter methods are maintained within the EU and in respect of third countries. The two-year extension is designed for the Commission to continue its attempt to reach an agreement at international level (OIE) on the determination of BSE status of countries on the basis of risk. The Commission would at the same time conclude the scientific risk assessments.

Impact on U.S. Trade
The United States is required to remove SRM's and MRM (mechanically recovered meat) from animal products for export to the EU. The United States fully expects to be placed in Category I or II once the categorization is completed and would not be required to remove SRM's and MRM once Regulation 999/2001 is fully implemented. However, in August 2004 the European Food Safety Agency (EFSA) published new scientific reports on the GBR classifications for seven countries (See GAIN report E34050). The U.S. was classified in level three which means "BSE is likely but not confirmed or confirmed at a lower level". The risk assessment was based on information submitted by the countries concerned, and relates in particular to imports of bovines and meat and bone meal from the UK and other BSE-risk countries. The scientific risk assessments of all countries have not been fully concluded. For only one third of the countries requesting the determination of the BSE status, the Scientific Steering Committee has adopted a final opinion. However, even the application of transitional measures of Regulation 999/2001 is extremely disruptive for the U.S. industry.

EU Legislation - Amendments to Framework Regulation 999/2001
In 2004, several new amendments were made to Regulation 999/2001. The confirmation on January 28, 2005, in a press release “Case of BSE in a goat confirmed: Commission extends testing program”, that BSE had been identified in a goat, which was slaughtered in France in 2002, was already incorporated in two amendments. Another important amendment set stricter rules for the import of cervid products from Canada and the United States (see GAIN Report E35023).

EC 876/2004 of 29 April 2004 – trade in ovine and caprine animals for breeding, which sets new rules for the trade in goats and sheep, with the exception of sheep of the ARR/ARR prion protein genotype, which are exempted.

EC 1492/2004 of 23 August 2004 – modification of eradication measures for bovine, ovine and caprine animals, trade and import conditions for semen and embryos of ovine and caprine animals and the list of specified risk materials. This regulation under certain conditions allows for the exemption of culling all animals of the cohort of a bovine infected with BSE, as well as setting rules for ovine and caprine herds, in which BSE is identified and the a movement restriction on herds identified with or suspected of having scrapie, until the results of further investigation are available. The regulation also restricts trade of live animals, ova and semen of goats and sheep, with the exception of sheep of the ARR/ARR prion protein genotype, which are exempted, starting January 1, 2005. Furthermore, the regulation redefines the list of SRM to be removed from bovines.

EC 1471/2004 of 18 August 2004 – introducing requirements for the import of cervid products from Canada and the United States. This regulation imposes the removal of Specific Risk Materials (SRM) from all cervid meats exported to the EU and limits exports of wild game to areas free of Chronic Wasting Disease (CWD) from January 1, 2005.

Under Regulation 1326/2001 (amended by Commission Regulation 1234/2003 setting the conditions for use of fishmeal, hydrolized proteins and dicalcium phosphates in feed for non-ruminant farmed animals), the transitional measures passed in July 2001, only countries recognized as provisionally BSE-free (GBR-1) are not required to remove SRM's in order to export to the EU. The EU currently recognizes New Zealand, Australia, Norway, Chile, Argentina, Paraguay, Nicaragua, Botswana, Namibia and Swaziland as provisionally BSE-free.

Background
On July 30, 1997, the European Commission adopted Commission Decision 97/534/EC, commonly knows as the Specified Risk Materials (SRM) ban. The ban prohibited the use of SRMs in any products sold in the EU. The original date of implementation was July 1, 2998, but this was delayed due to controversy over product sector coverage. In addition to food and feed, the ban would have significantly affected production of pharmaceuticals, cosmetics, medical devices and fertilizers. In September 1999, the EU implemented specific regulations for SRMs on medical products for human use (Directive 99/820/EC). It also provided guidelines on how companies would comply with this directive.

In June 2000, Commission Decision 2000/148/EC was adopted, which repealed Commission Decision 97/534/EC, but set new requirements for handling SRMs. This new measure limited the scope of the ban to food, feed and fertilizer and required slaughterhouses and authorized meat cutting and processing plants in all EU member states, regardless of their BSE status, to remove the SRMs mentioned above. The measure became effective October 1, 2001 for all EU member states. Initially the ban did not apply to third countries. However in March 2001, the EU published the results of their geographical BSE risk (GBR) assessment of third countries exporting food, feed or fertilizer products to the EU. The United States' BSE status is provisionally recognized as "unlikely, but cannot be excluded (GBR-2)".

Reports
EU Directorate for Health and Consumer Protection presents its TSE Roadmap GAIN report E35164 (August, 2005): On July 15, 2005, DGSANCO presented a whole series of possible amendments to its TSE policy in its "TSE Roadmap. These possible amendments to EC Regulation 999/2001 result from recent years' improvement in the EU-25 BSE situation and also addresses recent problems that have come up with the current measures. These amendments could halve the cost of the present BSE/TSE measures in the EU or more. Some of these amendments could also lower the present burden on some U.S. exports of processed animal by-products.

BSE/TSE Situation in the EU-25 - Update GAIN report E35023 (February, 2005): This report focuses on recent BSE/TSE events and legislation in the EU. A first case of BSE was recently confirmed in a French goat, which was slaughtered in 2002. As a result the European Commission has adopted new legislation with relation to TSE and scrapie in ovine and caprine herds, as well as imposing trade restrictions on live animals, ova and semen of goats and sheep. This report also offers an update on the BSE situation in the EU for 2004.

EFSA publishes new report on the Geographical BSE Risk Assessment GAIN report E34050 (August, 2004): In August 2004 the European Food Safety Agency (EFSA) published new scientific reports on the GBR classifications for seven countries. The U.S. was classified in level three which means "BSE is likely but not confirmed or confirmed at a lower level". The risk assessment was based on information submitted by the countries concerned, and relates in particular to imports of bovines and meat and bone meal from the UK and other BSE-risk countries.

European Commissioner Byrne's first regular BSE report of the year GAIN report E24044 (May, 2004): On February 19, 2004, European Commissioner David Byrne's first regular BSE report of the year was published, which indicates a 38 percent drop in the overall number of BSE cases in the European Union. The report also addresses: Evolution of BSE, Feed Ban, Increase of The Age Limit for Removal of Vertebral Column, Geographical BSE Risk (GBR) Assessment, BSE Status, BSE in USA, BSE in Portugal, BSE in the UK, Strain Typing of Scrapie Cases in Sheep and Goats and New Member States.

Mad Cow Disease - The EU and the US GAIN report E24002 (January, 2004): Mad Cow Disease appears to have begun in the United Kingdom in the late 1980's, and subsequently spread through most of the EU. Great efforts have been made by the EU to decrease the number of BSE-infected cattle in recent years. Most recently a single dairy cow in the United States was diagnosed with Mad Cow Disease. Data within this report facilitate putting this finding into a worldwide context.

Links
BSE - U.S. Departments of Agriculture / FAS
BSE/Scrapie - European Commission / DG Health and Consumer Protection


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

http://www.useu.be/agri/srm.html

>>>The scientific risk assessments of all countries have not been fully concluded. For only one third of the countries requesting the determination of the BSE status, the Scientific Steering Committee has adopted a final opinion. However, even the application of transitional measures of Regulation 999/2001 is extremely disruptive for the U.S. industry.<<<

thus, GWs BSE Minimal Risk Region was born, the legal trading of all strains of TSE aka MAD COW DISEASEs...TSS

Voluntary Report - public distribution

Date: 8/26/2004

GAIN Report Number: E34050

E34050

EU-25

Livestock and Products

EFSA publishes new report on the Geographical BSE

Risk Assessment

2004

Approved by:

Stan Cohen

U.S. Mission to the EU

Prepared by:

Karin Bendz

Report Highlights:

In August 2004 the European Food Safety Agency (EFSA) published new scientific reports on

the GBR classifications for seven countries. The U.S. was classified in level three which

means "BSE is likely but not confirmed or confirmed at a lower level".

The risk assessment was based on information submitted by the countries concerned, and

relates in particular to imports of bovines and meat and bone meal from the UK and other

BSE-risk countries.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Brussels USEU [BE2]

[E3]

USDA Foreign Agricultural Service

GAIN Report

Global Agriculture Information Network

Template Version 2.09

GAIN Report - E34050 Page 2 of 4

UNCLASSIFIED USDA Foreign Agricultural Service

On August 20, 2004 the European Food Safety Authority (EFSA) published up-to-date

scientific reports on the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR)

for seven countries. The countries are Australia, Canada, Mexico, Norway, South Africa,

Sweden and the United States.

The GBR evaluations are based on information submitted by the countries concerned in

response to a European Commission recommendation in 1998, which set out the information

requirements for such an assessment. The scientific reports address the GBR in a number of

countries based on data covering the period 1980-2003.

The information concerns in particular imports of bovines and meat and bone meal (MBM)

from the United Kingdom and other BSE-risk countries, rendering standards for animal byproducts,

use specific risk materials (SRM’s), and feeding of meat and bone meal (MBM) to

ruminants.

Table of the classification of the countries

GBR of the country/Region

GBR

level

Presence of one or more cattle clinically or preclinically

infected with the BSE agent in a

geographical region/country

Status Before Status After

I Highly unlikely Australia (I)

Norway (I) Australia (I)

II Unlikely but not excluded

Sweden (II)

Canada (II)

USA (II)

Sweden (II)

Norway (II)

III Likely but not confirmed or confirmed at a lower level South Africa (N/A)

Mexico (N/A),

Canada (III)

USA (III)

South Africa (III)

Mexico (III)

IV Confirmed at a higher level

The result of the report is that Australia and Sweden were kept at the same level as before

the update, while Norway, Canada and the U.S. were classed at a higher level.

The EFSA concludes that the BSE agent that was found in the U.S. was probably imported

into the U.S. and could have reached domestic cattle in the middle of the 1980s. Cattle

imported in the mid-1980s could have been rendered in the late 1980s and therefore led to

an internal challenge in the early 1990s. EFSA concludes that it is possible that MBM’s

imported into the U.S. reached domestic cattle and posed a risk in the early 1990s.

According to the EFSA, a processing risk developed in the late 1980s and early 1990s 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-1990s 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.

This assessment deviates from the previous assessment (Scientific Steering Committee

(SSC) opinion, 2000) because at that time several exporting countries were not considered a

potential risk.

GAIN Report - E34050 Page 3 of 4

UNCLASSIFIED USDA Foreign Agricultural Service

It is also worth noting that the current GBR conclusions are not dependent on the large

exchange of imports between the U.S. and Canada. The threat from European exports to the

U.S. varied from moderate to high. These challenges indicate that it was likely that BSE

infectivity was introduced into the North American continent.

EFSA and its Scientific Expert Working group on GBR are concerned that the inspection

missions of the Food and Veterinary office (FVO – DG SANCO) conducted in member states

and third countries didn’t assess the available information in light of the risk posed by BSE.

They recommend including 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 very

to extremely unstable. Thus, the probability of cattle to be (pre-clinically or clinically)

infected with the BSE-agent persistently increases.

Canada

For Canada the EFSA evaluation concludes that the BSE agent was probably imported to the

country in the 1980s and could have been rendered in the late 1980s and therefore posed a

risk in the early 1990s. 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 the UK in the mid-1980s could have been slaughtered. This risk grew significantly in

the mid-1990s when domestic cattle, infected by imported MBM, reached processing. This

risk increased over the years with continued imports of cattle and MBM from BSE risk

countries.

Australia

The EFSA concludes that in the case of Australia, an extremely or very unstable system was

exposed to a very low or negligible challenge through the import of cattle. Given the

negligible level of external challenge through MBM it is highly unlikely that any internal risk

occurred.

This report is drafted from the EFSA scientific report. The full report can be found at:

www.efsa.eu.int

GAIN Report - E34050 Page 4 of 4

UNCLASSIFIED USDA Foreign Agricultural Service

Visit our website: our website www.useu.be/agri/usda.html provides a broad range of

useful information on EU import rules and food laws and allows easy access to USEU reports,

trade information and other practical information.

E-mail: AgUSEUBrussels@usda.gov

Related reports from USEU Brussels:

Report

Number

Title Date Released

E24047 Host Country BSE Response Questionnaire

2004

04/05/04

E24044 European Commissioner David Byrn’s first

regular BSE report of the year

04/04/04

E24006 BSE – Potential Concerns of the European

Commission

01/09/04

These reports can be accessed through our website www.useu.be/agri or through

the FAS website http://www.fas.usda.gov/scriptsw/attacherep/default.asp.

http://www.fas.usda.gov/gainfiles/200408/146107318.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)

Report

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 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.


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

SUMMARY

Summary of Scientific Report
http://www.efsa.eu.int
1 of 1
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 of 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 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

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf

REPORT (6 PAGES)

snip...

EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of
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

snip...

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


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

Important legal notice


|
32005R1292
Commission Regulation (EC) No 1292/2005 of 5 August 2005 amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards animal nutrition (Text with EEA relevance)

Official Journal L 205 , 06/08/2005 P. 0003 - 0011

Commission Regulation (EC) No 1292/2005

of 5 August 2005

amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards animal nutrition

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies [1], and in particular the first paragraph of Article 23 thereof,

Whereas:

(1) Regulation (EC) No 999/2001 lays down rules on the feeding of proteins derived from animals in order to prevent the dissemination of transmissible spongiform encephalopathies (TSEs) to animals.

(2) That Regulation prohibited the use of certain animal proteins in the feeding of farmed animals either because such proteins may potentially contain TSE infectivity or because they could jeopardise the detection of small amounts of potentially TSE infected proteins in feedingstuffs. It also established zero-tolerance of prohibited animal constituents in feedingstuffs.

(3) Commission Directive 2003/126/EC of 23 December 2003 on the analytical method for the determination of constituents of animal origin for the official control of feedingstuffs [2] provides that official analysis of feedingstuffs with a view to officially control the presence, identification or estimation of the amount of constituents of animal origin in feedingstuffs are to be carried out in accordance with that Directive. Proficiency testing of laboratories, carried out in accordance with that Directive by the Commission’s Institute for Reference Materials and Measurements (IRMM-JRC), has demonstrated that the performance of laboratories for detecting small amounts of mammalian proteins in feedingstuffs has improved considerably.

(4) That improvement in laboratory performance has resulted in the detection of the adventitious presence of bone spicules, particularly in tuber and root crops. Scientific evidence has demonstrated that contamination of such crops by bone spicules present in the soil cannot be avoided. Consignments of contaminated tuber and root crops are to be disposed of in accordance with Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition [3], and often have to be destroyed as a result. In order to prevent a disproportionate application of that Directive, Member States should be allowed to make a risk assessment on the presence of animal constituents in tuber and root crops before considering a breach of the feed ban.

(5) On 25 and 26 May 2000, the Scientific Steering Committee (SSC) updated its report and opinion on the safety of hydrolysed proteins produced from ruminant hides, adopted during its meeting of 22 and 23 October 1998. The conditions under which hydrolysed proteins may be considered safe according to that opinion are laid down in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption [4]. Since 1 May 2004, those conditions have also applied to hydrolysed proteins imported from third countries. Therefore the feeding to ruminants of hydrolysed proteins produced from ruminant hides and skins ruminants should no longer be prohibited.

(6) In its opinion of 17 September 1999 on intra-species recycling, and again in its opinion of 27 and 28 November 2000 on the scientific basis for banning animal protein from feed for all farmed animals, the SSC stated that there is no evidence of the natural occurrence of TSE in non-ruminant farmed animals producing food, such as pigs and poultry. Furthermore, given that controls on the ban on animal proteins are based on the detection of bones and muscles fibres in feedingstuffs, blood products and hydrolysed proteins derived from non-ruminants should not jeopardise controls on the presence of potentially TSE infected proteins. Therefore, the restrictions on feeding to farmed animals of blood products and hydrolysed derived from non-ruminants should be relaxed.

(7) The conditions for transport, storage and packaging of bulk feedingstuffs containing processed animal proteins should be clarified.

(8) Continuous evaluation of the competence and training of laboratory staff should be provided for to maintain or improve the quality of the official controls.

(9) Regulation (EC) No 999/2001 should therefore be amended accordingly. For practical reasons and in the interests of clarity, it is appropriate to replace the amended Annex IV in its entirety.

(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Annex IV to Regulation (EC) No 999/2001 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 1 September 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.


Done at Brussels, 5 August 2005.

For the Commission

Markos Kyprianou

Member of the Commission

[1] OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 260/2005 (OJ L 46, 17.2.2005, p. 31).

[2] OJ L 339, 24.12.2003, p. 78.

[3] OJ L 265, 8.11.1995, p. 17. Directive as last amended by Directive 2001/46/EC of the European Parliament and of the Council (OJ L 234, 1.9.2001, p. 55).

[4] OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 416/2005 (OJ L 66, 12.3.2005, p. 10).

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

ANNEX

Annex IV to Regulation (EC) No 999/2001 is replaced by the following:

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

"ANNEX IV

ANIMAL FEEDING

I. Extension of the prohibition provided for in Article 7(1)

The prohibition provided for in Article 7(1) shall be extended to the feeding:

(a) to farmed animals, with the exception of the feeding to carnivorous fur producing animals, of:

(i) processed animal protein;

(ii) gelatine of ruminant origin;

(iii) blood products;

(iv) hydrolysed protein;

(v) dicalcium phosphate and tricalcium phosphate of animal origin (dicalcium phosphate and tricalcium phosphate);

(vi) feedingstuffs containing the proteins listed in points (i) to (v).

(b) to ruminants, of animal protein and feedingstuffs containing such protein.

II. Derogations from the prohibitions provided for in Article 7(1) and (2), and specific conditions for the application of such derogations.

A. The prohibitions provided for in Article 7(1) and (2) shall not apply to:

(a) the feeding to farmed animals of the proteins referred to in points (i), (ii), (iii) and (iv) and of feedingstuffs derived from such proteins:

(i) milk, milk-based products and colostrum;

(ii) eggs and egg products;

(iii) gelatine derived from non-ruminants;

(iv) hydrolysed proteins derived from parts of non-ruminants and from ruminant hides and skins;

(b) the feeding to non-ruminant farmed animals of the proteins referred to in points (i), (ii) and (iii), and of products derived from such proteins:

(i) fishmeal, in accordance with the conditions laid down in point B;

(ii) dicalcium phosphate and tricalcium phosphate, in accordance with the conditions laid down in point C;

(iii) blood products derived from non-ruminants in accordance with the conditions laid down in point D;

(c) the feeding to fish of blood meal derived from non-ruminants in accordance with the conditions laid down in point D;

(d) the feeding to farmed animals of tuber and root crops and feedingstuffs containing such products following the detection of bone spicules may be permitted by the Member States if there has been a favourable risk assessment. The risk assessment shall take into account at least the amount and possible source of contamination and the final destination of the consignment.

B. The following conditions shall apply for the use of fishmeal referred to in point A(b)(i) and feedingstuffs containing fishmeal in the feeding of non-ruminant farmed animals (not applicable to the feeding of carnivorous fur producing animals):

(a) the fishmeal shall be produced in processing plants dedicated exclusively to the production of fish derived products;

(b) before release for free circulation in the Community, each consignment of imported fishmeal shall be analysed by microscopy in accordance with Directive 2003/126/EC;

(c) feedingstuffs containing fishmeal shall be produced in establishments which do not produce feedingstuffs for ruminants and which are authorised for this purpose by the competent authority.

By way of derogation from point (c):

(i) a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing fishmeal shall not be required for home compounders:

- registered by the competent authority,

- keeping only non-ruminants,

- producing complete feedingstuffs for use only in the same holding, and

- provided that the feedingstuffs containing fishmeal used in the production contain less than 50 % crude protein;

(ii) the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing fishmeal for other animal species may be authorised by the competent authority subject to the following conditions:

- bulk and packaged feedingstuffs destined for ruminants are kept in facilities physically separate from those for bulk fishmeal and bulk feedingstuffs containing fishmeal during storage, transport and packaging,

- feedingstuffs destined for ruminants are manufactured in facilities physically separate from facilities where feedingstuffs containing fishmeal are manufactured,

- records detailing the purchases and uses of fishmeal and the sales of feedingstuffs containing fishmeal are kept available to the competent authority for at least five years, and

- routine tests are carried out on feedingstuffs destined for ruminants to ensure that prohibited proteins including fishmeal are not present.

(d) The label and accompanying document of feedingstuffs containing fishmeal shall clearly indicate the words "contains fishmeal — shall not be fed to ruminants".

(e) Bulk feedingstuffs containing fishmeal shall be transported by means of vehicles which do not at the same time transport feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination.

(f) The use and storage of feedingstuffs containing fishmeal shall be prohibited in farms where ruminants are kept.

By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing fishmeal in farms where ruminants are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing fishmeal are fed to ruminants.

C. The following conditions shall apply for the use of dicalcium phosphate and tricalcium phosphate referred to in point A(b)(ii) and feedingstuffs containing such proteins in the feeding of non-ruminant farmed animals (not applicable to the feeding of carnivorous fur producing animals):

(a) Feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be produced in establishments which do not prepare feedingstuffs for ruminants and which are authorised for this purpose by the competent authority.

By way of derogation from that condition:

(i) a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall not be required for home compounders:

- registered by the competent authority,

- keeping only non-ruminants,

- producing complete feedingstuffs for use only in the same holding, and

- provided that the feedingstuffs containing dicalcium phosphate or tricalcium phosphate used in the production contain less than 10 % total phosphorus;

(ii) the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing dicalcium phosphate or tricalcium phosphate for other animal species may be authorised by the competent authority subject to the following conditions:

- bulk and packaged feedingstuffs destined for ruminants are manufactured in facilities physically separate from those where feedingstuffs containing dicalcium phosphate or tricalcium phosphate are manufactured,

- bulk feedingstuffs destined for ruminants are during storage, transport and packaging kept in facilities physically separate from those for bulk dicalcium phosphate, bulk tricalcium phosphate and bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate,

- records detailing the purchases and uses of dicalcium phosphate or tricalcium phosphate and the sales of feedingstuff containing dicalcium phosphate or tricalcium phosphate are kept available to the competent authority for at least five years.

(b) The label and accompanying document of the feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall clearly indicate the words "contains dicalcium/tricalcium phosphate of animal origin – shall not be fed to ruminants".

(c) Bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be transported by means of vehicles which do not at the same time transport feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination.

(d) The use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be prohibited in farms where ruminants are kept.

By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate in farms where ruminants are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing dicalcium phosphate or tricalcium phosphate are fed to ruminants.

D. The following conditions shall apply for the use of blood products referred to in point A(b)(iii) and blood meal referred to in point A(c) and of feedingstuffs containing such proteins, in the feeding of respectively non-ruminant farmed animals and fish:

(a) The blood shall be derived from EU approved slaughterhouses which do not slaughter ruminants and which are registered as not slaughtering ruminants, and it shall be transported directly to the processing plant in vehicles dedicated exclusively to the transport of non-ruminant blood. If the vehicle was previously used for the transport of ruminant blood, it shall be, following cleaning, inspected by the competent authority before the transport of non-ruminant blood.

By way of derogation from that condition, the competent authority may permit the slaughter of ruminants in a slaughterhouse collecting non-ruminant blood intended for the production of blood products and blood meal for use in feed for respectively non-ruminant farmed animals and fish if the slaughterhouse has a recognised control system. That control system shall at least include:

- keeping the slaughtering of non-ruminants physically separate from the slaughtering of ruminants,

- keeping collection, storage, transport and packaging facilities for blood of ruminant origin physically separate from those for blood of non-ruminant origin, and

- regular sampling and analysis of blood of non-ruminant origin to detect the presence of ruminant proteins

(b) The blood products and blood meal shall be produced in an establishment exclusively processing non-ruminant blood.

By way of derogation from that condition, the competent authority may permit the production of blood products and blood meal for use in feed for respectively non-ruminant farmed animals and fish in establishments processing ruminant blood, which have a recognised control system in place preventing cross-contamination. That control system shall at least include:

- processing of non-ruminant blood in a closed system physically separate from the processing of ruminant blood,

- keeping of bulk raw material and bulk finished products of ruminant origin during storage, transport and packaging in facilities physically separate from those for bulk raw material and bulk finished products of non-ruminant origin, and

- regular sampling and analysis of non-ruminant blood products and blood meal to detect the presence of ruminant proteins.

(c) Feedingstuffs containing blood products or blood meal shall be produced in establishments which do not prepare feedingstuffs for respectively ruminants or farmed animals other than fish and which are authorised for this purpose by the competent authority.

By way of derogation from that condition:

(i) a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing blood products or blood meal shall not be required for home compounders:

- registered by the competent authority,

- keeping only non-ruminants in case blood products are used, or only fish in case blood meal is used,

- producing complete feedingstuffs for use only in the same holding, and

- provided that the feedingstuffs containing blood products or blood meal used in the production contain less than 50 % total protein.

(ii) the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing blood products or blood meal for respectively non-ruminant farmed animals or fish may be authorised by the competent authority subject to the following conditions:

- bulk and packaged feedingstuffs destined for ruminants or farmed animals other than fish are manufactured in facilities physically separate from those where feedingstuffs containing respectively blood products or blood meal are manufactured,

- bulk feedingstuffs kept, during storage transport and packaging, in physically separate facilities as follow:

(a) feedingstuff destined for ruminants is kept separate from blood products and from feedingstuffs containing blood products;

(b) feedingstuff destined for farmed animals other than fish is kept separate from blood meal and feedingstuffs containing blood meal,

records detailing the purchases and uses of blood products and blood meal, and the sales of feedingstuffs containing such products, are kept available to the competent authority for at least five years.

(d) The label, accompanying commercial document or health certificate, as appropriate, of the feedingstuffs containing blood products or blood meal shall clearly indicate the words "contains blood products – shall not be fed to ruminants" or "contains blood meal – shall only be fed to fish" as appropriate.

(e) Bulk feedingstuffs containing blood products shall be transported by means of vehicles which do not transport at the same time feedingstuffs for ruminants and bulk feedingstuffs containing blood meal by means of vehicles which do not transport at the same time feedingstuffs for farmed animals other than fish. If the vehicle is subsequently used for the transport of feedingstuffs intended for respectively ruminants or farmed animals other than fish, it shall be thoroughly cleaned in accordance with a procedure to avoid cross-contamination approved by the competent authority.

(f) The use and storage of feedingstuffs containing blood products shall be prohibited in farms where ruminants are kept, and that of feedingstuffs containing blood meal shall be prohibited in farms where farmed animals other than fish are kept.

By way of derogation, the competent authority may permit the use and storage of feedingstuffs containing respectively blood products or blood meal in farms where respectively ruminants or farmed animals other than fish are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing respectively blood products or blood meal are fed to respectively ruminants or species other than fish.

III. General implementing conditions

A. This Annex shall apply without prejudice to the provisions in Regulation (EC) No 1774/2002.

B. Member States shall keep up-to-date lists of:

(a) slaughterhouses approved for the collection of blood in accordance with point D(a) of Part II;

(b) approved processing plants producing dicalcium phosphate, tricalcium phosphate, blood products or blood meal, and

(c) establishments, with the exception of home compounders, authorised for manufacturing feedingstuffs containing fishmeal and the proteins referred to in point (b) which operate in accordance with the conditions laid down in points B(c), C(a) and D(c) of Part II.

(a) Bulk processed animal protein, with the exception of fishmeal, and bulk products, including feedingstuffs, organic fertilisers and soil improvers, containing such proteins, shall be stored and transported in dedicated facilities. The store or vehicle may only be used for other purposes, following cleaning, and after having been inspected by the competent authority.

(b) Bulk fishmeal referred to in point A(b)(i) of Part II, bulk dicalcium phosphate and bulk tricalcium phosphate referred to in point A(b)(ii) of Part II, blood products referred to in point A(b)(iii) of Part II and blood meal referred to in point A(c) of Part II shall be stored and transported in stores and vehicles dedicated to that purpose.

(c) By way of derogation from point (b):

(i) stores or vehicles may be used for the storage and transport of feedingstuffs containing the same protein;

(ii) stores or vehicles, following cleaning, may be used for other purposes after having been inspected by the competent authority; and

(iii) stores and vehicles transporting fishmeal may be used for other purposes if the company has a control system in place, recognised by the competent authority, to prevent cross-contamination. The control system shall at least include:

- records on material transported and cleaning of the vehicle, and

- regular sampling and analysis of feedingstuffs transported to detect the presence of fishmeal.

The competent authority shall carry out frequent on-the-spot checks to verify the correct application of the above control system.

D. Feedingstuffs, including petfood, which contain blood products of ruminant origin or processed animal proteins, other than fishmeal, shall not be manufactured in establishments which produce feedingstuffs for farmed animals, with the exception of feedingstuffs for carnivorous fur producing animals.

Bulk feedingstuffs, including petfood, which contain blood products of ruminant origin or processed animal proteins, other than fishmeal, shall during storage, transport and packaging be kept in facilities physically separate from facilities for bulk feedingstuffs for farmed animals, with the exception of feedingstuffs for carnivorous fur producing animals.

Petfood and feedingstuffs intended for carnivorous fur producing animals containing dicalcium phosphate or tricalcium phosphate referred to in point A(b)(ii) of Part II, and blood products referred to in point A(b)(iii) of Part II shall be manufactured and transported in accordance with points C(a) and (c) and points D(c) and (e), respectively of Part II.

1. The export to third countries of processed animal proteins derived from ruminants, and of products containing such processed animal proteins, shall be prohibited.

2. The export of processed animal proteins derived from non-ruminants and of products containing such proteins shall only be permitted by the competent authority subject to the following conditions:

- they are destined for uses not prohibited by Article 7,

- a written agreement with the third country is made prior to exportation, which includes an undertaking from the third country to respect the final use and not to re-export the processed animal protein or products containing such proteins for uses prohibited by Article 7.

3. Member States which permit exports in accordance with point 2 shall for the effective implementation of this Regulation inform the Commission and the other Member States of all terms and conditions as agreed with the third country concerned, in the context of the Standing Committee on the Food Chain and Animal Health.

Points 2 and 3 shall not apply to:

- exports of fishmeal, provided it fulfils the conditions set out in point B of Part II,

- products containing fishmeal,

- petfood.

F. The competent authority shall carry out documentary and physical checks, including tests on feedingstuffs, throughout the production and distribution chain in accordance with Directive 95/53/EC to control compliance with its provisions and with the provisions of this Regulation. Where any presence of prohibited animal protein is detected, Directive 95/53/EC shall apply. The competent authority shall verify on a regular basis the competence of laboratories carrying out analyses for such official controls, in particular by evaluating the results of ring trials. If the competence is considered unsatisfactory, a re-training of the laboratory staff shall be undertaken as the minimal corrective measure."

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Important legal notice


|
32005R0260
Commission Regulation (EC) No 260/2005 of 16 February 2005 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rapid testsText with EEA relevance

Official Journal L 046 , 17/02/2005 P. 0031 - 0033

Commission Regulation (EC) No 260/2005

of 16 February 2005

amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rapid tests

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies [1], and in particular the first subparagraph of Article 23 thereof,

Whereas:

(1) Regulation (EC) No 999/2001 sets out a list of rapid tests approved for TSE monitoring.

(2) In its opinion of 16 November 2004, the European Food Safety Authority (EFSA) recommended the inclusion of seven new BSE rapid post mortem tests in the list of rapid tests approved for monitoring of bovine spongiform encephalopathy (BSE).

(3) The rapid tests currently listed in Annex X to Regulation (EC) No 999/2001 have been approved for sheep based on data provided by the test manufacturers showing that their tests may also be used for monitoring of TSE in sheep.

(4) The EFSA is currently evaluating rapid post mortem tests intended for small ruminants. A list of approved rapid tests for use in the surveillance programme for small ruminants is to be established on the basis of the opinion to be published. Accordingly, the currently approved rapid tests should be used for detecting TSE in small ruminants, until the publication of that opinion.

(5) Regulation (EC) No 999/2001 should therefore be amended accordingly.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Annex X to Regulation (EC) No 999/2001 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.


Done at Brussels, 16 February 2005.

For the Commission

Markos Kyprianou

Member of the Commission

[1] OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1993/2004 (OJ L 344, 20.11.2004, p. 12).

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ANNEX

In Annex X, Chapter C, point 4 is replaced by the following:

"4. Rapid tests

For the purposes of carrying out the rapid tests in accordance with Article 5(3) and Article 6(1), the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals:

- immuno-blotting test based on a Western blotting procedure for the detection of the protease-resistant fragment PrPRes (Prionics-Check Western test),

- chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test & Enfer TSE Kit version 2.0, automated sample preparation),

- sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad TeSeE test),

- microplate based immunoassay (ELISA) which detects protease resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),

- automated conformation-dependent immunoassay comparing the reactivity of a detection antibody to the protease sensitive and protease resistant forms of PrPSc (some fraction of the protease resistant PrPSc is equivalent to PrPRes) and to PrPC (InPro CDI-5 test),

- chemiluminescent ELISA for qualitative determination of PrPSc (CediTect BSE test),

- immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA),

- microplate based chemiluminiscent immunoassay for the detection of PrPSc in bovine tissues (Institut Pourquier Speed’it BSE),

- lateral flow immunoassay using two different monoclonal antibodies to detect Proteinase K resistant PrP fractions (Prionics Check PrioSTRIP),

- two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrPSc (Roboscreen Beta Prion BSE EIA Test Kit),

- sandwich ELISA for the detection of Proteinase K (PK) resistant PrPSc (Roche Applied Science PrionScreen).

For the purposes of carrying out the rapid tests in accordance with Article 5(3) and Article 6(1), the following methods shall be used as rapid tests for the monitoring of TSE in small ruminants:

- immuno-blotting test based on a Western blotting procedure for the detection of the protease-resistant fragment PrPRes (Prionics-Check Western test),

- chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test),

- sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad TeSeE test, the former Bio-Rad Platelia test),

- microplate based immunoassay (ELISA) which detects protease resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),

- automated conformation-dependent immunoassay comparing the reactivity of a detection antibody to the protease sensitive and protease resistant forms of PrPSc (some fraction of the protease resistant PrPSc is equivalent to PrPRes) and to PrPC (InPro CDI-5 test).

The producer of the rapid tests must have a quality assurance system in place agreed by the Community reference laboratory, which ensures that the test performance does not change. The producer must provide the test protocol to the Community reference laboratory.

Modifications to rapid tests or to test protocols may only be made following advance notification to the Community reference laboratory, and provided that the Community reference laboratory finds that the modification does not reduce the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the national reference laboratories."

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Daily Update

On August 17, 2005, no inconclusive test results were reported.

National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC) Testing Summary

The BSE enhanced surveillance program involves the use of a rapid screening test, followed by confirmatory testing for any samples that come back "inconclusive." The weekly summary below captures all rapid tests conducted as part of the enhanced surveillance effort. It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test returned a non-definitive result on July 27, 2005. That sample underwent additional testing at NVSL, as well as at the Veterinary Laboratories Agency in Weybridge, England, and results were negative.
To view the IHC testing numbers from 1990 through 2004, click on the following link: http://www.aphis.usda.gov/lpa/issues/bse/surveillance/figure2f.html

Weekly Summary

Cumulative Total from June 1, 2004: 439,126


http://www.aphis.usda.gov/lpa/issues/bse/surveillance/figure2f.html


Jim Rogers (202) 690-4755

USDA Press Office (202) 720-4623


Statement by Chief Veterinary Medical Officer John Clifford Animal and Plant Health Inspection Service Regarding Non-Definitive BSE Test Results
July 27, 2005
Late yesterday, we received non-definitive test results on an animal sampled as part of a voluntary extension of our enhanced BSE surveillance program. USDA is conducting further testing at the National Veterinary Services Laboratories in Ames , Iowa , in consultation with experts from the international reference laboratory in Weybridge , England . We are also sending samples from this animal to the Weybridge laboratory for further testing. It is important to note that this animal poses no threat to our food supply because it did not enter the human food or animal feed chains.

The sample was submitted to us by a private veterinarian. As an extension of our enhanced surveillance program, accredited private veterinarians, who often visit farms in remote areas, collect samples when warranted. The sample in question today was taken from a cow that was at least 12 years of age and experienced complications during calving. The veterinarian treated the sample with a preservative, which readies it for testing using the immunohistochemistry (IHC) test —an internationally recognized confirmatory test for BSE. Neither the rapid screening test nor the Western blot confirmatory test can be conducted on a sample that has been preserved.

Our laboratory ran the IHC test on the sample and received non-definitive results that suggest the need for further testing. As we have previously experienced, it is possible for an IHC test to yield differing results depending on the “slice” of tissue that is tested. Therefore, scientists at our laboratory and at Weybridge will run the IHC test on additional “slices” of tissue from this animal to determine whether or not it was infected with BSE. We will announce results as soon as they are compiled, which we expect to occur by next week.

I would note that the sample was taken in April, at which time the protocols allowed for a preservative to be used (protocols changed in June 2005). The sample was not submitted to us until last week, because the veterinarian set aside the sample after preserving it and simply forgot to send it in. On that point, I would like to emphasize that while that time lag is not optimal, it has no implications in terms of the risk to human health. The carcass of this animal was destroyed, therefore there is absolutely no risk to human or animal health from this animal.

Regardless of the outcome of the further testing, I want to emphasize that human and animal health in the United States are protected by a system of interlocking safeguards. The most important of these is the ban on specified risk materials from the food supply and the Food and Drug Administration’s feed ban. And by any measure, the incidence of BSE in this country is extremely low. Our enhanced surveillance program is designed to provide information about the level of prevalence of BSE in the United States . We are extremely gratified that to date, all sectors of the cattle industry have cooperated in this program by submitting samples from more than 419,000 animals from the highest risk populations. To date, only one animal has tested positive for the disease as part of the surveillance program. These interlocking safeguards continue to protect our food supply.

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http://www.aphis.usda.gov/lpa/news/2005/07/bsestatement_vs.html

Release No. 0508.04
Contact:
Office Of Communications (202)720 4623


Printable version


Statement by John Clifford, Deputy Administrator Animal & Plant Health Inspection Service

November 23, 2004

"The USDA National Veterinary Services Laboratories (NVSL) in Ames, Iowa, has determined that the inconclusive screening test sample reported on Nov. 18 has tested negative for BSE upon confirmatory testing.

"The Nov. 18 sample is the first that has tested inconclusive under an APHIS protocol announced in August that calls for public reporting of screening results only after two reactive screens. NVSL used the immunohistochemistry (IHC) test, an internationally-recognized gold standard test for BSE, and received a negative result on Nov. 22. Because the Nov. 18 screening test results were reactive in both the first and second screens, NVSL scientists made the recommendation to run the IHC test a second time. On Nov. 23 they reported the second IHC test was negative. Negative results from both IHC tests make us confident that the animal in question is indeed negative for BSE.

"APHIS began an enhanced surveillance program on June 1 and to date has tested over 121,000 samples for BSE. Screening tests are designed to be extremely sensitive and false positives are not unexpected. APHIS has reported three inconclusives including the Nov. 18 sample and all have tested negative on confirmatory testing."


Last Modified: 11/23/2004


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2004/11/0508.xml

DR. CLIFFORD: "Thank you, Mr. Secretary. And thanks everyone for being on the phone tonight.

"Since the USDA enhanced surveillance program for BSE began in June 2004 more than 375,000 animals from the targeted cattle population have been tested for BSE using a rapid test. Three of these animals tested inconclusive and were subsequently subjected to the immunohistochemistry (IHC) testing. The IHC is an internationally recognized confirmatory test for BSE. All three inconclusive samples tested negative using the IHC test.

"As the Secretary said earlier this week, USDA's Office of Inspector General which has been partnering with APHIS, FSIS and ARS, the Agriculture Research Service, by impartially reviewing BSE-related activities and making recommendations for improvement, recommended that all three of these samples be subjected to a second internationally recognized confirmatory test, the Western Blot.

"We received final results a short time ago. As the Secretary stated, of the three samples two were negative, but the third came back reactive on that test.

"Because of the conflicting results on the IHC and Western Blot test, a sample from this animal will be sent to the OIE recognized reference laboratory for BSE in Weybridge, England. USDA will also be conducting further testing which will take several days to complete.

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2005/06/0207.xml

ANNOUNCES BSE TEST RESULTS AND NEW BSE CONFIRMATORY TESTING PROTOCOL

WASHINGTON, June 24, 2005 -- Agriculture Secretary Mike Johanns today announced that the U.S. Department of Agriculture has received final test results from The Veterinary Laboratories Agency in Weybridge, England, confirming that a sample from an animal that was blocked from the food supply in November 2004 has tested positive for bovine spongiform encephalopathy (BSE). Johanns also directed USDA scientists to work with international experts to thoughtfully develop a new protocol that includes performing dual confirmatory tests in the event of another "inconclusive" BSE screening test.


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THANKS TO THE HONORABLE PHYLLIS FONG OF THE OIG !

Johann's did everything in his power NOT to confirm this mad cow in TEXAS.

HE SHOULD BE FIRED!

HOWEVER, he did succeed in covering up this mad cow, and about 9,200 others where no rapid test at all was used.

FOR IMMEDIATE RELEASE
Statement
May 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

Statement on Texas Cow With Central Nervous System Symptoms
On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.

FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.

FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.

Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).

FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.

To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.

Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.

FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.

####

http://www.fda.gov/bbs/topics/news/2004/NEW01061.html

USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing.

http://www.aphis.usda.gov/lpa/issues/bse/surveillance/figure2f.html

Important legal notice


|
32005R0214
Commission Regulation (EC) No 214/2005 of 9 February 2005 amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in caprine animals (Text with EEA relevance)

Official Journal L 037 , 10/02/2005 P. 0009 - 0012


Commission Regulation (EC) No 214/2005

of 9 February 2005

amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in caprine animals

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies [1], and in particular the first paragraph of Article 23 thereof,

Whereas:

(1) Regulation (EC) No 999/2001 lays down rules for the monitoring of transmissible spongiform encephalopathies (TSE) in caprine animals.

(2) On 28 January 2005, a panel of experts on TSEs in small ruminants, chaired by the Community Reference laboratory for TSEs (CRL), confirmed the detection of bovine spongiform encephalopathy (BSE) in a goat slaughtered in France. It was the first case of BSE in a small ruminant under natural conditions.

(3) The former Scientific Steering Committee (SSC) adopted during its meeting on 4- 5 April 2002 an opinion on safe sourcing of small ruminant materials should BSE become likely in small ruminants. In its opinion, adopted during its meeting of 26 November 2003, the Scientific Panel on Biological Hazards of the European Food Safety Authority (EFSA) endorsed the statement of the SSC opinion with regard to the TSE-related safety of certain small ruminant products. In its statement of 28 January 2005, the above Panel of EFSA also stresses that the significance of this single case of BSE infection in a goat in France is yet to be assessed. In order to do so, the results of an increased monitoring of TSEs in goats will be essential.

(4) In line with the SSC and EFSA opinions and statement above, the monitoring of goats should be extended in order to improve Community eradication programmes. Those programmes also increase the level of consumer protection, although the safe sourcing of goat products is further assured by the current measures, in particular the provisions on the removal of specified risk materials, in Regulation (EC) No 999/2001.

(5) The extended monitoring should be based on a recommendation for a statistically valid survey by the CRL in order to determine the prevalence of BSE in goats as soon as possible and to improve knowledge of the geographical and within-flock distribution. It should therefore apply to all Member States with a focus on the Member States affected by BSE.

(6) Regulation (EC) No 999/2001 should therefore be amended accordingly.

(7) In view of the importance to ensure the highest level of consumer protection and to evaluate the prevalence of BSE in goats, the amendments made by this Regulation should enter into force without delay.

(8) The monitoring programme in caprine animals should be reviewed after at least 6 months of effective monitoring and when the EFSA has delivered its opinion on a quantitative assessment of the residual risk posed by goat meat and meat products derived there from.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health Committee,

HAS ADOPTED THIS REGULATION:

Article 1

Annex III to Regulation (EC) No 999/2001 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.


Done at Brussels, 9 February 2005.

For the Commission

Markos Kyprianou

Member of the Commission

[1] OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 36/2005 (OJ L 10, 13.1.2005, p. 9).

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

ANNEX

In Annex III, in Part II of Chapter A, points 2 and 3 are replaced by the following:

"2. Monitoring in ovine and caprine animals slaughtered for human consumption

(a) Ovine animals

Member States, in which the population of ewes and ewe lambs put to the ram exceeds 750000 animals, shall test a minimum annual sample of 10000 ovine animals slaughtered for human consumption in accordance with the sampling rules set out in point 4 [1].

(b) Caprine animals

Member States shall test healthy slaughtered caprine animals in accordance with the sampling rules set out in point 4 and the minimum sample sizes listed in Table A.

Where a Member State experiences difficulty in collecting sufficient numbers of healthy slaughtered caprine animals to reach its allotted minimum sample size, it may choose to replace a maximum of 50 % of its minimum sample size by testing dead caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out in point 3.

Member State | Minimum sample size in healthy slaughtered caprine animals |

Spain | 125500 |

France | 93000 |

Italy | 60000 |

Greece | 20000 |

Cyprus | 5000 |

Austria | 5000 |

Other Member States | all |

3. Monitoring in ovine and caprine animals not slaughtered for human consumption

Member States shall test in accordance with the sampling rules set out in point 4 and the minimum sample sizes indicated in table B and table C, ovine and caprine animals which have died or been killed, but which were not:

- killed in the framework of a disease eradication campaign, or

- slaughtered for human consumption.

Member State population of ewes and ewe lambs put to the ram | Minimum sample size of dead ovine animals |

< 750000 | 10000 |

100000-750000 | 1500 |

40000-100000 | 500 |

< 40000 | 100 |

Member State population of goats which have already kidded and goats mated | Minimum sample size of dead caprine animals |

< 750000 | 10000 |

250000-750000 | 3000 |

40000-250000 | 1000 |

< 40000 | 100 % up to 200 |

[1] The minimum sample size has been calculated to detect a prevalence in slaughtered animals of 0,03 % with a 95 % confidence.

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

http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:32005R0214:EN:HTML

SCRAPIE USA MONTHLY REPORT 2005

AS of March 31, 2005, there were 70 scrapie infected source flocks (Figure
3). There were 11 new infected and source flocks reported in March (Figure
4) with a total of 51 flocks reported for FY 2005 (Figure 5). The total
infected and source flocks that have been released in FY 2005 are 39 (Figure
6), with 1 flock released in March. The ratio of infected and source flocks
released to newly infected and source flocks for FY 2005 = 0.76 : 1. IN
addition, as of March 31, 2005, 225 scrapie cases have been confirmed and
reported by the National Veterinary Services Laboratories (NVSL), of which
53 were RSSS cases (Figure 7). This includes 57 newly confirmed cases in
March 2005 (Figure 8). Fourteen cases of scrapie in goats have been reported
since 1990 (Figure 9). The last goat cases was reported in January 2005. New
infected flocks, source flocks, and flocks released or put on clean-up plans
for FY 2005 are depicted in Figure 10. ...

FULL TEXT ;

http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.htm
l


SCRAPIE USA JUNE 2005 UPDATE


AS of June 30, 2005, there were 114 scrapie infected and source flocks
(Figure 3). There were 14 new infected and source flocks reported in June
(Figure 4) with a total of 123 flocks reported for FY 2005 (Figure 5).


snip...


In addition, as of June 30, 2005, 448 scrapie cases have been confirmed and
reported by the National Veterinary Services Laboratories (NVSL), of which
106 were RSSS cases (Figure 7). This includes 81 newly confirmed cases in
June 2005 (Figure 8). Fifteen cases of scrapie in goats have been reported
since 1990 (Figure 9). The last goat case was reported in May 2005.


snip...end


http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.htm
l


USDA/APHIS

SOSS

Phase II: Scrapie: Ovine Slaughter Surveillance

Study 2002-2003


http://www.aphis.usda.gov/vs/ceah/ncahs/nahms/sheep/SOSSphase2.pdf


12/10/76
AGRICULTURAL RESEARCH COUNCIL
REPORT OF THE ADVISORY COMMITTE ON SCRAPIE
Office Note
CHAIRMAN: PROFESSOR PETER WILDY

snip...

A The Present Position with respect to Scrapie
A] The Problem

Scrapie is a natural disease of sheep and goats. It is a slow
and inexorably progressive degenerative disorder of the nervous system
and it ia fatal. It is enzootic in the United Kingdom but not in all
countries.

The field problem has been reviewed by a MAFF working group
(ARC 35/77). It is difficult to assess the incidence in Britain for
a variety of reasons but the disease causes serious financial loss;
it is estimated that it cost Swaledale breeders alone $l.7 M during
the five years 1971-1975. A further inestimable loss arises from the
closure of certain export markets, in particular those of the United
States, to British sheep.

It is clear that scrapie in sheep is important commercially and
for that reason alone effective measures to control it should be
devised as quickly as possible.

Recently the question has again been brought up as to whether
scrapie is transmissible to man. This has followed reports that the
disease has been transmitted to primates. One particularly lurid
speculation (Gajdusek 1977) conjectures that the agents of scrapie,
kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of
mink are varieties of a single "virus". The U.S. Department of
Agriculture concluded that it could "no longer justify or permit
scrapie-blood line and scrapie-exposed sheep and goats to be processed
for human or animal food at slaughter or rendering plants" (ARC 84/77)"
The problem is emphasised by the finding that some strains of scrapie
produce lesions identical to the once which characterise the human
dementias"

Whether true or not. the hypothesis that these agents might be
transmissible to man raises two considerations. First, the safety
of laboratory personnel requires prompt attention. Second, action
such as the "scorched meat" policy of USDA makes the solution of the
acrapie problem urgent if the sheep industry is not to suffer
grievously.

snip...

76/10.12/4.6

http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf


Like lambs to the slaughter
31 March 2001
Debora MacKenzie
Magazine issue 2284
What if you can catch old-fashioned CJD by eating meat from a sheep infected
with scrapie?
FOUR years ago, Terry Singeltary watched his mother die horribly from a
degenerative brain disease. Doctors told him it was Alzheimer's, but
Singeltary was suspicious. The diagnosis didn't fit her violent symptoms,
and he demanded an autopsy. It showed she had died of sporadic
Creutzfeldt-Jakob disease.

Most doctors believe that sCJD is caused by a prion protein deforming by
chance into a killer. But Singeltary thinks otherwise. He is one of a number
of campaigners who say that some sCJD, like the variant CJD related to BSE,
is caused by eating meat from infected animals. Their suspicions have
focused on sheep carrying scrapie, a BSE-like disease that is widespread in
flocks across Europe and North America.

Now scientists in France have stumbled across new evidence that adds weight
to the campaigners' fears. To their complete surprise, the researchers found
that one strain of scrapie causes the same brain damage in ...

The complete article is 889 words long.

full text;

http://www.newscientist.com/article.ns?id=mg16922840.300

Neurobiology
Adaptation of the bovine spongiform encephalopathy agent to primates and
comparison with Creutzfeldt- Jakob disease: Implications for human health
Corinne Ida Lasmézas*,, Jean-Guy Fournier*, Virginie Nouvel*, Hermann Boe*,
Domíníque Marcé*, François Lamoury*, Nicolas Kopp, Jean-Jacques Hauw§, James
Ironside¶, Moira Bruce, Dominique Dormont*, and Jean-Philippe Deslys*
* Commissariat à l'Energie Atomique, Service de Neurovirologie, Direction
des Sciences du Vivant/Département de Recherche Medicale, Centre de
Recherches du Service de Santé des Armées 60-68, Avenue du Général Leclerc,
BP 6, 92 265 Fontenay-aux-Roses Cedex, France; Hôpital Neurologique Pierre
Wertheimer, 59, Boulevard Pinel, 69003 Lyon, France; § Laboratoire de
Neuropathologie, Hôpital de la Salpêtrière, 83, Boulevard de l'Hôpital,
75013 Paris, France; ¶ Creutzfeldt-Jakob Disease Surveillance Unit, Western
General Hospital, Crewe Road, Edinburgh EH4 2XU, United Kingdom; and
Institute for Animal Health, Neuropathogenesis Unit, West Mains Road,
Edinburgh EH9 3JF, United Kingdom

Edited by D. Carleton Gajdusek, Centre National de la Recherche
Scientifique, Gif-sur-Yvette, France, and approved December 7, 2000
(received for review October 16, 2000)


Abstract
Top
Abstract
Introduction
Materials and Methods
Results
Discussion
Conclusions
References
There is substantial scientific evidence to support the notion that bovine
spongiform encephalopathy (BSE) has contaminated human beings, causing
variant Creutzfeldt-Jakob disease (vCJD). This disease has raised concerns
about the possibility of an iatrogenic secondary transmission to humans,
because the biological properties of the primate-adapted BSE agent are
unknown. We show that (i) BSE can be transmitted from primate to primate by
intravenous route in 25 months, and (ii) an iatrogenic transmission of vCJD
to humans could be readily recognized pathologically, whether it occurs by
the central or peripheral route. Strain typing in mice demonstrates that the
BSE agent adapts to macaques in the same way as it does to humans and
confirms that the BSE agent is responsible for vCJD not only in the United
Kingdom but also in France. The agent responsible for French iatrogenic
growth hormone-linked CJD taken as a control is very different from vCJD but
is similar to that found in one case of sporadic CJD and one sheep scrapie
isolate. These data will be key in identifying the origin of human cases of
prion disease, including accidental vCJD transmission, and could provide
bases for vCJD risk assessment.


http://www.pnas.org/cgi/content/full/041490898v1

TSS




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