MEMO/03/3

Brussels, 8 January 2003

Questions and Answers on BSE

What is the current state of play on BSE in the EU?

The overall incidence of BSE in the European Union is falling, led by the improvement in the situation in the UK where the number of cases in 2002 is expected to be around 3% of the number of cases registered in 1992 or 1993. In a few Member States the number of cases is still rising in 2002, notably due to the more extended testing for BSE since July 2001. There is an extensive range of EU laws in place to protect the public against the risks from BSE. Member States must ensure full implementation of all EU rules relating to BSE. If these measures are strictly implemented, consumers can have confidence in the safety of beef.

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001^[1] brings all existing BSE measures as adopted over the years through more than sixty Commission Decisions into a single, comprehensive framework, consolidating and updating them in view of scientific advice and international standards. In addition it introduced a number of new instruments to manage the risk of BSE and other similar diseases such as scrapie in all animal species and relevant products.

BSE and vCJD

What is the origin of BSE and what is its incidence in the EU?

Bovine spongiform encephalopathy (BSE) is a disease of the brain in cattle. It was first diagnosed in the UK in 1986. It reached epidemic proportions due to the inclusion in cattle feed of meat and bone meal produced from animal carcasses. Up to 1 October 2002, there have been about 181,000 cases in the UK and about 3,200 cases elsewhere in the European Union. The distribution of the year of birth of BSE cases detected in 2002 is similar to that of 2001: most cattle were born in 1994, 1995 or 1996. This is a strong indication that the number of new animals having got infected since 1996 is decreasing, and that measures taken in 1996-1997 are producing a positive effect. At present, all healthy slaughtered cattle above 30 months are tested in the EU before release for human consumption and BSE is detected in less than 1 per 30,000 cattle. The animals with a positive test result are completely destroyed.

What about its human equivalent - vCJD?

Variant Creutzfeldt-Jacob Disease (vCJD) was first diagnosed in 1996. It is now generally assumed to be caused by the transmission of BSE to humans. There are 137 confirmed or suspected cases in the EU up to 1 January 2003, mostly in young people. Most cases have occurred in the UK (129) and some in France (6), Ireland (1) and Italy (1).

Estimates of the future number of vCJD cases vary widely as too little is known about the incubation period between exposure to the infective agent and the emergence of symptoms. However, it is clear that future cases will be overwhelmingly due to past exposure to infective material before the strengthening of controls in recent years.

What is the incidence of BSE by Member State?

Currently, the overall BSE incidence in the Community is falling, not only as a result of the decline in BSE cases as observed in the UK but also in most other Member States. In the UK the incidence has fallen sharply from over 37,056 cases in 1992 at the peak of the epidemic to 1194 in 2001.

In other Member States the number of cases varied in 2001 from 277 in France to 1 in Austria, Finland and Greece. These were the only cases ever detected in the latter three Member States until now. Luxembourg did not detect BSE in 2001, but has reported one case in 2002, as well as one case in 1997. Sweden has so far not reported BSE.

Details on the number of cases in the EU can be consulted on the chapter on statistics in the BSE web page of the European Commission.

What is the current testing programme for BSE in the EU?

In addition to the compulsory examination of all animals showing signs suggestive of BSE, rapid post mortem testing for BSE must, as of 1 January 2001, be carried out on:

• Animals slaughtered as emergencies or showing signs of any kind of illness at the ante mortem inspection in the slaughterhouse. From January 2001 to June 2001: all animals over 30 months of ageAs of 1 July 2001: all animals over 24 months of age
• All bovine animals over 30 months of age subject to normal slaughter for human consumption. By way of derogation, Sweden is allowed to test only a random sample.
• Fallen stock: cattle which have died or been killed on the farm or in transport, but not slaughtered for human consumption. January 2001 to June 2001: A random sample of bovine animals over 30 months of age,As of 1 July 2001: All bovine animals over 24 months of age
• In the UK, where all bovine animals over 30 months of age are destroyed under the Over Thirty Months Scheme (OTMS), BSE testing must be carried out on the following animals slaughtered under that scheme: all bovine animals subject to casualty slaughter, all animals over 42 months of age born after 1 August 1996 and subject to normal slaughter and a random sample of bovine animals born before 1 August 1996 and subject to normal slaughter

In total more than 8.5 million cattle have been tested in 2001 and more than 10 million cattle will be tested in 2002. Details on the number of tests and the number of detected cases can be consulted on the chapter on statistics in the BSE web page of the European Commission. The Commission is co-financing the testing programme with currently 14€ per test (10.5€ in 2003).

What is the expected future evolution of the disease?

Up until the middle of 2000, the majority of BSE cases detected were found by means of traditional passive surveillance, i.e. through the examination and mandatory reporting of animals suspected of showing signs or clinical symptoms of BSE. Since rapid post mortem testing started, it has become evident that additional cases can be picked up by active monitoring. Thus animals with non-typical signs, such as kicking, lameness, loss of weight and reduced milk yield will not escape detection. Such conditions are so common that it would not be practicable to treat all those animals as BSE suspects. BSE cases have also been found in slaughtered animals without any previous signs of illness.

The systematic active monitoring started in January 2001 in target groups such as fallen stock and healthy slaughtered cattle without any previous signs of BSE. In 2002, more than 2/3 of all BSE cases were detected in this way.

It was expected that systematic active monitoring would increase the number of detected BSE cases when the monitoring was intensified in July 2001. Since then the number of positive cases detected per month is stable or even decreasing in most Member States. In addition to the reduction of positive cases per month, the age structure of the positive BSE cases is shifting towards older animals in all Member States. This is a positive signal and shows that the measures taken from 1996 onwards are having effect.

The average incubation period of BSE in cattle is 4-6 years, but may in certain cases be much longer. Therefore BSE cases will probably continue to occur until 2010 or later.

EU measures to tackle BSE

What has the EU done to protect the public - what are the rules in place?

All Community measures are based on the opinions of the independent scientific committees of leading experts who provide the best possible scientific advice to the European Commission. New scientific evidence is regularly reviewed by the EU Scientific Steering Committee and other specialised scientific committees, which continue to give top priority to BSE related issues.

The European Commission's top priority is to protect animal and public health, and to ensure that food is safe from farm to table. To that end, and to ensure that meat intended for human consumption is safe, the Commission has introduced a comprehensive set of stringent Community measures in relation to BSE since 1990, covering:

• Veterinary inspection: a requirement for animals presented for slaughter to be inspected by veterinary surgeons to ensure that suspected cases do not enter the food and feed chains, as of 9 April 1990;
• A ban on the feeding of mammalian meat and bone meal (MBM) to cattle, sheep and goats, as of July 1994: This was introduced in the light of the clarification by the scientific committees that the spread of BSE was caused by the consumption of feed contaminated by ruminant protein in the form of MBM;
• High processing standards for the treatment of ruminant animal waste since 1 January 1995. These were re-enforced on 1 April 1997, requiring pressure-cooking (133 ºC/3 bars/20 minutes) for all mammalian waste used for the production of MBM, to reduce infectivity to a minimum to avoid recycling the infectious agent if present in animal cadavers;
• Surveillance measures for the detection, control and eradication of BSE, as of 1 May 1998, involving active monitoring by veterinarians and passive monitoring through tests;
• Culling: animals with a high probability of having received the same potentially infected feed as a BSE case must be killed and destroyed (culled). Animals of the same age from the same herd (cohort animals) are most likely to have received the same potentially infected feed and should therefore always be culled. Depending on the epidemiological situation and the traceability of animals, it may be necessary to cull also the other bovine animals from the same herd. In addition, the latest born offspring to female BSE cases must be culled, due to potential maternal transmission. Member States having alternative measures in place offering equivalent guarantees may benefit from a derogation.The rules on culling apply as of 1 July 2001.
• The requirement to remove specified risk materials (SRMs like spinal cord, brain, eyes, tonsils, parts of the intestines) from cattle, sheep and goats throughout the EU from 1 October 2000 from the human and animal food chains. The list of SRM has been extended to include the entire intestine of bovines and vertebral column, as of March 2001 (see full SRM list in Annex 1). The obligation is also mandatory for imports of meat and meat products from third countries into the EU except for countries where the geographical risk assessment indicates the BSE presence is high unlikely i.e. Argentina, Australia, Botswana, Brazil, Chile, Costa Rica, El Salvador, Iceland, Namibia, New-Zealand, Nicaragua, Panama, Paraguay, Singapore, Swaziland, Uruguay and Vanuatu.
• The introduction of targeted testing for BSE, with a focus on high risk animal categories, from 1 January 2001 (see above);
• A total EU wide suspension on the use of processed animal protein in feeds for any animals farmed for the production of food, since 1 January 2001. The ban was re-enforced in the light of experience and advice from the SSC and the Commission's Food and Veterinary Office, to minimise any risk of cross-contamination such as mixing of safe livestock feed with feed containing animal protein contaminated with BSE agent. The re-enforced measures required inter alia recall of MBM and feed containing it, dedication of processing (including storage and transport) standards and continued microscopic testing of feed to ensure it contains no MBM; Only certain animal proteins such as fishmeal, which are considered as safe, can be used under very strict conditions. A proposal to tighten-up treatment standards for ruminant fats is expected after the relevant scientific advice will have been updated.
• Stringent controls on animal feed: Regulation (EC) No 1774/2002 of the European Parliament and the Council laying down health rules concerning animal by-products not intended for human consumption was adopted on 3 October 2002 and enters into force on 1 May 2003. The Regulation is, after the TSE Regulation adopted in 2000, the second key action of the White Paper on Food safety and is a major component of the Commission strategy to combat and eradicate feed-borne crises such as BSE, foot and mouth disease, swine fever and dioxin.

It requires that^[2]: (i) only material from animals fit for human consumption following veterinary inspection may enter the feed chain, (ii) feed must be processed to highest rendering standards (pressure-cooking) and (iii) rendering facilities producing feed must be dedicated to such production to avoid possible cross-contamination. Also, the new Regulation extends the ban on intra-species recycling (cannibalism) that has been in place since 1994 in relation to ruminant animals, to other animal species;

How are BSE rules monitored and enforced?

Member States are responsible for ensuring that EU rules are put into practice in their respective territories: The Commission's Food and Veterinary Office (FVO) carries out inspections to verify the correct implementation, enforcement and controls of Community legislation by the competent national authorities. When a confirmed breach of the legislation is reported, the Commission initiates infringement procedures against the Member State concerned. The FVOs inspection reports are published on the Commission's website at:

http://ec.europa.eu/food/fs/inspections/vi/reports/index_en.html

What is the BSE situation in third countries?

Native cases of BSE have been detected in countries outside the EU. The number of cases in countries outside the EU can be consulted on the BSE web page in the Chapter Statistics – overview of BSE cases worldwide. The EU’s Scientific Steering Committee (SSC) has identified potential BSE risks in third countries based on factors such as past imports of live bovines and meat and bone meal from the United Kingdom and other BSE affected countries, and the feeding of mammalian meat and bone meal (MBM) to ruminants.

The EU has accordingly decided that European consumers should be afforded a level of protection in relation to imports equivalent to the level demanded of EU sourced products. These import requirements are laid down in 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.

How is the risk of BSE in third countries evaluated and how are they classified in BSE risk categories?

At the Commission’s initiative, the EU’s Scientific Steering Committee has carried out “geographical BSE risk (GBR) assessments” of the situation with respect to BSE in the EU Member States and in third countries. The methodology for this assessment was developed over a period of more than 2 years and published for the first time on the Internet in December 1998. The assessments are based on information submitted by the countries concerned in response to a Commission recommendation in 1998 setting out the information required for such an assessment. The information concerns in particular imports of bovines and meat and bone meal (MBM) from the United Kingdom and other BSE-affected countries, rendering standards for animal by-products, use of so called Specified Risk Materials (SRMs), feeding of MBM to ruminants etc. The methodology was updated with an opinion on 11 January 2002.

The SSC has identified four transitional categories based on the GBR assessments, as follows:

• Level I BSE highly unlikely
• Level II BSE unlikely but not excluded
• Level III BSE likely but not confirmed, or confirmed at a lower level
• Level IV BSE confirmed at a higher level

The Regulation (EC) No 999/2001 which came into force on 1 July 2001 foresees the categorisation of countries into five categories of BSE Status which is based on the current OIE Code. The Commission is currently engaged in classifying countries in relation to BSE. The final determination of the BSE Status comprises two steps. As a first step a risk assessment is carried out taking into account specific pre-defined factors. In a second step, additional criteria are evaluated. Based on the risk assessment and the evaluation of the additional criteria the BSE Status is established. Pending the determination of the BSE Status, transitional measures based on the classical geographical BSE risk assessment as undertaken by the SSC apply for imports.

What are the rules for imports from third countries?

The Regulation (EC) No 999/2001 came into force on 1 July 2001. It provides a layer of security in relation to BSE and asks the same measures to be applied for imports of beef into the EU like they are in the EU. For example, it prohibits imports of specific risk materials (SRM) or meat products containing SRMs from third countries and the third country has to ensure that the slaughter techniques of animals do not include techniques prohibited in the EU. The rules apply also to a list of bovine, ovine and caprine products (rendered fats, gelatine, petfood, bone and bone products, raw material for the manufacture of animal feedingstuffs) from third countries. Also, an international certificate is required for live bovines attesting that an effective feed ban has been in place, and showing a permanent system of identification of live bovines to their herd of origin.

For those countries where the existence of BSE is considered to be highly unlikely by the Scientific Steering Committee, no BSE related import restrictions are foreseen.

These rules are proportionate and non-discriminatory. The geographical BSE risk of third countries has been assessed/is assessed in the same manner by the Scientific Steering Committee as for Member States of the EU. This geographical BSE risk is the sole determining factor in deciding the level of protection required in relation to BSE. The existence of BSE in 17 third countries has been considered to be highly unlikely and they are therefore exempted from any restrictions. No Member State of the EU has received a similar status. The WTO rules have been respected by duly notifying the EU measures on BSE to third countries. However, in line with the EU´s commitment to keep evolving science under permanent review, any future new evidence will always be evaluated.

Trade implications are limited by these measures. Trade in carcass beef is not interrupted as there is provision for the removal of vertebral column (as SRM) in the EU rather than in the third country before export. Third countries must however have to ensure that the slaughter techniques of animals do not include techniques prohibited in the EU. However, most trade in beef is in deboned form and therefore is unaffected.

How are the Candidate Countries affected?

In the accession negotiations all candidate countries have committed themselves to fully comply with the EU rules on combating BSE. In fact, important progress has already been achieved: for example, all of them are already removing the specified risk materials from the food chain and majority of them are testing all healthy cattle aged over 30 months. The Commission is closely monitoring the progress. In line with this, the FVO completed early 2002 the first series of missions in all candidate countries to review their BSE measures.

The Commission is also encouraging the use of various support measures open to candidate countries for technical assistance. For example the use of BSE test kits in the candidate countries is co-financed and technical advice is provided through the PHARE programme.

What research activities on TSEs is the EU doing?

Introduction, 1990-1996

The European Commission has sponsored research into Transmissible Spongiform Encephalopathies (TSEs) since 1990. This research effort was rapidly and substantially increased following the announcement by the UK Government (20/03/1996) that the appearance of 10 cases of a new variant of Creutzfeldt-Jakob Disease (vCJD) could be linked to exposure to Bovine Spongiform Encephalopathy (BSE).

Action Plan on TSEs and Fourth Framework Programme, 1994-1998

In April 1996, the Commission invited Professor Charles Weissmann to Chair a group with the objectives of producing an inventory of the state of knowledge on BSE, and proposing future research priorities. Professor Weissmann’s report was published in October 1996 and formed the basis of a communication from the Commission to the Council (COM (96) 582) proposing an Action Plan on TSEs. The Action Plan also took into account the recommendations of the Multidisciplinary Scientific Committee as well as ongoing national and Community research activities. Based on the Council recommendations, the action plan comprised two levels:

The co-ordination of activities between Member States, aimed at harmonisation of data collection and diagnostic criteria

A specific call for RTD actions, intended to stimulate research efforts at a Community level and to mobilise new and complementary expertise in order to attain European critical mass in the area.

The first of three calls for research proposals under this initiative was made in December 1996, the last in March 1998. A total of 54 projects were commissioned under this Action Plan, with support totalling €50.7m. This support derived from the BIOMED, BIOTECH and FAIR programmes. The Action Plan resulted in an excellent mobilisation of expertise in a wide range of scientific disciplines, from more than 120 laboratories throughout the Member States and associated countries.

The Fifth Framework Programme, 1998-2002

The Fifth Framework Programme (1998-2002) builds on the foundations of the 4^th FP, and has seen 26 TSE projects (~€ 30m) supported both from general calls for research projects (11), as well as from 2001’s specific call for TSE research (15).

Specific Call for TSE Research and the Inventories of TSE Research Activities in Europe, 2001

In November 2000, the Research Council requested the Commission to establish a TSE Expert Group with a mandate to:

• examine the state of TSE research
• encourage the exchange of scientific information between research teams
• identify ongoing research activities which need to be strengthened, as well as new research activities which need to be launched.

The Group is composed of representatives nominated from the Member States, Associated Countries, some members of the TSE/BSE ad hoc group of the Scientific Steering Committee and some co-ordinators of EU research projects. In April 2002 it was expanded to include members from Central and Eastern European States.

Included in the aims of the Action Plan was the objective to expand and regularly update the inventory of TSE research activities in Member States, originally drafted by Professor Weismann. An analysis of the most recent version of this document (April 2001) by the TSE Expert Group and the Commission Services resulted in the launch of a specific call for TSE proposals, intended to fill the gaps in the European TSE research effort, and a communication from the Commission to the Council and the European Parliament (COM (2001) 323). A total of 15 new TSE projects were commissioned from this call with support totalling €21m, all of which, subject to the successful conclusion of contract negotiation, will commence in 2002.

The Sixth Framework Programme and Future Actions, 2002

2002 also sees the launch of the Sixth Framework Programme for Research and Technological Development. The most up to date details of this can be found at

http://ec.europa.eu/research/fp6/index_en.html

In September 2000, a catalogue of the 54 projects funded under the Action Plan was produced, and remains available from the DG RTD Commission Services; this is currently being updated to include results and outcomes from these projects and abstracts of more recently funded projects.

Further enquiries on BSE can be send to mailbox of the Health & Consumer protection Directorate-General:

sanco-mailbox@ec.europa.eu

Annex

Full SRM list

The following tissues are designated as specified risk material:

1. the skull including the brain and eyes, the tonsils, the vertebral column^[3] excluding the vertebrae of the tail, the transverse processes of the lumbar and thoracic vertebrae and the wings of the sacrum, but including dorsal root ganglia and spinal cord of bovine animals aged over 12 months, and the intestines from the duodenum to the rectum and the mesentery of bovine animals of all ages;
2. the skull including the brain and eyes, the tonsils and the spinal cord of ovine and caprine animals aged over 12 months or which have a permanent incisor erupted through the gum, and the spleen of ovine and caprine animals of all ages.

In addition to the specified risk material listed in (a), the following tissues must be designated as specified risk material in the United Kingdom of Great Britain and Northern Ireland and in Portugal, with the exception of the Autonomous Region of the Azores: the entire head excluding the tongue, including the brain, eyes, trigeminal ganglia and tonsils; the thymus, the spleen and the spinal cord of bovine animals aged over 6 months.

^[1] http://ec.europa.eu/food/fs/bse/bse36_en.pdf
updates at:
http://ec.europa.eu/food/fs/bse/legislation_en.html#general%20framework

^[2] see also: IP/02/1361

^[3] Sweden, the United Kingdom and Portugal may derogate from the compulsory removal of vertebral column under strict conditions.