Commission Regulation (EC) No 1248/2001
of 22 June 2001
amending Annexes III, X and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance and testing of transmissible spongiform encephalopathies
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 Articles 20(2) and 23 thereof,
Whereas:
(1) Detailed rules for monitoring of transmissible spongiform encephalopathies (TSEs) in bovine, ovine and caprine animals are laid down in Annex III to Regulation (EC) No 999/2001. These rules include systematic testing of bovine animals over 30 months of age entering the food chain and random testing of bovine animals over 30 months of age not entering the food chain. In addition, all bovine animals subject to casualty slaughter or found sick when slaughtered for destruction under the over thirty months scheme (OTMS) shall be tested. Ovine and caprine animals with clinical signs compatible with TSE shall be subject to active surveillance.
(2) In view of the detection of bovine spongiform encephalopathy (BSE) in two bovine animals at the age of 28 months in routine testing of casualty slaughtered animals and to provide an early warning system of the emergence of any unfavourable trends in BSE incidence in younger animals, the age limit should be reduced to 24 months in animals belonging to certain risk populations.
(3) In the monitoring carried out during the first trimester of 2001, positive BSE cases were detected in all Member States except in Greece, Luxembourg, Austria, Finland and Sweden. The number of bovine animals belonging to certain risk groups tested in the above Member States were: 248 in Greece, 763 in Luxembourg, 3295 in Austria, 4527 in Finland and 8254 in Sweden.
(4) In its opinion of 6 July 2000 on the geographical risk of BSE (GBR), the Scientific Steering Committee (SSC) concluded that the GBR level of Luxembourg was III (BSE confirmed at a low level) and the GBR level of Austria, Finland and Sweden was II (BSE unlikely, but not excluded). Greece did not submit a dossier for assessment, referring to legal and technical uncertainties.
(5) In the light of the monitoring carried out in Austria, Finland and Sweden and of the assessment of the SSC, the presence of BSE in those Member States is unlikely, but not excluded. If present, BSE would most likely be detected by examining bovine animals which have died on farms, which have been subject to casualty slaughter or have been found sick at normal slaughter. Those Member States should therefore be allowed to reduce the testing in healthy slaughtered bovine animals.
(6) With a view to additional information of the occurrence of BSE in the United Kingdom, the testing in the OTMS should be expanded to include all animals born within one year after the effective enforcement of the feed ban. Other bovine animals slaughtered under the OTMS should be tested at random.
(7) Member States should be allowed to test other bovine animals on a voluntary basis, in particular where those animals are considered to present a higher risk, provided it is done without disrupting trade.
(8) It is necessary to clarify the measures following testing of bovine animals and to introduce measures to prevent carcases potentially contaminated by test-positive carcases from entering the food chain.
(9) Rapid post-mortem testing should be introduced on a random basis to improve the detection of scrapie in ovine and caprine animals. To obtain a more complete picture of the situation, it is necessary to carry out random sampling in two different target populations: dead-on-farm animals and slaughtered animals.
(10) In Member States with small national herds of sheep and goats it is difficult to carry out statistically meaningful sampling in both target groups. Those Member States should therefore be allowed to use a smaller sample size but targeted at animals where the likelihood to find positive cases is highest.
(11) In view of the role of genetic resistance in the development of clinical scrapie and the possibility to use breeding programmes in the prevention, control and eradication of scrapie, the genotype of all scrapie cases should be determined and cases found in resistant genotypes should be submitted for strain-typing.
(12) The list of national reference laboratories should be updated.
(13) Following the introduction of rapid tests in monitoring programmes for ovine and caprine animals it is necessary to lay down appropriate diagnostic methods and protocols. Furthermore, the diagnostic methods and protocols laid down for bovine animals should be updated.
(14) According to Article 22 of Regulation (EC) No 999/2001, a conclusive statistical survey shall be used to confirm or overturn the risk analysis conclusions carried out as the first step in determining the BSE status of a country or a region. The minimum criteria for the statistical survey are laid down in Part B of Annex XI. In view of the lower BSE risk in Austria, Finland and Sweden, as assessed by the SSC, and the disproportionate resources involved, a derogation should be provided for those Member States to exclude from the survey dead-on-farm animals in remote areas with a low animal density.
(15) In the interest of clarity Commission Decisions 98/272/EC(2) on epidemio-surveillance for transmissible spongiform encephalopathies, as last amended by Decision 2001/8/EC(3), and 2000/764/EC(4) on the testing of bovine animals for the presence of bovine spongiform encephalopathy, as amended by Decision 2001/8/EC, should be repealed.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 999/2001 is amended as follows:
1. The text in Annex III is replaced by the text in Annex I to this Regulation.
2. The text in Annex X, Chapter A, point 3, is replaced by the text in Annex II to this Regulation.
3. The text in Annex X, Chapter C, is replaced by the text in Annex III to this Regulation.
4. The text in Annex XI, Chapter B, is replaced by the text in Annex IV to this Regulation.
Article 2
1. Decisions 98/272/EC and 2000/764/EC are repealed.
2. References to the repealed Decisions shall be construed as references to Regulation (EC) No 999/2001. In particular, references to Annex IVA of Decision 98/272/EC shall be construed as references to Annex X, Chapter C, point 4, to Regulation (EC) No 999/2001.
Article 3
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Communities.
It shall apply from 1 July 2001. However, the provisions of Annex III, Chapter A, section II, to Regulation (EC) No 999/2001, as set out in Annex I to this Regulation, shall apply from 1 January 2002.
The provisions of Annex III to Regulation (EC) No 999/2001, as set out in Annex I to this Regulation, shall be reviewed in the light of the results obtained during the first six months of the monitoring.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 June 2001.