Commission Decision
of 5 June 2000
amending Decision 98/272/EC on epidemio-surveillance for transmissible spongiform encephalopathies
(notified under document number C(2000) 1144)
(Text with EEA relevance)
(2000/374/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(1), as last amended by Directive 92/118/EEC(2), and in particular Article 9(4) thereof,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(3), as last amended by Directive 92/118/EEC, and in particular Article 10(4) thereof,
Whereas:
(1) Commission Decision 98/272/EC of 23 April 1998 on epidemio-surveillance for transmissible spongiform encephalopathies(4) lays down the rules for measures to be taken by Member States where a transmissible spongiform encephalopathy (TSE) is suspected in an animal, the minimum requirements for the monitoring of bovine spongiform encephalopathy (BSE) and scrapie and the rules for sampling and laboratory testing for the presence of a TSE.
(2) It is necessary to further clarify the measures in relation to animals killed following a suspicion of a TSE.
(3) A report of the evaluation of tests for the diagnosis of TSE in bovines was published by the Commission on 8 July 1999 and three tests were found to have an excellent sensitivity and an excellent specificity in detecting TSE in animals in the clinical stage of the disease.
(4) The use of the test in monitoring for BSE in bovine animals could significantly improve the efficacy of the monitoring, in particular if targeted on fallen stock and emergency slaughtered animals, as demonstrated in a monitoring programme carried out in Switzerland.
(5) The monitoring programme should be reviewed on a regular basis in the light of the results and experience gained in implementing the programme, therefore it is necessary to amend the rules on reporting and records and to introduce an additional report covering the first six months.
(6) The rules for laboratory testing for the diagnosis of BSE in bovine animals should be revised in the light of the recommendations of the Manual of Standards for Diagnostic Tests and Vaccines of the World Organisation for Animal Health (Office international des épizooties) and the evaluation of the tests.
(7) It is necessary to list the national reference laboratories for TSEs.
(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
Article 1
Decision 98/272/EC is amended as follows:
1. The last sentence in Article 3(2) is replaced by the following:"All parts of the body of the suspect animal, including the hide, shall be retained under official supervision until a negative diagnosis has been made or until it has been destroyed by incineration or, under exceptional circumstances, burned or buried in strict compliance with the conditions laid down in Article 3(2) of Council Directive 90/667/EEC(5)."
2. In Article 4, paragraph 1, the word "Annex" is replaced by "Annex I".
3. In Article 4, paragraph 2 is replaced by the following:
"2. Member States shall submit an annual report to the Commission covering at least the information referred to in Annex II, part A. The report for each calendar year shall be submitted at the latest by 31 March of the following year. The Commission shall present a summary of the country reports for each period covering at least the information referred to in Annex II, part B, to the Standing Veterinary Committee within three months of the receipt of the country reports."
4. In Article 4, the following paragraph 3 is added:
"3. Member States shall ensure that all official investigations and laboratory examinations are recorded in accordance with Annex III."
5. Article 5 is replaced by the following:
"Article 5
1. Sampling and laboratory testing for the presence of BSE in bovine animals shall be carried out using the methods and protocols laid down in Annex IV. Sampling and laboratory testing for the presence of scrapie in sheep shall be carried out using the methods and protocols laid down in the Manual of Standards for Diagnostic Tests and Vaccines of the World Organisation for Animal Health (Office international des épizooties), May 1999 edition.
2. The national reference laboratory in each Member State, as set out in Annex V, shall ensure coordination of diagnostic methods and protocols between the laboratories approved for testing for the presence of TSEs and regularly verify the use of those diagnostic methods and protocols."
6. The following Article 8a is added:
"Article 8a
Without prejudice to Article 4(2), Member States shall submit a report covering January-June 2001 including at least the information referred to in Annex II, part A, to the Commission by 1 October 2001, at the latest.
The provisions of Annex I and II shall be reviewed every six months in the light of the results of the monitoring and experience gained in implementing the programme. The provisions of Annex IV shall be reviewed in the light of the development of the Manual of Standards for Diagnostic Tests and Vaccines of the World Organisation for Animal Health (Office international des épizooties). The provisions of Annex IV A shall be reviewed in the light of further evaluation of diagnostic methods."
7. The Annex is replaced by the Annex to the present Decision.
Article 2
This Decision shall apply from 1 January 2001.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 5 June 2000.