Diagnostic procedures and bio-safety requirements
Article 17
1
Member States shall ensure that:
a
diagnostic procedures, sampling and laboratory testing to detect the presence of classical swine fever are carried out in accordance with the diagnostic manual;
b
a national laboratory is responsible for coordinating standards and methods of diagnosis in each Member State in accordance with the provisions of Annex III.
Member States shall make the details of their national laboratory, and any subsequent changes, available to the other Member States and to the public in a manner that may be specified in accordance with the procedure referred to in Article 26(2).
2
The national laboratories referred to in paragraph 1(b) shall liaise with the Community reference laboratory as mentioned in Annex IV. Without prejudice to the provisions of Decision 90/424/EEC, and in particular Article 28 thereof, the powers and duties of the laboratory shall be those appearing in the said Annex.
3
In order to ensure uniform procedures to diagnose classical swine fever, within two months from the date when this Directive enters into force and in accordance with the procedure referred to in Article 26(2), a classical swine fever diagnostic manual shall be approved, establishing at least:
a
minimum bio-safety requirements and quality standards to be observed by the classical swine fever diagnostic laboratories and for the transport of samples;
b
criteria and procedures to be followed when clinical or post-mortem examinations are carried out to confirm or exclude the presence of classical swine fever;
c
criteria and procedures to be followed for collection of samples from live pigs or their carcases, to confirm or exclude classical swine fever by laboratory examinations, including sampling methods for serological or virological screenings carried out in the framework of the application of the measures provided for in this Directive;
d
laboratory tests to be used for the diagnosis of classical swine fever, including:
- tests for the differential diagnosis between classical swine fever virus and other pestiviruses
- if available and suitable, tests to distinguish the antibody pattern elicited by a marker vaccine from the one elicited by the wild type of classical swine fever virus,
- criteria for the evaluation of the results of the laboratory tests;
e
laboratory techniques for the genetic typing of classical swine fever virus isolates.
4
In order that appropriate bio-safety conditions are guaranteed to protect animal health, the classical swine fever virus, its genome and antigens and vaccines for research, diagnosis or manufacture shall be manipulated or used only in places, establishments or laboratories approved by the competent authority.
The list of approved places, establishments or laboratories shall be transmitted to the Commission before 1 May 2003 and kept updated hereafter.
5
The provisions of Annexes III and IV and the diagnostic manual may be supplemented or amended in accordance with the procedure referred to in Article 26(2).
Substituted by Council Directive 2008/73/EC of 15 July 2008 simplifying procedures of listing and publishing information in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/426/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 91/496/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC and 2005/94/EC (Text with EEA relevance).
Substituted by Corrigendum to Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (Official Journal of the European Communities L 316 of 1 December 2001).