Diagnostic procedures and bio-safety requirements
Article 18
1
Member States shall ensure that:
a
diagnostic procedures, sampling and laboratory testing to detect the presence of African swine fever are carried out in accordance with the diagnostic manual;
b
a national laboratory is responsible for coordinating standards and diagnostic methods in each Member State in accordance with Annex IV.
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 23(2).
2
The national laboratories referred to in Annex IV shall liaise with the Community reference laboratory as indicated in Annex V. Without prejudice to the provisions of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field , and in particular Article 28 thereof, the powers and duties of the laboratory shall be those described in that Annex.
3
In order to ensure uniform procedures to diagnose African swine fever and an appropriate differential diagnosis with classical swine fever, within six months of the date when this Directive enters into force and in accordance with the procedure referred to in Article 23(2), an African swine fever diagnostic manual shall be adopted to establish at least:
a
minimum quality standards to be observed by African 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 African swine fever;
c
criteria and procedures to be followed for the collection of samples from live pigs or their carcases, to confirm or exclude African 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 African swine fever, including criteria for evaluating the results of the laboratory tests;
e
laboratory techniques for the genetic typing of the African swine fever virus isolate.
4
In order that appropriate bio-safety conditions are guaranteed to protect animal health, the African 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 not later than 1 January 2004 and shall be kept updated thereafter.
5
Annexes IV and V and the diagnostic manual may be supplemented or amended in accordance with the procedure referred to in Article 23(2).
OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision 2001/572/EC (OJ L 203, 28.7.2001, p. 16).
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).