1997D0432 — EN — 04.12.1998 — 001.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:

Official Journal No page date ►M1 Commission Decision of 3 December 1998 L 340 50 16.12.1998

NB: This consolidated version contains references to the European unit of accout and/or the ecu, which from 1 January 1999 should be understood as references to the euro — Council Regulation (EEC) No 3308/80 (OJ L 345, 20.12.1980, p. 1) and Coundil Regulation (EC) No 1103/97 (OJ L 162, 19.6.1997, p. 1).

▼B

COMMISSION DECISION

of 2 July 1997

on a Community financial contribution for a surveillance programme relating to the eradication of foot-and-mouth disease in Albania, Federal Republic of Yugoslavia and Former Yugoslav Republic of Macedonia

(Only the Danish, English and Italian texts are authentic)

(97/432/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field ( 1 ), as last amended by Council Decision 94/370/EC ( 2 ), and, in particular Articles 12 and 13 thereof, Whereas outbreaks of foot-and-mouth disease during the late spring and/or summer of 1996 were reported by Albania, Former Yugoslav Republic of Macedonia and the Federal Republic of Yugoslavia; Whereas the appearance of foot-and-mouth disease in Eastern European countries is a serious danger to the Community's livestock population; Whereas as a result of outbreaks of foot-and-mouth disease in May 1996 in Albania, the Commission adopted 13 June 1996 Decision 96/367/EC ( 3 ) concerning protection measures in relation to foot-and-mouth disease in Albania; Whereas by 14 June 1996 the Commission by adopting Decision 96/368/EC ( 4 ) on a Community financial contribution concerning measures to control foot-and-mouth disease in Albania, made available up to a maximum of 600 000 doses of vaccines to the Albanian authorities; Whereas due to outbreaks of foot and mouth disease in the Former Yugoslav Republic of Macedonia, the Commission adopted Decision 96/439/EC ( 5 ) on 18 July 1996, on a Community financial contribution to measures to control foot-and-mouth disease in the former Yugoslav Republic of Macedonia; Whereas within the context of the said Decision, a total of 250 000 doses of vaccine to protect bovine animals against foot-and-mouth disease were made available; Whereas the programmes established for vaccination against foot-and-mouth disease in Albania and Former Yugoslav Republic of Macedonia may have included vaccination of livestock incubating foot-and-mouth disease virus, but not showing signs of the disease; Whereas it cannot be excluded that the implementation of a vaccination programme in Albania and Former Yugoslav Republic of Macedonia has produced ‘carrier animals’; Whereas the foot-and-mouth disease situation in certain areas of Albania, Federal Republic of Yugoslavia and Former Yugoslav Republic of Macedonia remains unclear, as regards antibodies to foot-and-mouth disease virus elicited due to field virus or vaccine virus antigen; Whereas a sero-surveillance programme designed to detect antibodies to the foot-and-mouth disease virus has been drawn up for certain areas of Albania, Federal Republic of Yugoslavia and Former Yugoslav Republic of Macedonia; Whereas the said programme when carried out can provide valuable information on the disease situation in the area subjected to the surveillance programme; Whereas a team of experts from Member States and the European Commission in cooperation with the veterinary authorities of Albania, Federal Republic of Yugoslavia and Former Yugoslav Republic of Macedonia have drawn up a sero-surveillance programme for the areas affected by foot-and-mouth disease; Whereas the said programme includes that the collection of blood samples is carried out by the third countries concerned and that laboratory examinations of the collected blood samples are carried out at selected National Foot and Mouth Disease laboratories in Member States of the European Union; Whereas the programme in particular will be based on a very close cooperation between: — the veterinary central administration of Albania and the national foot-and-mouth disease laboratory in Italy, — the veterinary central administration of the Former Yugoslav Republic of Macedonia (FYROM) and the national foot-and-mouth disease laboratory in Denmark, — the veterinary central administration of the Federal Republic of Yugoslavia (FRY) and the national foot-and-mouth disease laboratory of the United Kingdom; Whereas the starting date of the programme shall take into account local constrains which may affect collection of blood samples in areas subject to sero-surveillance; Whereas the starting date may vary from area to area; Whereas Annex B of Council Directive 85/511/EEC of 18 November 1985, introducing Community measures for the control of foot-and-mouth disease ( 6 ), as last amended by Commission Decision 92/380/EEC ( 7 ), lists national laboratories authorized to handle live foot-and-mouth disease virus; Whereas Community financial aid should be granted to laboratories and third countries engaged in the implementation of the established sero-surveillance programme; Whereas for supervisory purposes Articles 8 and 9 of Council Regulation (EEC) No 729/70 of 21 April 1970 on financing of the Common Agricultural Policy ( 8 ), as last amended by Regulation (EC) No 1287/95 ( 9 ), should apply; Whereas the measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee, HAS ADOPTED THIS DECISION:

Article 1

1. The sero-surveillance programme for foot-and-mouth disease described in Annex I for certain areas of Albania, Federal Republic of Yugoslavia and Former Yugoslav Republic of Macedonia is hereby approved.

2. For the implementation of the sero-surveillance programme referred to in paragraph 1, the Community will provide a financial contribution of a maximum of ECU 236 790.

3. The financial contribution referred to in paragraph 2 shall be provided to national foot-and-mouth disease laboratories, listed in Annex II, for actions described in Annex III.

Article 2

The Community's financial contribution shall be paid as follows:

— 50 % by way of advance at the request of the National Foot and Mouth Disease laboratories referred to in Annex II. The request for advanced financial contribution shall be accompanied by information on the date laboratory examinations will commence on samples obtained from the areas included in the sero-surveillance programme,

— the balance following presentation and acceptance of supporting technical and financial documents. These documents must be presented to the European Commission not later than ►M1 twelve ◄ months after the starting date of laboratory examinations referred to in Annex I.

Article 3

Articles 8 and 9 of Regulation (EEC) No 729/70 shall apply mutatis mutandis.

Article 4

This Decision is addressed to Denmark, Italy and the United Kingdom.

ANNEX I

SERO-SURVEILLANCE PROGRAMME FOR FOOT-AND-MOUTH DISEASE

Objective

The sero-surveillance programme referred to in Article 1 (1) has the objective:

— to assess the level and geographical distribution of antibodies linked to vaccines used and to field virus,

— to confirm that foot-and-mouth disease is under control in selected areas of Albania, Federal Republic of Yugoslavia and Former Yugoslav Republic of Macedonia.

Furthermore, it has the objective to validate a newly-developed laboratory test designed to differentiate antibodies to foot-and-mouth disease virus caused by field virus infection or as a result of vaccination.

Design of sero-surveillance programme

The sero-surveillance programme is designed to detect the presence of antibodies to foot-and-mouth disease virus type A22 produced by field virus and vaccine virus, respectively. The programme takes into account that due to the applied husbandry system a village may be considered as one epidemiological unit. In areas close to a confirmed outbreak, the programme should be designed so as to detect antibodies at 5 % prevalence with a 95 % level of confidence.

The implementation of the programme shall be based on a close cooperation between:

(a) the veterinary central administration of Albania and the national foot-and-mouth disease laboratory in Italy. About 2 380 blood samples shall be collected from animals (cattle, sheep and goats) kept in 11 different districts in Albania and sent to Italy for laboratory examination;

(b) the veterinary central administration of the Former Yugoslav Republic of Macedonia and the national foot-and-mouth disease laboratory in Denmark. About 7 460 blood samples shall be collected from animals (cattle, sheep, goats and pigs) kept in 29 different districts in to Former Yugoslav Republic of Macedonia and sent to Denmark for laboratory examination;

(c) the veterinary central administration of the Federal Republic of Yugoslavia and the national foot-and-mouth disease laboratory of the United Kingdom. About 6 420 blood samples shall be collected from animals (cattle, sheep, goats and pigs) kept in 37 different communities in the Federal Republic of Yugoslavia and sent to the United Kingdom for laboratory examination.

The national foot-and-mouth disease laboratories mentioned under (a), (b) and (c) shall

— inform the Commission about the date laboratory examinations will commence on samples obtained from the areas included in the sero-surveillance programme,

— prepare and submit a report on the work carried out to the Commission. The report shall contain an epidemiological analysis of data obtained during the implementation of the sero-surveillance programme. The report shall be submitted to the Commission not later than four months after the date laboratory examinations were commenced.

ANNEX II

National laboratories authorized to handle live foot-and-mouth disease virus in accordance with the provisions of Council Directive 85/511/EEC and agreed to participate in the implementation of the sero-surveillance programme referred to in Article 1 (1)

1. Instituto Zooprofilattico Spesimentale della Lombardia e dell'Emilia Romagna, Brescia, Italy;

2. Statens Veterinære Institut for Virusforskning, Lindholm, Denmark;

3. Institute for Animal Health, Pirbright, Woking, Surrey, United Kingdom.

ANNEX III

IMPLEMENTATION OF SERO-SURVEILLANCE PROGRAMME FOR ANTIBODIES TO FOOT-AND-MOUTH DISEASE VIRUS

CHAPTER A

Sero-surveillance programme, Albania

Instituto Zooprofilattico Spesimentale della Lombardia e dell'Emilia, Romagna, Brescia, Italy will carry out the following actions in relation to laboratory examinations of a maximum of 2 500 blood samples originating from Albania.



(in ecus) Actions Estimated costs I. Provide Albania with equipment for: (a) identification of animals 2 500 (b) collection of blood samples 2 500 (c) transport of blood samples 500 II. Cover costs incurred for: (a) transport of equipment referred to under I (a), (b) and (c) 500 (b) transport of blood samples from Albania to Brescia 500 III. Reagents to National Foot and Mouth Disease Laboratory in Albania 5 000 IV. Cover costs incurred for travel of scientist/epidemiologist involved in sero-surveillance programme (a) 2 return tickets Milan-Tirana 1 750 (b) 10 days subsistence 800 V. Perform laboratory examinations of blood samples A-22 virus strain 2 500 samples (ELISA) (1) 17 500 1 000 samples (NSP) (2) 8 000 150 samples (VN) (3) 3 000 O1 virus strain 300 samples (ELISA) 2 100 VI. Collate and analyze field and laboratory data, prepare and distribute report 720 Total maximum 45 370 (1) ELISA: Enzyme-linked immunosorbent assay. (2) NSP: Non-structural proteins. (3) VN: Virus neutralization.

CHAPTER B

Sero-surveillance programme, Former Yugoslav Republic of Macedonia

Statens Veterinære Institut for Virusforskning, Lindholm, Denmark will carry out the following actions in relation to laboratory examinations of a maximum of 7 500 blood samples originating in the Former Yugoslav Republic of Macedonia (FYROM)



(in ecus) Actions Estimated costs I. Provide FYROM with equipment for: (a) identification of animals 7 500 (b) collection of blood samples 7 500 (c) transport of blood samples 1 500 II. Cover costs incurred for: (a) transport of equipment referred to under I (a), (b) and (c) 1 000 (b) transport of blood samples from FYROM to Lindholm 1 000 III. Reagents to National Foot and Mouth Disease Laboratory in FYROM 5 000 IV. Cover costs incurred for travel of scientist/epidemiologist involved in sero-surveillance programme (a) 2 return tickets Copenhagen-Skopje 2 500 (b) 10 days subsistence 800 V. Perform laboratory examinations of blood samples A-22 virus strain 7 500 samples (ELISA) (1) 52 500 2 000 samples (NSP) (2) 16 000 300 samples (VN) (3) 6 000 O1 virus strain 300 samples (ELISA) 2 100 VI. Collate and analyze field and laboratory data, prepare and distribute report 2 080 Total maximum 105 480 (1) ELISA: Enzyme-linked immunosorbent assay. (2) NSP: Non-structural proteins. (3) VN: Virus neutralization.

CHAPTER C

Sero-surveillance programme, Federal Republic of Yugoslavia

Institute for Animal Health, Pirbright, Woking, Surrey, UK will carry out the following actions in relation to laboratory examinations of a maximum of 6 500 blood samples originating from the Federal Republic of Yugoslavia.



(in ecus) Actions Estimated costs I. Provide FRY with equipment for: (a) identification of animals 6 500 (b) collection of blood samples 6 500 (c) transport of blood samples 1 200 II. Cover costs incurred for: (a) transport of equipment referred to under I (a), (b) and (c) 1 000 (b) transport of blood samples from FRY to Pirbright 1 000 III. Reagents to National Foot and Mouth Disease Laboratory in the Federal Republic of Yugoslavia 5 000 IV. Cover costs incurred for travel of scientist/epidemiologist involved in sero-surveillance programme (a) 2 return tickets London-Beograd 2 500 (b) 10 days subsistence 800 V. Perform laboratory examinations of blood samples A-22 virus strain 6 500 samples (ELISA) (1) 45 500 500 samples (NSP) (2) 4 000 390 samples (VN) (3) 7 800 O1 virus strain 300 samples (ELISA) 2 100 VI. Collate and analyze field and laboratory data, prepare and distribute report 2 040 Total maximum 85 940 (1) ELISA: Enzyme-linked immunosorbent assay. (2) NSP: Non-structural proteins. (3) VN: Virus neutralization.

CHAPTER D

Reimbursement of expenditures

Expenditures mentioned in chapters A, B and C will be reimbursed as follows:

(a) Actions I to IV : The relevant documentation (invoices) will be communicated to the Commission.

(b) Action V : Financial participation calculated on the basis of the number of tests performed. The unit price per tests is for:



— the ELISA: ECU 7, — the NSP test: ECU 8, — the VN test: ECU 20.

(c) Action VI : Financial participation calculated on the basis of the number of samples (ECU 100/500 samples) and geographical areas (districts or communities) investigated (20 ECU/one geographical area).

( 1 ) OJ No L 224, 18. 8. 1990, p. 19.

( 2 ) OJ No L 168, 2. 7. 1994, p. 31.

( 3 ) OJ No L 145, 19. 6. 1996, p. 17.

( 4 ) OJ No L 145, 19. 6. 1996, p. 19.

( 5 ) OJ No L 181, 20. 7. 1996, p. 37.

( 6 ) OJ No L 315, 26. 11. 1985, p. 11.

( 7 ) OJ No L 198, 17. 7. 1992, p. 54.

( 8 ) OJ No L 94, 28. 4. 1970, p. 13.

( 9 ) OJ No L 125, 8. 6. 1995, p. 1.