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COUNCIL DECISION

OF 26 MARCH 1973

ON ACTION TO PROTECT COMMUNITY LIVESTOCK AGAINST CERTAIN FOOT-AND-MOUTH DISEASES

( 73/88/EEC )

THE COUNCIL OF THE EUROPEAN COMMUNITIES ,

HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLE 43 THEREOF

HAVING REGARD TO THE PROPOSAL FROM THE COMMISSION ;

HAVING REGARD TO THE OPINION OF THE EUROPEAN PARLIAMENT ;

WHEREAS , ACCORDING TO THE COUNCIL RESOLUTION OF 12 MARCH 1968 ( 1 ) , THE GUARANTEEING OF ADEQUATE PROTECTION OF HUMAN AND ANIMAL HEALTH AND THE IMPLEMENTATION OF MEASURES TO COMBAT EPIZOOTIC DISEASES CONSTITUTE BASIC PRINCIPLES FOR COMMUNITY MEASURES TO BE ADOPTED IN THE VETERINARY FIELD ;

WHEREAS , WITH THIS OBJECTIVE IN MIND , IT IS ADVISABLE TO ENSURE THE PROTECTION OF COMMUNITY TERRITORY AGAINST THE DANGER CONSTITUTED BY THE A 22 SUB-TYPE FOOT-AND-MOUTH VIRUS ; WHEREAS THAT VIRUS CAN ONLY BE COMBATED BY A SPECIFIC VACCINE WHICH MAY NOT BE PRODUCED IN THE LABORATORIES OF THE MEMBER STATES ; WHEREAS A RECOMMENDATION OF THE INTERNATIONAL OFFICE FOR EPIZOOTIC DISEASES , FORMALLY PROHIBITS THE PREPARATION OF SUCH VACCINES IN TERRITORY UNAFFECTED BY THIS VIRUS ;

WHEREAS THE COMMUNITY SHOULD THEREFORE DECIDE UPON AND FINANCE THE ESTABLISHMENT AND STORAGE OUTSIDE ITS TERRITORY OF A RESERVE STOCK OF VACCINE TO COMBAT THE A 22 SUB-TYPE OF FOOT-AND-MOUTH DISEASE IN ORDER TO FIGHT INSTANTLY THE FIRST ATTACKS OF THE VIRUS WITHOUT BEING OBLIGED TO ATTEND THE MASS PRODUCTION OF THE NECESSARY VACCINE ; WHEREAS , FURTHERMORE , IN ORDER TO ACCELERATE SUCH MASS PRODUCTION , PROVISION SHOULD BE MADE UNDER THE SAME CONDITIONS FOR THE STRAIN SUITABLE FOR THE METHOD OF CULTURE USED FOR PRODUCTION OF SUCH VACCINE TO BE KEPT AT THE DISPOSAL OF THE COMMUNITY ;

WHEREAS THE DANGER FROM THE A 22 FOOT-AND-MOUTH VIRUS MAY VARY , DEPENDING ON DEVELOPMENTS DURING THE NEXT FEW YEARS ; WHEREAS , THEREFORE , THE PROTECTION MEASURES REFERRED TO ABOVE SHOULD ONLY BE DECIDED UPON ON A TEMPORARY BASIS ;

WHEREAS , IN ADDITION , DURING THE PERIOD IN WHICH THEY ARE APPLIED , THESE MEASURES MAY PROVE INADEQUATE ; WHEREAS IT IS THEREFORE ADVISABLE TO PROVIDE THAT , SHOULD EPIZOOTIOLOGICAL CONDITIONS SO REQUIRE , THE AMOUNTS AND THE TYPES OR SUB-TYPES OF VACCINES WHICH THE COMMUNITY MUST USE TO COMBAT EXOTIC SPECIES OF FOOT-AND-MOUTH DISEASE , MAY BE CHANGED ;

WHEREAS IMPLEMENTATION OF THE MEASURES PROVIDED FOR MAY BE ENSURED BY A CONTRACT CONCLUDED BY THE COMMISSION ; WHEREAS THE CLAUSES OF THAT CONTRACT SHOULD BE LAID DOWN ACCORDING TO A COMMUNITY PROCEDURE ;

WHEREAS WHERE AN EPIDEMIC BREAKS OUT IN THE TERRITORY OF THE COMMUNITY DETAILED RULES FOR THE DISTRIBUTION AND USE OF THE VACCINE SHOULD ALSO BE LAID DOWN ACCORDING TO A COMMUNITY PROCEDURE ;

WHEREAS , MOREOVER , IN ORDER TO PROTECT THE COMMUNITY , IT MAY PROVE NECESSARY TO MAKE PROVISION FOR THE POSSIBILITY OF SUPPLYING VACCINE TAKEN FROM THE COMMUNITY STOCK TO THIRD COUNTRIES AFFECTED BY THE A 22 VIRUS ,

HAS ADOPTED THIS DECISION :

ARTICLE 1

1 . THERE SHALL BE ESTABLISHED , STOCKED AND MAINTAINED AT THE DISPOSAL OF THE COMMUNITY A RESERVE :

( A ) OF FOOT-AND-MOUTH VACCINE OF SUB-TYPE A 22 ;

( B ) OF FOOT-AND-MOUTH VIRUS OF THE SUB-TYPE A 22 , SUITABLE FOR FRENKEL CULTURE , SUFFICIENT TO START 5 50-LITRE TANKS OF FRENKEL CULTURE ;

( C ) OF FOOT-AND-MOUTH VIRUS OF SUB-TYPE A 22 , SUITABLE FOR BHK CULTURE AND CULTURE ON CALF KIDNEY CELLS ;

( D ) OF 50 MILLILITRES OF SERUM OF THE A 22 SUB-TYPE FOR DIAGNOSIS AND TITRATION .

2 . THE RESERVE REFERRED TO IN PARAGRAPH 1 ( A ) , MODIFIED IF NECESSARY IN ACCORDANCE WITH PARAGRAPH 3 , SHALL BE A TOTAL OF 2 MILLION DOSES , TO BE SUPPLIED IN BATCHES AT INTERVALS TO BE DETERMINED IN THE CONTRACT REFERRED TO IN ARTICLE 3 .

3 . IF EPIZOOTIOLOGICAL CONDITIONS SO REQUIRE A DECISION MAY BE TAKEN IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 7 :

A ) TO INCREASE BY A MAXIMUM OF 50 % THE VACCINE RESERVE REFERRED TO IN PARAGRAPH 1 ( A ) ;

B ) TO PROVIDE FOR THE POSSIBILITY WHEN THE CONTRACT IS DRAWN UP , OR DURING THE PERIOD OF ITS EXECUTION , FOR THE SUPPLY OF

- OTHER EXOTIC TYPES OR SUB-TYPES OF FOOT-AND-MOUTH DISEASE VIRUS SUITABLE FOR THE CULTURES REFERRED TO IN PARAGRAPH 1 ( B ) AND ( C ) ,

- CORRESPONDING TYPES AND SUB-TYPES OF VACCINES AND CORRESPONDING SERUMS FOR DIAGNOSIS AND TITRATION .

ARTICLE 2

APPROPRIATIONS TO MEET THE EXPENDITURE RESULTING FROM THE ACTION PROVIDED FOR IN ARTICLE 1 SHALL BE ENTERED IN THE COMMUNITY BUDGET UNDER THE SECTION " COMMISSION " .

THIS EXPENDITURE SHALL ALSO COVER THE EXPENSES OCCASIONED BY THE INSPECTIONS WHICH MAY BE CARRIED OUT AT ANY TIME , AND IN PARTICULAR DURING THE PRODUCTION OF THE VACCINE .

ARTICLE 3

THE ACTION LAID DOWN IN ARTICLE 1 SHALL BE IMPLEMENTED BY THE CONCLUSION OF A CONTRACT BETWEEN THE COMMISSION AND THE PERSONS RESPONSIBLE FOR THE SUPPLY OF THE PRODUCTS REFERRED TO IN ARTICLE 1 ( 1 ) ( A ) AND ( B ) , WHICH SHALL BE PRODUCED AT THE RAZI/IFFA INSTITUTE IN TEHERAN . AS REGARDS THE OTHER PRODUCTS , THE CONTRACT SHALL BE ENTERED INTO WITH THE APPROPRIATE INSTITUTIONS .

THE TERMS OF THE CONTRACT SHALL BE ADOPTED IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 6 .

ARTICLE 4

IF AN EXOTIC FORM OF FOOT-AND-MOUTH DISEASE SHOULD BREAK OUT IN THE TERRITORY OF A MEMBER STATE , THE WHOLE OF THE AVAILABLE RESERVE OF VACCINE MAY BE DELIVERED TO THAT STATE ; THE STATE CONCERNED SHALL BE FREE TO USE AN AMOUNT OF THE VACCINE EQUAL TO 400 000 DOSES ; THE USE OF THE REMAINDER SHALL BE DECIDED UPON IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 7 .

ARTICLE 5

IF THE HEALTH SITUATION WITHIN THE COMMUNITY SO PERMITS A DECISION MAY BE TAKEN , IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 6 , TO DONATE TO THIRD COUNTRIES AFFECTED BY EXOTIC SPECIES OF FOOT-AND-MOUTH DISEASE VIRUS PART OF THE COMMUNITY STOCK OF VACCINE .

ARTICLE 6

1 . WHERE THE PROCEDURE LAID DOWN IN THIS ARTICLE IS TO BE USED , MATTERS SHALL WITHOUT DELAY BE REFERRED BY THE CHAIRMAN , EITHER ON HIS OWN INITIATIVE OR AT THE REQUEST OF A MEMBER STATE , TO THE STANDING VETERINARY COMMITTEE ( HEREINAFTER CALLED " COMMITTEE " ) ESTABLISHED BY THE COUNCIL DECISION OF 15 OCTOBER 1968 .

2 . WITHIN THE COMMITTEE THE VOTES OF MEMBER STATES SHALL BE WEIGHTED AS PROVIDED IN ARTICLE 148 ( 2 ) OF THE TREATY . THE CHAIRMAN SHALL NOT VOTE .

3 . THE REPRESENTATIVE OF THE COMMISSION SHALL SUBMIT A DRAFT OF THE MEASURES TO BE ADOPTED . THE COMMITTEE SHALL DELIVER ITS OPINION ON SUCH MEASURES WITHIN TWO DAYS . OPINIONS SHALL BE DELIVERED BY A MAJORITY OF FORTY-ONE VOTES .

4 . THE COMMISSION SHALL ADOPT THE MEASURES AND SHALL APPLY THEM IMMEDIATELY WHERE THEY ARE IN ACCORDANCE WITH THE OPINION OF THE COMMITTEE . IF THEY ARE NOT IN ACCORDANCE WITH THE OPINION OF THE COMMITTEE OR IF NO OPINION IS DELIVERED , THE COMMISSION SHALL WITHOUT DELAY SUBMIT TO THE COUNCIL THE MEASURES TO BE ADOPTED . THE COUNCIL SHALL ADOPT THE MEASURES BY A QUALIFIED MAJORITY .

IF , WITHIN THREE MONTHS FROM THE DATE ON WHICH THE PROPOSAL WAS SUBMITTED TO IT , THE COUNCIL HAS NOT ADOPTED ANY MEASURES , THE COMMISSION SHALL ADOPT THE PROPOSED MEASURES AND APPLY THEM IMMEDIATELY , SAVE WHERE THE COUNCIL HAS DECIDED BY A SIMPLE MAJORITY AGAINST THOSE MEASURES .

ARTICLE 7

1 . WHERE THE PROCEDURE LAID DOWN IN THIS ARTICLE IS TO BE USED , MATTERS SHALL WITHOUT DELAY BE REFERRED TO THE CHAIRMAN , EITHER ON HIS OWN INITIATIVE OR AT THE REQUEST OF A MEMBER STATE , TO THE STANDING VETERINARY COMMITTEE ( HEREINAFTER CALLED THE " COMMITTEE " ) SET UP BY THE COUNCIL DECISION OF 15 OCTOBER 1968 .

2 . WITHIN THE COMMITTEE THE VOTES OF THE MEMBER STATES SHALL BE WEIGHTED AS PROVIDED IN ARTICLE 148 ( 2 ) OF THE TREATY . THE CHAIRMAN SHALL NOT VOTE .

3 . THE REPRESENTATIVE OF THE COMMISSION SHALL SUBMIT A DRAFT OF THE MEASURES TO BE ADOPTED . THE COMMITTEE SHALL DELIVER ITS OPINION ON SUCH MEASURES WITHIN TWO DAYS . OPINIONS SHALL BE DELIVERED BY A MAJORITY OF FORTY-ONE VOTES .

4 . THE COMMISSION SHALL ADOPT THE MEASURES AND SHALL APPLY THEM IMMEDIATELY WHERE THEY ARE IN ACCORDANCE WITH THE OPINION OF THE COMMITTEE . WHERE THEY ARE NOT IN ACCORDANCE WITH THE OPINION OF THE COMMITTEE OR IF NO OPINION IS DELIVERED , THE COMMISSION SHALL WITHOUT DELAY SUBMIT TO THE COUNCIL A PROPOSAL REGARDING THE MEASURES TO BE ADOPTED . THE COUNCIL SHALL ADOPT THE MEASURES BY A QUALIFIED MAJORITY .

IF , WITHIN FIFTEEN DAYS OF THE DATE ON WHICH THE PROPOSAL WAS SUBMITTED TO IT , THE COUNCIL HAS NOT ADOPTED ANY MEASURES , THE COMMISSION SHALL ADOPT THE PROPOSED MEASURES AND APPLY THEM IMMEDIATELY , SAVE WHERE THE COUNCIL HAS DECIDED BY A SIMPLE MAJORITY AGAINST THOSE MEASURES .

ARTICLE 8

THE PROVISIONS OF ARTICLES 6 AND 7 SHALL APPLY FOR EIGHTEEN MONTHS FROM THE DATE ON WHICH A MATTER WAS FIRST REFERRED TO THE COMMITTEE EITHER UNDER ARTICLE 6 ( 1 ) OR 7 ( 1 ) OR UNDER ANY CORRESPONDING RULES .

ARTICLE 9

THE ACTION PROVIDED FOR IN THIS DECISION SHALL BE LIMITED TO A PERIOD OF 2 YEARS FROM THE DATE OF THE SIGNATURE OF THE CONTRACT PROVIDED FOR IN ARTICLE 3 .

BEFORE THE EXPIRY OF THIS PERIOD THE COUNCIL , ACTING IN ACCORDANCE WITH THE VOTING PROCEDURE LAID DOWN IN ARTICLE 43 OF THE TREATY SHALL DECIDE WHETHER THIS ACTION SHOULD BE EXTENDED OR WHETHER IT IS NECESSARY TO AMEND THIS DECISION .

ARTICLE 10

THIS DECISION IS ADDRESSED TO THE MEMBER STATES .

DONE AT BRUSSELS , 26 MARCH 1973 .

FOR THE COUNCIL

THE PRESIDENT

A . LAVENS

( 1 ) OJ NO C 22 , 18 . 3 . 1968 , P . 18 .