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SECTION 8

VACCINATION

Article 49

USE, MANUFACTURE, SALES AND CONTROLS OF FOOT-AND-MOUTH DISEASE VACCINES

Member States shall ensure that:

(a) the use of foot-and-mouth disease vaccines is prohibited on their territory except as provided for in this Directive;
(b) the production, storage, supply, distribution and sale of foot-and-mouth disease vaccines on their territory are carried out under official control;
(c) the marketing of foot-and-mouth disease vaccines is under the supervision of the competent authorities in accordance with Community legislation;
(d) the use of foot-and-mouth disease vaccines for purposes other than to induce active immunity in animals of susceptible species, notably laboratory investigations, is authorized by the competent authorities and carried out under appropriate bio-security conditions.

DECISION ON INTRODUCING EMERGENCY VACCINATION

1. It may be decided to introduce emergency vaccination where at least one of the following conditions applies:

(a) outbreaks of foot-and-mouth disease have been confirmed and threaten to become widespread in the Member State where such outbreaks have been confirmed;
(b) other Member States are at risk due to the geographical situation of or the prevailing meteorological conditions in relation to reported outbreaks of foot-and- mouth disease in a Member State;
(c) other Member States are at risk due to epidemiologically relevant contacts between holdings on their territories and holdings keeping animals of susceptible species in a Member States where there are outbreaks of foot-and-mouth disease;
(d) Member States are at risk due to the geographical situation or the prevailing meteorological conditions in a neighbouring third country where there are outbreaks of foot-and-mouth disease;

2. When deciding on the introduction of emergency vaccination, consideration shall be given to the measures provided for in Article 15 and to the criteria listed in Annex X.

3. The decision to introduce emergency vaccination shall be adopted in accordance with the procedure referred to in Article 89 (3), either on request of the Member State directly affected or at risk, or on the Commission's own initiative.

4. By way of derogation from paragraph 3, the decision to introduce emergency vaccination may be taken by the Member State concerned and implemented in accordance with this Directive, after a written notification to the Commission which shall include the specifications provided for in Article 51.

5. If a Member State introduces emergency vaccination in accordance with paragraph 4, that decision shall be immediately reviewed in the Standing Committee on the Food Chain and Animal Health and Community measures shall be adopted in accordance with the procedure referred to in Article 89 (3)..49

Article 51

CONDITIONS FOR EMERGENCY VACCINATION

1. The decision to introduce emergency vaccinat ion in accordance with Article 50 (3) and (4) shall specify the conditions under which such vaccination shall be carried out and these conditions must specify at least:

(a) the delimitation in accordance with Article 45 of the geographical area in which emergency vaccination is to be carried out;
(b) the species and the age of the animals to be vaccinated;
(c) the duration of the vaccination campaign;
(d) a specific prohibition on movements of vaccinated and non-vaccinated animals of susceptible species and their products;
(e) the special identification and special registration of the vaccinated animals pursuant to Article 47;
(f) other matters appropriate to the emergency situation.

2. The conditions for emergency vaccination as provided for in paragraph 1, shall ensure that such vaccination is carried out in accordance with Article 52, irrespective of whether the vaccinated animals are subsequently killed and disposed of or stay alive.

Article 52

PROTECTIVE VACCINATION

1. Member States applying protective vaccination shall ensure that:

(a) the vaccination zone shall be regionalised in accordance with Article 45, and where necessary in close co-operation with neighbouring Member States;
(b) vaccination shall be carried out swiftly and in conformity with principle rules of hygiene and bio-security so as to avoid possible spread of foot-and-mouth disease virus;
(c) all measures applied in the vaccination zone shall be carried out without prejudice to the measures provided for in Section 7;.50
(d) where the vaccination zone includes parts of or the entire protection or surveillance zone:
(i) the measures applicable for the protection zone or surveillance zone in accordance with this Directive shall be maintained within that part of the vaccination zone until such measures have been removed in accordance with Article 36 or Article 44;
(ii) after the measures applied in the protection zone and surveillance zone have been removed, the measures applicable for the vaccination zone as provided for in Articles 54 to 58 shall continue to apply.

2. Member States applying protective vaccination shall ensure that the vaccination zone is surrounded by a surveillance area (surveillance zone as defined by the Office International des Epizooties) of at least 10 km width from the perimeters of the vaccination zone

(a) in which vaccination is prohibited; (b) in which intensified surveillance is carried out;
(c) in which the movement of animals of susceptible species is subject to controls by the competent authorities;
(d) which remains in place until the foot-and-mouth disease and infection free status is recovered in accordance with Article 61.

Article 53

SUPPRESSIVE VACCINATION

1. Member States shall notify the Commission if they decide to introduce suppressive vaccination and shall provide details of the control measures to be taken which shall include at least those provided for in Article 21.

2. Member States shall ensure that suppressive vaccination is carried out as follows:

(a) only within a protection zone;
(b) only on clearly identified holdings subject to the measures provided for in Article 10 (1).

However, for logistical reasons and by way of derogation from Article 10 (1) (a), the killing of all animals on such holdings may be delayed as long as necessary to comply with Directive 93/119/EEC and the provisions of Article 10 (1) (c) of this Directive;.

Article 54

MEASURES APPLICABLE IN THE VACCINATION ZONE DURING THE PERIOD FROM THE BEGINNING OF EMERGENCY VACCINATION UNTIL AT LEAST 30 DAYS HAVE ELAPSED FOLLOWING THE COMPLETION OF SUCH VACCINATION (PHASE 1)

1. Member States shall ensure that the measures provided for in paragraphs 2 to 6 are applied in the vaccination zone during the period from the beginning of the emergency vaccination until at least 30 days have elapsed following the completion of such vaccination.

2. Movement of live animals of susceptible species shall be prohibited within and out of the vaccination zone.
By way of derogation from the prohibition provided for in the first subparagraph, and after clinical inspection of such live animals and the herds of origin or dispatch of those animals, the competent authorities may authorise their direct transport for immediate slaughter in a slaughterhouse designated by the competent authority and situated within the vaccination zone or in exceptional cases close to that zone.

3. Fresh meat produced from vaccinated animals slaughtered during the period referred to in paragraph 1 shall: (a) bear the cross stamp provided for in Article 5a of Directive 72/461/EEC; (b) be stored and transported separately from meat not bearing a cross stamp referred to in point (a), and shall subsequently be transported in sealed containers to an establishment designated by the competent authorities for treatment in accordance with Annex VII.

4. Milk and milk products produced from vaccinated animals may be placed on the market within or outside the vaccination zone, provided that such milk and milk products have undergone at least one of the treatments specified in Parts A or B of Annex IX depending on the intended use.

5. The collection of semen for artificial insemination from male animals kept in semen collection centres situated within the vaccination zone shall be suspended.
By way of derogation from the prohibition provided for in the first subparagraph, the competent authorities may authorise the collection of semen at semen collection centres within the vaccination zone for the production of frozen semen, subject to the following conditions:

(a) it is ensured that the semen collected during the period referred to in paragraph 1 is stored separately for at least 30 days;
(b) prior to dispatch of the semen:
(i) the donor males have been vaccinated following a negative test for antibodies against foot-and-mouth disease virus carried out prior to vaccination;.
(ii) a negative result has been achieved in a virus isolation test or an approved test for the detection of antibody against non-structural proteins, carried out at the end of the quarantine period for the semen on samples taken from all animals of susceptible species present at that time on the semen collection centre;
(iii) the semen complies with the conditions of Article 4 (3) of Chapter II of Directive 88/407/EEC.

6. Collection of ova and embryos from donor females shall be prohibited.

Article 55

MEASURES APPLICABLE IN THE VACCINATION ZONE DURING THE PERIOD FROM EMERGENCY VACCINATION UNTIL THE SURVEY AND THE CLASSIFICATION OF HOLDINGS ARE COMPLETED (PHASE 2)

1. Member States shall ensure that the measures provided for in paragraphs 2 to 5 are applied in the vaccination zone during a period starting not earlier than 30 days from the date of completion of emergency vaccination and terminating with the completion of the measures provided for in Articles 56 and 57.

2. Movement of animals of susceptible species within and out of the vaccination zone shall be prohibited.

3. By way of derogation from the prohibition provided for in paragraph 2, the competent authorities may authorise direct transport for immediate slaughter of animals of susceptible species from holdings referred to in Article 57 (4) to a slaughterhouse situated within or out of the vaccination zone on the following condit ions:

(a) during transport those animals shall not come into contact with other animals of susceptible species;
(b) the animals shall be accompanied by an official document certifying that all animals of susceptible species on the holding of origin or dispatch have undergone a survey as provided for in Article 56 (2);
(c) the transport vehicles shall be cleansed and disinfected before loading and after the animals have been delivered, with the date and time of the cleaning and disinfection being recorded in the logbook of the means of transport;
(d) the animals shall have passed the ante-mortem health inspection at the slaughterhouse during the 24 hours before slaughter and have in particular undergone examination for mouth and feet disease and not shown signs of that disease.

4. Fresh meat, excluding offal, produced from vaccinated large and small ruminants during the period referred to in paragraph 1, may be placed on the market within and outside the vaccination zone under the following condit ions:.

(a) the establishment shall be operated under strict veterinary control;
(b) only fresh meat, excluding offal, which was subjected to the treatment described in Annex VIII or fresh meat obtained from animals reared and slaughtered outside the vaccination zone shall be processed in the establishment;
(c) all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I of Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark provided for in Chapter VI of Annex I of Directive 94/65/EC;
(d) the fresh meat shall be clearly identified, and transported and stored separately from meat which is not eligible for dispatch outside the zone in accordance with this Directive.

5. Compliance with the conditions in paragraph 4 shall be certified by the competent authority for fresh meat intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authorities and in the case of intra-Community trade communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification.

6. Fresh meat produced from vaccinated porcine animals slaughtered during the period referred to in paragraph 1 shall bear the stamp provided for in Article 5a of Directive 72/461/EEC (cross stamp) and shall be stored and transported separately from meat not bearing that stamp and subsequently be transported in sealed containers to an establishment designated by the competent authorities for treatment in accordance with Annex VII.

7. Milk and milk products produced from vaccinated animals may be placed on the market within or outside the vaccination zone, provided that depending on the final use for either human consumption or non-human consumption it has undergone at least one of the treatments referred to in Parts A and B of Annex IX. Such treatment shall have been undergone, in an establishment located in the vaccination zone or, in exceptional cases and subject to authorisation by the competent authorities, close to that zone. The competent authorities shall certify such treatment.

8. The placing on the market of products of animal origin other than those referred to in paragraphs 5 and 6 shall be subject to the conditions provided for in Articles 30, 31, 32 and 41.

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