1.Notwithstanding Article 18(1)(a), when classical swine fever has been confirmed in pig holdings and the epidemiological data available suggest that it threatens to spread, emergency vaccination may be introduced in pig holdings in accordance with the procedures and provisions laid down in paragraphs 2 to 9 of this Article.
2.Without prejudice to the provisions of Article 5(2), the main criteria and risk factors to be considered for the application of emergency vaccination are laid down in Annex VI. These criteria and risk factors may subsequently be amended or supplemented to take account of scientific developments and experiences, in accordance with the procedure referred to in Article 26(2).
3.Where a Member State intends to introduce vaccination, it shall submit to the Commission an emergency vaccination plan, which shall at least include information on:
(a)the disease situation which has led to the request for emergency vaccination;
(b)the extent of the geographical area in which emergency vaccination is to be carried out and the number of pig holdings in this area;
(c)categories of pigs and the approximate number of pigs to be vaccinated;
(d)the vaccine to be used;
(e)the duration of the vaccination campaign;
(f)the identification and registration of the vaccinated animals;
(g)measures for the movement of pigs and their products;
(h)the criteria that will be considered to decide if vaccination or the measures referred to in Article 7(2) will be applied in contact holdings;
(i)other matters appropriate to the emergency, including the clinical and laboratory examinations to be carried out on samples taken in the vaccinated holdings and in the other holdings located in the vaccination area, in particular if a marker vaccine is to be used.
The Commission shall immediately examine the plan in collaboration with the Member State concerned. In accordance with the procedure referred to in Article 27(2), the emergency vaccination plan may be approved or amendments and additions may be requested before approval is given.
In accordance with the procedure referred to in Article 27(2), the emergency vaccination plan may subsequently be amended or supplemented to take account of developments in the situation.
4.Without prejudice to Articles 10 and 11, any Member State which carries out emergency vaccination shall ensure that during the vaccination period:
(a)no live pigs leave the vaccination area, unless to be transported to a slaughterhouse designated by the competent authority and situated within the vaccination area or close to that area for immediate slaughter or to a rendering plant or to a suitable place where they are immediately killed and their carcases are processed under official supervision;
(b)all fresh pig meat produced from pigs vaccinated during the emergency vaccination is either processed or marked and treated in accordance with the provisions referred to in Article 10(3)(f), fourth indent;
(c)semen, ova and embryos collected from the pigs to be vaccinated during the 30 days prior to vaccination are traced and destroyed under official supervision.
5.The provisions laid down in paragraph 4 shall apply for a minimum of 6 months following completion of the vaccination operations in the area in question.
6.In accordance with the procedure referred to in Article 27(2) and before the end of the six-month period referred to in paragraph 5, measures shall be taken to ban:
(a)seropositive pigs from leaving the holding where they are kept, except for immediate slaughter;
(b)the collection of semen, embryos or ova from seropositive pigs;
(c)piglets of seropositive sows from leaving their holding of origin unless being transported to:
(c)a slaughterhouse for immediate slaughter,
a holding designated by the competent authority, from which they are to be sent directly to the slaughterhouse,
a holding after obtaining a negative result from a serological test for antibodies against the classical swine fever virus.
7.By way of derogation from paragraph 3, the decision to introduce emergency vaccination may be taken by a Member State provided that Community interests are not jeopardised and that the following conditions are met:
(a)an outline emergency vaccination plan must be drawn up in accordance with Article 22. The specific plan and the decision to adopt emergency vaccination must be notified to the Commission before the start of the vaccination operations;
(b)in addition to the information referred to in paragraph 3, the plan must prescribe that all the pigs in the holdings where the vaccine is to be used will be slaughtered or killed as quickly as possible after completion of the vaccination operations in accordance with paragraph 4(a), and the fresh meat produced from these pigs will be either processed or marked and treated in accordance with the provisions laid down in Article 10(3)(f), fourth indent.
When this decision is taken, the vaccination plan shall be immediately reviewed in the Standing Veterinary Committee. In accordance with the procedure referred to in Article 27(2), the plan may be approved or amendments and additions may be requested before approval is given.
8.Notwithstanding the provisions laid down in paragraphs 5 and 6, the measures provided for in paragraph 4 may be lifted after:
(a)all the pigs in the holdings where vaccine has been used have been slaughtered or killed in accordance with paragraph 4(a), and the fresh meat produced from these pigs has been either processed or marked and treated in accordance with Article 10(3)(f), fourth indent;
(b)all the holdings where vaccinated pigs had been kept have been cleansed and disinfected in accordance with Article 12.
Where the measures provided for in paragraph 4 are lifted, Member States shall also ensure that:
(a)reintroduction of pigs in the holdings above shall not take place until at least 10 days after completion of the cleaning and disinfection operations, and after all pigs in the holdings where vaccine has been applied have been slaughtered or killed;
(b)after reintroduction, pigs on all holdings in the vaccination area shall undergo clinical and laboratory examinations as laid down in the diagnostic manual in order to detect the possible presence of classical swine fever virus. In case of pigs reintroduced in holdings where the vaccine had been applied, these examinations shall not take place until at least 40 days have elapsed after the reintroduction, during which time pigs shall not be allowed to move from the holding.
9.In those cases where a marker vaccine has been used during the vaccination campaign, derogations from the provisions referred to in paragraphs 4, 5 and 6 may be authorised in accordance with the procedure referred to in Article 27(2), in particular with respect to the marking of meat of the vaccinated pigs and its subsequent use, and the destination of the treated products. Such authorisation shall be subject to the following conditions:
(a)the vaccination plan shall have been approved before the starting of the vaccination operations in accordance with paragraph 3,
(b)a specific request shall have been submitted to the Commission by the Member State concerned, accompanied by a comprehensive report on the implementation of the vaccination campaign, its results and the overall epidemiological situation, and
(c)an on-the-spot check on the implementation of the vaccination campaign shall have been carried out in accordance with the procedures referred to in Article 21.
The adoption of derogations from the provisions referred to in paragraphs 4, 5 and 6 shall be based on the risk that classical swine fever virus is spread by movements or trade of the vaccinated pigs, their offspring or their products.