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CONTROL AND ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES CHAPTER A Measures following the suspicion of the presence of a TSE in ovine and caprine animals If a TSE is suspected in an ovine or caprine animal on a holding in a Member State and until the results of the confirmatory examinations are available, all other ovine and caprine animals on that holding shall be placed under an official movement restriction. If there is evidence that the holding where the animal was present when the TSE was suspected is unlikely to be the holding where the animal could have been exposed to the TSE, the Member State may decide that other holdings or only the holding of exposure shall be placed under official control, depending on the epidemiological information available. The milk and the milk products derived from the ovine and caprine animals of a holding placed under official control, which are present on that holding from the date when the presence of the TSE is suspected until the results of the confirmatory examinations are available, shall only be used within that holding. CHAPTER B

1. The inquiry referred to in Article 13(1)(b) must identify:

(a) in the case of bovine animals:

— all other ruminants on the holding of the animal in which the disease was confirmed,

— where the disease was confirmed in a female animal, its progeny born within a period of two years prior to, or after, the clinical onset of the disease,

— all animals of the cohort of the animal in which the disease was confirmed,

— the possible origin of the disease,

— other animals on the holding of the animal in which the disease was confirmed or on other holdings which may have become infected by the TSE agent or been exposed to the same feed or contamination source,

— the movement of potentially contaminated feedingstuffs, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question;

(b) in the case of ovine and caprine animals:

— all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed,

— insofar as they are identifiable, the parents, and in the case of females all embryos, ova and the last progeny of the female animal in which the disease was confirmed,

— all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those referred to in the second indent,

— the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source,

— the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question.

2. The measures laid down in Article 13(1)(c) shall comprise at least the following:

2.1. In the case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in the second and third indents of point 1(a); however, the Member State may decide:

— not to kill and destroy animals of the cohort referred to in the third indent of point 1(a) if evidence has been provided that such animals did not have access to the same feed as the affected animal,

— to defer the killing and destruction of animals of the cohort referred to in the third indent of point 1(a) until the end of their productive life, provided that they are bulls continuously kept at a semen collection centre and it can be ensured that they are completely destroyed following death.

2.2. In the case of confirmation of TSE in an ovine or caprine animal: 2.2.1. In cases where BSE cannot be excluded If BSE cannot be excluded after the results of the secondary molecular testing carried out in accordance with the methods and protocols set out in Annex X, Chapter C, point 3.2(c) (ii), the killing and complete destruction, without delay, of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b). The animals over 18 months of age killed for destruction shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. The prion protein genotype of all ovine animals, up to a maximum of 50, shall be determined. The milk and the milk products derived from the animals to be destroyed, which were present on the holding between the date of confirmation that BSE cannot be excluded and the date of complete destruction of the animals, shall be disposed of in accordance with Article 12 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council (). Following the killing and complete destruction of all animals, the conditions set out in point 3 shall apply to the holding.

2.2.2. In cases where BSE and atypical scrapie can be excluded If BSE and atypical scrapie are excluded in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, the holding shall be subject to the conditions set out in point (a). In addition, pursuant to the decision of the Member State responsible for the holding, the holding shall be subject to the conditions of either option 1 set out in point (b), or option 2 set out in point (c), or option 3 set out in point (d). In case of a holding with a mixed ovine and caprine flock, the Member State responsible for the holding may decide to apply the conditions of one of the options to the ovine animals of the holding and a different option to the caprine animals of the holding:

(a) The milk and milk products derived from the animals to be destroyed or slaughtered and which were present on the holding between the date of confirmation of the case of TSE and the date of the completion of the measures to be applied in the holding as laid down in point (b) and (c), or derived from the infected flock/herd until all the restrictions laid down in point (d) and point 4 are lifted, shall not be used for the feeding of ruminants, except for the feeding of ruminants within that holding. The placing on the market of such milk and milk products as feed for non-ruminants shall be limited to the territory of the Member State responsible for the holding. The commercial document accompanying consignments of such milk and milk products and any packaging containing such consignments shall be clearly marked with the words: ‘shall not be fed to ruminants’. The use and the storage of feedingstuffs containing such milk and milk products shall be prohibited on holdings where ruminants are kept. Bulk feedingstuffs containing such milk and milk products shall be transported by means of vehicles which do not transport feedingstuffs for ruminants at the same time. If those vehicles are subsequently used for the transport of feedingstuffs intended for ruminants, they shall be thoroughly cleaned in order to avoid cross- contamination, in accordance with a procedure approved by the Member State responsible for the holding.

(b) Option 1 — killing and complete destruction of all animals The killing and complete destruction, without delay, of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). The animals over 18 months of age killed for destruction shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. The prion protein genotype of all ovine animals, up to a maximum of 50, shall be determined. By way of derogation from the conditions set out in the first paragraph of option 1, Member States may decide instead to carry out the measures listed in (i) or (ii):

(i) to replace the killing and complete destruction of all animals, without delay, by their slaughtering for human consumption, without delay, provided that:

— the animals are slaughtered for human consumption within the territory of the Member State responsible for the holding;

— all animals which are over 18 months of age slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.

(ii) to exempt the lambs and kids less than three months old from killing and complete destruction without delay, provided that they are slaughtered for human consumption not later than when they are three months of age. Movement of animals mentioned in points (i) and (ii) from the holding to the slaughterhouse shall be allowed. Following the killing and complete destruction or slaughtering for human consumption of all animals the conditions set out in point 3 shall apply to the holding where it has been decided to apply option 1.

(c) Option 2 – killing and complete destruction of the susceptible animals only The prion protein genotyping of all ovine and caprine animals present in the holding, except lambs and kids less than three months old provided that they are slaughtered for human consumption not later than when they are three months of age. Killing and complete destruction, without delay, of all ovine and/or caprine animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of:

— breeding rams of the ARR/ARR genotype,

— breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are pregnant at the time of the inquiry, the lambs subsequently born, if their genotype meets the requirements of this subparagraph,

— ovine animals carrying at least one ARR allele which are intended solely for human consumption,

— caprine animals carrying at least one of the following alleles: K222, D146 and S146,

— if the Member State responsible for the holding so decides, lambs and kids less than three months old provided that they are slaughtered for human consumption not later than when they are three months of age. The animals over 18 months of age killed for destruction, shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. By way of derogation from the conditions set out in the first and second paragraph of option 2, Member States may decide instead to carry out the measures listed in (i), (ii) or (iii):

(i) to replace the killing and complete destruction of the animals referred to in the second paragraph of option 2 by their slaughtering for human consumption, provided that:

— the animals are slaughtered for human consumption within the territory of the Member State responsible for the holding,

— all animals over 18 months of age slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2;

(ii) to delay the genotyping and subsequent killing and complete destruction or slaughtering for human consumption of the animals referred to in the second paragraph of option 2, for a period not exceeding three months. This derogation can be applied in situations where the index case is confirmed close to the commencement of the lambing and/or kidding season, provided that the ewes and/or goats and their new-born are kept isolated from ovine and/or caprine animals of other holdings during the whole period;

(iii) to delay the killing and complete destruction or slaughtering for human consumption of the animals referred to in the second paragraph of option 2 for a maximum period of three years from the date of confirmation of the index case, in ovine or caprine flocks and holdings where ovine and caprine animals are kept together. The application of the derogation set out in the present paragraph shall be limited to cases where the Member State responsible for the holding considers that the epidemiological situation cannot be handled without killing the relevant animals, but that this cannot be carried out immediately due to the low level of resistance in the ovine and caprine population of the holding, coupled with other considerations, including economic factors. Breeding rams other than those of the ARR/ARR genotype shall be killed or castrated without delay. All possible measures to quickly build up genetic resistance in the ovine and/or caprine population of the holding shall be implemented, including reasoned breeding and culling of ewes to increase the frequency of the ARR allele and eliminate the VRQ allele, and the breeding of bucks carrying the K222, D146 or S146 alleles. The Member State responsible for the holding shall ensure that the number of animals to be killed at the end of the period of delay is not greater than immediately after the index case was confirmed. In the case of the application of the derogation set out in the present paragraph, the measures set out in point 4 shall apply to the holding until the complete destruction or slaughtering for human consumption of the animals referred to in the second paragraph of option 2, after which the restrictions laid down in point 3 shall be applicable. Following the killing and complete destruction or slaughtering for human consumption of the animals referred to in the second paragraph of option 2, the conditions set out in point 3 shall apply to the holding.

(d) Option 3 – no mandatory killing and complete destruction of animals A Member State may decide not to kill and completely destroy the animals identified by the inquiry referred to in the second and third indents of point 1(b) where the criteria laid down in at least one of the following four indents are met:

— it is difficult to obtain replacement male ovine animals of the ARR/ARR genotype and female ovine animals carrying at least one ARR allele and no VRQ allele, or caprine animals carrying at least one of the following alleles: K222, D146 and S146,

— the frequency of the ARR allele within the ovine breed or holding or the K222, D146 or S146 alleles within the caprine breed or holding is low,

— it is deemed necessary in order to avoid inbreeding,

— it is deemed necessary by the Member State based on a reasoned consideration of all the epidemiological factors. The prion protein genotype of all ovine and caprine animals, up to a maximum of 50 of each species, shall be determined within a period of three months from the date of confirmation of the index case of classical scrapie. When additional classical scrapie cases are detected in a holding where option 3 is being applied, the relevance of the reasons and criteria founding the decision to apply option 3 to this holding shall be reassessed by the Member State. If it is concluded that applying option 3 does not ensure a proper control of the outbreak, the Member State shall switch the management of this holding from option 3 to either option 1 or option 2 as laid down in points (b) and (c). The conditions set out in point 4 shall immediately apply to a holding where it has been decided to apply option 3. The Member States allowing recourse to option 3 in the management of classical scrapie outbreaks shall keep records of the reasons and criteria founding each individual application decision.

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2.3. If an animal infected with TSE has been introduced from another holding:

(a) a Member State may decide, based on the history of the infected animal, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed;

(b) in the case of land used for common grazing by more than one flock or herd, Member States may decide to limit the application of eradication measures to a single flock or herd, based on a reasoned consideration of all the epidemiological factors;

(c) where more than one flock or herd is kept on a single holding, Member States may decide to limit the application of the eradication measures to the flock or herd in which the TSE has been confirmed, provided it has been verified that the flocks or herds have been kept isolated from each other and that the spread of infection between the flocks or herds through either direct or indirect contact is unlikely.

3. Following the killing and complete destruction or slaughtering for human consumption of all animals identified in a holding in accordance with point 2.2.1, point 2.2.2(b) or point 2.2.2(c), the following restrictions shall apply:

3.1. The holding shall be subject to an intensified TSE monitoring protocol. This shall include the testing for the presence of TSE in animals over the age of 18 months, which have died or have been killed in the holding but not in the framework of a disease eradication campaign. Ovine animals of the ARR/ARR genotype and caprine animals carrying at least one of the K222, D146 or S146 alleles are exempt. Testing shall be carried out in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.

3.2. Only the following animals may be introduced to the holding:

— male ovine animals of the ARR/ARR genotype,

— female ovine animals carrying at least one ARR allele and no VRQ allele,

— caprine animals provided that a cleaning and disinfection of all animal housing on the premises has been carried out following destocking.

3.3. Only the following breeding rams, breeding bucks and ovine and caprine germinal products may be used in the holding:

— male ovine animals of the ARR/ARR genotype,

— semen from rams of the ARR/ARR genotype,

— embryos carrying at least one ARR allele and no VRQ allele,

— breeding bucks and caprine germinal products as defined in the measures decided by the Member State to build up genetic resistance in the caprine population of the holding.

3.4. Movements of animals from the holding shall either be allowed for the purposes of destruction or shall be subject to the following conditions:

(a) the following animals may be moved from the holding for all purposes, including breeding:

— ARR/ARR ovine animals,

— ewes carrying one ARR allele and no VRQ allele, provided that they are moved to other holdings which are restricted following the application of measures in accordance with points 2.2.2(b) (option 1), 2.2.2(c) (option 2), or 2.2.2(d) (option 3),

— caprine animals carrying at least one of the following alleles: K222, D146 and S146,

— caprine animals provided that they are moved to other holdings which are restricted following the application of measures in accordance with points 2.2.2(b) (option 1), 2.2.2(c) (option 2) or 2.2.2(d) (option 3);

(b) the following animals may be moved from the holding to go directly for slaughter for human consumption:

— ovine animals carrying at least one ARR allele,

— caprine animals,

— if the Member State so decides, lambs and kids less than three months old on the date of slaughter,

— all animals when the Member State has decided to apply the derogations laid down in points 2.2.2(b)(i) and 2.2.2(c)(i);

(c) if the Member State so decides, lambs and kids may be moved to one other holding located within its territory solely for the purposes of fattening prior to slaughter subject to compliance with the following conditions:

— the holding of destination does not contain any ovine or caprine animals other than those being fattened prior to slaughter,

— at the end of the fattening period, the lambs and kids originating from the holdings subject to the eradication measures shall be transported directly to a slaughterhouse located within the territory of the same Member State to be slaughtered not later than when they are 12 months of age.

3.5. The restrictions set out in points 3.1 to 3.4 shall continue to apply to the holding:

(a) until the date of attainment of ARR/ARR status by all ovine animals in the holding, provided that no caprine animals are kept on the holding; or (b) until the date all caprine animals on the holding carry at least one of the K222, D146 or S146 alleles, provided that no ovine animals are kept on the holding; or (c) until the date of attainment of ARR/ARR status by all ovine animals on the holding and all caprine animals on the holding carry at least one of the K222, D146 or S146 alleles; or (d) for a period of two years from the date when all the measures referred to in point 2.2.1, point 2.2.2(b), or point 2.2.2(c) have been completed, provided that no TSE case other than atypical scrapie is detected during this two-year period.

4. Following the decision to implement option 3 laid down in point 2.2.2(d) or the derogation provided for in point 2.2.2(c)(iii) the following measures shall immediately apply to the holding: