LegalizeCommission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance) (Text with EEA relevance)
(c) since the beginning of the sampling referred to in point (b), all bovine animals introduced into the establishment: (i) originate from establishments free from EBL; or (ii) originate from establishments where there has been no evidence of EBL either clinical, post-mortem, or as a result of a diagnostic test for EBL within the 24 months prior to their dispatch; and — if over 24 months of age, they have been subjected to serological tests, with negative results, on two occasions at an interval of not less than 4 months while kept in isolation from other bovine animals of the establishment; or they have been subjected to a serological test, with a negative result, within 30 days prior to their introduction provided all bovine animals have been tested in accordance with point (b); — if less than 24 months of age, they were born to dams, that have been subjected to a serological test for EBL, with negative results, carried out on samples taken during the past 12 months on two occasions at an interval of not less than 4 months; and
(d) since the beginning of the sampling referred to in point (b), all germinal products of bovine animals introduced into the establishment originate from: (i) establishments free from EBL; or (ii) approved germinal product establishments.
2.By way of derogation from point 1, the status free from EBL may be granted to an establishment if all bovine animals originate from establishments free from EBL located either in a Member State or zone free from EBL or in a Member State or zone covered by an approved eradication programme.
The status free from EBL of an establishment keeping bovine animals may only be maintained if:
(a) the requirements laid down in points (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled; and
(b) serological testing for EBL is carried out, with negative results, on samples taken (i) at intervals of not more than 36 months from all bovine animals over 24 months of age; or (ii) in accordance with point (b) or (c) of Section 2 of Chapter 2, as relevant, if the establishment is located in a Member State or zone free from EBL.
1.The status free from EBL of an establishment keeping bovine animals must be suspended if:
(a) one or more of the requirements laid down in Section 2 are not fulfilled;
(b) a case of EBL in a bovine animal that is kept on the establishment is suspected.
2.The status free from EBL may only be restored if:
(a) the requirements laid down in points (c) and (d) of point 1 of Section 1 and point (b) of Section 2 are fulfilled;
(b) the results of further investigations substantiate absence of EBL and the status of all suspected cases has been determined.
1.The status free from EBL of an establishment keeping bovine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended; or
(b) a case of EBL has been confirmed in a bovine animal kept in the establishment.
2.If the status free from EBL has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in points (c) and (d) of point 1 of Section 1 and point (b) of Section 2 are fulfilled.
3.If the status free from EBL has been withdrawn in accordance with point 1(b), it may only be regained if:
(a) any bovine animal presenting a positive test result for EBL and all of their offspring younger than 24 months of age have been removed;
(b) all bovine animals over 12 months of age have been tested negative in a serological test, on two occasions at an interval of not less than 4 months, where the first test must be carried out on samples not taken earlier than 4 months after the removal of the last confirmed case.
4.By way of derogation from point (3)(a), the offspring of dams that have been tested positive in a serological test for EBL or which have shown lesions of EBL may be kept in the establishment if:
(a) they have been separated from the dam immediately after calving and tested negative in a PCR test, on two occasions, where the first sample must be taken within the period of 3 to 5 weeks and the second within 8 to 10 weeks postpartum; and
(b) they remain in the establishment until they are 24 months of age and are tested negative in a serological test, or they are sent before that test directly to the slaughterhouse in accordance with the requirements laid down in Article 27(4).
The status free from EBL as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) at least 99,8 % of the bovine establishments are free from EBL; and
(b) all bovine animals over 24 months of age slaughtered within this Member State or zone are subjected to an official post-mortem examination with samples from all animals with tumours that could be caused by EBL being subjected to laboratory examination to confirm or rule out the presence of EBL.
The status free from EBL as regards kept bovine animals of a Member State or a zone may only be maintained if:
(a) the requirements set out in Section 1 continue to be fulfilled; and
(b) during the first 5 years after the granting of the status free from EBL, surveillance is carried out based on: (i) annual random sampling to detect at least, with a 95 % level of confidence, establishments infected with EBL at a target prevalence rate of 0,2 %; or (ii) serological testing of all bovine animals over 24 months of age on at least one occasion;
(c) following the first 5 years after the granting of the status free from EBL, surveillance is carried out to demonstrate the absence of infection, taking into account the systems of production and the risk factors identified.
PART IV
INFECTIOUS BOVINE RHINOTRACHEITIS/INFECTIOUS PUSTULAR VULVOVAGINITIS
1.The status free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) may only be granted to an establishment keeping bovine animals if:
(a) during the past 12 months there has been no confirmed case of IBR/IPV in bovine animals kept in the establishment;
(b) during the past 2 years none of the bovine animals kept in the establishment has been vaccinated against IBR/IPV;
(c) the bovine animals kept in the establishment have been subjected to at least one of the following testing regimes taking into account previous DIVA vaccinations, where serological tests for the detection of antibodies against whole BoHV-1 or, if necessary, antibodies against BoHV-1-gE have been carried out on: (i) a blood, milk or meat juice sample taken from each bovine animal over a period of not more than 12 months; or (ii) blood, milk or meat juice samples taken on at least two occasions at an interval of not less than 2 months and not more than 12 months from — all female bovine animals over 12 months of age, and — all male bovine animals used or intended for breeding over 12 months of age, and — a random sample of male animals not intended for breeding over 12 months of age. The number of animals tested must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 10 %; or (iii) in the case of an establishment in which at least 30 % of the bovine animals are lactating, — bulk milk samples taken on at least three occasions at intervals of not less than 3 months from lactating female bovine animals representing all epidemiological units of the establishment, and — blood samples taken from all non-lactating female bovine animals over 12 months of age, and from all male bovine animals used or intended for breeding over 12 months of age, and — a random blood or meat juice sample taken from male bovine animals not intended for breeding older than 12 months of age. The number of animals tested must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 10 %; or (iv) in the case of an establishment in which less than 5 % of the kept bovine animals are male and at least 95 % of the female animals over 24 months are intended or used for milk production, bulk milk samples taken on at least six occasions at intervals of not less than 2 months from lactating female bovine animals representing all epidemiological units of the establishment;
(d) since the beginning of the sampling referred to in point (c) all bovine animals introduced into the establishment: (i) originate from establishments free from IBR/IPV and, in case the establishments of origin are located in a Member State or zone that is neither free from IBR/IPV nor covered by an approved eradication programme, have tested negative in a serological test for the detection of antibodies against whole BoHV-1 or, if necessary, antibodies against BoHV-1-gE on a sample taken after their introduction and before the granting of the status free from IBR/IPV; or (ii) have been subjected to quarantine prior to their introduction and have tested negative in serological test for the detection of antibodies against whole BoHV-1 on a sample taken not earlier than 21 days after the beginning of the quarantine; and
(e) since the beginning of the sampling referred to in point (c) all germinal products of bovine animals introduced into the establishment originate from: (i) establishments free from IBR/IPV; or (ii) approved germinal product establishments.
2.By way of derogation from point 1, the status free from IBR/IPV may be granted to an establishment if all bovine animals originate from establishments free from IBR/IPV located either in a Member State or zone free from IBR/IPV or in a Member State or zone under an approved eradication programme, provided they fulfil the requirements set out in points (c) and (d) of Section 2, as relevant.
The status free from IBR/IPV may only be maintained in an establishment keeping bovine animals if:
(a) the requirements laid down in points (a), (b) and (e) of point 1 of Section 1 continue to be fulfilled;
(b) serological testing for the detection of antibodies against whole BoHV-1 or, if necessary, antibodies against BoHV-1-gE is carried out taking into account previous vaccinations with a DIVA vaccine, with negative results, (i) on blood, milk or meat juice samples taken annually from all bovine animals older than 24 months of age; or (ii) in the case of an establishment, in which at least 30 % of the bovine animals are lactating, at least annually on: — bulk milk samples taken on at least three occasions at intervals of not less than 3 months from lactating female bovine animals representing all epidemiological units of the establishment, and — blood samples taken from all breeding male bovine animals older than 24 months of age; or, (iii) in the case of an establishment, in which less than 5 % of the kept bovine animals are male and at least 95 % of the female animals over 24 months are intended or used for milk production, at least annually on bulk milk samples taken on at least six occasions at intervals of not less than 2 months from lactating female bovine animals representing all epidemiological units of the establishment; or (iv) provided the status free from IBR/IPV has been maintained for the past 3 consecutive years, annually on blood or milk samples taken from a number of bovine animals that must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 10 %; or (v) if the establishment is located in a Member State or zone free from IBR/IPV, on samples taken in accordance with point 1(b) of Section 2 of Chapter 2 or point 3 of Section 2 of Chapter 2, if relevant.
(c) only bovine animals that have not been vaccinated against infection with IBR/IPV are introduced into the establishment if it is located in a Member State or zone: (i) free from IBR/IPV; or (ii) where a vaccination ban is in place as part of the eradication strategy under an approved eradication programme.
(d) all bovine animals that are introduced fulfil the requirements laid down in point 1(d)(ii) of Section 1 or originate from establishments free from IBR/IPV and have tested negative in a serological test for the detection of antibodies against whole BoHV-1 or, if necessary, antibodies against BoHV-1-gE on a sample taken in the establishments of origin within 15 days prior to their dispatch, in cases where: (i) the establishment is located in a Member State or zone free from IBR/IPV and the establishments of origin are not located in a Member State or zone free from IBR/IPV; or (ii) the establishment is located in a Member State or zone covered by an approved eradication programme and the establishments of origin are located in a Member State or zone that is neither free from IBR/IPV nor covered by an approved eradication programme.
1.The status free from IBR/IPV of an establishment keeping bovine animals must be suspended if:
(a) one or more of the requirements laid down in Section 2 are not fulfilled;
(b) a case of IBR/IPV is suspected in a bovine animal kept in the establishment.
2.The status free from IBR/IPV may only be restored if:
(a) the requirements laid down in points 1(b) and (e) of Section 1 and points (b), (c) and (d) of Section 2 are fulfilled;
(b) the results of further investigations substantiate absence of IBR/IPV and the status of all suspected cases has been determined.
1.The status free from IBR/IPV of an establishment keeping bovine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended;
(b) a case of IBR/IPV has been confirmed in a bovine animal kept in the establishment.
2.If the status free from IBR/IPV has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in points (b) and (e) of point 1 of Section 1 and points (b), (c) and (d) of Section 2 are fulfilled.
3.If the status free from IBR/IPV has been withdrawn in accordance with point 1(b), it may only be regained if:
(a) all confirmed cases have been removed;
(b) at least one of the testing regimes laid down in point 1(c) of Section 1 has been carried out with negative results on samples that have been taken not earlier than 30 days after the removal of the last confirmed case.
The status free from IBR/IPV as regards kept bovine animals may only be granted to a Member State or a zone if
(a) vaccination against IBR/IPV has been prohibited for kept bovine animals; and
(b) at least 99,8 % of the establishments representing at least 99,9 % of the corresponding bovine population are free from IBR/IPV.
1.The status free from IBR/IPV as regards kept bovine animals of a Member State or a zone may only be maintained if:
(a) the requirements laid down in Section 1 continue to be fulfilled; and
(b) surveillance is carried out annually based on random sampling that must allow at least for the detection, with a 95 % level of confidence, of the infection of establishments with BoHV-1 at a target prevalence rate of 0,2 % of the establishments or of BoHV-1 infected bovine animals with a target prevalence rate of 0,1 % of the bovine population.
2.By way of derogation from point 1(a), the use of DIVA vaccination may be authorised by the competent authority in the event of an outbreak, if:
(a) the result of the epidemiological enquiry and investigations according to Article 25 has demonstrated that only a limited number of establishments were involved in the outbreak;
(b) its use is limited to controlling this outbreak as deemed necessary by the competent authority;
(c) the bovine animals are DIVA vaccinated under the supervision of the competent authority and the use of DIVA vaccines is documented for each animal;
(d) the DIVA vaccinated bovine animals are only moved directly to a slaughterhouse or to an establishment in another zone or Member State where no vaccination ban is in place.
3.By way of derogation from point 1(b), surveillance may be carried out to demonstrate yearly the absence of infection with BoHV-1 taking into account the systems of production and the risk factors identified, provided no outbreaks have been detected for 5 consecutive years following the granting of the status free from IBR/IPV in this Member State or zone.
PART V
INFECTION WITH AUJESZKY’S DISEASE VIRUS
1.The status free from infection with Aujeszky’s disease virus (ADV) may only be granted to an establishment keeping porcine animals if:
(a) during the past 12 months there has been no confirmed case of infection with ADV in porcine animals kept in the establishment;
(b) during the past 12 months none of the porcine animals kept in the establishment has been vaccinated against AD;
(c) during the past 12 months, the porcine animals kept in the establishment have been subjected to one of the following testing regimes taking into account previous DIVA vaccinations where serological tests for the detection of antibodies against ADV or, if necessary, antibodies against ADV-gE have been carried out, with negative results, on: (i) a blood or meat juice sample taken from each porcine animal; or (ii) blood or meat juice samples taken on two occasions at an interval of 2 to 3 months from a number of animals that must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 10 %.
(d) since the beginning of the sampling referred to in point (c), all porcine animals introduced into the establishment: (i) originate from establishments free from infection with ADV and, in case the establishments of origin are located in a Member State or zone that is neither free from infection with ADV nor covered by an approved eradication programme, have tested negative in a serological test for the detection of antibodies against whole ADV or, if necessary, antibodies against ADV-gE after their introduction and before the granting of the status free from infection with ADV; or (ii) have been subjected to quarantine for a period of at least 30 days prior to their introduction and have tested negative in a serological test for the detection of antibodies against whole ADV on two occasions at an interval of not less than 30 days between collection of each sample. The sample for the last test must be taken within 15 days prior to dispatch.
(e) since the beginning of the sampling referred to in point (c) all germinal products from porcine animals introduced into the establishment originate from: (i) establishments free from infection with ADV; or (ii) approved germinal product establishments.
2.By way of derogation from point 1, the status free from infection with ADV may be granted to an establishment if all porcine animals originate from establishments free from infection with ADV located either in a Member State or zone free from infection with ADV or in a Member State or zone covered by an approved eradication programme, provided they fulfil the requirements set out in point (d) of Section 2.
The status free from infection with ADV of an establishment keeping porcine animals may only be maintained if:
(a) the requirements laid down in points (a), (b) and (e) of point 1 of Section 1 continue to be fulfilled;
(b) serological testing is carried out, with negative results, on a representative number of blood or meat juice samples taken from the porcine animals kept in the establishment, to verify the absence of infection with ADV based on a testing regime that takes into account the production cycle and the risk of introduction of ADV: (i) at least once a year, in case all kept porcine animals are not vaccinated against AD, with tests for the detection of antibodies against whole ADV; or (ii) at least twice a year, with tests for the detection of antibodies against whole ADV and tests for the detection of antibodies against ADV-gE, if necessary;
(c) provided the establishment is located in a Member State or zone free from infection with ADV, the serological testing referred to in point (b) is carried out, as required, in accordance with the surveillance provided for in point 1(b) of Section 2 of Chapter 2 or point 4 of Section 2 of Chapter 2, if relevant;
(d) all porcine animals, that are introduced: (i) fulfil the requirements set out in point 1(d)(ii) of Section 1; or (ii) originate from establishments free from infection with ADV and have been subjected to a serological test for antibodies against whole ADV, with a negative result, on a sample collected in the establishments of origin within 15 days prior to their dispatch, in cases where: — the establishment is located in a Member State or zone free from infection with ADV and the establishments of origin are not located in a Member State or zone free from infection with ADV; or — the establishment is located in a Member State or zone covered by an approved eradication programme and the establishments of origin are located in a Member State or zone that is neither free from infection with ADV nor covered by an approved eradication programme. The number of porcine animals tested must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 10 %. By way of derogation from the first subparagraph, for porcine animals less than 4 months old born to DIVA-vaccinated dams the serological test for the detection of antibodies against ADV-gE may be used.
1.The status free from infection with ADV of an establishment keeping porcine animals must be suspended if:
(a) one or more of the requirements laid down in Section 2 are no longer fulfilled;
(b) a case of infection with ADV is suspected in a porcine animal kept in the establishment.
2.The status free from infection with ADV may only be restored if:
(a) the requirements laid down in points (b) and (e) of point 1 of Section 1 and point (b) or (c), if relevant, and (d) of Section 2 are fulfilled;
(b) the results of further investigations substantiate absence of infection with ADV and the status of all suspected cases has been determined.
1.The status free from infection with ADV of an establishment keeping porcine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended;
(b) a case of infection with ADV has been confirmed in a porcine animal kept in the establishment.
2.If the status free from infection with ADV has been withdrawn in accordance with point 1(a), it may only be regained if the requirements set out in points (b) and (e) of point 1 of Section 1 and point (b) or (c), if relevant, and (d) of Section 2 are fulfilled.
3.If the status free from infection with ADV has been withdrawn in accordance with point 1(b), it may only be regained, if all porcine animals of the establishment have been removed.
The status free from infection with ADV as regards kept porcine animals may only be granted to a Member State or a zone if:
(a) vaccination against AD has been prohibited for kept porcine animals for the previous 12 months;
(b) surveillance has been carried out to demonstrate that no establishment in the respective Member State or zone has had any clinical, virological or serological evidence of infection with ADV for at least the previous 24 months; and
(c) in case, infection with ADV is known to be established in wild porcine animals, measures have been implemented to prevent any transmission of ADV from wild to kept porcine animals.
1.The status free from infection with ADV as regards kept porcine animals of a Member State or a zone may only be maintained if:
(a) the requirements defined in points (a) and (c) of Section 1 continue to be fulfilled; and
(b) surveillance is carried out annually based on random sampling to allow at least for the detection, with a 95 % level of confidence, of establishments infected with ADV at a target prevalence rate of 0,2 %. The number of blood or meat juice samples to be taken from the porcine animals kept in an establishment must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 20 %.
2.By way of derogation from point 1, the status free from infection with ADV in the porcine population of a Member State or zone may be maintained in the event of an outbreak, if:
(a) all the porcine animals in the affected establishments have been removed;
(b) an epidemiological enquiry and investigations including clinical examination and serological or virological testing has been carried out by the competent authority: (i) in all establishments keeping porcine animals that have been directly or indirectly in contact with the infected establishment to rule out infection; and (ii) in all establishments keeping porcine animals located within at least a 2-kilometre radius of an infected establishment, to demonstrate that these establishments are not infected. The number of blood or meat juice samples to be taken from porcine animals kept in these establishments must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 10 %; or (iii) in case a DIVA vaccination has been used, serological testing for antibodies against ADV-gE has been carried out on two occasions at an interval of 2 months in establishments keeping porcine animals located within the vaccinated radius from the infected establishment to demonstrate the absence of infection;
(c) the result of the investigation according to point (b) has demonstrated that only a limited number of establishments were involved in the outbreak;
(d) the relevant control measures as referred to in Article 24 have been immediately implemented in each establishment infected with ADV, including where necessary vaccination with DIVA vaccines.
3.By way of derogation from point (a) of Section 1, the use of DIVA vaccination may be authorised by the competent authority in the event of an outbreak referred to in point 2, if:
(a) its use is limited to control this outbreak as deemed necessary by the competent authority;
(b) the porcine animals are DIVA vaccinated under the supervision of the competent authority and the use of DIVA vaccines is documented for each animal;
(c) the DIVA vaccinated porcine animals are only moved directly to a slaughterhouse or to an establishment in another Member State or zone where no vaccination ban is in place.
4.By way of derogation from point 1(b), surveillance may be carried out to demonstrate annually the absence of ADV infection taking into account the systems of production and the risk factors identified, provided no outbreaks have been detected for 2 consecutive years following the granting of the status free from infection with ADV in this Member State or zone.
PART VI
BOVINE VIRAL DIARRHOEA
1.The status free from bovine viral diarrhoea (BVD) may only be granted to an establishment keeping bovine animals if:
(a) during the past 18 months there has been no confirmed case of BVD in a bovine animal kept in the establishment;
(b) the bovine animals kept in the establishment have been subjected to at least one of the following testing regimes taking into account possible previous vaccinations: (i) tests for the detection of BVD virus (BVDV) antigen or genome have been carried out, with negative results, on samples of all bovine animals. At least from all calves born in the previous 12 months, the samples must have been taken after or at the same time as official identification, but not later than 20 days postpartum. The dams of those calves with negative test results do not need to be tested; (ii) serological tests for the detection of antibodies against BVDV have been carried out, with negative results, on samples taken over a period of not less than 12 months on at least three occasions at intervals of not less than 4 months from bovine animals which have been kept in the establishment for at least 3 months prior to testing. The number of animals tested must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 50 % and must be at least five animals or all the animals if there are fewer than five animals kept. In case the bovine animals of the establishment are kept in separate groups without direct contact with each other, a respective number of animals of each group must be tested; (iii) a combination of the testing regimes set out in points (i) and (ii) has been applied over a period of not less than 12 months. The capacity of the combined testing regime to detect the disease must be equivalent to that of the testing regimes referred to in points (i) and (ii);
(c) since the beginning of the sampling referred to in point 1(b), all bovine animals introduced into the establishment: (i) originate from establishments free from BVD located in a Member State or zone free from BVD; or (ii) originate from establishments free from BVD, where — serological tests referred to in point 1(c) (ii) or (iii) of Section 2 of Chapter 1 have been carried out, with negative results, within the past 4 months; or — prior to their dispatch, they have been tested individually to exclude BVDV transmission into the establishment of destination taking into account the testing history and, if relevant, the animal’s stage of gestation; or (iii) have tested negative in a test for BVDV antigen or genome, and — have been subjected to quarantine for a period of at least 21 days prior to their dispatch and, in case of pregnant dams, have tested negative for antibodies against BVDV on samples taken after not less than 21 days of quarantine; or — have tested positive for antibodies against BVDV either prior to their dispatch or, in case of pregnant dams, before insemination preceding the current gestation;
(d) since the beginning of the sampling referred to in point 1(b) all germinal products of bovine animals introduced into the establishment originate from: (i) establishments free from BVD; or (ii) approved germinal product establishments.
2.By way of derogation from point 1, the status free from BVD may be granted to an establishment if:
(a) all bovine animals originate from establishments free from BVD located in a Member State or zone free from BVD or in a Member State or zone covered by an approved eradication programme and fulfil the requirements laid down in point 1(c), if relevant; or
(b) all bovine animals originate from establishments free from BVD, are not intended for breeding and the status free from BVD of the establishment is maintained in accordance with point 2 of Section 2.
1.The status free from BVD of an establishment keeping bovine animals may only be maintained if:
(a) the requirements laid down in point (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled;
(b) no bovine animal has been vaccinated against BVD since the status free from BVD was granted to the establishment;
(c) at least one of the following testing regimes is carried out with negative results: (i) each new-born calf is tested negative for BVDV antigen or genome on a sample taken after or at the same time as official identification, but not later than 20 days postpartum; (ii) serological tests for the detection of antibodies against BVDV are carried out at least annually on samples taken from bovine animals that have been kept in the establishment for at least 3 months prior to testing. The number of animals tested must allow at least for the detection, with a 95 % level of confidence, of seropositive animals at a target prevalence rate of 50 % and must be at least five animals or all the animals if there are fewer than five animals kept; In case the bovine animals of the establishment are kept in separate groups without direct contact with each other, a respective number of animals of each group must be tested; (iii) a combination of the testing regimes laid down in points (i) and (ii) is applied. The capacity of the combined testing regime to detect the disease must be equivalent to that of the testing regimes referred to in points (i) and (ii); (iv) if the establishment is located in a Member State or zone free from BVD, tests are carried out on samples taken in accordance with point 1(b) of Section 2 of Chapter 2 or point 3 of Section 2 of Chapter 2, if relevant;
(d) only bovine animals that have not been vaccinated against BVD are introduced into the establishment if it is located in a Member State or zone free from BVD.
2.By way of derogation from point 1, the status free from BVD of an establishment keeping bovine animals referred to in point 2(b) of Section 1 may be maintained without testing the bovine animals in accordance with point 1(c) if:
(a) the requirements laid down in point 2(b) of Section 1 continue to be fulfilled;
(b) they are not used for breeding;
(c) they have no contact with animals that are intended or used for breeding and are moved from this establishment to a slaughterhouse, (i) directly, or; (ii) via an assembly operation, which is carried out in the same Member State or zone, and where only animals that comply with the requirements laid down in points (b) and (c) and originate from establishments that comply with the requirement laid down in point (a) are assembled.
1.The status free from BVD of an establishment keeping bovine animals must be suspended if:
(a) one or more of the requirements laid down in Section 2 are not fulfilled;
(b) a case of BVD is suspected in a bovine animal kept in the establishment.
2.The status free from BVD may only be restored if:
(a) the requirements laid down in point 1(c) and (d) of Section 1 and point 1(b)(c) and (d) and, if relevant, point 2 of Section 2 are fulfilled.
(b) the results of further investigations substantiate absence of BVD and the status of all suspected cases has been determined.
1.The status free from BVD of an establishment keeping bovine animals must be withdrawn if:
(a) one or more of the requirements laid down in Section 2 are not fulfilled after the maximum period of time referred to in point (b) of Article 20(3) has lapsed since the status was suspended;
(b) a case of BVD has been confirmed in a bovine animal kept in the establishment.
2.If the status free from BVD has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in point 1(c) and (d) of Section 1 and point 1(b), (c) and (d) and, if relevant, point 2 of Section 2 are fulfilled.
3.If the status free from BVD has been withdrawn in accordance with point 1(b), it may only be regained if:
(a) all animals tested positive for BVDV have been removed;
(b) the status in relation to infection with BVDV of each bovine animal kept in the establishment has been determined;
(c) all calves that might have been infected in utero with BVDV were born and kept in isolation until they tested negative for BVDV antigen or genome.
The status free from BVD as regards kept bovine animals may only be granted to a Member State or a zone if:
(a) vaccination against BVD has been prohibited for kept bovine animals;
(b) no case of BVD has been confirmed in a kept bovine animal for at least the previous 18 months; and
(c) at least 99,8 % of the establishments representing at least 99,9 % of the bovine population are free from BVD.
1.The status free from BVD as regards kept bovine animals of a Member State or a zone may only be maintained if:
(a) the requirements laid down in point (a) and (c) of Section 1 continue to be fulfilled; and
(b) surveillance is carried out annually that must allow at least for the detection, with a 95 % level of confidence, of establishments infected with BVDV at a target prevalence rate of 0,2 % of the establishments or of BVDV infected bovine animals with a target prevalence rate of 0,1 % of the bovine population.
2.By way of derogation from point 1(a), the use of vaccination may be authorised by the competent authority in the event of an outbreak, if:
(a) the results of the epidemiological enquiry and investigations according to Article 25 have demonstrated that only a limited number of establishments were involved in the outbreak;
(b) only a limited number of bovine animals deemed necessary by the competent authority to control this outbreak are vaccinated under the supervision of the competent authority and the use of vaccination is documented for each animal.
3.By way of derogation from point 1(b), surveillance may be carried out to demonstrate annually the absence of BVD taking into account the systems of production and the risk factors identified, provided no outbreaks have been detected for 5 consecutive years following the granting of the status free from BVD in this Member State or zone.
ANNEX V
DISEASE SPECIFIC REQUIREMENTS FOR THE GRANTING AND MAINTENANCE OF THE DISEASE-FREE STATUS AT THE LEVEL OF MEMBER STATES OR ZONES
PART I
INFECTION WITH RABIES VIRUS
1.For the purpose of eradication programmes for infection with rabies virus (RABV), anti-rabies vaccination must only be carried out on pet animals that are identified and must fulfil the requirements laid down in Annex III to Regulation (EU) No 576/2013 of the European Parliament and of the Council (8).
2.For the purpose of eradication programmes for infection with RABV, anti-rabies vaccination of kept animals, other than those referred to in the first paragraph, must be risk-based and carried out with the purpose of protecting humans from being exposed to rabies virus, using vaccines that meet the requirements laid down in points (1)(a) and (1)(b)of Annex III to Regulation (EU) No 576/2013 of the European Parliament and of the Council.
1.For the purpose of eradication programmes for infection with RABV the oral vaccination against infection with RABV of wildlife must:
(a) be organised and implemented as regular planned or emergency campaigns taking into account the risk assessment provided in point (a) of Article 32(2);
(b) be subjected to an adequate vaccine distribution in terms of timing and coverage of the vaccination area, taking into account the biology of the targeted animal population, the epidemiological situation and the topography of the area;
(c) be subjected, with the support of geographical information systems, to assessment of the correct geographical distribution of vaccine baits with a frequency that allows, if necessary, the adoption of corrective measures; and
(d) be subjected to monitoring of vaccination effectiveness, that may include the detection of the presence of biomarker and serological testing in dead animals from the targeted animal population for the vaccination.
2.For the purpose of eradication programmes for infection with RABV the vaccination against infection with RABV of stray dog populations must:
(a) be organised and implemented, if necessary, as part of control and management measures of stray dog populations, taking into account the risk assessment provided for in point (a) of Article 32(2);
(b) comply with the requirements of Section 1.
1.The status free from infection with RABV may only be granted to a Member State or a zone if:
(a) surveillance has been implemented in accordance with the requirements laid down in Article 3(1) at least for the past 24 months; and
(b) no case of infection with RABV has been confirmed during the past 24 months in the targeted animal population.
2.By way of derogation from point 1(b), if a case of infection with RABV has been confirmed, the status may be granted if the infection of the case did not occur in the Member State or in the zone; and
(a) the case has been officially confirmed and no epidemiological link may have occurred and resulted in any additional case, which includes detection of the case at a border control post, or in a quarantine establishment or the quarantine facilities of a confined establishment; or
(b) epidemiological link may have occurred and no additional case was detected by increased surveillance and epidemiological enquiry and investigations during the 6 months following the death of the case.
The status free from infection with RABV of a Member State or a zone may only be maintained if:
(a) surveillance is implemented in accordance with the requirements laid down in Article 3(1) with the objective of an early detection of the disease; and
(b) no case of infection with RABV has been confirmed in the targeted animal population or a case occurred and the conditions laid down in point 2 of Section 1 were complied with.
PART II
INFECTION WITH BLUETONGUE VIRUS (SEROTYPES 1-24)
1.The surveillance of infection with bluetongue virus (serotypes 1-24) (infection with BTV) to ensure early detection of introduction or recurrence of infection with any of the serotypes 1-24 of BTV that were not reported during the previous 2 years must include:
(a) general surveillance requirements as provided for in point (a) of Article 3(1);
(b) active surveillance as provided for in Section 4.
2.The design of the surveillance provided for in point 1 must address:
(a) the risk of infection with limited clinical manifestations;
(b) the risk of introduction of BTV serotypes associated with the circulation of any of the serotypes 1-24 of BTV in the vicinity; and
(c) any other identified relevant risk factor for introduction of any of the serotypes 1-24 of BTV not reported in the previous 2 years.
3.The surveillance in an area(s) adjacent to any infected Member State, zone or third country must be increased in an area of up to 150 km from the limit with the Member State, zone, or third country. The demarcation of the area of increased surveillance may be adapted to relevant ecological or geographical features likely to facilitate or interrupt the transmission of BTV or adapted due to the implementation of disease control measures that supports the choice between a greater or lesser distance.
4.The surveillance provided for in point 1(b) and point 3 must have the capacity at least to detect, with a 95 % level of confidence, the infection in the targeted animal population at a target prevalence rate of 5 %, unless otherwise specified in Section 2 of Chapter 4.
1.The surveillance of infection with BTV to ensure the timely demarcation of the spread of the infection when one or more serotypes of BTV is present and, if necessary, to monitor the prevalence rate must include:
(a) general surveillance requirements as provided for in point (a) of Article 3(1); and
(b) active surveillance as provided for in Section 4.
2.The design of the surveillance provided for in point 1 must take into account: all available information on the epidemiology of the disease and biology of the vector that prevail on the territory.
3.The target prevalence rate of the surveillance provided for in point 1 must be adapted to the epidemiological situation, taking into the main risk factors such as the targeted animal population and the vector population.
1.The surveillance of infection with BTV to demonstrate the absence of infection with any of the serotypes 1-24 that has been previously detected in the territory must include:
(a) general surveillance requirements as provided for in point (a) of Article 3(1); and
(b) active surveillance as provided for in Section 4.
2.The design of the surveillance provided for in point 1 must address:
(a) the risk of infection with limited clinical manifestations;
(b) all available information on the epidemiology of the disease and biology of the vector that prevail on the territory; and
(c) any specific risk of persistence of the infection identified.
3.The surveillance provided for in point 1(b) must have the capacity at least to detect, with a 95 % level of confidence, the infection in the targeted animal population at a target prevalence rate of 1 %.
1.The geographical units referred to in point (a) of Article 40(1) must be based on a grid of 45 km by 45 km and can be adapted to:
(a) the epidemiological situation, how fast the infection is spreading and the shape and size of the zones covered by the eradication programme in the event of confirmation of the infection; and
(b) the zones in accordance with point (b) of Article 13(2).
2.Active surveillance must be based on one or a combination of the following activities:
(a) monitoring of sentinel animals using serological or virological testing; and
(b) structured prevalence surveys, based on a random or risk-based sampling strategy using serological or virological testing.
3.The frequency of the sampling must:
(a) at least be annual, in the period of the year when infection or seroconversion is most likely to be detected; and
(b) be monthly during the vector activity season where regular information is needed due to the risk of the infection spreading.
4.The animals sampled must:
(a) not be vaccinated against the serotype(s) of BTV targeted for surveillance;
(b) no longer be covered by maternal immunity in case their mother was vaccinated or infected;
(c) be resident for a sufficient time in the relevant geographical unit and not have been protected from exposure to the vector;
(d) be representative for the geographical distribution of the targeted animal population in the relevant geographical unit; and
(e) be initially seronegative when surveillance is based on serological testing of sentinels.
5.The sample size in each geographical unit must be calculated in accordance with the target prevalence rate based on the objectives assigned in Sections 1-3.
6.When surveillance must be adapted as provided for in point (c) of Article 43(2), it must at least include a survey:
(a) on the introduced animals that: (i) must be based on the sampling and testing of all introduced animals; (ii) must take place as soon as possible after their introduction; or
(b) on the targeted animal population the most at risk due to the possible circulation of the virus that: (i) must have a capacity at least to detect, with a 95 % level of confidence, infection with BTV at a target prevalence rate of 5 %; (ii) must either: — not take place before 21 days has elapsed after the introduction of animals if it is a one-shot survey; or — must be conducted with a frequency adapted to the frequency of the movements of the animals that may jeopardise the health status.
This survey is not required if the frequency of the sampling is carried out in accordance with point 3(b).
1.Entomological surveillance must consist of at least an active annual programme of vector catching by means of permanently sited aspiration traps intended to determine the population dynamics of the vector and, where relevant, the vector-free period.
2.Aspiration traps equipped with ultraviolet light must be used in accordance with pre-established protocols; the traps must be operated throughout the night and operate at least:
(a) one night per week during the month before the expected beginning and during the month before the expected end of the vector-free period; and
(b) one night per month during the vector-free period.
On the basis of the evidence obtained in the first 3 years of operating the aspiration traps, the frequency of operation of those traps may be adjusted.
3.At least one aspiration trap must be placed in each geographical unit referred to in point (a) of Article 40(1) throughout the seasonally BTV-free zone. A proportion of the midges collected in the aspiration traps must be sent to a specialised laboratory capable of counting and identifying the suspected vector species or complexes.
4.When entomological surveillance is organised in the context of determination of a vector-free period, a maximum threshold of Culicoides species must be defined for the interpretation of the results. In the absence of sound evidence supporting the determination of the maximum threshold, total absence of Culicoides imicola specimens and less than five parous Culicoides per trap must be used as maximum threshold.
1.The animals originate from a Member State or a zone free from infection with BTV and have not been vaccinated with a live vaccine against infection with BTV in the last 60 days before the date of movement.
2.The animals originate from a Member State or a zone covered by the eradication programme and at least one of the following requirements is complied with:
(a) the animals have been kept in a seasonally BTV-free Member State or zone established in accordance with paragraph 3 of Article 40: (i) for at least 60 days prior to the date of movement; (ii) for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the entry date of the animal into the seasonally BTV-free Member State or zone; or (iii) for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the entry date of the animal into the seasonally BTV-free Member State or zone;
(b) the animals have been protected against attacks by the vectors during transportation to the place of destination and they have been kept protected against attacks by vectors in a vector protected establishment: (i) for at least 60 days prior to the date of movement; or (ii) for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the date of the commencement of the period of protection against attacks by vectors; or (iii) for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of commencement of the period of protection against attacks by vectors;
(c) the animals have been vaccinated against all serotypes 1-24 of BTV reported during the past 2 years in that Member State or zone, the animals are within the immunity period guaranteed in the specifications of the vaccine and meet at least one of the following requirements: (i) they have been vaccinated more than 60 days before the date of movement; or (ii) they have been vaccinated with an inactivated vaccine and subjected to a PCR test, with negative results on samples collected at least 14 days after the onset of the immunity set in the specifications of the vaccine.
(d) the animals have been subjected with positive results to a serological test able to detect specific antibodies against all serotypes 1-24 of BTV reported during the past 2 years in that Member State or zone and: (i) the serological test have been carried out on samples collected at least 60 days before the date of movement; or (ii) the serological test have been carried out on samples collected at least 30 days before the date of the movement and the animals have been subjected to a PCR test, with negative results, carried out on samples collected not earlier than 14 days before the date of movement.
3.The animals originate from a Member State or a zone neither BTV-free nor covered by an eradication programme for infection with BTV and:
(a) they comply with point 2(b); or
(b) the animals have been kept at least for the last 60 days prior to departure either in an area of at least 150 km radius from the establishment where they are kept, or in a Member State, where surveillance in compliance with the requirements laid down in Sections 1 and 2 of Chapter 1 have been carried out at least for the last 60 days prior to departure and: (i) they have been vaccinated in accordance with point 2(c) against all serotypes 1-24 of BTV reported during the past 2 years in an area of at least 150 km radius centred on the place where the animals were kept; or (ii) they have been immunised in accordance with point 2(d) against all serotypes 1-24 of BTV reported during the past 2 years in an area of at least 150 km radius centred on the place where the animals were kept.
4.The animals originate from a Member State or a zone not BTV-free, are destined for immediate slaughter and the following requirements apply:
(a) no case of infection with BTV has been reported in the establishment of origin for a period of at least 30 days prior to the date of movement;
(b) the animals are transported directly from the Member State or zone of origin to the slaughterhouse of destination where they are slaughtered within 24 hours of arrival;
(c) the operator of the establishment of origin have informed the operator of the slaughterhouse of destination of the movement at least 48 hours prior to the loading of the animals.
5.The animals originate from a Member State or a zone neither BTV-free nor covered by an eradication programme for infection with BTV and the animals comply with the requirements set out in point 2(a).
6.The animals originate from a Member State or a zone not BTV-free and:
(a) they have been protected from vector attacks by insecticides or repellents for at least 14 days prior to the date of movement; and
(b) they have been subjected during that period to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of protection from vector attacks.
7.The animals comply with specific animal health requirements defined by the competent authority to ensure they have sufficient immunological protection prior to departure.
8.The animals comply with any of the requirements provided for in points 2, 3 5, 6 or 7 only for the serotypes of BTV reported for the past 2 years in the Member State or zone of origin and not in the Member State or zone of destination during the same period.
1.The donor animals have been kept at least for a period of 60 days prior to and during the collection of germinal products in a Member State or a zone free from infection with BTV.
2.The germinal products originate from a Member State or a zone covered by the eradication programme for infection with BTV and at least one of the requirements set out in point (a) for semen, point (b) for in vivo derived embryos of bovine animals or point (c) for embryos other than in vivo derived embryos of bovine animals and oocytes is complied with:
(a) semen have been obtained from donor animals that comply with at least one of the following requirements: (i) they have been protected against attacks by vectors in a vector protected establishment for a period of at least 60 days before commencement of collection and during collection of the semen; (ii) they have been kept in a seasonally BTV-free Member State or zone for a period of at least 60 days before commencement of collection and during collection of the semen; (iii) they have been subjected to a serological test, with negative results, on samples collected between 28 and 60 days from the date of each collection of the semen; (iv) they have been subjected, with negative results, to a direct diagnostic method carried out on samples collected: — at commencement and final collection of the semen to be consigned; and — during the period of semen collection: at least every 7 days in the case of a virus isolation test, or at least every 28 days, in the case of a PCR test;
(b) in vivo derived embryos of bovine animals have been obtained from donor animals that do not show any clinical signs of infection with BTV on the day of collection and are collected, processed and stored in accordance with Part 2 of Annex III of Commission Delegated Regulation (EU) 2020/686 (9);
(c) embryos other than in vivo derived embryos of bovine animals and oocytes have been obtained from donor animals that comply with at least one of the following requirements: (i) they have been protected against attacks by vectors in a vector protected establishment for at least 60 days before commencement of collection and during collection of the embryos/oocytes; (ii) they have been subjected to a serological test, with negative results, on samples collected between 28 and 60 days from the date of each collection of the embryos/oocytes; (iii) they have been subjected to a PCR test, with negative results, on samples collected on the day of collection of the embryos/oocytes; (iv) they have been kept in a seasonally BTV-free Member State or zone for a period of at least 60 days before collection of the embryos/oocytes.
3.The germinal products originate from a Member State or a zone neither BTV-free nor covered by an eradication programme for infection with BTV and comply with the requirements set out either in point 2(a)(i), 2(a)(iii), 2(a)(iv), 2(b), 2(c)(i), 2(c)(ii) or 2(c)(iii).
4.The germinal products originate from a Member State or a zone neither BTV-free nor covered by an eradication programme for infection with BTV and must comply with either point 2(a)(ii) or 2(c)(iv).
The status of vector protected establishment may only be granted to an establishment if:
(a) it has appropriate physical barriers at entry and exit points;
(b) openings must be vector screened with mesh of appropriate gauge which must be impregnated regularly with an approved insecticide according to the manufacturers’ instructions;
(c) vector surveillance and control must be carried out within and around the vector protected establishment;
(d) measures must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector protected establishment; and
(e) standard operating procedures must be in place, including descriptions of back-up and alarm systems, for operation of the vector protected establishment and transport of animals to the place of loading.
1.The status free from infection with BTV may only be granted to a Member State or to a zone, where BTV has never been reported, if:
(a) surveillance in accordance with Section 1 of Chapter 1 has been conducted at least for the past 24 months; and
(b) no case of infection with BTV has been confirmed during the past 24 months in the targeted animal population.
2.The status free from infection with BTV may only be granted to a Member State or to a zone where BTV has already been reported if:
(a) surveillance in accordance with Section 3 of Chapter 1 has been conducted at least for the past 24 months; and
(b) no case of infection with BTV has been confirmed during the past 24 months in the targeted animal population.
1.The status free from infection with BTV may only be maintained if:
(a) the requirements laid down in point 1 of Section 1 are complied with; and
(b) animals and germinal products from the targeted animal population are only moved into or through the Member State or zone when the requirements laid down in Articles 43 and 45 are complied with.
2.The intensity and frequency of the surveillance referred to in point 1 of Section 1 must be duly adapted to:
(a) the health status of neighbouring Member States, zones or third countries in accordance with point 3 of Section 4 of Chapter 1;
(b) the introduction of animals from the targeted animal population that may have jeopardised the health status of the Member State or zone, in accordance with point 6 of Section 4 of Chapter 1.
3.If no circulation of the infection has been detected for 2 consecutive years following granting of the status free from infection with BTV of a Member State or of a zone, surveillance must be based on:
(a) random annual surveillance at least to detect, with a 95 % level of confidence, the infection with BTV at a target prevalence rate of 20 %; or
(b) risk-based annual surveillance to detect infection with BTV carried out taking into account the systems of production and the risk factors identified.
1.The seasonally BTV-free status may only be established in a Member State or zone thereof if:
(a) the beginning and the end of the vector-free period and therefore of the seasonally BTV-free period has been demonstrated based on entomological surveillance in accordance with Section 5 of Chapter 1; and
(b) the cessation of the transmission of BTV has been demonstrated by: (i) the implementation of surveillance in accordance with Section 2 of Chapter 1 at least for the past 12 months including one full vector activity season; and (ii) the absence of new cases of infection with any of the serotypes 1-24 of BTV since the end of the vector activity season.
2.By way of derogation from point 1(a), if the seasonally BTV-free period has been successfully demonstrated for a period of 3 consecutive years, additional criteria such as temperature may replace entomological surveillance to substantiate the beginning and the end of the seasonally BTV-free period on the basis of scientific evidence.
3.The seasonally BTV-free Member State or zone must immediately stop when there is evidence of the end of the vector-free period or of circulation of the virus.
PART III
INFESTATION WITH VARROA SPP.
The status free from infestation with Varroa spp. may only be granted to the relevant honeybee population of a Member State or of a zone if:
(a) a risk assessment has been conducted, identifying all potential factors for Varroa spp. occurrence and its potential presence in the past;
(b) an ongoing awareness programme has been in place for at least one year to encourage reporting of all cases suggestive of Varroa spp.;
(c) there has been no confirmed case of infestation with Varroa spp. either in kept or in wild honeybee colonies;
(d) for at least one year, an annual surveillance has demonstrated the absence of infestations with Varroa spp. on a representative sample of kept honeybees of the Member State or zone thereof that allows at least for the detection, with a 95 % level of confidence, of the infestation with Varroa spp. at a target prevalence rate of 1 % of the apiaries and at a within-apiary target prevalence rate of 5 % of the beehives;
(e) in the presence of a wild self-sustaining population of the species of the genus Apis there has been in place for at least one year an ongoing surveillance programme in the wild population which demonstrates no evidence of infestation with Varroa spp.; and
(f) during the whole duration of the surveillance referred to in point (d) the competent authority makes appropriate arrangements for the survey and further handling of honeybees in any stage of their lifecycle, including honeybee brood, which are moved into that Member State or into that zone to prevent the infestation of its population from introduced honeybees of lesser health status.
The status free from infestation with Varroa spp. granted to the relevant honeybee population of a Member State or of a zone may only be maintained if:
(a) the competent authority maintains a surveillance that: (i) demonstrates the absence of infestations with Varroa spp. annually on a representative sample of kept honeybees of the free area; (ii) enables the early detection of infestation with Varroa spp. in apiaries and beehives; (iii) takes into consideration specifically target areas with higher likelihood of introduction of or infestation with Varroa spp., based on a risk assessment;
(b) all the suspected cases have been investigated and no case of infestation with Varroa spp. has been confirmed, either in kept or in wild honeybee colonies;
(c) either there is no wild self-sustaining population of the species of the genus Apis or there is an ongoing surveillance programme in the wild population which demonstrates no evidence of infestation with Varroa spp.; and
(d) the honeybees in any stage of their lifecycle, including honeybee brood, are only moved into the free area when: (i) they come from a Member State or zone thereof or from a third country or territory with disease-free status regarding infestation with Varroa spp.; and (ii) they are protected from infestation with Varroa spp. during transport.
PART IV
STATUS FREE FROM INFECTION WITH NEWCASTLE DISEASE VIRUS- WITHOUT VACCINATION
The status free from infection with Newcastle disease virus (NDV) status without vaccination in the population of poultry and captive birds of Galliformes species may only be granted to a Member State or to a zone if for at least the past 12 months:
(a) vaccination against infection with NDV in poultry and in captive birds of Galliformes species has been prohibited;
(b) no poultry and no captive birds of Galliformes species vaccinated against infection with NDV has been kept in establishments keeping poultry or captive birds of Galliformes species;
(c) general surveillance requirements have been carried out in accordance with point (a) of Article 3(1) for the early detection of infection with NDV;
(d) one of the following testing regime has applied: (i) all establishments keeping breeding poultry have been tested for the presence of antibodies against infection with NDV with negative results, on blood samples from at least 60 birds randomly chosen from each establishment and tested serologically by Haemagglutination inhibition (HI) test; or (ii) a survey has been conducted on a representative sample of establishments which has at least the capacity at least to detect, with a 95 % level of confidence, the infection at a target prevalence rate of 1 % in the poultry establishments and at a within-establishment prevalence rate of seropositive birds of 10 %; and
(e) no case of infection with NDV has been confirmed in poultry and captive birds of Galliformes species.
1.The status free from infection with NDV without vaccination granted to a Member State or to a zone may only be maintained if the requirements in points (a) to (e) of Section 1 continue to be fulfilled.
2.By way of derogation from paragraph 1, the status free from infection with NDV without vaccination granted to a Member State or to a zone may be maintained in the event of the confirmation of outbreaks of infection with NDV if:
(a) the competent authority has only notified a limited number of primary outbreaks during a calendar year;
(b) the competent authority has concluded that only a limited number of secondary outbreaks epidemiologically linked to each primary outbreak occurred; and
(c) the disease control measures were applied for a duration not longer than three months for each primary outbreak and related secondary outbreaks.
3.The status free from infection with NDV without vaccination granted to a Member State or to a zone is not affected by the confirmation of the infection in another bird population, provided the competent authority has assessed, taking into account the implementation of all necessary measures to prevent transmission of infection with NDV to poultry and captive birds of Galliformes species, that the status was not jeopardised.
PART V
INFESTATION WITH ECHINOCOCCUS MULTILOCULARIS
The surveillance to demonstrate the absence of infestation with Echinococcus multilocularis in the wild definitive host population must:
describe the target wild definitive host Canidae population and include the density, age structure, geographical and gender distribution, taking into account the relative risks of infestation with the Echinococcus multilocularis in different species and subpopulations of the target wild definitive host Canidae population;
consist in the ongoing collection, during each 12-month surveillance period, of samples from wild definitive host Canidae tested negative with one of the methods referred to in Section 7 of Annex III;
be designed to allow, on an appropriate risk-based or representative sample of wild definitive host Canidae, the detection of the Echinococcus multilocularis parasite, if present in any epidemiologically relevant geographical unit in the Member State or zone thereof in the wild definitive host population at a prevalence of not more than 1 % at a confidence level of at least 95 %.
The status free from infestation with Echinococcus multilocularis may only be granted to a Member State or a zone thereof if:
for the past three consecutive 12-month periods, the Member State has implemented an annual surveillance, which has demonstrated that, in accordance with Article 67, the infestation with Echinococcus multilocularis has not been established because of the absence of red foxes, as wild definitive host animals, in its entire territory;
in the presence of wild definitive host Canidae populations and provided that there has been no confirmed case of infestation with Echinococcus multilocularis in those animals, one of the following requirements is fulfilled:
(a) there has been no confirmed case of infestation with Echinococcus multilocularis in wild definitive host Canidae during the past 25 years in accordance with Article 70(1), point (a) and for the past 10 years, the requirements set out in Article 70(2), points (b) and (d) have been met; (b) for the past three consecutive 12-month periods, an annual surveillance programme, which complies with the requirements set out in Section 1, has demonstrated the absence of infestation with Echinococcus multilocularis in wild definitive host Canidae.
The status free from infestation with Echinococcus multilocularis granted to a Member State or a zone thereof may only be maintained if:
for a Member State or zone thereof which has been granted a status free from infestation with Echinococcus multilocularis in accordance with point 1 of Section 2, the competent authority:
(a) maintains an annual surveillance to detect the presence of wild red foxes on its territory; (b) immediately notifies the Commission and the other Member States of the detection of the presence of wild red foxes;
for a Member State or zone thereof which has been granted a status free from infestation with Echinococcus multilocularis in accordance with point 2 of Section 2, the competent authority maintains an annual surveillance that:
(a) demonstrates the absence of infestation with Echinococcus multilocularis in wild definitive host Canidae in accordance with the requirements set out in Section 1; (b) enables the early detection of infestation with Echinococcus multilocularis in wild definitive host Canidae.
ANNEX VI
SPECIFIC REQUIREMENTS AS REGARDS DISEASES OF AQUATIC ANIMALS
PART I
RISK-BASED SURVEILLANCE
1.1.Risk-based health surveillance which includes health visits and possible sampling is applied in certain approved aquaculture establishments and in certain approved groups of aquaculture establishments in a manner that is appropriate to the nature of the production and which has the objective of detecting:
(a) increased mortality;
(b) listed diseases;
(c) emerging diseases.
1.2.The frequency of such visits will depend on the risk the approved aquaculture establishment or approved group of aquaculture establishments poses in relation to contracting and spreading disease. This risk applies to listed diseases and to potential emerging diseases and will therefore include aquaculture establishments and groups of aquaculture establishments keeping listed species and in certain cases, aquaculture establishments and groups of aquaculture establishments keeping non-listed species. The competent authority must determine the risk posed by each approved aquaculture establishment or approved group of aquaculture establishments and rank them as high, medium or low risk.
Chapter 2 provides details of the risk factors to be taken into account during the risk ranking process. Such risk ranking will be repeated and updated if any of the risk factors outlined in points (a) to (l) indicate that the risk posed by the establishment has changed.
1.3.Chapter 3 sets out the minimum frequency of health visits which must be completed, based on whether the competent authority has designated an establishment to be high, medium or low risk.
1.4.Risk-based animal health surveillance in aquaculture establishments and groups of aquaculture establishments may be combined with health visits and sampling which are carried out:
(a) as part of compulsory or optional eradication programmes for one or more listed diseases; or
(b) to demonstrate and maintain disease free status for one or more listed diseases; or
(c) as part of a surveillance programme for one or more category C diseases.
The risk ranking referred to in point 1.2 of Chapter 1 must as a minimum, take into account the risk factors referred to in points (a) and (b). Where relevant, points (c) to (l) will also be considered:
(a) possibility of the direct spread of pathogens via water;
(b) movements of aquaculture animals;
(c) type of production;
(d) species of aquaculture animals kept;
(e) biosecurity system, including staff competence and training;
(f) density of aquaculture establishments and processing establishments in the area around the establishment concerned;
(g) proximity of establishments with a lower health status than the establishment concerned;
(h) disease history of the establishment concerned and of other local establishments;
(i) presence of infected wild aquatic animals in the area around the establishment concerned;
(j) risk posed by human activities in the proximity of the establishment concerned for example angling, the presence of transport routes, ports at which ballast water is exchanged;
(k) access to the establishment concerned by predators which may cause disease spread;
(l) track record of the establishment as regards compliance with the requirements of the competent authority.
The frequency of risk-based health visits which must be carried out in certain approved establishments and approved groups of establishments depends upon the risk ranking referred to in Chapter 2 and shall be carried out as follows:
(a) at least once per year in high risk establishments;
(b) at least once every two years in medium risk establishments;
(c) at least once every three years in low risk establishments.
PART II
DISEASE- SPECIFIC REQUIREMENTS FOR DISEASE-FREE STATUS OF AQUATIC ANIMALS
Part II covers the disease-specific requirements for disease-free status as regards the following listed diseases:
| Viral haemorrhagic septicaemia (VHS) | Chapter 1 |
|---|---|
| Infectious haematopoietic necrosis (IHN) | Chapter 1 |
| Infection with HPR-deleted infectious salmon anaemia virus | Chapter 2 |
| Infection with Marteilia refringens | Chapter 3 |
| Infection with Bonamia exitiosa | Chapter 4 |
| Infection with Bonamia ostreae | Chapter 5 |
| Infection with white spot syndrome virus (WSSV) | Chapter 6 |
Health visits and sampling for the surveillance referred to in Article 3(2)(b)(ii) and (iii) must comply with the following requirements:
(a) health visits and, where appropriate sampling, must be carried out during the period of the year when the water temperature is below 14 °C or when temperatures below 14 °C are not reached, samples must be taken at the lowest annual temperatures;
(b) when targeted surveillance in wild populations is required due to the small number of aquaculture establishments in an eradication programme, the number and geographical distribution of sampling points must be determined to obtain a reasonable coverage of the Member State, zone or compartment. The sampling points must be representative of the different ecosystems where wild populations of susceptible species are located;
(c) when establishments or wild populations are to be subject to health visits or sampled more than once per year, in accordance with Sections 2 to 4, the intervals between the health visits and between the collection of samples must be at least 4 months, or as long as possible, taking into account the temperature requirements provided for in point (a);
(d) all production units, such as ponds, tanks and net cages, must be examined for the presence of dead, weak or abnormally behaving fish. Particular attention must be paid to the water outlet area where weak fish tend to accumulate because of the water current;
(e) fish of listed species to be collected as samples must be selected as follows: (i) if rainbow trout are present, only fish of that species must be selected for sampling, except where other susceptible species are present which show typical signs of VHS or IHN; if rainbow trout are not present, the sample must be representative of all other susceptible species which are present; (ii) if weak, abnormally behaving or freshly dead but not decomposed fish are present, such fish must be selected; if more than one water source is utilised for fish production, fish representing all water sources must be included in the sample; (iii) the fish selected must include fish collected in such a way that all production units, such as net cages, tanks and ponds, of the establishment, as well as all year classes, are proportionally represented in the sample.
The status free from VHS or free from IHN may only be granted to a Member State, a zone or a compartment with an unknown health status with regard to VHS or IHN if:
(a) all establishments and, when required, sampling points in wild populations selected in accordance with point (b) of Section 1, have been subject to one of the following scheme: (i) model A — 2-year scheme The establishments or sampling points must have been subject to health visits and sampled for a minimum period of 2 consecutive years as laid down in Table 1.A. During that 2-year period, the testing of all samples using the diagnostic methods set out in point 2 of section 5 must have produced negative results for VHS or IHN, and any suspicion of VHS or IHN must have been ruled out in accordance with the sampling and diagnostic methods set out in point 3 of Section 5; (ii) model B — 4-year scheme with reduced sample size The establishments or sampling points must have been subject to health visits and sampled for a minimum period of 4 consecutive years as laid down in Table 1.B. During that 4-year period, the testing of all samples using the diagnostic methods set out in point 2 of Section 5 must have produced negative results for VHS or IHN and any suspicion of VHS or IHN must have been ruled out in accordance with the sampling and diagnostic methods set out in point 3 of Section 5;
(b) if VHS or IHN have been detected during the surveillance referred to in point (a); before starting a new 2-year or 4-year scheme, relevant establishments in the Member State, zone or compartment must: (i) be subject to the minimum disease control measures laid down in Articles 58 to 65; (ii) be repopulated with fish from an establishment in a Member State, zone or compartment with status free from VHS or status free from IHN or from an establishment in a Member State, zone or compartment covered by an eradication programme for VHS or IHN.
| Type of establishment | Number of health visits per year to each establishment | Number of samplings per year in each establishment | Number of fish in the sample (1) | |
|---|---|---|---|---|
| Number of growing fish | Number of broodstock fish (2) | |||
| (a) Establishments with broodstock | 2 | 2 | 50 (first visit) 75 (second visit) | 30 (first or second visit) |
| (b) Establishments with broodstock only | 2 | 1 | 0 | 75 (first or second visit) |
| (c) Establishments without broodstock | 2 | 2 | 75 (first AND second visit) | 0 |
| Maximum number of fish per pool: 10 | ||||
| (1) In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater. (2) Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping. | ||||
| Type of establishment | Number of health visits per year to each establishment | Number of samplings per year in each establishment | Number of fish in the sample (1) | |
| --- | --- | --- | --- | --- |
| Number of growing fish | Number of broodstock fish (2) | |||
| First 2 years | ||||
| (a) Establishments with broodstock | 2 | 1 | 30 (second visit) | 0 |
| (b) Establishments with broodstock only | 2 | 1 | 0 | 30 (first or second visit) |
| (c) Establishments without broodstock | 2 | 1 | 30 (first or second visit) | 0 |
| Last 2 years | ||||
| (a) Establishments with broodstock | 2 | 2 | 30 (first visit) | 30 (second visit) |
| (b) Establishments with broodstock only | 2 | 2 | 30 (first AND second visit) | |
| (c) Establishments without broodstock | 2 | 2 | 30 (first AND second visit) | |
| Maximum number of fish per pool: 10 | ||||
| (1) In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater. (2) Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping. |
1.The status free from VHS or free from IHN may only be granted to a Member State, a zone or a compartment known to be infected with VHS or IHN, if all establishments keeping listed species within that Member State, zone or compartment have been subject to an eradication programme that complies with the following requirements:
(a) the minimum control measures laid down in Articles 55 to 65 must have been effectively applied and a restricted zone of an appropriate size as provided for in point (c) of Article 58(1), where appropriate, divided into a protection zone and surveillance zone; must have been established in the vicinity of the establishment(s) declared infected with VHS or IHN, taking into account the requirements set out in point 2;
(b) all establishments keeping listed species within the protection zone, or where a protection zone has not been established, the restricted zone, not infected with VHS or IHN must be subject to an investigation comprising at least the following elements: (i) the collection of samples for testing of 10 fish, when clinical signs or post-mortem lesions consistent with infection with VHS or IHN are observed or minimum 30 fish, when clinical signs or post-mortem lesions are not observed; (ii) in those establishments where the tests referred to in (i) have produced negative results; health visits must continue once per month during the period when the water temperature is below 14 °C, except when fish ponds, tanks, raceways or net cages are covered with ice, until the protection zone is withdrawn in accordance with point (c);
(c) relevant establishments must be emptied in accordance with Article 62, cleaned and disinfected in accordance with Article 63 and fallowed in accordance with Article 64. The duration of the fallowing period referred to in point (a) of Article 64(2) must be at least 6 weeks. When all establishments infected within the same protection zone, or where a protection zone has not been established, the restricted zone, are emptied, at least 3 weeks of synchronised fallowing must be carried out. When fallowing of the infected establishments is carried out, the restricted zone or the protection zone, when it has been established, must be converted into a surveillance zone until the scheme set out in Section 2 is completed;
(d) repopulation may only take place when all infected establishments have been emptied, cleaned, disinfected and fallowed in accordance with point (c);
(e) all establishments other than those referred to in point (f) which keep listed species within the Member State, zone or compartment covered by the eradication programme and when surveillance in wild populations is required, all sampling points selected in accordance with point (b) of Section 1, must subsequently be subject to the scheme laid down in Section 2;
(f) an individual establishment which keeps listed species and which has a health status which is independent of the health status of the surrounding waters is not required to comply with the scheme laid down in Section 2 following a disease outbreak, provided the establishment complies with the requirements set out in paragraph 3 of Article 80 and is repopulated with fish sourced from Member States, zones or compartments with status free from VHS or status free from IHN.
2.The restricted zone must have been defined on a case-by-case basis and:
(a) it must take into account factors influencing the risks for the spread of VHS or IHN to kept and wild fish, such as: (i) the number, rate and distribution of the mortalities of fish on the establishment infected with VHS or IHN, or in other aquaculture establishments; (ii) the distance to and density of neighbouring establishments; (iii) the proximity to slaughterhouses; (iv) contact establishments; (v) species present at the establishments; (vi) the farming practices applied in the infected establishments and the neighbouring establishments; (vii) the hydrodynamic conditions; and (viii) other factors of epidemiological significance identified;
(b) the geographical demarcation in coastal areas must comply with the following minimum requirements: (i) the protection zone must consist of an area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the establishment infected with VHS or IHN, or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; and (ii) the surveillance zone must consist of an area surrounding the protection zone, of overlapping tidal excursion zones; or an area surrounding the protection zone and included in a circle of radius 10km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; or (iii) where separate protection and surveillance zones are not established, the restricted zone must consist of an area comprising both the protection zone and the surveillance zone;
(c) the geographical demarcation in inland areas must comprise the entire water catchment area in which the establishment infected with VHS or IHN is located. The competent authority may limit the extent of the restricted zone to parts of the water catchment area, provided this limitation does not compromise the disease control measures with respect to VHS or IHN.
1.When targeted surveillance is required in order to maintain the status free from VHS or free from IHN of a Member State, a zone or a compartment, in accordance with Article 81, all establishments keeping listed species within the Member State, zone or compartment concerned must be subject to health visits and fish must be sampled in accordance with Table 1.C, taking into account the risk level of the establishment for the contraction of VHS or IHN.
2.When determining the frequency of health visits required to maintain the status free from VHS or the status free from IHN of compartments, where the health status regarding VHS or IHN is dependent on the health status of the aquatic animal populations in surrounding natural waters, the risk for the contraction of VHS or IHN must be regarded as high.
3.Disease-free status must only be maintained as long as all samples tested, using the diagnostic methods set out in point 2 of Section 5, have produced negative results for VHS or IHN and any suspicion of VHS or IHN has been ruled out in accordance with the diagnostic methods set out in point 3 of Section 5.
| Risk level (1) | Number of health visits per year to each establishment | Number of fish in the sample (2), (3) |
|---|---|---|
| High | 1 every year | 30 |
| Medium | 1 every 2 years | 30 |
| Low | 1 every 3 years | 30 |
| Maximum number of fish per pool: 10 | ||
| (1) Risk level assigned to the establishment by the competent authority as set out in Chapter 2 of Part I other than in the case of dependent compartments where all establishments are deemed to be high risk. (2) One sample to be taken during every health visit. (3) In the case of coastal zones or coastal compartments, the samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater. |
1.The organs or tissue material to be sampled and examined must be the spleen, the anterior kidney, and either heart or encephalon. When sampling broodstock, ovarian or seminal fluid may also be examined.
In case of small fry, whole fish may be sampled.
Samples from a maximum of 10 fish may be pooled.
2.The diagnostic method for the granting or the maintenance status free from VHS or status free from IHN in accordance with Sections 2 to 4 must be:
(a) virus isolation in cell culture with subsequent identification of the virus using ELISA, indirect fluorescent antibody test (IFAT), virus neutralisation test or virus genome detection; or
(b) Reverse Transcription quantitative PCR (RT-qPCR) detection.
The detailed procedures to carry out these diagnostic methods must be those approved by the EURL for fish diseases.
3.When a suspicion of VHS or IHN is required to be confirmed or ruled out in accordance with Article 55, the following health visit, sampling and testing procedures must comply with the following requirements:
(a) the suspected establishment must be subject to at least one health visit and one sampling of 10 fish, when clinical signs or post-mortem lesions consistent with infection with VHS or IHN are observed or minimum 30 fish, when clinical signs or post-mortem lesions are not observed. Samples shall be tested using one or more of the diagnostic methods set out in points 2(a) and 2(b) in accordance with the detailed diagnostic methods and procedures approved by the EURL for fish diseases;
(b) the presence of VHS must be considered as confirmed, if one or more of those diagnostic methods are positive for VHSV. The presence of IHN must be considered as confirmed, if one or more of those diagnostic methods are positive for IHNV. The confirmation of the first case of VHS or IHN in Member States, zones or compartments previously not infected must be based on conventional virus isolation in cell culture with subsequent immunochemical or molecular identification or with genome detection including confirmation by sequencing of the amplification (RT-PCR) product;
(c) Suspicion of VHS or IHN may be ruled out, if cell cultivation or RT-qPCR tests reveal no further evidence of the presence of VHSV or IHNV.
Health visits and sampling for the surveillance referred to in Article 3(2)(b)(ii) and (iii) must comply with the following requirements:
(a) when health visits and sampling of establishments must be carried out more than once per year in accordance with Sections 2 to 4, the intervals between the health visits or collection of samples shall be as long as possible;
(b) when targeted surveillance in wild populations is required due to the low number of aquaculture establishments in the eradication programme, the number and geographical distribution of sampling points must be determined to obtain a reasonable coverage of the Member State, zone or compartment;
(c) the sampling points must be representative of the different ecosystems where the wild populations of susceptible species are located;
(d) all production units, such as ponds, tanks and net cages, must be examined for the presence of dead, weak or abnormally behaving fish. Particular attention must be paid to the edge of cages or the water outlet area as relevant, where weak fish tend to accumulate because of the water current;
(e) fish of listed species to be collected as samples must be selected as follows: (i) if Atlantic salmon are present, only fish of that species must be selected for sampling, except where other susceptible species are present which show typical signs of infection with HPR- deleted ISAV. If there are no Atlantic salmon in the establishment, the sample must be representative of all other susceptible species which are present; (ii) if moribund or freshly dead, but not decomposed fish are present, such fish must be selected, in particular fish demonstrating anaemia, haemorrhages or other clinical signs suggesting circulatory disturbances; if more than one water source is utilised for fish production, fish representing all water sources must be included in the sample; (iii) the fish selected must include fish collected in such a way that all production units, such as net cages, tanks and ponds, of the establishment as well as all year classes are proportionally represented in the sample.
The status free from infection with HPR-deleted ISAV may only be granted to a Member State, a zone or a compartment with an unknown health status with regard to infection with HPR-deleted ISAV if all establishments and, when required, selected sampling points in wild populations selected in accordance with (b) of Section 1, have been subject to the following scheme:
(a) the establishments or sampling points have been subject to health visits and sampled for a minimum period of 2 consecutive years as laid down in Table 2.A;
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