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Commission 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)
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during the past 18 months there has been no confirmed case of BVD in a bovine animal kept in the establishment;
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:
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;
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;
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);
since the beginning of the sampling referred to in point 1(b), all bovine animals introduced into the establishment:
originate from establishments free from BVD located in a Member State or zone free from BVD; or
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
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;
since the beginning of the sampling referred to in point 1(b) all germinal products of bovine animals introduced into the establishment originate from:
establishments free from BVD; or
approved germinal product establishments.
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
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.
the requirements laid down in point (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled;
no bovine animal has been vaccinated against BVD since the status free from BVD was granted to the establishment;
at least one of the following testing regimes is carried out with negative results:
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;
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;
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);
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;
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.
the requirements laid down in point 2(b) of Section 1 continue to be fulfilled;
they are not used for breeding;
they have no contact with animals that are intended or used for breeding and are moved from this establishment to a slaughterhouse,
directly, or;
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.
one or more of the requirements laid down in Section 2 are not fulfilled;
a case of BVD is suspected in a bovine animal kept in the establishment.
the requirements laid down in points (c) and (e) of point 1 of Section 1 and points (b), (c), (d) of point 1 and, if relevant, point 2 of Section 2 are fulfilled.
the results of further investigations substantiate absence of BVD and the status of all suspected cases has been determined.
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;
a case of BVD has been confirmed in a bovine animal kept in the establishment.
all animals tested positive for BVDV have been removed;
the status in relation to infection with BVDV of each bovine animal kept in the establishment has been determined;
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:
vaccination against BVD has been prohibited for kept bovine animals;
no case of BVD has been confirmed in a kept bovine animal for at least the previous 18 months; and
at least 99,8 % of the establishments representing at least 99,9 % of the bovine population are free from BVD.
the requirements laid down in point (a) and (c) of Section 1 continue to be fulfilled; and
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.
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;
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.
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