Commission Delegated Regulation (EU) 2020/689Show full title

ANNEX IV U.K. DISEASE-SPECIFIC REQUIREMENTS FOR THE GRANTING, MAINTENANCE, SUSPENSION AND WITHDRAWAL OF THE DISEASE-FREE STATUS AT THE LEVEL OF ESTABLISHMENTS AND DISEASE-SPECIFIC REQUIREMENTS FOR THE GRANTING AND MAINTENANCE OF THE DISEASE-FREE STATUS AT THE LEVEL OF MEMBER STATES OR ZONES

PART I U.K. INFECTION WITH BRUCELLA ABORTUS, B. MELITENSIS AND B. SUIS

CHAPTER 1 U.K. Establishment free from infection with Brucella abortus, B. melitensis and B. suis without vaccination

Section 1 U.K. Granting of the status

1. The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may only be granted to an establishment keeping bovine, ovine or caprine animals if: U.K.

(a)

during the past 12 months there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in bovine, ovine or caprine animals kept in the establishment;

(b)

during the past 3 years none of the bovine, ovine or caprine animals in the establishment has been vaccinated against infection with Brucella abortus, B. melitensis and B. suis;

(c)

the entire bovine animals over 12 months of age and the entire ovine or caprine animals over 6 months of age present in the establishment at the time of sampling have tested negative to serological test, on two occasions as follows:

(i)

the first test must be carried out on samples taken not earlier than 3 months after the removal of the last confirmed case and of the last animal that tested positive in an immunological test;

(ii)

the second test must be carried out on samples taken not earlier than 6 months and not later than 12 months following the date of sampling referred to in point (i);

(d)

animals showing clinical signs consistent with infection with Brucella abortus, B. melitensis and B. suis, such as abortions, have been subjected to investigations with negative results;

(e)

since the beginning of the sampling referred to in point (c)(i) all bovine, ovine or caprine animals introduced into the establishment originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination and have not been vaccinated against infection with Brucella abortus, B. melitensis and B. suis during the past 3 years, and

(i)

originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;

(ii)

are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and must have tested negative in a serological test carried out on a sample taken:

• during the 30 days prior to their introduction into the establishment; or

• during the 30 days following their introduction provided they have been kept isolated during this period; or

(iii)

are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition; and

(f)

since the beginning of the sampling referred to in point (c)(i), all germinal products of bovine, ovine or caprine origin introduced into or used in the establishment originate from:

(i)

establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; or

(ii)

approved germinal product establishments.

2. By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may be granted to an establishment if all bovine, ovine or caprine animals originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination and have not been vaccinated during the past 3 years, and: U.K.

(a)

originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;

(b)

are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and have tested negative in a serological test carried out on a sample taken:

• during the 30 days prior to their introduction into the establishment; or

• during the 30 days following their introduction into the establishment provided they have been kept isolated during this period; or

(c)

are post-parturient females kept in isolation since their introduction into the establishment until they tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition.

3. By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may be granted to an establishment with the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination if: U.K.

(a)

the requirements set out in points (a), (b), (d), (e) and (f) of point 1 are fulfilled; and

(b)

the requirement set out in point (b)(i) of Section 2 is fulfilled.

Section 2 U.K. Maintenance of the status

The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals may only be maintained if:

(a)

the requirements set out in points (a), (b), (d), (e) and (f) of point 1 of Section 1 continue to be fulfilled; and

(b)

serological testing is carried out with negative results on samples taken from:

(i)

all entire bovine animals over 12 months of age and all entire ovine or caprine animals over 6 months of age at appropriate intervals of not more than 12 months determined by the competent authority, taking into account the type of production, the situation of the disease and the identified risk factors; or

(ii)

entire bovine animals over 12 months of age and entire ovine or caprine animals over 6 months of age kept in establishments located in a Member State or in a zone free from infection with Brucella abortus, B. melitensis and B. suis, in accordance with a testing regime set up by the competent authority, taking into account the type of production and the identified risk factors.

Section 3 U.K. Suspension and restoring of the status

1. The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals must be suspended if: U.K.

(a)

one or more of the requirements set out in Section 2 are not fulfilled; or

(b)

a case of infection with Brucella abortus, B. melitensis and B. suis is suspected in a bovine, ovine or caprine animal kept in the establishment.

2. The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may only be restored if: U.K.

(a)

the requirements set out in points (b), (d), (e) and (f) of point 1 of Section 1 and in point (b) of Section 2 are fulfilled;

(b)

the results of further investigations substantiate absence of infection with Brucella abortus, B. melitensis and B. suis and the status of all suspected cases has been determined.

Section 4 U.K. Withdrawal and regaining of the status

1. The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination of an establishment keeping bovine, ovine or caprine animals must be withdrawn if: U.K.

(a)

one or more of the requirements set out 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)

the infection with Brucella abortus, B. melitensis and B. suis cannot be ruled out in accordance with point 2(b) of Section 3;

(c)

a case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in a bovine, ovine or caprine animal kept in the establishment; or

(d)

it is justified by other needs to control infection with Brucella abortus, B. melitensis, B. suis.

2. If the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled. U.K.

3. If the status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if all confirmed cases and all animals that have tested non-negative have been removed and the remaining bovine, ovine or caprine animals fulfil the requirements set out in point 1(c) of Section 1. U.K.

4. By way of derogation from point 3, where the infection with B. suis biovar 2 was confirmed in a single bovine, ovine or caprine animal kept in the establishment, the status may be regained after negative testing was obtained on samples taken in accordance with the requirements set out in point 1(c)(i) of Section 1. U.K.

CHAPTER 2 U.K. Establishment free from infection with Brucella abortus, B. melitensis and B. suis with vaccination

Section 1 U.K. Granting of the status

1. The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may only be granted to an establishment keeping bovine, ovine or caprine animals if: U.K.

(a)

the requirements set out in points (a), (c) and (d) of point 1 of Section 1 of Chapter 1 are fulfilled;

(b)

since the beginning of the sampling referred to in point (c)(i) of point 1 of Section 1 of Chapter 1, all bovine, ovine, or caprine animals introduced into the establishment originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination or free from infection with Brucella abortus, B. melitensis and B. suis with vaccination and:

(i)

originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;

(ii)

are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and have tested negative in a serological test on a sample taken

• during the 30 days prior to their introduction into the establishment; or

• during the 30 days following their introduction into the establishment provided they have been kept isolated during this period; or

(iii)

are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition; and

(c)

since the beginning of the sampling referred to in point (c)(i) of point 1 of Section 1 of Chapter 1, all germinal products of bovine, ovine or caprine origin introduced into or used in the establishment originate from:

(i)

establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination or free from infection with Brucella abortus, B. melitensis and B. suis with vaccination; or

(ii)

approved germinal product establishments.

2. By way of derogation from point 1, the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may be granted to an establishment if all bovine, ovine or caprine animals originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination, and: U.K.

(a)

originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;

(b)

are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and have tested negative in a serological test carried out on a sample taken:

(i)

during the 30 days prior to their introduction into the establishment; or

(ii)

during the 30 days following their introduction into the establishment provided they have been kept isolated during this period; or

(c)

are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition.

Section 2 U.K. Maintenance of the status

The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals may only be maintained if:

(a)

the requirements set out in points (b) and (c) of point 1 of Section 1 of this Chapter and in points (a) and (d) of point 1 of Section 1 of Chapter 1 continue to be fulfilled; and

(b)

serological testing is carried out with negative results on samples taken from all entire bovine animals over 12 months of age and all entire ovine or caprine animals over 6 months of age at appropriate intervals of not more than 12 months determined by the competent authority taking into account the type of production, the situation of the disease and the identified risk factors.

Section 3 U.K. Suspension and restoring of the status

1. The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals must be suspended if: U.K.

(a)

one or more of the requirements set out in Section 2 are not fulfilled; or

(b)

a case of infection with Brucella abortus, B. melitensis and B. suis is suspected in a bovine, ovine or caprine animal kept in the establishment.

2. The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination may only be restored if: U.K.

(a)

the requirements set out in point 1(d) of Section 1 of Chapter 1 and points (b) and (c) of point 1 of Section 1 and point (b) of Section 2 are fulfilled;

(b)

the results of further investigations substantiate absence of infection with Brucella abortus, B. melitensis and B. suis and the status of all suspected cases has been determined.

Section 4 U.K. Withdrawal and regaining of the status

1. The status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination of an establishment keeping bovine, ovine or caprine animals must be withdrawn if: U.K.

(a)

one or more of the requirements set out 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)

the infection with Brucella abortus, B. melitensis and B. suis cannot be ruled out in accordance with point 2(b) of Section 3;

(c)

a case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in a bovine, ovine or caprine animal kept in the establishment; or

(d)

it is justified by other needs to control infection with Brucella abortus, B. melitensis, B. suis.

2. If the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled. U.K.

3. If the status free from infection with Brucella abortus, B. melitensis and B. suis with vaccination has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if all confirmed cases and all animals that have tested non-negative have been removed and the remaining bovine, ovine or caprine animals fulfil the requirements set out in point 1(c) of Section 1 of Chapter 1. U.K.

4. By way of derogation from point 3, where the infection with Brucella suis biovar 2 was confirmed in a single bovine, ovine or caprine animal kept in the establishment, the status may be regained after negative testing was obtained on samples taken in accordance with the requirements set out in point 1(c)(i) of Section 1 of Chapter 1. U.K.

CHAPTER 3 U.K. Member State or zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals

Section 1 U.K. Granting of the status as regards kept bovine animals

The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals may only be granted to a Member State or a zone if:

(a)

for at least the past 3 years there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals;

(b)

general surveillance requirements have been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the early detection of infection with Brucella abortus, B. melitensis and B. suis in kept bovine animals, which included at least:

(i)

the regular submission of samples from abortion cases for laboratory testing;

(ii)

the timely investigation of abortion cases that may have been caused by infection with Brucella abortus, B. melitensis and B. suis;

(c)

during the past 3 years, at least 99,8 % of the establishments keeping bovine animals, representing at least 99,9 % of the bovine population, have maintained their status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination;

(d)

vaccination of bovine animals against Brucella abortus, B. melitensis and B. suis has not taken place at least for the past 3 years and no bovine animal introduced into the Member State or zone has been vaccinated during the past 3 years prior to its introduction.

Section 2 U.K. Maintenance of the status as regards kept bovine animals

1. The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals of a Member State or a zone may only be maintained if: U.K.

(a)

the requirements set out in points (a), (b) and (d) of Section 1 continue to be fulfilled; and

(b)

for the first 2 consecutive years following granting of the status, annual surveillance based on a representative sample of all establishments keeping bovine animals has been carried out that must allow at least for the detection, with a 95 % level of confidence, of infection with Brucella abortus, B. melitensis and B. suis, at a target prevalence rate of 0,2 % of the establishments keeping bovine animals or a target prevalence rate of 0,1 % of the bovine population;

(c)

if no case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in kept bovine animals for 2 consecutive years following granting of the status, surveillance must be based on:

(i)

random annual surveillance that must allow at least for the detection, with a 95 % level of confidence, of infection with Brucella abortus, B. melitensis and B. suis, at a target prevalence rate of 0,2 % of the establishments keeping bovine animals or a target prevalence rate of 0,1 % of the bovine population; or

(ii)

risk-based annual surveillance to detect infection with Brucella abortus, B. melitensis and B. suis taking into account the systems of production and the risk factors identified, including spread of infection from other animals than kept bovine animals.

2. The status of a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals is not affected by the confirmation of infection of Brucella abortus, B. melitensis and B. suis in an animal population other than kept bovine animals provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis to kept bovine animals. U.K.

3. By way of derogation from point 1(a), the status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept bovine animals of a Member State or a zone may be maintained in the event of the confirmation of a case of infection with Brucella abortus, B. melitensis and B. suis if: U.K.

(a)

the establishment in which the infection with Brucella abortus, B. melitensis and B. suis was detected in kept bovine animals has been immediately subjected to the relevant disease control measures laid down in Article 24;

(b)

within 60 days after the first confirmation of the infection, the competent authority has conducted an epidemiological enquiry and investigations, as laid down in Article 25, to identify the likely source and the distribution of the infection and established conclusions on the likely source of infection and only a limited number of establishments were infected and those establishments are epidemiologically linked to the first detected outbreak;

(c)

the relevant disease control measures laid down in Article 21 or Article 24 have been immediately implemented in each establishment identified with suspected or confirmed cases following implementation of the measures provided for in point (b) until their disease-free status is restored or regained;

(d)

the surveillance referred to in point 1 has been adapted and has demonstrated that the incident has been resolved.

CHAPTER 4 U.K. Member State or zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals

Section 1 U.K. Granting of the status as regards kept ovine and caprine animals

The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals may only be granted to a Member State or a zone if:

(a)

for at least the past 3 years there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals;

(b)

general surveillance requirements have been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the early detection of infection with Brucella abortus, B. melitensis and B. suis in kept ovine and caprine animals, which included at least:

(i)

the regular submission of samples from abortion cases for laboratory testing;

(ii)

the timely investigation of abortion cases that may have been caused by infection with Brucella abortus, B. melitensis and B. suis;

(c)

during the past 3 years, surveillance has been carried out on the ovine and caprine population and at least 99,8 % of the establishments keeping ovine or caprine animals, representing at least 99,9 % of the ovine and caprine population, have maintained their status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; and

(d)

vaccination of ovine and caprine animals against Brucella abortus, B. melitensis and B. suis has not taken place for at least the past 3 years and no ovine or caprine animal introduced into the Member State or zone has been vaccinated during the past 3 years prior to introduction.

Section 2 U.K. Maintenance of the status as regards kept ovine and caprine animals

1. The status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals of a Member State or a zone may only be maintained if: U.K.

(a)

the requirements defined in points (a), (b) and (d) of Section 1 continue to be fulfilled; and

(b)

for the first 2 consecutive years following granting of the status, annual surveillance based on a representative sample of all establishments where ovine or caprine animals are kept shall be carried out that must allow at least for the detection, with a 95 % level of confidence, of infection with Brucella abortus, B. melitensis and B. suis at a target prevalence rate of 0,2 % of the establishments keeping ovine or caprine animals or a target prevalence rate of 0,1 % of the ovine and caprine population;

(c)

if no case of infection with Brucella abortus, B. melitensis and B. suis has been confirmed in kept ovine and caprine animals for 2 consecutive years following granting of the status, surveillance must be based on:

(i)

random annual surveillance that must allow at least for the detection, with a 95 % level of confidence, of infection with Brucella abortus, B. melitensis and B. suis at a target prevalence rate of 0,2 % of the establishments keeping ovine or caprine animals or a target prevalence rate of 0,1 % of the ovine and caprine population; or

(ii)

risk-based annual surveillance to detect infection with Brucella abortus, B. melitensis and B. suis, which takes into account the systems of production and the risk factors identified, including spread of infection from other animals than kept ovine and caprine animals.

2. The status of a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals is not affected by the confirmation of infection of Brucella abortus, B. melitensis and B. suis in an animal population other than kept ovine and caprine animals provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with Brucella abortus, B. melitensis and B. suis to kept ovine and caprine animals. U.K.

3. By way of derogation from point 1(a), the status free from infection with Brucella abortus, B. melitensis and B. suis as regards kept ovine and caprine animals of a Member State or a zone may be maintained in the event of the confirmation of a case of infection with Brucella abortus, B. melitensis and B. suis if: U.K.

(a)

the establishment in which the infection with Brucella abortus, B. melitensis and B. suis was detected in kept ovine and caprine animals has been immediately subjected to the relevant disease control measures laid down in Article 24;

(b)

within 60 days after the first confirmation of the infection, the competent authority has conducted an epidemiological enquiry and investigations, as laid down in Article 25, to identify the likely source and the distribution of the infection and established conclusions on the likely source of infection and only a limited number of establishments were infected and those establishments are epidemiologically linked to the first detected outbreak;

(c)

the relevant disease control measures laid down in Article 21 or Article 24 have been immediately implemented in each establishment identified with suspected or confirmed cases following implementation of the measures provided for in point (b) until their disease-free status is restored or regained; and

(d)

the surveillance referred to in point 1 has been adapted and has demonstrated that the incident has been resolved.

PART II U.K. INFECTION WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX

CHAPTER 1 U.K. Establishment free from infection with Mycobacterium tuberculosis complex

Section 1 U.K. Granting of the status

1. The status free from infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, Mycobacterium tuberculosis, Mycobacterium caprae) (MTBC) may only be granted to an establishment keeping bovine animals if: U.K.

(a)

during the past 12 months there has been no confirmed case of infection with MTBC in bovine animals kept in the establishment;

(b)

the bovine animals over 6 weeks of age present in the establishment at the time of testing or sampling have tested negative to immunological test on two occasions as follows:

(i)

the first test must be carried out on bovine animals or samples taken from bovine animals not earlier than 6 months after the removal of the last confirmed case and of the last animal that tested positive in an immunological test;

(ii)

the second test must be carried out on bovine animals or on samples taken from bovine animals not earlier than 6 months and not later than 12 months following the date of testing of the bovine animal or taking of the samples referred to in point (i);

(c)

since the beginning of the testing or sampling referred to in point (b)(i), all bovine animals introduced into the establishment originate from establishments free from infection with MTBC and:

(i)

originate from a Member State or a zone free from infection with MTBC;

(ii)

are bovine animals over 6 weeks of age and have tested negative in an immunological test:

• during the 30 days prior to their introduction into the establishment; or

• during the 30 days after their introduction provided they have been kept isolated during this period; and

(d)

since the beginning of the testing or sampling referred to in point (b)(i), all germinal products of bovine origin introduced into or used in the establishment originate from:

(i)

establishments free from infection with MTBC; or

(ii)

approved germinal product establishments.

2. By way of derogation from point 1, the status free from infection with MTBC may be granted to an establishment if all bovine animals originate from establishments free from infection with MTBC and: U.K.

(a)

originate from a Member State or a zone free from infection with MTBC;

(b)

if they are bovine animals over 6 weeks of age, they have tested negative to an immunological test:

(i)

during the 30 days prior to their introduction into the establishment; or

(ii)

during the 30 days after their introduction provided they have been kept in isolation during this period.

3. By way of derogation from points 1(c) and 2(b), the competent authority may not require the test if: U.K.

(a)

the bovine animals introduced into the establishment:

(i)

have tested negative in an immunological test carried out during the past 6 months; and

(ii)

originate from establishments where the bovine animals have tested negative to a testing regime as provided for in points 1(c) or 2 of Section 2 carried out during the past 6 months; or

(b)

the bovine animals introduced into the establishment:

(i)

have tested negative in an immunological test carried out during the past 12 months; and

(ii)

originate from establishments where the bovine animals have tested negative to a testing regime as provided for in point 2(b) or 2 (c) of Section 2 carried out during the past 12 months.

Section 2 U.K. Maintenance of the status

1. The status free from infection with MTBC of an establishment keeping bovine animals may only be maintained if: U.K.

(a)

the requirements set out in points (a), (c) and (d) of point 1 of Section 1 continue to be fulfilled;

(b)

any suspected case of infection with MTBC in a bovine animal kept on that establishment or introduced from that establishment into a slaughterhouse is notified to the competent authority and investigated; and

(c)

an immunological test has been carried out, with negative results, on all bovine animals over 6 weeks of age, at intervals of not more than 12 months.

2. By way of derogation from point 1(c), the competent authority may modify the testing regime as follows: U.K.

(a)

in a Member State or in a zone where the annual percentage, calculated on 31 December of each year, of establishments infected with MTBC is not more than 1 % during the last 24 months, the interval between tests may be extended to 24 months;

(b)

in a Member State or in a zone where the annual percentage, calculated on 31 December of each year, of establishments infected with MTBC is not more than 0,2 % for the last 48 months, the interval between tests may be extended to 36 months;

(c)

in a Member State or in a zone where the annual percentage, calculated on 31 December of each year, of establishments infected with MTBC is not more than 0,1 % for the last 72 months, the interval between tests may be extended to 48 months;

(d)

in a Member State or a zone free from infection with MTBC, if the risk of transmission of MTBC from wild animals to bovine animals has been assessed by appropriate surveillance, the interval between tests may be based on the type of production and the risk factors identified, taking into account at least the following risks:

(i)

a location associated with suspected or confirmed infection with MTBC in wild animals;

(ii)

a history of infection with MTBC within the last 5 years;

(iii)

an epidemiological link with establishments in any of points (i) or (ii).

Section 3 U.K. Suspension and restoring of the status

1. The status free from infection with MTBC of an establishment keeping bovine animals must be suspended if: U.K.

(a)

one or more of the requirements laid down in Section 2 are not fulfilled; or

(b)

a case of infection with MTBC is suspected in a bovine animal kept in the establishment.

2. The status free from infection with MTBC may only be restored, if: U.K.

(a)

the requirements laid down in points 1(c) and 1(d) of point 1 of Section 1, 1(b), of Section 2 and, as relevant, in point 1(c) or in point 2 of Section 2 are fulfilled;

(b)

the results of further investigations substantiate absence of infection with MTBC and the status of all suspected cases has been determined. In case, suspected bovine animals are slaughtered in that context, investigations must include examination of samples with direct diagnostic methods.

Section 4 U.K. Withdrawal and regaining of the status

1. The status free from infection with MTBC of an establishment keeping bovine animals must be withdrawn if: U.K.

(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)

the infection with MTBC cannot be ruled out in accordance with point 2(b) of Section 3;

(c)

a case of infection with MTBC has been confirmed in a bovine animal kept in the establishment; or

(d)

it is justified by other needs to control infection with MTBC.

2. If the status free from infection with MTBC has been withdrawn in accordance with point 1(a), it may only be regained if the requirements laid down in Section 2 are fulfilled. U.K.

3. If the status free from infection with MTBC has been withdrawn in accordance with point 1(b), 1(c) or 1(d), it may only be regained if: U.K.

(a)

all confirmed cases and all animals that have tested non negative in a immunological test have been removed; and

(b)

the remaining bovine animals fulfil the requirements set out in point 1(b) of Section 1.

4. By way of derogation from point 3(b), the status may be regained if: U.K.

(a)

all bovine animals over 6 weeks of age present in the establishment at the time of testing have tested negative in two immunological tests as follows:

(i)

the first test must be carried out on bovine animals or samples taken from bovine animals not earlier than 2 months after the removal of the last confirmed case and of the last animal that tested positive in an immunological test;

(ii)

the second test must be carried out on bovine animals or on samples taken from bovine animals not earlier than 2 months and not later than 12 months following the date of testing or sampling of the bovine animal as referred to in point (i); and

(b)

at least one of the following conditions apply:

(i)

the conclusion of the epidemiological enquiry indicates that the infection is due to the introduction of one or more infected animals into the establishment during the past 12 months prior to the detection of the infection with MTBC; or

(ii)

only a single case was confirmed or only a single bovine animal tested positive in an immunological test for MTBC since the detection of the infection with MTBC, and the status of the establishment has not been withdrawn during the past 3 years; or

(iii)

bovine animals in the establishment have tested negative in an immunological test carried out less than 12 months prior to the detection of the infection with MTBC in accordance with point 1(c) or 2 of Section 2.

CHAPTER 2 U.K. Member State or zone free from infection with MTBC

Section 1 U.K. Granting of the status as regards kept bovine animals

The status free from infection with MTBC as regards kept bovine animals may only be granted to a Member State or a zone if:

(a)

during the past 3 years at least 99,8 % of the establishments keeping bovine animals, representing at least 99,9 % of the bovine population, have maintained their status free from infection with MTBC and the incidence rate of establishments confirmed infected during the year did not exceed 0,1 %; and

(b)

general surveillance requirements have been carried out for the past 3 years in accordance with point (a) of Article 3(1) for the detection of infection with MTBC in kept bovine animals and included at least:

(i)

the systematic research of lesions of infection with MTBC in all bovine animals slaughtered through ante- and post-mortem surveillance;

(ii)

the investigations of lesions that could be due to infection with MTBC.

Section 2 U.K. Maintenance of the status

1. The status free from infection with MTBC as regards kept bovine animals of a Member State or a zone may only be maintained if: U.K.

(a)

the requirements in point (b) of Section 1 continue to be fulfilled; and

(b)

for the first 2 consecutive years following granting of the status random annual surveillance based on a representative sampling of all establishments where bovine animals are kept must be carried out to demonstrate with a 95 % level of confidence, that:

(i)

at least 99,8 % of the establishments, representing at least 99,9 % of the bovine population are free from infection with MTBC;

(ii)

the incidence rate of establishment confirmed infected during the year does not exceed 0,1 %;

(c)

if the conditions in point (b) were fulfilled for 2 consecutive years, surveillance is based on:

(i)

random annual surveillance to demonstrate at least with a confidence level of 95 %, that the incidence rate of establishments confirmed infected during the year does not exceed 0,1 %; or

(ii)

risk-based annual surveillance carried out to detect infection with MTBC, taking into account the systems of production, the risk factors identified, including the spread of infection from other animals than kept bovine animals and increased surveillance in establishments associated with at least one of the specific risks referred to in point 2(d) of Section 2 of Chapter 1.

2. The status of a Member State or a zone free from infection with MTBC is not affected by the confirmation of infection with MTBC in the animal population other than kept bovine animals, provided that effective measures have been implemented, and are periodically assessed, to prevent transmission of infection with MTBC to kept bovine animals. U.K.

PART III U.K. ENZOOTIC BOVINE LEUKOSIS

CHAPTER 1 U.K. Establishment free from enzootic bovine leukosis

Section 1 U.K. Granting of the status

1. The status free from enzootic bovine leukosis (EBL) may only be granted to an establishment keeping bovine animals if: U.K.

(a)

during the past 24 months there has been no confirmed case of EBL in bovine animals kept in the establishment;

(b)

during the past 12 months, bovine animals older than 24 months of age kept in the establishment have tested negative to a serological test, on at least two occasions at an interval of not less than 4 months;

(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. U.K.

Section 2 U.K. Maintenance of the status

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.

Section 3 U.K. Suspension and restoring of the status

1. The status free from EBL of an establishment keeping bovine animals must be suspended if: U.K.

(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: U.K.

(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.

Section 4 U.K. Withdrawal and regaining of the status

1. The status free from EBL of an establishment keeping bovine animals must be withdrawn if: U.K.

(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. U.K.

3. If the status free from EBL has been withdrawn in accordance with point 1(b), it may only be regained if: U.K.

(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: U.K.

(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).

CHAPTER 2 U.K. Member State or zone free from EBL

Section 1 U.K. Granting of the status

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.

Section 2 U.K. Maintenance of the status

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 U.K. INFECTIOUS BOVINE RHINOTRACHEITIS/INFECTIOUS PUSTULAR VULVOVAGINITIS

CHAPTER 1 U.K. Establishment free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis

Section 1 U.K. Granting of the status

1. The status free from infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) may only be granted to an establishment keeping bovine animals if: U.K.

(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. U.K.

Section 2 U.K. Maintenance of the status

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.

Section 3 U.K. Suspension and restoring of the status

1. The status free from IBR/IPV of an establishment keeping bovine animals must be suspended if: U.K.

(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: U.K.

(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.

Section 4 U.K. Withdrawal and regaining of the status

1. The status free from IBR/IPV of an establishment keeping bovine animals must be withdrawn if: U.K.

(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. U.K.

3. If the status free from IBR/IPV has been withdrawn in accordance with point 1(b), it may only be regained if: U.K.

(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.

CHAPTER 2 U.K. Member State or zone free from IBR/IPV

Section 1 U.K. Granting of the status

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.

Section 2 U.K. Maintenance of the status

1. The status free from IBR/IPV as regards kept bovine animals of a Member State or a zone may only be maintained if: U.K.

(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: U.K.

(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. U.K.

PART V U.K. INFECTION WITH AUJESZKY’S DISEASE VIRUS

CHAPTER 1 U.K. Establishment free from infection with Aujeszky’s disease virus

Section 1 U.K. Granting of the status

1. The status free from infection with Aujeszky’s disease virus (ADV) may only be granted to an establishment keeping porcine animals if: U.K.

(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. U.K.

Section 2 U.K. Maintenance of the status

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.

Section 3 U.K. Suspension and restoring of the status

1. The status free from infection with ADV of an establishment keeping porcine animals must be suspended if: U.K.

(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: U.K.

(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.

Section 4 U.K. Withdrawal and regaining of the status

1. The status free from infection with ADV of an establishment keeping porcine animals must be withdrawn if: U.K.

(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. U.K.

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. U.K.

CHAPTER 2 U.K. Member State or zone free from infection with Aujeszky’s disease virus

Section 1 U.K. Granting of the status

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.

Section 2 U.K. Maintenance of the status

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: U.K.

(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: U.K.

(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: U.K.

(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. U.K.

PART VI U.K. BOVINE VIRAL DIARRHOEA

CHAPTER 1 U.K. Establishment free from bovine viral diarrhoea

Section 1 U.K. Granting of the status

1. The status free from bovine viral diarrhoea (BVD) may only be granted to an establishment keeping bovine animals if: U.K.

(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: U.K.

(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.

Section 2 U.K. Maintenance of the status

1. The status free from BVD of an establishment keeping bovine animals may only be maintained if: U.K.

(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: U.K.

(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.

Section 3 U.K. Suspension and restoring of the status

1. The status free from BVD of an establishment keeping bovine animals must be suspended if: U.K.

(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: U.K.

(a)

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.

(b)

the results of further investigations substantiate absence of BVD and the status of all suspected cases has been determined.

Section 4 U.K. Withdrawal and regaining of the status

1. The status free from BVD of an establishment keeping bovine animals must be withdrawn if: U.K.

(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 points (c) and (e) of point 1 of Section 1 and points (b), (c) and (d) of point 1 and, if relevant, point 2 of Section 2 are fulfilled. U.K.

3. If the status free from BVD has been withdrawn in accordance with point 1(b), it may only be regained if: U.K.

(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.

CHAPTER 2 U.K. Member State or zone free from bovine viral diarrhoea

Section 1 U.K. Granting of the status

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.

Section 2 U.K. Maintenance of the status

1. The status free from BVD as regards kept bovine animals of a Member State or a zone may only be maintained if: U.K.

(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: U.K.

(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. U.K.