Commission Regulation (EC) No 1266/2007 of 26 October 2007 on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue (Text with EEA relevance) (c. 1266)

ANNEX I U.K. Minimum requirements for bluetongue monitoring and surveillance programmes (referred to in Article 4)

1. Minimum requirements for bluetongue monitoring programmes to be implemented by Member States in restricted zones U.K.

Bluetongue monitoring programmes in restricted zones shall be aimed at providing information on the dynamics of bluetongue in a zone already subjected to restrictions.

The geographical unit of reference shall be defined by a grid of around 45 × 45 km (approximately 2 000 km²) unless specific environmental conditions justify a different size. In certain Member States, the region as defined in Article 2 of Directive 64/432/EEC may be used as the geographical unit of reference for monitoring purposes.

Bluetongue monitoring programmes must consist at least of the following elements:

1.1.

Serological monitoring with sentinel animals:

• Serological monitoring with sentinel animals shall consist of an active annual programme of testing sentinel animals aimed at assessing the circulation of bluetongue virus within the restricted zones. Where possible, sentinel animals must be bovine animals. They must be free from antibodies as demonstrated by means of a preliminary seronegative test and must be located in areas of the restricted zone where, following a risk analysis considering entomological and ecological evaluations, the presence of the vector has been confirmed or habitats suitable for the vector’s breeding are present,

• Sentinel animals shall be tested at least every month during the period of activity of the vector involved, if known. In the absence of such information the sentinel animals shall be tested at least monthly throughout the year. However, the testing frequency may be adjusted to the seasonal variations of the epidemiological situation during the year to establish the beginning and the end of the circulation of bluetongue virus within the restricted zones,

• The minimum number of sentinel animals per geographical unit must be representative and sufficient in order to detect a monthly incidence of seroconversion(1) of 2 % with a 95 % confidence in each geographical unit.

1.2.

Entomological monitoring

• Entomological monitoring shall consist of an active programme of vector catching by means of permanently sited traps intended to determine the population dynamics and overwintering features of the Culicoides species in the sampled site in order to determine the seasonally vector-free period in the bluetongue seasonally-free zone in accordance with Annex V,

• Only aspiration traps equipped with ultraviolet light shall be used in accordance with pre-established protocols. The traps must be operated throughout the night and operate at a rate of at least one night per week at least during the period of the year necessary to determine the beginning and the end of the seasonally vector free period. At least one trap must be placed in each geographical unit all over the restricted zone. The frequency of operation of the traps must be adjusted to the seasonal variations of the epidemiological situation during the year to optimise the determination of the population dynamics and overwintering features of the Culicoides and may be amended on the basis of the evidence obtained in the three first years of operation of the traps. An adequate proportion of the midges collected in the insect traps must be sent to a specialised laboratory capable of counting and identifying Culicoides species on a routine basis.

2. Minimum requirements for bluetongue surveillance programmes to be implemented by the Member States outside restricted zones U.K.

Bluetongue surveillance programmes outside restricted zones shall be aimed at the detection of virus circulation in a bluetongue-free Member State or epidemiologically relevant geographical area and must consist at least of the following elements:

2.1.

Passive clinical surveillance:

• shall consist of a formal and ongoing system aimed at detecting and investigating suspicions of bluetongue including an early warning system for reporting suspicious cases. Owners or holders of animals as well as veterinarians must report promptly any suspicion of bluetongue to the competent authority. All suspected cases of bluetongue must be investigated immediately,

• must be specially reinforced during the season of vector activity, and in particular at its beginning,

• must ensure that awareness campaigns are put in place and aimed, in particular, at enabling veterinarians and farmers in identifying clinical signs of bluetongue.

2.2.

Serological surveillance:

• shall consist of an active annual programme of serological testing of susceptible species populations, aimed at detecting evidence of the bluetongue virus transmission through random or targeted serological and/or virological testing proportional to the risk of infection of the Member State or epidemiologically relevant geographical area and performed in the period of the year when seroconversion is more likely to be detected,

• must be designed in such a way that the samples are representative of the bovine population in the Member State or in an epidemiologically relevant geographical area and the sample size has been calculated to detect a prevalence of 0,5 % with 95 % confidence in the bovine population of that Member State or geographical area,

• must ensure that samples sizes are adjusted to the structure of the bovine population to be sampled and for the use of targeted surveillance, focusing the sampling for the surveillance on high-risk populations in which specific commonly known risk factors exist. The design of the targeted surveillance must ensure that seropositive animals from vaccinated or immunised populations referred to in points 5, 6 and 7 of Part A of Annex III do not interfere with the bluetongue surveillance programme.

2.3.

Entomological surveillance:

• shall consist of an active annual programme of vector catching aimed at gathering information on the proven and potential vector species in the Member State or in an epidemiologically relevant geographical area, their distribution and seasonal profiles,

• shall be implemented in all Member States where information on the proven and potential vector species, their distribution and seasonal profiles in the Member State is lacking.

ANNEX II U.K. Information to be transmitted by the Member States to the BT-Net system (referred to in Article 5(2))

The information to be transmitted by the Member States to the BT-Net system shall include at least the following:

1. Bluetongue serological/virological data U.K.

(a)

Administrative division/unit

(b)

Animal species tested

(c)

Type of surveillance system scheme (sentinel system or periodical survey)

(d)

Type of diagnostic tests performed (ELISA, Serum-neutralisation, PCR, virus isolation)

(e)

Month and year

(f)

Number of tested animals(2)

(g)

Number of positive animals

(h)

Serotype serologically or virologically determined (data to be provided in case of positive results to serum-neutralization or virus isolation tests)

2. Bluetongue entomological data U.K.

(a)

Administrative division

(b)

Site unique identity (a unique code for each trapping site)

(c)

Collection date

(d)

Latitude and longitude

(e)

Total number of Culicoides spp. collected

(f)

Number of C. imicola collected, if available

(g)

Number of C. obsoletus Complex collected, if available

(h)

Number of C. obsoletus sensu strictu collected, if available

(i)

Number of C. scoticus collected, if available

(j)

Number of C. Pulicaris Complex collected, if available

(k)

Number of C. Nubeculosus complex collected, if available

(l)

Number of C. dewulfii collected, if available

(m)

Other relevant data

3. Bluetongue vaccination data U.K.

(a)

Administrative division

(b)

Year/semester

(c)

Type of vaccine

(d)

Serotype combination

(e)

Animal species vaccinated

(f)

Total number of herds in the Member State

(g)

Total number of animals in the Member State

(h)

Total number of herds under the vaccination programme

(i)

Total number of animals under the vaccination programme

(j)

Total number of herds vaccinated

(k)

Number of animals vaccinated (where the vaccination type is vaccination of young animals)

(l)

Number of young animals vaccinated (where the vaccination type is mass vaccination)

(m)

Number of adults vaccinated (where the vaccination type is mass vaccination)

(n)

Doses of vaccine administered.

[F1 ANNEX III U.K. Conditions for exemption from the exit ban (referred to in Articles 7(2)(a) and 8(1)(a))

Textual Amendments

F1 Substituted by Commission Regulation (EC) No 289/2008 of 31 March 2008 amending Regulation (EC) No 1266/2007 on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue (Text with EEA relevance).

[F2 A. Animals U.K.

The animals must have been protected against attacks by the vector Culicoides during transportation to the place of destination.

In addition, at least one of the conditions set out in points 1 to 7 must be complied with.

1. The animals were kept until dispatch during the seasonally vector-free period defined in accordance with Annex V, in a bluetongue seasonally-free zone for at least 60 days prior to the date of movement and were subjected to an agent identification test according to the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) (OIE Terrestrial Manual), with negative results, carried out not earlier than seven days before the date of movement. U.K.

However, that agent identification test shall not be necessary for Member States or regions of a Member State where sufficient epidemiological data, obtained following the implementation of a monitoring programme for a period of not less than three years, substantiate the determination of the seasonally vector-free period defined in accordance with Annex V.

The Member States making use of that possibility shall inform the Commission and the other Member States in the framework of the Standing Committee on the Food Chain and Animal Health.

Where animals referred to in this point are intended for intra-Community trade, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC:

‘Animal(s) were kept until dispatch in a bluetongue seasonally-free zone during the seasonally vector-free period that started on … ( insert date ) since birth or for at least 60 days and, if appropriate ( indicate as appropriate ), were then subjected to an agent identification test according to the OIE Terrestrial Manual on samples taken within seven days prior to dispatch, with negative results, in conformity with Annex III.A(1) to Regulation (EC) No 1266/2007.’

2. The animals have been kept, until dispatch, protected against attacks by vectors for a period of at least 60 days prior to the date of dispatch. U.K.

Where animals referred to in this point are intended for intra-Community trade, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC:

‘Animal(s) in conformity with Annex III.A(2) to Regulation (EC) No 1266/2007.’

3. The animals have been kept, until dispatch, in a bluetongue seasonally-free zone during the seasonally vector-free period, defined in accordance with Annex V, or have been protected against attacks by vectors for a period of at least 28 days and were subjected during that period to a serological test according to the OIE Terrestrial Manual to detect antibodies to the bluetongue virus group, with negative results, carried out at least 28 days following the date of the commencement of the period of protection against attacks by vectors or the seasonally vector-free period. U.K.

Where animals referred to in this point are intended for intra-Community trade, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC:

‘Animal(s) in conformity with Annex III.A(3) to Regulation (EC) No 1266/2007.’

4. The animals have been kept until dispatch in a bluetongue seasonally-free zone during the seasonally vector-free period, defined in accordance with Annex V, or have been protected against attacks by vectors for a period of at least 14 days and were subjected during that period to an agent identification test according to the OIE Terrestrial Manual, with negative results, carried out at least 14 days following the date of commencement of the period of protection against attacks by vectors or the seasonally vector-free period. U.K.

Where animals referred to in this point are intended for intra-Community trade, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC:

‘Animal(s) in conformity with Annex III.A(4) to Regulation (EC) No 1266/2007.’

5. The animals originate from a herd vaccinated according to a vaccination programme adopted by the competent authority and the animals have been vaccinated against the serotype(s) present or likely to be present in an epidemiologically relevant geographical area of origin, the animals are still within the immunity period of time guaranteed in the specifications of the vaccine approved in the vaccination programme and the animals meet at least one of the following requirements: U.K.

(a)

they have been vaccinated more than 60 days before the date of movement;

(b)

they have been vaccinated with an inactivated vaccine before at least the number of days necessary for the onset of the immunity protection set in the specifications of the vaccine approved in the vaccination programme and were subjected to an agent identification test according to the OIE Terrestrial Manual, with negative results, carried out at least 14 days after the onset of the immunity protection set in the specifications of the vaccine approved in the vaccination programme;

(c)

they were previously vaccinated and they have been re-vaccinated with an inactivated vaccine within the immunity period of time guaranteed in the specifications of the vaccine approved in the vaccination programme;

(d)

they were kept during the seasonally vector-free period, defined in accordance with Annex V, in a bluetongue seasonally-free zone, since birth or for a period of at least 60 days before the date of vaccination and have been vaccinated with an inactivated vaccine before at least the number of days necessary for the onset of the immunity protection set in the specifications of the vaccine approved in the vaccination programme.

Where animals referred to in this point are intended for intra-Community trade, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC:

‘Animal(s) vaccinated against bluetongue serotype/s … ( insert serotype/s ) with … ( insert name of the vaccine ) with a inactivated/modified live vaccine (indicate, as appropriate) in conformity with Annex III.A(5) to Regulation (EC) No 1266/2007.’

6. The animals have never been vaccinated against bluetongue and were always kept in an epidemiologically relevant geographical area of origin where not more than one serotype was or is present or likely to be present and: U.K.

(a)

they were subjected to two serological tests according to the OIE Terrestrial Manual to detect antibodies against the bluetongue virus serotype, with positive results; the first test must be carried out on samples taken between 60 and 360 days before the date of movement and the second test being carried out on samples taken not earlier than seven days before the date of the movement; or

(b)

they were subjected to a serological test according to the OIE Terrestrial Manual to detect antibodies against the bluetongue virus serotype, with positive results; the test must be carried out at least 30 days before the date of the movement and the animals were subjected to an agent identification test according to the OIE Terrestrial Manual, with negative results, carried out not earlier than seven days before the date of the movement.

Where animals referred to in this point are intended for intra-Community trade, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC:

‘Animal(s) subjected to a serological test according to the OIE Terrestrial Manual to detect antibodies against the bluetongue virus serotype … ( indicate serotype ) in conformity with Annex III.A(6) to Regulation (EC) No 1266/2007.’

7. The animals have never been vaccinated against the bluetongue virus and were subjected with positive results to two adequate serological tests according to the OIE Terrestrial Manual able to detect specific antibodies against all the bluetongue virus serotypes present or likely to be present, in the epidemiologically relevant geographical area of origin, and: U.K.

(a)

the first test must have been carried out on samples that were taken between 60 and 360 days before the date of movement and the second test must have been carried out on samples that were taken not earlier than seven days before the date of movement; or

(b)

the specific serotype serological test must have been carried out at least 30 days before the date of the movement and the animals were subjected to an agent identification test according to the OIE Terrestrial Manual, with negative results, carried out not earlier than seven days before the date of movement.

Where animals referred to in this point are intended for intra-Community trade, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC:

‘Animal(s) subjected to a specific serological test according to the OIE Terrestrial Manual to detect antibodies against all the bluetongue virus serotypes … ( indicate serotypes ) present or likely to be present in conformity with Annex III.A(7) to Regulation (EC) No 1266/2007.’

For pregnant animals, at least one of the conditions set out in points 5, 6 and 7 must be complied with before insemination or mating, or the condition set out in point 3 must be complied with, the test being carried out not earlier than seven days before the date of movement.

Where animals are intended for intra-Community trade, one of the following additional wordings shall be added, as appropriate, to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC:

• ‘ Animal(s) is (are) not pregnant ’ , or

• ‘ Animal(s) may be pregnant and complies (comply) with the condition(s) … ( set out in points 5, 6 and 7 before insemination or mating, or set out in point 3; indicate as appropriate ) ’ .]

Textual Amendments

F2 Substituted by Commission Regulation (EC) No 708/2008 of 24 July 2008 amending Regulation (EC) No 1266/2007 as regards the conditions for exempting certain animals of susceptible species from the exit ban provided for in Council Directive 2000/75/EC (Text with EEA relevance).

B. Semen of animals U.K.

Semen must have been obtained from donor animals which comply with at least one of the following conditions:

(a)

they have been kept outside a restricted zone for a period of at least 60 days before commencement of, and during, collection of the semen;

(b)

they have been protected against attacks by vectors for a period of at least 60 days before commencement of, and during, collection of the semen;

(c)

they were kept during the seasonally vector-free period in a bluetongue seasonally-free zone, defined in accordance with Annex V, for a period of at least 60 days before commencement of, and during, collection of the semen and were subjected to an agent identification test according to the OIE Terrestrial Manual, with negative results, carried out not earlier than seven days before the date of commencement of collection of the semen.

However, that agent identification test shall not be necessary in Member States or regions of a Member State where sufficient epidemiological data, obtained following the implementation of a monitoring programme during a period of not less than three years, substantiate the determination of the seasonally vector-free period, as defined in Annex V.

The Member States making use of that possibility shall inform the Commission and the Member States in the framework of the Standing Committee on the Food Chain and Animal Health;

(d)

they have been subjected to a serological test according to the OIE Terrestrial Manual to detect antibodies to the bluetongue virus group, with negative results, at least every 60 days during the collection period and between 21 and 60 days following the final collection;

(e)

they have been subjected, with negative results, to an agent identification test according to the OIE Terrestrial Manual carried out on blood samples collected:

(i)

at commencement and final collection; and

(ii)

during the period of semen collection:

• at least every seven days, in the case of a virus isolation test,

• at least every 28 days, in the case of a polymerase chain reaction test.

Where the semen referred to in this Section is intended for intra-Community trade or export to a third country, the following additional wording shall be added to the corresponding health certificates laid down in Council Directive 88/407/EEC (3) and Commission Decision 95/388/EC (4) , or referred to in Decision 93/444/EEC:

‘Semen obtained from donor animals which comply with … ( point (a), (b), (c), (d) or (e), indicate as appropriate ) of Annex III.B to Regulation (EC) No 1266/2007’ .

C. Ova and embryos of animals U.K.

1. In vivo derived embryos and ova of bovine animals must have been obtained from donor animals which do not show any clinical signs of bluetongue on the day of collection. U.K.

2. Embryos and ova of animals other than bovine animals and in vitro produced bovine embryos must have been obtained from donor animals which comply with at least one of the following conditions: U.K.

(a)

they have been kept outside a restricted zone for at least 60 days before commencement of, and during, collection of the embryos/ova;

(b)

they have been protected against attacks by vectors for at least 60 days before commencement of, and during, collection of the embryos/ova;

(c)

they have been subjected to a serological test according to the OIE Terrestrial Manual to detect antibodies to the bluetongue virus group, between 21 and 60 days following collection of the embryos/ova, with negative results;

(d)

they have been subjected to an agent identification test according to the OIE Terrestrial Manual on a blood sample taken on the day of collection of the embryos/ova, with negative results.

3. Where the ova and embryos referred to in points 1 and 2 are intended for intra-Community trade or export to a third country, the following additional wording shall be added to the corresponding health certificates laid down in Council Directive 89/556/EEC (5) and Decision 95/388/EC, or referred to in Decision 93/444/EEC: U.K.

‘Embryos/ova obtained from donor animals which comply with … (point 1; point 2(a), point 2(b), point 2(c) or point 2(d), indicate as appropriate) of Annex III.C to Regulation (EC) No 1266/2007’ .

Point 2(a) of Annex B to Directive 89/556/EEC shall not apply to ova and embryos collected from donor animals kept in holdings subject to veterinary prohibition or quarantine measures pertaining to bluetongue.]

ANNEX IV U.K. Criteria for the designation of slaughterhouses for exemption from the exit ban (referred to in the second paragraph of Article 8(4))

For the purpose of the risk assessment for the designation of slaughterhouses for the channelling of movements of animals from a holding located in a restricted zone for immediate slaughter, the competent authority of destination shall use at least the following criteria:

1.

the data available through the monitoring and surveillance programmes, especially as regards the vector’s activity;

2.

the distance from the point of entry in the non-restricted zone to the slaughterhouse;

3.

the entomological data on the route;

4.

the period of the day during which the transport takes place in relation to the hours of activity of the vectors;

5.

the possible use of insecticides and repellents in compliance with Council Directive 96/23/EC(6);

6.

the location of the slaughterhouse as regards livestock holdings;

7.

the biosecurity measures in place at the slaughterhouse.

ANNEX V U.K. Criteria for the definition of the seasonally vector-free period (referred to in Article 9(3))

For the purpose of determining a bluetongue seasonally-free zone, the seasonally vector-free period for a determinate epidemiologically relevant geographical area of a Member State (epidemiologically relevant geographical area) shall be defined by the competent authority using at least the following criteria:

1. General criteria U.K.

(a) A bluetongue monitoring and/or surveillance programme must be in place. U.K.

(b) The specific criteria and thresholds used for the determination of the seasonally vector-free period shall be defined considering the Culicoides species proven or suspected to be the main vectors in the epidemiologically relevant geographical area. U.K.

(c) The criteria used for the determination of the seasonal vector-free period shall be applied considering data from current and previous years (historical data). In addition, the aspects linked to surveillance data standardization shall be taken into consideration. U.K.

2. Specific criteria U.K.

(a) No bluetongue virus circulation within the epidemiologically relevant geographical area, as demonstrated by bluetongue surveillance programmes or other evidence suggesting a halt in bluetongue virus. U.K.

(b) Cessation of vector and likely vector activity, as demonstrated through entomological surveillance as part of the bluetongue monitoring and/or surveillance programmes. U.K.

(c) Captures of Culicoides species proven or suspected to be the vectors of the serotype present in the epidemiologically relevant geographical area below a maximum threshold of vectors collected that shall be defined for the epidemiologically relevant geographical area. 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. U.K.

3. Additional criteria U.K.

(a) Temperature conditions that impact on the behaviour of the vectors activity for the epidemiologically relevant geographical area. The temperature thresholds shall be defined in consideration of the ecological behaviour of Culicoides species proven or suspected to be the vectors of the serotype present in the epidemiologically relevant geographical area. U.K.

(1)

It has been estimated that 20 % is the normal annual rate of seroconversion in an infected zone. However, in the Community, virus circulation mainly takes place in a period of around six months (end of spring/mid autumn). Therefore 2 % is a conservative estimation of the expected monthly rate of seroconversion.

(2)

If pools of sera are used, an estimation of the number of animals corresponding to the pools tested must be reported.

(3)

[F1 OJ L 194, 22.7.1988, p. 10 .]

(4)

[F1 OJ L 234, 3.10.1995, p. 30 .]

(5)

[F1 OJ L 302, 19.10.1989, p. 1 .]

(6)

OJ L 125, 23.5.1996, p. 10. Directive as last amended by Directive 2006/104/EC.

Textual Amendments

F1 Substituted by Commission Regulation (EC) No 289/2008 of 31 March 2008 amending Regulation (EC) No 1266/2007 on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue (Text with EEA relevance).