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)

[F1 ANNEX I U.K. Minimum requirements for bluetongue monitoring and surveillance programmes (referred to in Article 4)

Textual Amendments

F1 Substituted by Commission Implementing Regulation (EU) No 456/2012 of 30 May 2012 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).

1. General requirements U.K.

Bluetongue monitoring and surveillance programmes shall be aimed at;

(a)

detecting any possible incursions of the bluetongue virus and;

(b)

where appropriate, demonstrating the absence of certain serotypes of that virus in a Member State or epidemiologically relevant geographical area; or

(c)

determining the seasonally vector free period (entomological surveillance).

The geographical unit of reference for the purposes of bluetongue monitoring and surveillance shall be defined by a grid of around 45 x 45 km (approximately 2 000 km ² ) unless specific environmental conditions justify a different size.

If appropriate, Member States may also use the ‘region’ as defined in Article 2.2(p) of Directive 64/432/EEC or the regions as defined in Annex X to Commission Decision 2005/176/EC of 1 March 2005 laying down the codified form and the codes for the notification of animal diseases pursuant to Council Directive 82/894/EEC (1) as the geographical unit of reference for monitoring and surveillance purposes.

2. Bluetongue monitoring and surveillance programmes aimed at detecting any possible incursions of the bluetongue virus U.K.

Bluetongue monitoring and surveillance programmes aimed at detecting any possible incursions of the bluetongue virus shall consist of at least passive clinical surveillance and active laboratory-based surveillance.

2.1.

Passive clinical surveillance shall consist of a formal and properly documented ongoing system aimed at detecting and investigating any suspicions, including an early warning system for reporting suspicions. Owners or holders and veterinarians must promptly report any suspicion to the competent authority.

2.2.

Active laboratory-based surveillance shall consist of an annual programme of at least one, or a combination of, serological/virological monitoring with sentinel animals, serological/virological surveys, or targeted monitoring and surveillance based on a risk assessment.

• Sampling may take place at pre-defined intervals throughout the year but shall at least be carried out once a year performed in the period of the year when infection or seroconversion is most likely to be detected.

• The bluetongue monitoring and surveillance programmes must be designed in such a way that the samples are taken from susceptible animals (that is animals which have not been vaccinated and which have been exposed to the competent vector), which are representative for the structure of the susceptible species population in the epidemiologically relevant geographical area.

• The sample size must be calculated to detect the appropriate design prevalence based on the known risk of the target population with 95 % confidence in the susceptible species population of that epidemiologically relevant geographical area. In the absence of scientific information on the expected prevalence for the target population the sample size must be calculated to detect a prevalence of 20 %.

• Whenever the samples do not originate from individual animals, the sample size must be adjusted according to the sensitivity of the diagnostic procedures applied.

• Laboratory-based surveillance shall be designed in such a way that positive screening tests are followed by the specific serotype serological/virological tests targeted to the bluetongue serotype or serotypes expected to be present in the epidemiologically relevant geographical area necessary to ascertain the specific serotype circulating.

3. Bluetongue monitoring and surveillance programmes aimed at demonstrating the absence of certain serotypes of the bluetongue virus in a Member State or epidemiologically relevant geographical area U.K.

Bluetongue monitoring and surveillance programmes aimed at the demonstration of the absence of bluetongue virus circulation must comply with the conditions set out in points 2.1 and 2.2. The sample size used for the active laboratory-based surveillance must be calculated to detect a prevalence of 5 % (2) with 95 % confidence. In addition:

(a)

for the purpose of removing an epidemiologically relevant geographical area from a restricted zone as referred to in Article 6(2), Member States must demonstrate the absence of bluetongue virus circulation during a period of at least two years, including two seasons of vector activity;

Member States shall submit to the Commission relevant historical epidemiological information on the monitoring and surveillance programme in place and its yearly results during the past three years, including at least:

(i)

a description of the surveys currently being carried out and the type of diagnostic test performed (ELISA, serum neutralisation, PCR, virus isolation);

(ii)

the sampled species and the number of samples taken per susceptible animal species; if pools of sera are used, an estimation of the numbers of animals corresponding to the pools tested must be reported;

(iii)

the geographical coverage of the samples;

(iv)

the frequency and timing of sampling;

(v)

the number of positive results specified by animals species and geographical location.

(b)

for the purpose of demarcating a ‘ provisionally free area ’ as referred to in Article 7(2a), Member States must demonstrate the absence of bluetongue virus circulation during a period of at least one year, including one season of vector activity.

Member States shall submit to the Commission relevant historical epidemiological information on the monitoring and surveillance programme in place and its results during the past two years, including at least the information as laid down in points (a)(i) to (v).

4. Bluetongue monitoring and surveillance programmes aimed at determining the seasonally vector free period (entomological surveillance) U.K.

Entomological surveillance to determine the seasonally vector-free period as referred to in Annex V, shall meet the following requirements:

(a)

it must consist of at least an active annual programme of vector catching by means of permanently sited aspiration traps intended to determine the population dynamics of the vector;

(b)

aspiration traps equipped with ultraviolet light must be used in accordance with pre-established protocols; the traps must be operated throughout the night and operate at a rate of at least:

• one night per week during the month before the expected beginning and during the month before the expected end of the seasonally vector-free period,

• one night per month during the seasonally vector-free period.

On the basis of the evidence obtained in the three first years of the operation of the aspiration traps, the frequency of operation of those traps may be adjusted;

(c)

at least one aspiration trap must be placed in each epidemiologically relevant area all over the bluetongue seasonally free zone. A proportion of the midges collected in the aspiration traps must be sent to a specialised laboratory capable of counting and identifying the suspected vector species.]

[F1 ANNEX II U.K. Criteria for the ‘ vector protected establishment ’ (referred to in points 2, 3and 4 of Section A of Annex III, point (b) of Section B and point 2(b) of Section C in that Annex)

1. A vector protected establishment shall at least comply with the following: U.K.

(a)

it must have appropriate physical barriers at entry and exit points;

(b)

openings of the vector protected establishment must be vector screened with mesh of appropriate gauge which must be impregnated regularly with an approved insecticide according to the manufacturers’ instructions;

(c)

vector surveillance and control must be carried out within and around the vector protected establishment;

(d)

measures must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector protected establishment;

(e)

standard operating procedures must be in place, including descriptions of back-up and alarm systems, for operation of the vector protected establishment and transport of animals to the place of loading.

2. The competent authority shall approve an establishment as vector protected, if the criteria in point 1 are met. It shall verify at the appropriate frequency, but at least three times during the required protection period (at the beginning, during and at the end of the period) the effectiveness of the measures carried out by means of a vector trap inside the vector protected establishment.] U.K.

[F2 ANNEX III U.K. Conditions for exemption from the exit ban (referred to in Articles 7(2)(a) and 8(1)(a))

Textual Amendments

F2 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).

[F3 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. [F1 The animals have been kept, until dispatch, protected against attacks by vectors in a vector protected establishment in accordance with the criteria set out in Annex II 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. [F1 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 in a vector protected establishment in accordance with the criteria set out in Annex II 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 on samples collected from that animal 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. [F1 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 in a vector protected establishment in accordance with the criteria set out in Annex II 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 on samples collected from that animal 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.’

[F1 5. 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 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 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;

(c)

they were previously vaccinated and they have been revaccinated with an inactivated vaccine within the immunity period of time guaranteed in the specifications of the vaccine;

(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.

Where animals referred to in this point are intended for intra-Union 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.’]

[F1 6. The animals 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.’

[F1 7. The animals 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.’

[F1 For pregnant animals being moved from a restricted zone for bluetongue virus serotype 8, at least one of the conditions set out in points 5, 6 and 7 must have been complied with before insemination or mating, or the condition set out in point 3 must be complied with. In case a serological test, as set out in point 3, is carried out, that test shall be 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

F3 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)

[F1 they have been protected against attacks by vectors in a vector protected establishment in accordance with the criteria set out in Annex II 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)

[F4 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 of the semen to be consigned;

(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 of the semen to be consigned; and

(ii)

during the period of semen collection:

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

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

Textual Amendments

F4 Substituted by Commission Regulation (EC) No 1108/2008 of 7 November 2008 amending Regulation (EC) No 1266/2007 as regards the minimum requirements for bluetongue monitoring and surveillance programmes and the conditions for exempting semen from the exit ban provided for in Council Directive 2000/75/EC (Text with EEA relevance).

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)

[F1 they have been protected against attacks by vectors in a vector protected establishment in accordance with the criteria set out in Annex II 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.

[F1 ANNEX V U.K. Criteria for the definition of the seasonally vector-free period (referred to in Article 9(2))]

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)

[F1 OJ L 59, 5.3.2005, p. 40 .]

(2)

[F1 For a transitional period until 31 August 2012 , the sample size of the survey may be calculated to detect a prevalence of 20 %.]

(3)

[F2 OJ L 194, 22.7.1988, p. 10 .]

(4)

[F2 OJ L 234, 3.10.1995, p. 30 .]

(5)

[F2 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 Implementing Regulation (EU) No 456/2012 of 30 May 2012 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 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).