Annex I is replaced by the following:
Bluetongue monitoring and surveillance programmes shall be aimed at;
detecting any possible incursions of the bluetongue virus and;
where appropriate, demonstrating the absence of certain serotypes of that virus in a Member State or epidemiologically relevant geographical area; or
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 km2) 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.
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.
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.
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.
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:
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:
a description of the surveys currently being carried out and the type of diagnostic test performed (ELISA, serum neutralisation, PCR, virus isolation);
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;
the geographical coverage of the samples;
the frequency and timing of sampling;
the number of positive results specified by animals species and geographical location.
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).
Entomological surveillance to determine the seasonally vector-free period as referred to in Annex V, shall meet the following requirements:
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;
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;
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.”
Annex II is replaced by the following:
it must have appropriate physical barriers at entry and exit points;
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;
vector surveillance and control must be carried out within and around the vector protected establishment;
measures must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector protected establishment;
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.
Annex III is amended as follows:
Section A is amended as follows:
in point 2, the first subparagraph is replaced by the following:
‘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.’;
in point 3, the first subparagraph is replaced by the following:
‘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.’;
in point 4, the first subparagraph is replaced by the following:
‘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.’;
point 5 is replaced by the following:
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:
they have been vaccinated more than 60 days before the date of movement;
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;
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;
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.’;’ ’;
in point 6, the introductory phrase is replaced by the following:
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:’;
point 7 is amended as follows:
the introductory phrase is replaced by the following:
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:’;
the third subparagraph is replaced by the following:
‘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.’;
in Section B, point (b) is replaced by the following:
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;’;
in Section C, in point 2, (b) is replaced by the following:
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;’;
For a transitional period until 31 August 2012, the sample size of the survey may be calculated to detect a prevalence of 20 %.’;