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)
Date: 2008-11-07
Institutions: European Commission
Subjects: EU Member State, animal breeding, animal disease, regulation of agricultural production, sheep, vaccination, veterinary legislation

8.11.2008

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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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

to

regard

Council Directive

Having
of
20 November 2000 laying down specific provisions for the
control and eradication of bluetongue (1), and in particular,
Articles 11 and 12 and the third paragraph of Article 19
thereof,

2000/75/EC

Whereas:

(1)

(2)

(3)

(4)

Directive 2000/75/EC lays down control
rules and
measures to combat and eradicate bluetongue. They
include the establishment of protection and surveillance
zones (‘restricted zones’), the implementation of blue­
tongue monitoring and surveillance programmes, and
an exit ban on animals leaving the restricted zones
(‘the exit ban’).

(EC) No

1266/2007

Commission Regulation
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
in relation to blue­
tongue (2) lays down rules to be applied in the event of
an outbreak of that disease.

susceptible species

Annex I to Regulation (EC) No 1266/2007 sets out the
minimum requirements for the bluetongue monitoring
and surveillance programmes. Annex III to that Regu­
lation sets out the conditions for exemption from the
exit ban with regard to animals, their semen, ova and
embryos. Annex V to that Regulation sets out criteria for
the purpose of determining a bluetongue seasonally-free
zone.

It is essential that appropriate bluetongue monitoring and
surveillance programmes are in place to achieve, among
others, the objectives of the detection of the presence of
the bluetongue virus at the earliest possible stage, to
demonstrate the absence of general or specific blue­
tongue virus serotypes, and for the determination of
the seasonally vector-free period. The bluetongue moni­
should include
toring and surveillance programmes

minimum requirements
ensuring sufficient
epidemiological conditions.

for Member

flexibility to take account of

States, while
local

(5)

(6)

(7)

(8)

(9)

A mass emergency vaccination campaign against various
types of bluetongue is being implemented in the EU. The
vaccination of animals against that disease represents a
major change of the immune status of the susceptible
species population and has implications for bluetongue
surveillance and monitoring programmes. Therefore,
certain modifications
the
to the
programmes need to be made.

requirements

for

Annex V to Regulation (EC) No 1266/2007 sets out
criteria for the purpose of determining a bluetongue
seasonally-free zone. For reasons of clarification and a
more harmonized approach, the beginning and the end
of the seasonally vector-free period should be based on
standardized surveillance data.

Section B of Annex III to Regulation (EC) No 1266/2007
sets out conditions for exemption from the exit ban with
regard to semen. It provides that semen must have been
obtained from donor animals which comply with certain
conditions, in order to be exempted. In the interests of
certainty of Community legislation,
it is appropriate to
clarify certain requirements as regards the testing regimes
of semen donor animals,
in particular as regards post-
collection testing.

Regulation (EC) No 1266/2007 should therefore be
amended accordingly.

The measures provided for in this Regulation are in
Standing
accordance with
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Regulation (EC) No 1266/2007 is amended as follows:

Article 1

(1) OJ L 327, 22.12.2000, p. 74.
(2) OJ L 283, 27.10.2007, p. 37.

1. Annex I is replaced by the text in the Annex to this Regu­

lation;

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2.

in Section B of Annex III, points (d) and (e) are replaced by
the following:

(ii) during the period of semen collection:

‘(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
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

— 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.’

Article 2

This Regulation shall enter into force on the 20th day following
that of
the European
Union.

its publication in the Official

Journal of

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 7 November 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

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ANNEX
‘ANNEX I

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

Bluetongue monitoring programmes shall be aimed at providing information on the dynamics of bluetongue in a
restricted zone. The objectives of bluetongue monitoring programmes are to detect the introduction of new
bluetongue serotypes and to demonstrate the absence of certain bluetongue serotypes. Other objectives may
include the demonstration of the absence of bluetongue virus circulation, the determination of the seasonally
vector free period and identifying the vector species.

The geographical unit of reference for the purposes of bluetongue monitoring and surveillance shall be defined
by a grid of around 45 × 45 km (approximately 2 000 km2) unless specific environmental conditions justify a
different size. Member States may also use the “region” as defined in Article 2(p) of Directive 64/432/EEC as the
geographical unit of reference for monitoring and surveillance purposes.

1.1.

Bluetongue monitoring programmes shall consist of at least passive clinical surveillance and active laboratory-
based surveillance, as set out in points 1.1.1 and 1.1.2.

1.1.1.

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. All suspicions due to the presence of
bluetongue serotypes not expected to be present in the epidemiologically relevant geographical area must
be thoroughly investigated immediately by the competent authority in order to ascertain the bluetongue
serotypes circulating;

— be specially reinforced during the season of vector activity;

— ensure that awareness campaigns are put in place and aimed, in particular, at enabling owners or holders and

veterinarians in identifying clinical signs of bluetongue.

1.1.2. Active laboratory-based surveillance shall consist of at least one, or a combination of, serological monitoring
with sentinel animals, serological/virological surveys, or targeted risk-based monitoring, as set out in points
1.1.2.1, 1.1.2.2 and 1.1.2.3.

1.1.2.1. 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 the bluetongue virus within the restricted zone. 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 once a 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 once a month
throughout the year;

— The minimum number of sentinel animals per geographical unit of reference for the purposes of bluetongue
monitoring and surveillance must be representative and sufficient in order to detect a monthly incidence of
seroconversion (1) of 2 % with 95 % confidence in each geographical unit of reference;

— Laboratory testing 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.

(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.

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1.1.2.2. Serological/virological surveys:

— shall consist of at least an active annual programme of serological/virological testing of susceptible species
populations, aimed at detecting evidence of bluetongue virus transmission through random serological and/or
virological testing implemented in all epidemiologically relevant geographical areas 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 and adjusted to the structure of the
susceptible species population to be sampled in the epidemiologically relevant geographical area and the
sample size has been calculated to detect a prevalence of 20 % with 95 % confidence in the susceptible
species population of that epidemiologically relevant geographical area;

— must ensure that seropositive animals from vaccinated or immunized populations do not interfere with the

serological surveys;

— must ensure that laboratory testing is 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;

— may also be designed to monitor vaccination coverage and distribution of different bluetongue serotypes

present in the restricted zone.

1.1.2.3. Targeted risk-based monitoring:

— shall consist of a formal and properly documented ongoing system aimed at demonstrating the absence of

certain specific bluetongue serotypes;

— applies to a target population of susceptible animals at a relative high risk, based on their location, the
geographical situation and the epidemiology of the bluetongue serotype or serotypes expected to be present
in the epidemiologically relevant geographical area;

— must have a sampling strategy that is adjusted to the defined target population. The sample size has been
calculated to detect the design prevalence (based on the known risk of the target population) with 95 %
confidence in the target population of that epidemiologically relevant geographical area. Whenever the
samples do not originate from individual animals, sample size must be adjusted according to the sensitivity
of the diagnostic procedures applied.

1.2.

To determine the seasonally vector-free period as referred to in Annex V to this Regulation, entomological
surveillance must meet the following requirements:

— it shall 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 their operation, the frequency of operation

of the aspiration 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.

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1.3.

Monitoring in order to provide the Commission with substantiated information demonstrating the absence of
bluetongue virus circulation in an epidemiological relevant geographical area during a period of two years, as
referred to in Article 6(2):

— shall consist of at least one, or a combination of, serological monitoring with sentinel animals, serologi­
cal/virological surveys and targeted risk-based monitoring, as set out in points 1.1.2.1, 1.1.2.2 and 1.1.2.3;

— must be designed in such a way that the samples are representative and adjusted to the structure of the
susceptible species population to be sampled in the epidemiologically relevant geographical area and the
sample size has been calculated to detect a prevalence of 20 % (1) with 95 % confidence in the susceptible
species population of that epidemiologically relevant geographical area if mass vaccination has not been
implemented; or

— must be designed in such a way that the samples are representative and adjusted to the structure of the
susceptible species population to be sampled in the epidemiologically relevant geographical area and the
sample size has been calculated to detect a prevalence of 10 % (2) with 95 % confidence in the susceptible
species population of that epidemiologically relevant geographical area if mass vaccination has been im­
plemented.

2.

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

Bluetongue surveillance programmes shall be aimed at detecting any possible incursions of the bluetongue virus
and at demonstrating the absence of that virus in a bluetongue-free Member State or epidemiologically relevant
geographical area.

Bluetongue surveillance programmes shall consist of at least passive clinical surveillance and active laboratory-
based surveillance, as set out in points 2.1 and 2.2.

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. All suspicions must be thoroughly
investigated by the competent authority immediately in order to confirm or rule out any outbreak of
bluetongue;

— must be specially reinforced during the season of vector activity in areas having a specific relative higher risk,

based on geographical and epidemiological data;

— must ensure that awareness campaigns are put in place and aimed,
holders and veterinarians in identifying clinical signs of bluetongue.

in particular, at enabling owners or

2.2.

Active laboratory-based surveillance shall consist of at least one, or a combination of serological monitoring with
sentinel animals, or serological/virological surveys, or targeted risk-based surveillance, as set out in points 2.2.1,
2.2.2 and 2.2.3.

2.2.1.

Serological monitoring with sentinel animals

— Serological monitoring with sentinel animals shall consist of an active annual programme of testing sentinel
animals, aimed at detecting the evidence of bluetongue virus transmission outside the restricted zones.
Specific attention must be given to areas at high risk, based on geographical and epidemiological data;

— Sentinel animals shall be tested at least once a month during the period of activity of the vector involved, if
that period is known. In the absence of such information, the sentinel animals shall be tested at least once a
month throughout the year;

(1) It has been estimated that 20 % is the normal annual rate of seroconversion in an infected zone. However, if there is evidence that the
annual rate of seroconversion in the epidemiologically relevant geographical area is lower than 20 % the sample size has to be
calculated to detect the lower estimated prevalence.

(2) It has been assumed that 10 % is the normal annual rate of seroconversion in a vaccinated zone. However, if there is evidence that the
annual rate of seroconversion in the epidemiologically relevant vaccinated geographical area is lower than 10 % the sample size has to
be calculated to detect the lower estimated prevalence.

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— The minimum number of sentinel animals per geographical unit of reference for the purposes of bluetongue
monitoring and surveillance must be representative and sufficient in order to detect a monthly incidence of
seroconversion (1) of 2 % with 95 % confidence in each geographical unit of reference.

2.2.2.

Serological/virological surveys:

— shall consist of at least an active annual programme of serological/virological testing of susceptible species
populations, aimed at detecting evidence of the bluetongue virus transmission outside the restricted zones
through random serological and/or virological testing implemented in all epidemiologically relevant geogra­
phical areas and performed in the period of the year when seroconversion is most likely to be detected;

— must be designed in such a way that the samples are representative and adjusted to the structure of the
susceptible species population to be sampled in the epidemiologically relevant geographical area and the
sample size has been calculated to detect a prevalence of 20 % with 95 % confidence in the susceptible
species population of that epidemiologically relevant geographical area;

— must ensure that seropositive animals from vaccinated or immunized populations do not interfere with the

serological surveys.

2.2.3.

Targeted risk-based surveillance

— shall consist of a formal and well documented ongoing system aimed at demonstrating the absence of certain

specific bluetongue serotypes;

— must be based on substantial knowledge of the local risk factors; such knowledge must allow the identifi­

cation of the specific relative higher risk target population to be sampled;

— must ensure that the targeted sampling strategy is adjusted to the target population defined at relative higher
risk and the sample size has been calculated to detect the design prevalence (based on the known risk of the
target population) with 95 % confidence in the target population of that epidemiologically relevant geogra­
phical area.

(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.’