2007/219/EC: Commission Decision of 30 March 2007 concerning a Community financial contribution towards a baseline survey on the prevalence of Salmonella in slaughter pigs to be carried out in Bulgaria and in Romania (notified under document number C(2007) 1394)
Date: 2007-03-30
Institutions: European Commission
Subjects: Bulgaria, EU financing, Romania, agricultural census, slaughter animal, swine, veterinary inspection, zoonosis, zootechnics

5.4.2007

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Official Journal of the European Union

L 95/41

COMMISSION DECISION

of 30 March 2007

concerning a Community financial contribution towards a baseline survey on the prevalence of
Salmonella in slaughter pigs to be carried out in Bulgaria and in Romania

(notified under document number C(2007) 1394)

(Only the Bulgarian and Romanian texts are authentic)

(2007/219/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Decision 90/424/EEC of 26 June
1990 on expenditure in the veterinary field (1), and in particular
Article 20 thereof,

(5)

Whereas:

(1)

(2)

(3)

Decision 90/424/EEC provides for Community financial
contributions towards specific veterinary measures. It also
provides for the Community to undertake or assist the
Member States in undertaking the technical and scientific
measures necessary for the development of veterinary
legislation and for
the development of veterinary
education or training.

Regulation (EC) No 2160/2003 of
the European
Parliament and of the Council of 17 November 2003
on the control of Salmonella and other specified food-
borne zoonotic agents (2), provides that a Community
target
the
is to be established for the reduction of
prevalence of Salmonella in populations of herds of
slaughter pigs by the end of 2007.

(6)

(7)

During its meeting of 16 March 2006, the Scientific
Panel on Biological Hazards of
the European Food
Safety Authority (EFSA) adopted an Opinion on the
request from the Commission related to ‘Risk assessment
and mitigation options of Salmonella in pig production’.
That opinion proposes
for a
baseline
study on the prevalence of Salmonella in
fattening pigs in the Community.

specifications

technical

In order to set the Community target, comparable data
on the prevalence of Salmonella in populations of
slaughter pigs in Bulgaria and in Romania needs to be
available. Such information is presently not available and
a special survey should therefore be carried out
to
monitor the prevalence of Salmonella in slaughter pigs
over a suitable period in those Member States.

A baseline study on Salmonella in fattening pigs is to be
carried out by the other Member States between October
2006 and
September 2007 in accordance with
Commission Decision 2006/668/EC of 29 September
2006 concerning a financial contribution from the
Community towards a baseline survey on the prevalence
of Salmonella in slaughter pigs to be carried out in the
Member States (3). The same procedures should be used
in the baseline studies in Bulgaria and in Romania.
However, the period of the survey should be shortened
in order to enable the analysis of the data of all Member
States at the same time.

The EFSA opinion recommends slaughterhouse sampling
by taking ileocaecal lymph nodes to reflect the Salmonella
status of pigs sent to slaughter. Such sampling should
therefore be used as a tool to monitor the prevalence of
Salmonella in slaughter pigs.

of

the

importance

and in Romania,

to provide the technical

in Bulgaria
should be

information
The survey is
necessary for the development of Community veterinary
legislation. Given
collecting
comparable data on the prevalence of Salmonella in
fattening pigs
those
granted a Community
States
Member
implementing the specific
financial contribution for
It is therefore appropriate
requirements of the survey.
to reimburse 100 % of
incurred in the
laboratory testing, subject to a ceiling. All other costs,
such as those relating to sampling, travel and adminis-
tration should not be eligible for any Community
financial contribution.

the costs

(1) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Regulation

(EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

(2) OJ L 325, 12.12.2003, p. 1. Regulation as last amended by Council

Regulation (EC) No 1791/2006.

(3) OJ L 275, 6.10.2006, p. 51.

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(8)

(9)

(10)

The financial contribution from the Community should
be granted provided that the survey is carried out in
to
accordance with Community
law and subject
compliance with certain other specified conditions.
In
particular, the financial contribution should be granted
in so far as the actions provided for are effectively carried
out and provided that
the
necessary information within the time limits provided
for.

the authorities furnish all

The Commission shall forward those results together with the
national aggregated data and assessments done by the Member
States to the European Food Safety authority, which shall
examine them.

2.
The national aggregated data and results referred to in
paragraph 1 shall be made available publicly in a form that
ensures confidentiality.

It is necessary to clarify the rate to be used for the
conversion of payment
in
national currencies as defined in Article 1(d) of Council
Regulation (EC) No 2799/98 of 15 December 1998
establishing agrimonetary arrangements for the euro (1).

applications

submitted

Article 4

Community financial contribution

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

1.
A Community financial contribution shall be granted to
Bulgaria and Romania for the costs incurred by them for
the bacteriological detection of
laboratory testing,
Salmonella spp., and the serotyping of the relevant isolates and
serology.

for

i.e.

HAS ADOPTED THIS DECISION:

Article 1

Subject matter and scope

A survey shall be carried out to assess the prevalence of
1.
Salmonella spp.
in Bulgaria and in Romania in slaughter pigs
sampled in slaughter houses in those Member States (the
survey).

The survey shall cover a period from 1 April 2007 to

2.
30 September 2007.

For

the purposes of

3.
competent
authority’ shall be the authority or authorities of a Member
State, as designated under Article 3(1) of Regulation (EC)
No 2160/2003.

this Decision,

‘the

Article 2

Technical specifications

The sampling and analysis for the purposes of the survey shall
be performed by the competent authority or under its super-
vision in accordance with the technical specifications set out in
Annex I.

Article 3

Collection of data, assessment and reporting

The competent authority shall collect and assess the
1.
results achieved pursuant
to Article 2 of this Decision and
shall report all necessary aggregated data and its assessment
thereof to the Commission.

(1) OJ L 349, 24.12.1998, p. 1.

2.

The maximum Community financial contribution shall be:

(a) EUR 20 per test for bacteriological detection of Salmonella

spp.;

(b) EUR 30 per test for serotyping of the relevant isolates.

However,
exceed the amounts set out in Annex II.

the Community financial contribution shall not

Article 5

Conditions for granting a Community financial
contribution

1.
The financial contribution provided for in Article 4 shall
be granted to Bulgaria and to Romania provided that the survey
is implemented in accordance with the relevant provisions of
Community law, including the rules on competition and on the
award of public contracts, and subject to compliance with the
following conditions:

(a)

the laws, regulations and administrative provisions required
to implement the survey shall come into force by 1 April
2007 at the latest;

(b) a progress report covering the first three months of the
survey shall be forwarded by 31 July 2007; the progress
report shall contain all information requested in Annex I;

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(c) a final report shall be forwarded by 31 October 2007 at the
latest, on the technical execution of the survey, together
with supporting evidence for the costs incurred and the
results attained during the period 1 April 2007 to 30
the supporting documents concerning
September 2007;
the costs incurred shall comprise at least the information
set out in Annex III;

down detailed rules for the application of the agrimonetary
system for the euro in agriculture and amending certain regu-
lations (1), the conversion rate for expenditure in a currency
other than the euro should be the rate most recently set by
the European Central Bank prior to the first day of the month
in which the application is submitted by the Member State
concerned.

(d) the survey shall be implemented effectively.

2.
An advance payment of 50 % of the total amount referred
to in Annex II may be paid at the request of Bulgaria or of
Romania.

Failure to comply with the time limits provided for in
3.
paragraph 1(c) shall entail a progressive reduction of
the
Community financial contribution to be paid, amounting to
25 % of the total amount by 15 November 2007, 50 % by
1 December 2007 and 100 % by 15 December 2007.

Article 7

Application

This Decision shall apply from 1 April 2007.

Article 8

Addressees

This Decision is addressed to the Republic of Bulgaria and to
Romania.

Article 6

Conversion rate for expenditure

Done at Brussels, 30 March 2007.

reasons of

administrative

For
expenditure
presented for a financial contribution by the Community
should be expressed in euro. In accordance with Commission
Regulation (EC) No 1913/2006 of 20 December 2006 laying

efficiency

all

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 365, 21.12.2006, p. 52.

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ANNEX I

1. Sampling frame

Technical specifications in accordance with Article 2

A minimum number of pigs, kept during at least the preceding three months in the Member State, shall be sampled, at
random, as follows:

Bulgaria: 192

Romania: 300

Bulgaria and Romania shall take a 10 % extra number of samples, to be analyzed in case some samples excluded from
the study for various reasons.

Sampling shall be stratified by slaughterhouses that participate and proportional to slaughterhouse capacity. Each of
those Member States shall rank all slaughterhouses according to their fattening pig throughput in the previous year.
Thus, they shall each identify those plants that accounted for at least 80 % of all slaughtered fattening pigs.

The total number of pigs and carcasses to be sampled in each of the slaughterhouses included in the study shall be
estimated by multiplying the sample size (for example, 2 400) by the proportion of fattening pigs processed in the
previous year. For example, if one slaughterhouse accounted for 25 % of fattening pigs slaughtered in the selected
slaughterhouses (those representing at least 80 % of all fattening pigs slaughtered in the Member State), then (2 400 ×
0,25) 600 pigs shall be sampled. These shall be evenly divided so that 50 pigs sampled in every month, for 12
months. A further example is shown in Table 1.

However, if a slaughterhouse is no longer in production, if a new facility has been opened or there is predicted to be a
significant change in plant throughput during the survey, then the estimated throughput shall be adjusted accordingly.

Table 1

Weighing of slaughterhouses for the purpose of allocating the number of fattening pigs to be sampled from
each slaughterhouse; calculation of sampled animals per slaughterhouse

Slaughterhouse ID

Number of
fattening pigs
processed previous
year

Percent of total
slaughter included
in the study

Number of samples per
slaughterhouse

Samples per month (/12)

0,176 × 2 400 = 422,4

422,4 : 12 = 36

AXD

SVH

TPB

MLG

GHT

Total

88 000

25 000

75 000

100 000

212 000

17,6

5,0

15,0

20,0

42,4

500 000 (1)

100,0

(1) This number must represent at least 80 % of slaughtered fattening pigs in a Member State.

For each slaughterhouse each month, a number between 1 and 31 shall be selected at random. If the randomly
selected number is a slaughtering day, for that month, then that day is selected for sampling. If not, then a new
number shall be selected randomly. This process shall be performed once a month and repeated as many times as
there are samples to be collected at the slaughterhouse. For example, in the slaughterhouse AXD the process shall be
repeated at least 36 times to select at least 36 working days randomly. Accordingly, there may be more than one
carcass to be sampled on the same day.

As the number of animals slaughtered on a specific day may vary enormously, the random selection of the individual
animal shall take place at the slaughterhouse at the date randomly selected for sampling. The given day, the total
number of animals must be known, and the personnel of the slaughterhouse shall then randomly select a carcass or
carcasses using the randomization sheet which has been provided to them and which has been generated using a
maximum that exceeds the highest possible number of fattening pigs slaughtered on any given day in any slaugh-
terhouse in the Member State.

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A randomization table may then look as shown in Table 2.

Table 2

Randomization table.

Slaughterhouse

Day of the month

Identity of carcass (1)

AXD

19

4

12

12

8

5

2

124

2

59

(1) The 5th carcass to be processed on the 19th day of that month should be sampled for the survey.

The following animals shall be excluded from the baseline study:

— animals with a live weight of less than 50 kg or more than 170 kg,

— animals that have undergone emergency slaughter,

— any carcass that is totally condemned.

2. Samples

2.1. Sampling in general

— The aggregate of ileocaecal lymph nodes or at least five individual ileocaecal lymph nodes of all selected pigs
shall be collected. If possible, at least 25 grams of lymph nodes without fat or connective tissues shall be
collected.

— Records shall be kept at the slaughterhouse on the date and time of sampling of each sample and the date and

time and name of the courier that takes delivery of the samples.

2.2. Details on sampling of ileocaecal lymph nodes

The mesenterium between the caecum and the part of the ileum that is closest to the caecum shall be torn and
the ileocaecal lymph nodes are presented at the surface of the torn-open area. Without a knife, but with gloved
fingers, the lymph nodes shall be bluntly ‘harvested’ from such opened mesenterium if individual lymph nodes
are collected. The lymph nodes or the aggregate shall be placed in a plastic bag which is marked with date, time,
slaughterhouse identification and sample identification code.

3. Transport

Samples shall be sent within 36 hours by express mail or courier and shall reach the laboratory no later than 72 hours
following sampling. Samples arriving more than 72 hours following sampling shall be discarded unless the analysis is
initiated within 96 hours following sampling and the cold chain has not been interrupted.

4. Analysis and serotyping of samples

Analysis and serotyping of samples shall take place at the national reference laboratory (NRL). Where the NRL does
not have the capacity to perform all analyses or if it is not the laboratory that performs detection routinely, the
competent authorities may decide to designate a limited number of other laboratories involved in official controls of
Salmonella to perform the analyses.

Those laboratories must have proven experience of using the required detection method and have a quality assurance
system complying with ISO standard 17025 and be subject to the supervision of the NRL.

At the laboratory, samples shall be kept refrigerated until bacteriological examination, which shall be carried out
within 24 hours following receipt of the samples so that analysis is initiated no later than 96 hours following the time
of collection of the samples.

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4.1. Sample preparation

Lymph nodes shall be surface de-contaminated before analysis by dipping into absolute alcohol and drying by air.

All lymph nodes shall be pooled and closed in a plastic bag and banged with a hammer or by similar means on
the plastic bag smashing the lymph nodes.

The homogenized lymph nodes shall be weighed and placed in a sterile container with pre-warmed buffered
peptone water (BPW) in dilution 1:10. Containers shall be incubated for a total of (18 ± 2) hours at (37 ± 1) °C.

4.2. Detection method

The method recommended by the Community Reference Laboratory (CRL) for Salmonella in Bilthoven, the
Netherlands, shall be used.

That method is described in the current version of draft Annex D of ISO 6579:2002: ‘Detection of Salmonella
spp. in animal faeces and in samples of the primary production stage’. In this method, the modified semi-solid
Rappaport-Vassiladis (MSRV) medium shall be used as the single selective enrichment medium.

4.3. Serotyping

All strains isolated and confirmed as Salmonella spp. shall be serotyped according to the Kaufmann-White scheme.

For quality assurance, 16 typable strains and 16 non-typable isolates shall be sent to the CRL. If less strains have
been isolated, all shall be sent.

4.4. Phage typing

In the case where isolates of Salmonella serovar Typhimurium and Salmonella serovar Enteritidis are phage typed
(optional), the methods described by WHO reference centre for phage typing of Salmonella of the Health
Protection Agency (HPA), Colindale, UK, shall be used.

4.5. Testing of anti-microbial susceptibility

In the case of testing for anti-microbial susceptibility (optional), a validated and controlled method for testing
shall be used, such as those recommended by the National Committee for Clinical Laboratory Standards (NCCLS,
since 1st of January 2005: ‘Clinical and Laboratory Standards Institute’ — CLSI).

Both agar diffusion and broth dilution methods shall be acceptable. Results shall be reported both as quantitative
data (MIC for dilution methods and inhibition zone diameter for diffusion methods) and as qualitative data
(proportion resistant isolates).

Qualitative data shall be based on interpretation according to epidemiological cut-off values presented by the
European Committee on Antimicrobial Susceptibility Testing (EUCAST) at: http://www.eucast.org

The isolates shall be tested for the susceptibility to the antimicrobial substances listed below:

— Ampicillin or Amoxicillin

— Tetracycline

— Chloramphenicol

— Florfenicol

— Nalidixic acid

— Ciprofloxacin (preferably) or Enrofloxacin

— Sulphonamide (preferably Sulfametoxazole)

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— Sulphonamide/Trimethoprim or Trimethoprim

— Gentamicin

— Streptomycin

— Kanamycin (preferably) or Neomycin

— 3rd generation cephalosporin, (preferably cefotaxime)

— Colistin (optional)

Before initiation of the study the two Member States shall organise training for the involved parties.

5. Records and sample storage

Records of bacteriology shall be kept on all samples processed in a format in accordance with or comparable to the
example given in Table 3.

All strains isolated shall be stored at the NRLs of the two Member States as long as it ensures integrity of the strains
for a minimum of five years.

All samples of meat juice for serology shall be stored frozen for two years.

Table 3

Example of records to be taken on all processed samples

Sample

Receipt

Analysis

D

I

e
s
u
o
h
r
e
t
h
g
u
a
l
S

EU012

EU023

EU083

e
m
a
N

PW

PW

PW

e
p
y
t

+
D

I

e
l
p
m
a
S

1 S

2 L

3 L

Etc

e
t
a
D

e
m
T

i

e
m
a
N

e
t
a
D

e
m
T

i

g
e
N

r
o

s
o
P

r
a
v
o
r
e
S

e
p
y
t
e
g
a
h
P

m
a
r
g
o
b
i
t
n
A

i

D

I

e
g
a
r
o
t
S

3-10-06

12:00 AB

3-10

14:00 Neg

4-10

8-10

12:30 AB

4-10

14:00

16:30 AB

9-10

9:00

Pos

Pos

Typh

DT104 ASTSu

(IDnr)

Agona

n.a.

ASTE

(IDnr)

6. Reporting from Bulgaria and Romania

The competent authority responsible for the preparation of the yearly national report on the monitoring of Salmonella
in animals pursuant to Article 9 of Directive 2003/99/EC shall collect and evaluate the results and report to the
Commission.

Those reports shall include at least the following information:

6.1. Overall description on the implementation of the survey programme

— description of the population under study stratified according to slaughterhouses capacity,

— description of randomization procedure, including notification system,

— sample size calculated,

— details of authorities and laboratories involved in sampling/testing/typing,

— overall results of the study (samples analyzed by bacteriology, number of positive, serovar, phage type and

antibiotic resistance testing).

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6.2. Complete data on each animal sampled and corresponding tests results

The Member States shall submit the results of the survey in the form of raw data using a data dictionary and data
collection forms provided by the Commission.

That dictionary and forms shall be established by the Commission and include at least the following:

— reference of the slaughterhouse,

— capacity of the slaughterhouse,

— date and time of sampling,

— reference of the samples (the number),

— type of samples taken: lymph nodes,

— date of dispatch to the laboratory.

The following information shall be collected in the Member States for each sample sent to the laboratory:

— ID of the laboratory (in case several laboratories are involved),

— means of transport of samples,

— date of reception by the laboratory,

— when testing lymph nodes, weight of the specimen,

— results for the individual samples tested: ‘negative’ or in case positive for Salmonella spp., also the results of

serotyping ‘Salmonella serovar’ or ‘untypable’,

— results for strains subject to antimicrobial susceptibility testing and/or phagetyping results.

ANNEX II

Maximum Community financial contribution to Bulgaria and Romania

(EUR)

Member State

Bulgaria

Romania

Amount

4 992

7 800

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ANNEX III

Certified financial report on the implementation of a baseline survey on the prevalence of Salmonella spp. in
herds of slaughter pigs

Reporting period: 1 April 2007 to 30 September 2007

Statement on costs incurred on the survey and eligible for Community financial contribution

Reference number of Commission Decision providing Community financial contribution:

........................................................

......................................................................................................................................................................................................................................

Costs incurred related to functions at/by

Number of tests

Total costs of testing incurred during
reporting period
(national currency)

Bacteriology for Salmonella spp.

Serotyping Salmonella isolates

Declaration by the beneficiary

We certify that

— the costs set out in the statement on costs are genuine and have been incurred in carrying out the tasks laid down in

Commission Decision 2007/219/EC and were essential for the proper performance of those tasks;

— all supporting documents for those costs are available for audit purposes.

Date:

..........................................................................................................................................................................................................................

Person financially responsible:

..........................................................................................................................................................................

Signature:

.................................................................................................................................................................................................................