2007/636/EC: Commission Decision of 28 September 2007 concerning a financial contribution from the Community towards a survey on the prevalence of Salmonella spp. in herds of breeding pigs to be carried out in the Member States (notified under document number C(2007) 4434)
Date: 2007-09-28
Institutions: European Commission
Subjects: EU financing, breeding animal, data collection, swine, veterinary inspection, zoonosis

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(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION DECISION

of 28 September 2007

concerning a financial contribution from the Community towards a survey on the prevalence of
Salmonella spp. in herds of breeding pigs to be carried out in the Member States

(notified under document number C(2007) 4434)

(2007/636/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

April 2007 a Report on a proposal for technical specifi-
for a baseline study on the prevalence of
cations
Salmonella in breeding pigs (3) (the EFSA report).

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,

Whereas:

(1)

(2)

contribution by

the Community

Decision 90/424/EEC lays down procedures governing a
financial
towards
including technical and
specific veterinary measures,
scientific measures.
It provides for the Community to
undertake, or assist Member States in undertaking, the
technical and scientific measures necessary for the devel-
opment of Community veterinary legislation and for the
development of veterinary education or training.

the European Parliament and of

Under Article 4 and Annex I of Regulation (EC) No
the
2160/2003 of
Council of 17 November 2003 on the control of
specified food-borne zoonotic
Salmonella
agents (2), a Community target is to be established for
reducing the prevalence of Salmonella in populations of
herds of breeding pigs.

and other

(3)

The Task Force on Zoonoses Data Collection of
the
European Food Safety Authority (EFSA) adopted on 30

(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 Regu-

lation (EC) No 1791/2006.

(4)

(5)

(6)

in the Member States needs

In order to set the Community target, comparable data
on the percentage of Salmonella infected holdings of
breeding pigs
to be
available. Such information is not available and a
special
to
monitor the prevalence of Salmonella in breeding pigs
to take account of
over a suitable period in order
survey should be
seasonal variations. The
possible
based on the EFSA report.

survey should therefore be

carried out

The EFSA report also recommends additional sampling
for the estimation of within-holding prevalence. Such
sampling should be carried out by a number of
Member States geographically representing the different
situations in the Community.

The survey is to provide technical information necessary
for the development of Community veterinary legislation.
Given the importance of collecting comparable data on
the prevalence of Salmonella in breeding pigs in the
Member States, they should be granted a Community
implementing the specific
financial contribution for
requirements of
to
survey.
reimburse 100 % of the costs incurred on the laboratory
testing, subject to a ceiling. All other costs incurred such
as sampling, travel, administration, etc. should not be
eligible for any Community financial contribution.

appropriate

the

is

It

(3) The EFSA Journal (2007) 99, pp. 1-28.

(7)

(8)

(9)

(10)

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The financial contribution from the Community should
be granted provided that the survey is carried out in
accordance with the relevant provisions of Community
law and subject
to compliance with certain other
conditions.

Article 3

Scope of the survey

1.
The Member States shall carry out a survey to assess the
prevalence of Salmonella spp. in breeding pigs sampled at farm
level in accordance with Annex I.

The financial contribution from the Community should
be granted insofar as the actions provided for are effec-
tively carried out and provided that the competent auth-
orities furnish all the necessary information within the
time limits provided for.

a

by

for

financial

contribution

For reasons of administrative efficiency all expenditure
presented
the
Community should be expressed in euro. In accordance
with Council Regulation (EC) No 1290/2005 of 21 June
2005 on the financing of
the common agricultural
policy (1),
the conversion rate for expenditure in a
currency other
than 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.

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

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Subject matter and scope

This Decision lays down rules on the financial contribution
from the Community towards a baseline survey to be carried
out in the Member States to assess the prevalence of Salmonella
spp. across the Community in breeding pigs sampled at farm
level (the survey).

The survey shall cover a one-year period commencing on

2.
1 January 2008.

Article 4

Performance of sampling and analyses

Sampling and analysis shall be performed by the competent
in accordance with the
authority or under its supervision,
technical specifications set out in Annex I.

Article 5

Conditions for granting a Community financial
contribution

The financial contribution from the Community towards
1.
the costs of analyses shall be granted to the Member States up
to the maximum total amount
in
Annex II for the duration of the survey.

for co-financing set out

2.
The financial contribution from the Community provided
for in paragraph 1 shall be granted to the Member States
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 national laws, regulations and administrative provisions
required to implement the survey must enter into force by
1 January 2008 at the latest;

The results of the survey shall be used to set a Community
target as provided for in Article 4 of Regulation (EC) No
2160/2003 and to consider the best approach to evaluate in
the future the achievement of such target.

(b) a progress report containing the information listed in point
5.1 of Annex I and covering the period from 1 January
2008 to 31 March 2008 must be submitted to the
Commission by 31 May 2008 at the latest;

Article 2

Definition
For the purposes of this Decision, ‘competent authority’ shall be
the authority or authorities of a Member State as designated
pursuant to Article 3 of Regulation (EC) No 2160/2003.

(c) a final report on the implementation of the survey, together
with supporting evidence for the costs incurred by the
Member States for the analyses and the results attained
during the period from 1 January 2008 to 31 December
2008 must be submitted to the Commission by 28 February
2009 at the latest;

(1) OJ L 209, 11.8.2005, p. 1. Regulation as last amended by Regu-

lation (EC) No 378/2007 (OJ L 95, 5.4.2007, p. 1).

(d) the survey must be implemented effectively.

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The supporting evidence for the costs incurred as referred to in
paragraph 2(c) shall comprise at least the information set out in
Annex III.

National data and results shall be made publicly available

3.
in a form that ensures confidentiality.

Failure to submit the final report referred to in paragraph
3.
2(c) shall entail a progressive reduction of the financial contri-
bution to be paid by the Community, amounting to 25 % of the
total amount by 31 March 2009, 50 % by 30 April 2009 and
100 % by 31 May 2009.

Article 6

Maximum amounts to be reimbursed

The maximum amounts of the financial contribution from the
Community towards the costs to be reimbursed to the Member
States for analyses covered by the survey shall not exceed the
following:

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

spp.;

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

Article 8

Conversion rate for expenditure
Where a Member State’s expenditure is in a currency other than
the euro, the Member State concerned shall convert it into euro
by applying the most recent exchange rate set by the European
Central Bank prior to the first day of the month in which the
application for the financial contribution from the Community
is submitted by the Member State.

Article 9

Application

This Decision shall apply from 1 January 2008.

Article 10

Addressees

Article 7

This Decision is addressed to the Member States.

Collection of data, assessment and reporting

The competent authority responsible for preparing the
to Article 9(1) of Directive
the

1.
yearly national report pursuant
2003/99/EC of
European
Council (1) shall collect and assess the results of the survey.

Parliament

and

the

of

Done at Brussels, 28 September 2007.

2.
The Commission shall forward the national data and the
assessment referred to in paragraph 1 to the European Food
Safety Authority, which shall examine them.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 325, 12.12.2003, p. 31.

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ANNEX I

Technical specifications referred to in Articles 3(1), 4 and 5(2)(b)

1.

OVERVIEW OF THE SURVEY

The survey shall be performed according to the overview in Figure 1.

Figure 1: overview of the survey

2.

SAMPLING FRAME

2.1.

The delineation of the population

The survey shall be carried out on holdings harbouring at least 80 % of the breeding pig population in a Member
State. Preferentially holdings having 50 breeding pigs or more shall be sampled. However, if those holdings
having 50 breeding pigs or more do not contain 80 % of the national herd of breeding pigs, then smaller
holdings with less than 50 breeding pigs shall also be sampled.

Holdings with breeding pigs shall be classified either as ‘breeding holdings’ or as ‘production holdings’. Breeding
holdings sell gilts and/or boars for breeding purposes. Typically, they sell 40 % or more of the gilts that they rear
for breeding whilst the remainder are sold for slaughter. In contrast, production holdings mainly sell pigs for
fattening or slaughter.

The Salmonella prevalence must be measured separately in breeding holdings (part 1 of the survey) and in
production holdings (part 2 of the survey), representing the herds as indicated in Figure 2, but excluding
weaner to finisher herds.

Figure 2: overview of holdings

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2.2.

The sample and the sampling strategy

Both parts of the survey shall have a similar two-stage sampling design. In the first stage, a random sample of
holdings shall be selected in every Member State from the breeding holdings and a second random sample shall
be selected from the production holdings group. The number of holdings required is discussed in section 2.3.
In the second stage, a number of pens shall be selected for sampling within every selected holding (see
section 2.2.2).

2.2.1.

First stage: selection of holdings

Each Member State must create two sampling frames. The first shall list all eligible breeding holdings (usually,
those holdings with at least 50 breeding pigs — see section 2.1) and the second shall list all eligible production
holdings. The required number of holdings for each part of the survey will then be selected at random from each
list. A random sample is intended to ensure that the survey includes holdings with a range of herd sizes and
from all regions of a Member State where pig keeping is practised. It is recognised that in some Member States,
there may be a few holdings (e.g. fewer than 10 % of all eligible holdings) with a very large herd size. Thus,
random selection may by chance result in none of these very large herds being selected. A Member State may use
a stratification criterion prior to holding selection — for example, to define a stratum containing the 10 % of
largest herds and to allocate 10 % of the required sample size to this stratum. Similarly, a Member State may
stratify the sample across administrative regions according to the proportion of eligible herds within each region.
Any stratification that is considered should be described in the report that a Member State submits to the
Commission in accordance with paragraph 5(1).

If a selected holding cannot be sampled (for example, if it no longer exists when sampling is carried out) a new
holding shall be selected at random from the same sampling frame. If any stratification (e.g. on herd size or
region) was in operation, then the new holding should be selected from the same stratum.

The primary sample size (number of holdings to be sampled) shall be approximately equally distributed over the
year to cover the different seasons, as far as possible. Samples shall be taken from approximately one twelfth of
the number of holdings each month.

Outdoor holdings must be included in the survey but there shall be no mandatory stratification on this
production type.

2.2.2.

Second stage: sampling on the holding

In each selected breeding herd and production herd the pens, yards or groups of breeding pigs over six months
of age to be sampled will be randomly selected.

The number of pens, yards or groups to be sampled must be proportionally allocated according to the numbers
of breeding pigs in the different stages of production (pregnant, non-pregnant and other categories of breeding
pigs). The exact age categories to be sampled are not prescribed, but this information shall be collected during
the sampling.

Breeding pigs that have arrived recently to the herd and are held in quarantine shall not be included in the
survey.

2.3.

The sample size calculation

2.3.1.

Primary sample size (first-stage sample size)

A regular primary sample size calculation shall be conducted for the breeding holdings and a second regular
primary sample size calculation shall be conducted for the production holdings. The primary sample size shall be
the number of breeding holdings to be sampled and the number of production holdings to be sampled in each
Member State and it shall be determined taking into account the following criteria, assuming simple random
sampling:

(a)

the total number of breeding holdings (breeding holdings, part 1 of the survey);

(b) the total number of production holdings (production holdings, part 2 of the survey);

(c) annual expected prevalence (p): 50 %;

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(d) desired confidence level (Z): 95 %, corresponding to a Zα value of 1,96;

(e) accuracy (L): 7,5 %;

(f) using these values and the formula: n∞ ¼

ðZαÞ2 pð1–pÞ
L2

The calculation shall be conducted firstly, for the breeding holdings and secondly, for the production holdings. In
each case, the assumptions in steps (c)-(e) above are the same.

For practical purposes, if there are 100 000 or more holdings in either the breeding herds sampling frame or the
production herds sampling frame then that population can be considered to be infinite and the number of
holdings to be randomly selected from that sampling frame is 171 (see Table 1). Where the number of breeding
herds or production herds is less than 100 000 a finite population correction factor is applied and fewer
holdings need to be sampled as shown in Table 1.

As an example, if there are in a Member State 1 000 holdings belonging to the production holding group and
250 holdings belonging to the breeding holding group, 147 holdings must be sampled in the production
holding group and 102 holdings must be sampled in the breeding holding group.

Number of holdings with breeding pigs to sample in either part of the survey as a function of the finite
population size (total number of holdings with breeding pigs in the Member States)

Table 1

Number of holdings with breeding pigs (N)

Sample size (n) for finite population size 7,5 % accuracy

100 000

10 000

5 000

2 000

1 000

500

250

150

125

100

90

80

70

60

50

40

30

20

10

171

169

166

158

147

128

102

80

73

64

59

55

50

45

39

33

26

18

10

Non-response shall be anticipated, e.g. by increasing the sample size in each group by 10 %. Any unsuitable
holding shall be replaced in the process of the survey (see Section 2.2.1).

In case an estimation of the number of ‘breeding holdings’ is not possible prior to the start of the survey, a
number of holding shall be selected for sampling as in Table 1 based on the total number of holdings with sows
(X holdings). The number of holdings to be sampled shall be increased by at least 30 % ((X + 30 %) holdings).
Prior to the survey, the competent authority shall identify a number of breeding holdings, equal to at least this
additional 30 %. While visiting the farms, the holding will be classified as breeding or production holding
according to the definitions above.

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2.3.2.

Secondary sample size (second-stage sample size)

In each selected holding routine faecal samples (see section 3.1) shall be collected from 10 randomly chosen
pens, yards or groups of breeding pigs. If necessary (for example, in farrowing accommodation or where sows
are kept in small groups of less than 10 individuals), a group can consist of more than one pen. At least 10
individual breeding pigs should contribute to each routine sample.

However, where on small holdings or holdings with large numbers of breeding pigs kept outdoors in paddocks,
the number of pens, yards or groups is less than 10, sampling of the same pen, yard or group shall be required
so that a total of 10 routine samples are submitted.

3.

SAMPLE COLLECTION IN THE HERDS

3.1.

Type and detail of the routine sample

The material collected for bacteriological analysis shall be freshly voided faeces representing the whole holding,
which is the unit of interest. Since every holding is unique, it shall be decided, before starting the sampling,
which pens, yards or groups within the holding are sampled. The sample collected shall be placed in a separate
container avoiding cross contamination and sent to the laboratory.

Each pooled sample shall total at least 25 g and two approaches may be employed to collect these pooled faeces
samples:

(1) where there is an accumulation of mixed faeces within an area of a pen or yard, a large swab (e.g. 20 cm
× 20 cm) can be used to pass through the faecal mass, ensuring that at least 25 g of mixed material is
collected. This may be achieved by for example, moving the swab along a two-metre zig-zag path such that
it is well coated with faecal material. If necessary, for example due to hot weather or on slatted flooring then
the swab may be moistened with an appropriate liquid such as drinking water;

(2) where there is no such accumulation, for example in a field, a large yard, a farrowing house, or pens or other
accommodation with low numbers of pigs per group, then individual pinches shall be selected from
individual
fresh faecal masses or places so that a minimum of 10 individuals, contribute to a total
sample volume of at least 25 g. The sites from which these pinches are collected should be distributed in
a representative manner across the area concerned.

Approach 1 shall be preferred where practical. In this approach at least 10 individual pigs must contribute to
each sample taken, otherwise approach 2 shall be applied.

3.2.

Additional sampling for the within-holding prevalence study

Together, 10 holdings, selected at random from the overall sample of breeding holdings and of production
holdings are subjected to more intensive sampling. On these holdings 10 routine samples shall be collected in
the same manner as described previously (section 3.1). In addition, 10 individual samples of at least 30 g shall be
collected in each selected pen and shall be identified in such a manner that these 10 individual samples can be
associated with the routine sample from that pen. Thus in total, 10 routine samples and 100 (10 × 10) individual
samples shall be collected from each of these 10 holdings. The processing of these samples is described in
section 4.3.1.

This sampling should be applied in the Czech Republic, Denmark, Romania, Slovenia, Sweden and the United
Kingdom.

3.3.

Sample information

All relevant information available from the sample shall be recorded on a sampling form produced by the
competent authority to enable the data requirements in Part 5 to be fulfilled.

Each sample and its sample form shall be labelled with a unique number which shall be used from sampling to
testing, and with the code of the pen. The competent authority must arrange for the issue and use of a unique
numbering system.

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3.4.

Transport of samples

Samples shall be preferably kept at between + 2 to + 8 °C and free of external contamination during transpor-
tation. The samples shall be sent to the laboratory as quick as possible within 36 hours by fast mail or courier
and shall reach the laboratory no later than 72 hours after sampling.

4.

LABORATORY ANALYTICAL METHODS

4.1.

Laboratories

Analysis and serotyping 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 control
of Salmonella to perform the analyses. These laboratories shall have proven experience of using the required
detection method and have a quality assurance system complying with ISO standard 17025 and be submitted to
the supervision of the NRL.

4.2.

Receipt of samples

At the laboratory, samples shall be kept refrigerated until bacteriological examination, which shall preferably be
carried out within 24 hours after receipt but in any case no later than 96 hours after the sample was collected.

4.3.

Sample analysis

Member States shall guarantee that all involved parties have been sufficiently trained to carry out the analyses.

4.3.1.

Preparation

In the laboratory, routine samples shall be mixed carefully and thoroughly before 25 g are collected for analysis.

For evaluation of the within-holding prevalence in accordance with paragraph 3.2, each of the individual
collected samples (30 g) needs to be divided into two parts. One part, weighing at least 25 g, shall be mixed
carefully and thoroughly and subsequently cultured individually. The remaining second part is to be used to
prepare an artificially pooled sample from the 10 individual samples in the selected pen, group or yard. This
latter part shall be prepared by adding 10 times 2,5 g of the individual samples to create an artificially pooled
sample of 25 g. The artificially pooled samples are mixed carefully and thoroughly before analysis. In total, 10
routine samples, 10 artificially pooled sample and 100 individual samples shall be analysed from each of the 10
holdings selected for the estimation of the within-holding prevalence.

4.3.2. Detection and identification methods

4.3.2.1. D e t e c t i o n o f S a l m o n e l l a

The method recommended by the Community Reference Laboratory (CRL) for Salmonella in Bilthoven, the
‘Detection of Salmonella
Netherlands, shall be used. This method is described in the Annex D of ISO 6579:
spp. in animal faeces and in samples of the primary production stage’. The latest version of Annex D shall be
used.

4.3.2.2. S e r o t y p i n g o f S a l m o n e l l a

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

For quality assurance, 16 typable strains and 16 non-typable isolates shall be sent to the CRL for Salmonella. A
proportion of these isolates shall be sent to the CRL on a quarterly basis. If fewer strains have been isolated all
shall be sent.

4.3.2.3. P h a g e t y p i n g o f S a l m o n e l l a

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

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5.

REPORTING FROM THE MEMBER STATES

5.1.

Overall description on the implementation of the survey

A report in text format shall include at least:

(a) Member State;

(b) description of the population of holdings with breeder pigs;

(1) breeding holdings:

(i) total number of breeder holdings;

(ii) total number of nucleus holdings;

(iii) total number of multiplier holdings;

(iv) number of breeder holdings planned to be sampled, and number of breeder holdings actually
sampled; number of holdings planned for sampling but not sampled and the reason therefor;

(v) comments on the overall representativeness of the breeding holdings sampling programme;

(2) production holdings:

(i) total number of production holdings;

(ii) total number of farrow to weaner/grower holdings;

(iii) total number of farrow to finish holdings;

(iv) number of production holdings planned to be sampled, and number of production holdings actually
sampled; number of holdings planned for sampling but not sampled and the reason therefor;

(v) possible comments on overall representativeness of the production holdings sampling programme;

(c) number of samples obtained and analysed:

(i) from breeding holdings;

(ii) from production holdings;

(iii) from holdings sampled for within-holding prevalence study;

(d) overall results:

(i) prevalence of breeding holdings and of production holdings infected with Salmonella, and serovars of

Salmonella;

(ii) outcome of within-holding prevalence study;

(e)

list of laboratories responsible in the baseline study for Salmonella:

(i) detection;

(ii) serotyping;

(iii) phage typing (if carried out).

5.2.

Complete data on each holding sampled and corresponding tests results

The Member States shall submit the results of the investigation electronically in the form of raw data using a data
dictionary and data collection forms provided by the Commission. This dictionary and forms shall be established
by the Commission.

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5.2.1.

The following information shall be collected in Member States for each holding selected for sampling:

(a) code of the holding;

(b) holding production type;

(i) indoor versus ‘any stage of the production kept outdoors’;

(ii) nucleus, multiplier, farrow to weaner, farrow to finish and farrow to grower;

(c) holding size: the number of breeding pigs present at the time of sampling (adult inventory);

(d) replacement policy: all replacement breeding pigs purchased; some replacement breeding pigs homebred or

all replacement breeding pigs homebred;

(e)

(voluntarily:) clinical symptoms of diarrhoea: were there symptoms of diarrhoea within the three months
before the sampling?

5.2.2.

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

(a) code of the sample;

(b) code of the laboratory involved in initial analysis;

(c) date of sample collection;

(d) date laboratory analysis begun;

(e) detection of Salmonella: qualitative result (positive/negative);

(f)

serotyping of Salmonella: serovar(s) detected (may be more than one);

(g) age of the pigs: all gilts versus mixed age breeding pigs;

(h)

sex: only sows; sows and boars or only boars;

(i) production stage: maternity; mating, gestation (other?);

(j) housing: slatted floor (fully/partly); solid floor; deep straw or other;

(k) diet: are pigs in this pen, yard or group fed compound feed exclusively?;

(l)

feed supplement:
probiotic)?;

is there any Salmonella reducing substance added to the feed (like organic acid, a

(m) systematic use of antibiotics: are antibiotics used in all animals of this group by any route of administration;

(n)

the last date of administration of antimicrobials to the animals (within the last four weeks).

5.2.3.

The following additional information shall be collected in Member States for each individual sample sent to the laboratory
within the frame of the sampling for the within-holding prevalence:

(a) code of the pooled sample;

(b) detection of Salmonella in each individual sample: qualitative result (positive/negative);

(c) serotyping of Salmonella in each individual sample: serovar(s) detected (may be more than one).

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Maximum Community financial contribution to the Member States referred to in Article 5

ANNEX II

Member State

Maximum total amount for co-financing of analyses (EUR)

Belgium — BE

Bulgaria — BG

Czech republic — CZ

Denmark — DK

Germany — DE

Estonia — EE

Ireland — IE

Greece — EL

Spain — ES

France — FR

Italy — IT

Cyprus — CY

Latvia — LV

Lithuania — LT

Luxembourg — LU

Hungary — HU

Malta — MT

Netherlands — NL

Austria — AT

Poland — PL

Portugal — PT

Romania — RO

Slovenia — SI

Slovakia — SK

Finland — FI

Sweden — SE

United Kingdom — UK

Total

59 800

52 260

102 960

98 280

57 980

9 360

43 420

39 260

82 680

82 680

79 300

20 020

3 380

13 780

11 960

74 360

0

87 100

59 020

85 020

54 860

107 900

81 120

54 080

64 740

81 120

102 960

1 609 400

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ANNEX III