APHIS Evaluation

of the

Swine Vesicular Disease

(SVD) Status of

Northern Italy

July 2012

United States Department of Agriculture

Animal and Plant Health Inspection Service

Veterinary Services

National Center for Import and Export

Regionalization Evaluation Services
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

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Table of Contents

List of Figures, Tables and Appendices...........................................................................3

Abbreviations.....................................................................................................................4

Section 1. Executive Summary..........................................................................................5

Section 2. Introduction ......................................................................................................8

Section 3. Hazard Identification.....................................................................................13

Section 4. Release Assessment.........................................................................................16

4.1. Authority, organization, and infrastructure of the veterinary services ................16

4.2. Disease status in the region..................................................................................25

4.3. Disease status of adjacent regions........................................................................29

4.4. Extent of active disease control program.............................................................29

4.5. Vaccination status of the region...........................................................................35

4.6. Separation from adjacent regions of higher risk..................................................35

4.7. Movement controls and biosecurity from higher-risk regions.............................35

4.8. Livestock demographics and marketing practices in the region..........................39

4.9. Disease surveillance in the region........................................................................43

4.10. Diagnostic laboratory capacity ...........................................................................48

4.11. Emergency response capacity.............................................................................49

4.12. Release assessment conclusions .........................................................................52

Section 5. Exposure Assessment .....................................................................................57

5.1. Waste feeding to susceptible swine .....................................................................57

5.2. Imported live animals ..........................................................................................58

5.3. Imported genetic material ....................................................................................58

Section 6. Consequence Assessment...............................................................................60

6.1. Effects on animal health and production .............................................................60

6.2. Control and eradication costs...............................................................................60

6.3. Market Impacts ....................................................................................................61

6.4. Effects on public health .......................................................................................62

6.5. Effects on the environment ..................................................................................62

6.6. Consequence assessment conclusions..................................................................62

Section 7. Risk Estimation...............................................................................................63

References.........................................................................................................................64
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List of Figures

Figure 1: Map of Italy, APHIS Regionalization of Italy for SVD......................................8

Figure 2: Organization Chart for Italian Veterinary Services...........................................17

Figure 3: Italy SVD Outbreaks, 2002 – 20011 ................................................................26

Figure 4: Swine population density in Italy......................................................................41

List of Tables

Table 1: Brescia Eradication Activity Timeline, 2007-2008 ...........................................28

Table 2: Italy’s National SVD Control Program Provisions ............................................30

Table 3: Swine populations in northern Italy....................................................................40

Table 4: Italy’s National SVD Surveillance Program Scheme.........................................44

Table 5: SVD Serological Surveillance, 2008-2011.........................................................46

Table 6: SVD Virological Surveillance, 2008-2011.........................................................47

List of Appendices

Appendix 1: Ministry of Health Ministerial Order dated 12 April 2008 ...................... A-1

Appendix 2: Assessment of the risky period in SVD outbreaks in Northern Italy...... A-44
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Abbreviations 

APHIS Animal and Plant Health Inspection Service

AUSL Aziende Sanitarie Locali (Local Health Unit)

BIP border inspection post 

CERVES Centre of Reference for Vesicular Diseases

CFR United States Code of Federal Regulations

CNSA National Food Safety Committee

CSF classical swine fever

CVO Chief Veterinary Officer 

DVPHNFS Department of Veterinary Public Health, Nutrition and Food Safety

EC European Commission

ELISA Enzyme-linked immunosorbent assay

EU European Union

FAO Food and Agriculture Organization of the United Nations

FMD foot and mouth disease

FVO Food and Veterinary Office of the European Commission 

ISS Istituto Superiore di Sanita) 

IZS Istituti Zooprofilattici Sperimentali

IZSLER Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia 

MIPAAF Ministry of Agriculture, Foodstuff and Forestry Policies 

MOH Ministry of Health

NAS Police for Health

OIE World Organization for Animal Health (formerly Office International des Epizooties)

PCR polymerase chain reaction

RPHS Regional Public Health Services 

RVS Regional Veterinary Services 

SVD swine vesicular disease

USDA United States Department of Agriculture

USMAF Airport and Border Health Offices

UVAC Veterinary Offices for Community Affairs

VS Veterinary Services, Animal and Plant Health Inspection Service

WHO World Health Organization
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Section 1. Executive Summary 

The European Commission (EC) on behalf of the government of Italy submitted a request to the 

U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) in 1997 

to regionalize Italy for swine vesicular disease (SVD) by considering Regions in northern Italy as 

being free of this disease. APHIS conducted a qualitative risk assessment and published a 

proposed rule in June 1999 to recognize eight Regions in northern Italy as SVD-free [1, 2]. 

However before that rule was made final, SVD outbreaks occurred in four of the eight regions: 

Abruzzo, Emilia-Romagna, Molise, and Piemonte. Therefore, in the final rule published in April 

2003, APHIS recognized only four Regions in northern Italy as SVD-free, namely, Friuli, 

Liguria, Marche, and Valle d’ Aosta [3]. 

In the intervening years, there have been several significant events affecting APHIS’ evaluation 

of Italy’s SVD status. Shortly after the 1999 risk assessment was released, Italy decentralized its 

veterinary authority giving greater autonomy over animal health to the Regions [4-9]. In the last 

ten years, over 590 SVD outbreaks have occurred in Italy, most notably in southern Italy,

although in 2006-2007 and 2009 there were spikes in outbreaks reported in central and northern 

Italy [10-24]. In response to the continued presence of SVD in certain areas of Italy, the 

European Commission (EC) issued Commission Decision 2005/779/EC, in November 2005, 

which included recognition of SVD-free Regions, Provinces and holdings in Italy and mandated 

certain protection measures against SVD be implemented in all of Italy [25]. Among these 

measures were provisions for SVD surveillance requirements, live pig movement restrictions, 

and communication requirements between Italy and the European Union (EU) Member States. 

In April 2007, APHIS conducted a site visit to northern and central Italy to evaluate the response 

to two ongoing SVD outbreaks and to assess EC’s SVD regionalization approach for Italy. 

During that visit, APHIS identified several areas of concern related to gaps in the authority, 

organization, and infrastructure of the Italian veterinary services [26]. These gaps appeared to 

complicate disease control efforts leading to greater spread of SVD, especially regarding live 

swine movements marketed through dealer’s premises. Problems with dealer’s premises were

often associated with insufficient biosecurity practices. At that time, APHIS concluded that the 

situation did not warrant consideration of additional recognition actions. 

In the following year, April 2008, the Italian Ministry of Health issued a Ministerial Order which 

implemented a national SVD control plan implementing and in some cases exceeding measures 

required by Decision 2005/779/EC [27]. In some Regions, particularly in northern Italy, 

Regional veterinary authorities have implemented additional measures exceeding those required 

by the national authorities and during outbreak undertook extraordinary actions to respond to the 

situation [14, 15]. In 2009, the Italian Ministry of Health revised its approach by requesting that 

APHIS consider recognizing a macro-region in northern Italy as being low-risk for SVD [28]. 

APHIS returned to Italy in December 2010 to conduct a site visit to four Regions in northern 

Italy, Lombardia, Emilia-Romagna, Veneto and Marche.
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This report represents APHIS’ risk assessment of the SVD disease status of north-central Italy 

Regions of Lombardia, Emilio-Romagna, Veneto, Piemonte, and the Autonomous Provinces of 

Trento and Bolzano, and re-evaluates the SVD disease status of the Region of Marche.

1

 

Supporting documentation reviewed for this risk assessment consists of documentation provided 

by the government of Italy, Ministry of Health, the European Commission, observations made by 

APHIS technical teams during a site visits in April 2007 and December 2010, peer-reviewed 

articles, and data from the World Organization for Animal Health (OIE) and other technical 

sources.

This risk assessment was conducted according to the format recommended by OIE and, 

therefore, includes a hazard identification section, a release assessment, an exposure assessment, 

a consequence assessment, and a risk estimate [29]. The hazard under consideration is the SVD 

virus. The risk assessment provides the basis for an APHIS decision on recognizing the SVD 

disease status in certain regions of Italy. 

Release Assessment

APHIS concludes that the SVD virus is not known to exist in the region of Italy under 

evaluation. However APHIS identified risk factors which pose risk of reintroducing the virus

into this region. These factors include: persistence of SVD virus in southern Italy, potential 

spread of virus due to high volume movements through certain type of holdings (dealers’ 

premises), and movement of swine, pork and pork products from areas of Italy considered by 

APHIS to be SVD-affected into the region under evaluation. 

APHIS intends to apply restrictions contained in Title 9, United States Code of Federal 

Regulations (CFR), Sections 94.13 and 94.14 to further mitigate any potential release of SVD 

virus. Based on evaluation of the 11 factors, as well as observations from the site visits, APHIS 

considers that, for the region under review by APHIS, Italy has the detection capabilities, 

reporting and traceability systems, and emergency response systems necessary to respond to any 

reintroduction of SVD, to identify and remove exposed or potentially infected breeding swine, 

pork or pork products from the export market channel, and to comply with APHIS’ certification 

requirements for exports to the United States. Therefore, APHIS concludes that the risk of 

exporting SVD-infected breeding swine, pork and pork products from the regions of Italy being 

evaluated by APHIS would be low. 

Exposure Assessment

APHIS assessed the likelihood of exposure of susceptible animal populations in the United 

States to SVD virus carried by breeding swine, pork or pork products, and swine genetic material 

imported from Italy. This assessment concluded that the likelihood of exposure of susceptible 

swine to the SVD virus via waste feeding was low, based on studies of the of the U.S. waste-

 1 The Region of Marche in central Italy was visited by APHIS because it is one of the four Regions currently 

recognized by APHIS as being SVD-free and the only one of the four Regions that recently experienced an outbreak 

of SVD. Mache is not a major pork production area of Italy and is considered by APHIS to be representative of the 

four Regions currently recognized by APHIS as being SVD-free.
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feeding sector. Although the unmitigated potential for exposure to infective virus via live swine 

or swine genetic material was comparatively high, APHIS concluded that the likelihood of 

exposure of U.S. domestic swine via breeding swine, pork or pork products, or swine genetic 

material from Italy was low. 

Consequence Assessment

The biologic and economic consequences of introducing SVD virus into the United States would 

vary based on the extent of the outbreak at the time of detection, the virus serotype introduced, 

and movement and demographics of affected swine, but could be expected to be substantial. 

Additionally, restrictions imposed by international trading partners could be expected to result in 

severe economic losses to the U.S. livestock industry.

Risk Estimation

In summary, although the consequences of a SVD outbreak in the United States would be high, 

the findings of the release and exposure assessments lead APHIS to consider the risk of SVDinfected swine, pork or pork products entering the United States from the region of Italy under 

evaluation by APHIS and exposing U.S. swine to the disease to be low.
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Section 2. Introduction

History

In July 1997, APHIS received a request from the European Commission (EC) for recognition of 

the SVD status of certain geographic areas of Italy. Italy is organized into 21 political subunits, 

19 Regions, each being further subdivided into Provinces, and 2 autonomous Provinces. The 

Provinces of Trento and Bolzano act independently with authority similar to that of a Region 

(see Figure 1). 

Figure 1: Map of Italy

Source: USDA:APHIS:VS:CEAH
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Based on information provided by the EC and Italian veterinary authorities, in 1999 APHIS 

released a qualitative risk assessment [1] of the SVD status of the following Regions of Italy:

• Abruzzo

• Emilia-Romagna

• Friuli

• Liguria

• Marche

• Molise

• Piemonte

• Valle d’Aosta

The 1999 risk assessment supported the conclusion that these 8 Regions were SVD-free. A rule 

published in June 1999 proposed to recognize these Regions as SVD-free, subject to certification 

requirements due to their proximity to adjacent SVD-affected areas in Italy [2]. However before 

the rule was made final, SVD outbreaks occurred in Abruzzo, EmiliaRomagna, Molise, and Piemonte. So the final rule, published in April 2003, recognized only 

four Regions (Friuli, Liguria, Marche, and Valle d’ Aosta) [3]. Since the risk assessment was 

written, Italy decentralized its veterinary authority giving greater autonomy to the Regions. 

Several EU Food and Veterinary Office (FVO) reports raised concerns about inconsistencies in 

implementing and enforcing EU animal health control measures [4-9].

Over the last ten years, numerous SVD outbreaks have occurred in Italy, most notably in 

southern Italy, although in 2006-2007 and 2009 there were spikes in outbreaks reported in 

central and northern Italy. A summary description of these outbreaks is included in a subsequent 

section of this report.

In November 2005, the European Commission (EC) issued Commission Decision 2005/779/EC 

[25] concerning animal health protection measures against SVD in Italy. The EC adopted this 

measure in response to the continued presence of SVD in Italy. This Decision outlined the EC’s 

approach to regionalization of Italy for SVD, including provisions for SVD-free recognition of 

Italian Regions, Provinces and holdings. In addition, it included provisions for SVD 

surveillance, live pig movement restrictions, and communication requirements between Italy and 

the European Union (EU) Member States. The Decision contains two annexes, one lists Regions 

of Italy recognized by the EC as free from SVD and the other lists Regions not recognized by the 

EC as free of SVD. Since November 2005, the EC has amended Decision 2005/779/EC on 

several occasions, modifying both the SVD control and surveillance measures and the lists of 

SVD-free Regions.

APHIS 2007 Site Visit

 

APHIS previously had individually evaluated each Region in Italy for SVD; however, in 2007 

APHIS intended to evaluate all of Italy for SVD in accordance with the EC regionalization 

approach. In 2007, APHIS conducted a site visit to assess the mitigating effect of 

implementation of EC regionalization measures described in Decision 2005/779/EC in 
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representative Regions of Italy as a means to assess the overall risk of importing swine, pork and 

pork products from all of Italy. This strategy was modeled on APHIS’ recognition of the EU as 

being low-risk for classical swine fever (CSF). The EU-CSF recognition was based on APHIS’s 

evaluation which showed that EC control measures imposed in Member States sufficiently 

mitigate the risk of introducing CSF into the United States from the recognized region of the EU. 

During that site visit, however, APHIS identified several areas of concern which led to the 

conclusion that APHIS’ intended risk assessment approach was not appropriate for assessing 

SVD risk in Italy at that time. Those concerns, described in a letter dated July 3, 2007 [26], 

were:

Concerns related to the authority, organization, and infrastructure of the veterinary services 

organization in Italy

• The lines of authority between the central veterinary authority within the Ministry of 

Health, the Regional veterinary authorities, and local veterinary authorities were not 

clear. There appeared to be variability between and within the Regions visited as to 

where authority for certain decisions and actions reside. Some variability was attributed 

to local or Regional measures implemented in excess of those stipulated by the national 

swine health plan (i.e., extraordinary measures). This finding suggested to APHIS that 

certain local or Regional authorities did not consider the basic provisions of the national 

plan to be sufficient to control SVD. Although APHIS was told that revisions to the 

national plan were anticipated, at the time of the site visit details of the proposed 

revisions were not known. 

• APHIS was concerned that clear lines of authority were needed to give credibility to 

certification statements by national authorities that would be required on export 

certificates. 

• Enforcement authority was not always apparent or easily identifiable to the site visit 

team. Approaches to enforcement seemed to vary from one Region to another. For 

example, some local authorities indicated that they approached enforcement by providing 

incentives for compliance rather than penalties for non-compliance. 

• Chains of communication did not always appear to be efficient. Communication errors 

appeared to have caused delays in the sharing of critical information during outbreaks. 

This was observed to be a problem both between Regions and the central authority (and 

ultimately to the European Commission), as well as from one Region to another. The 

team learned of several instances where outbreak information was not delivered in a 

timely fashion to Regional or national authorities. Communications appeared to be a 

particular problem with certain tracebacks and traceouts that involved more than one 

Region and the communication problems ultimately resulted in delayed actions relevant 

to disease control and eradication. 

• Significant variability was observed between the five Regions APHIS visited in their 

approach to SVD control. Differences were observed in emergency operations plans, 

surveillance sampling protocols, auditing procedures, implementation of animal 

movement controls prescribed by the EC, biosecurity guidelines and practices, 

procedures for cleaning and disinfection of transport vehicles, and even the date of 

implementation of revisions to Commission Decision 2005/779/EC. 
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Concerns about Dealer’s premises

• The APHIS team noted near unanimous agreement among veterinary authorities 

(national, regional, and local) and swine industry representatives that the existence of 

dealer premises represented a significant risk for spreading SVD within Italy. APHIS was 

advised that testing regimens were being revised to enhance earlier detection if disease 

occurred and thereby decreasing the likelihood of its spread. 

• The APHIS team was particularly concerned with deficiencies in biosecurity on the 

dealer premises, e.g., commingling of swine from multiple holdings. The team also 

perceived a lack of awareness of or concern regarding SVD among the holding 

employees. Deficiencies were also observed in the animal health control measures taken, 

such as with the cleaning and disinfection of transport vehicles and recording of swine 

movements onto and off the holding. 

Disease status concerns

• The recurrence of new outbreaks in Regions considered free of SVD raised concerns as to 

the effectiveness and enforcement of control measures. This concern was compounded by 

Italy’s inability to determine the source of the virus responsible for the outbreaks. 

APHIS 2010 Site Visit

During the period from the April 2007 and the December 2010, several significant events 

impacted the SVD situation in Italy. In April 2008, the Italian government published a 

Ministerial Decree which harmonized the SVD-control framework across Italy [27]. The 

Ministerial Decree reduced or eliminated several of the risky practices previously associated with 

the spread of SVD through dealer premises. During this time period there was an overall decline 

in the number of SVD outbreaks throughout Italy, especially in northern Italy [11, 12, 16-19]. 

These events are described in subsequent sections of this report.

In December 2010, APHIS conducted a site visit to northern and central Italy visiting four 

Regions. The Regions of Lombardia, Veneto, and Emilio-Romagna represent the major pork 

production area of Italy and are located in the Po River Valley in northern Italy. These Regions 

are considered by APHIS to be representative of all the northern pork production Regions of 

Italy. The Region of Marche in central Italy was visited by APHIS because it is one of the four

Regions currently recognized by APHIS as being SVD-free and the only one of the four Regions

that recently experienced an outbreak of SVD.2 Mache is not a major pork production area of 

Italy and is considered by APHIS to be representative of the four Regions currently recognized 

by APHIS as being SVD-free.

Documentation 

Supporting documentation reviewed for this risk assessment consists of documentation provided 

by the government of Italy, Ministry of Health, the European Commission, observations made by 

APHIS technical teams during a site visits in April 2007 and December 2010, peer-reviewed 

 2 The four Regions currently recognized by APHIS as being SVD-free are Friuli, Liguria, Marche, and Valle d’ 

Aosta.
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articles, and data from the World Organization for Animal Health (OIE) and other technical 

sources.

Methodology 

This risk assessment was conducted according to the format recommended by OIE and, 

therefore, includes a hazard identification section, a release assessment, an exposure assessment, 

a consequence assessment, and a risk estimate [29]. The hazard under consideration is the SVD 

virus. The risk assessment provides the basis for APHIS to decide whether to recognize the SVD 

disease status in certain regions of Italy. 

Application 

In this risk assessment, APHIS evaluates the SVD disease status of north-central Italy, including 

the Regions of Lombardia, Emilio-Romagna, Veneto, Piemonte, and the Autonomous Provinces 

of Trento and Bolzano, and re-evaluates the SVD disease status of the Region of Marche. APHIS 

has previously evaluated all of Italy for CSF in its evaluation of the European Union. In 

accordance with APHIS regulations regarding CSF from the EU, APHIS currently restricts the 

export of swine (i.e. live animals) from the EU, allowing only the export of breeding swine [30]. 

Other CSF-related restrictions apply to the export of swine semen and fresh pork to the US.

APHIS currently considers the Region of Sardinia in Italy to be affected with both CSF and 

African Swine Fever (ASF). 
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Section 3. Hazard Identification 

The OIE lists several animal diseases that are considered primary hazards associated with trade 

of animals and animal products. APHIS regulations mitigate the risk of introduction of these 

foreign animal diseases in to the United States. As such, APHIS conducts an import risk analysis 

addressing hazards of primary concern prior to initiating or resuming trade of animal 

commodities. APHIS considers swine vesicular disease (SVD) virus to be a potential hazard 

associated with trade of live swine and swine products. SVD was once endemic in much of 

Europe, but its distribution is currently limited to southern Italy. It has also been diagnosed in 

parts of Asia, and is still thought to be endemic in some areas [31].

Causative agent

SVD virus is a member of the viral family Picornoviridae, genus Enterovirus. One serotype and 

several strains have been identified [31, 32]. SVD virus isolates from Europe and Japan have 

been classified into at least four distinct groups, with two groups containing older isolates, and 

two groups containing more recent European isolates [31, 33, 34]. The different groups may 

represent distinct SVD virus introductions into Europe from Asia [33, 35]

Host range

Swine are the only natural hosts of SVD virus [32, 36]. Infections have been reported in humans 

working with SVD virus in the laboratory and in experimental mice, but these species are not 

significant in the epidemiology of the disease [31, 36-38].

Morbidity and mortality

The primary significance of SVD is its clinical similarity to foot and mouth disease [31, 36]. 

Clinical signs include fever, sudden lameness, and vesicles with subsequent erosions along the 

snout, feet, and teats [32, 36]. Signs can range from absent to mild to severe, depending on virus 

strain, route of infection, age of the animal, and husbandry. Morbidity rates may be low 

throughout an entire herd, but high in certain pens. Clinical recovery usually occurs with 2 to 3 

weeks, though a dark horizontal line may persist on the hooves due to a temporary disruption in 

growth [31, 32, 36, 38]. Production losses are not severe, and SVD causes essentially no 

mortality [31, 32, 39].

Persistence of SVD virus infection is rare [38, 40]. Some strains of SVD virus produce only 

mild clinical symptoms or are asymptomatic and detected only through laboratory surveillance 

[36, 38]. For example, a 2002 outbreak of SVD in Italy involved subclinical infection in all but 

one of 10,312 affected pigs [41]. 

Incubation period

The incubation period for SVD is generally 2 to 7 days [32, 36]. Large amounts of virus can be 

present in nasal and oral secretions and feces up to 2 days prior to the appearance of clinical 

signs [31, 32]. 
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Sources of virus and transmission

Blood and feces of sick animals, as well as epithelium from vesicles and vesicular fluid, are good 

sources of SVD virus. The period of highest shedding occurs during the first week after 

infection [31, 32]. The virus can be detected in the blood 2 days after exposure and subsequently 

in most other tissues and semen [32, 33, 42, 43]. Although SVD virus does not appear to have a 

tropism for skeletal muscle cells, it is viable and infectious in meat for long periods of time [31, 

32, 44]. Persistent infection is rare, but persistence of some strains in tissue for up to 100 days 

and fecal shedding for more than 4 months has been reported [32, 33, 38, 40].

SVD may be introduced into a herd by feeding garbage containing infected meat scraps, by 

introducing infected animals, or by fomites (such as an improperly cleaned livestock truck). High 

environmental stability is a key feature in the epidemiology of SVD. The SVD virus enters the 

body via broken skin, mucus membranes, or ingestion. After initial introduction into a herd, the 

disease spreads due to contact of susceptible pigs with infected pigs and feces [31-33, 38, 44]. 

Inactivation and survival

SVD virus is very stable in the environment. It is highly resistant to desiccation and freezing, 

and can survive for up to 11 months at -20°C to 12°C [33]. It is stable at pH2.5-12 [31-33], and 

is therefore unlikely to be destroyed by the post-mortem decrease in muscle pH that accompanies 

carcass maturation. SVD virus is also resistant to fermentation and smoking processes, and may 

remain in ham for 180 days, dried sausage for more than a year, and processed intestinal casings 

for more than 2 years [32]. The virus is resistant to many common disinfectants [33]. 

Inactivation can be achieved by heating at 60°C for 10 minutes [33].

Vaccination 

No vaccine against SVD is available [36].

Laboratory Diagnostics

Serologic (antibody detection) tests can be used to confirm clinical cases of SVD and detect 

subclinical infections. Since many cases of SVD are subclinical, the disease is often first 

suspected based on positive results on serologic tests performed for surveillance or export 

certification. The virus neutralization test is the OIE prescribed test for use in international 

trade. Enzyme-linked immunosorbent assay (ELISA) tests are also used: they can be performed 

more quickly than the virus neutralization test and IgM/IgG isotype specific ELISA’s are useful 

for determining the time of infection. An animal that is positive on ELISA and negative on 

follow-up virus neutralization can be considered uninfected. A small proportion of normal, 

uninfected pigs will display a positive result on serological tests for SVD, often presenting as the 

single positive animal in a herd that has no clinical signs or exposure history. These “singleton 

reactors” can be differentiated by retesting the positive animal and its herd mates [33, 36].
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Polymerase chain reaction (PCR) and ELISA are appropriate screening tests for SVD antigen 

detection, while virus isolation is the reference antigen detection test and should be used for 

confirmation. In the presence of clinical signs, demonstration of virus in lesion material or 

vesicular fluid via ELISA is sufficient to make a diagnosis of SVD. Testing of fecal samples 

from pen floors via PCR or virus isolation is used to detect subclinical infection [36].
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Section 4. Release Assessment

4.1. Authority, organization, and infrastructure of the veterinary services

Organization of the Official Veterinary Services [4-9, 13-15, 20, 21, 45]

Central authority

The central veterinary authority of Italy is the Ministry of Health (MOH), Department of 

Veterinary Public Health, Nutrition and Food Safety (DVPHNFS) which has the responsibility 

for animal health, food and feed safety, and animal welfare. DVPHNFS, one of four 

Departments within the Ministry of Health, was established by Decree 202 of 1 October 2005, as 

amended by law Number 244 of 30 November 2005. The Ministry of Agriculture, Foodstuff and 

Forestry Policies (MIPAAF) is responsible for the controls on quality and traceability of food 

and feed.

Italy’s chief veterinary officer (CVO) is the head official of the Department of Veterinary Public

Health, Nutrition and Food Safety and answers directly to the Minister of Health. The 

Department’s responsibility and authority is divided into three directorates, the Animal Health 

and Veterinary Medical Products General Directorate, Food Safety and Nutrition General 

Directorate, and the National Secretariat for Risk Assessment on the Food Chain. 

The Animal Health and Veterinary Medical Products General Directorate is further organized 

into nine sections:

• Office I – General Affairs

• Office II – Animal Health and Animal Identification

• Office III – Operational Management of the “National Centre for Animal Disease 

Control” and “Central Crisis Unit”

• Office IV – Veterinary Medical Products and Medical Devices for Veterinary Use

• Office V – Manufacturing Veterinary Medical Products and Medical Devices for 

Veterinary Use GMP Inspections

• Office VI – Animal Welfare

• Office VII – Products for Animal Feeding

• Office VIII – Border Inspection Post (BIP) and Veterinary Offices for Community 

Affairs (UVAC) Coordination

• Office IX – Audit

The Food Safety and Nutrition General Directorate also manages its responsibilities in nine 

sections:

• Office I – General affairs

• Office II – General food hygiene

• Office III – Products of animal origin hygiene

• Office IV – Foodstuffs for particular nutritional uses, food supplements, novel foods

• Office V – Human nutrition, healthy diet promotion, labeling

• Office VI – Food technology hygiene
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• Office VII – Phytosanitary products

• Office VIII – Rapid alert system for food and feed

• Office IX – Foodstuff export

The National Secretariat for Risk Assessment on the Food Chain is divided into four sections:

• Office I – General affairs

• Office II – Assessment of physical, chemical and biological risk

• Office III – Consumer relations

• Office IV – Secretary’s office of National Food Safety Committee (CNSA)

Figure 2: Organization Chart for Italian Veterinary Services

Source: Ministry of Health 

Central authority field offices

The Ministry of Health has the authority and the responsibility to operate local offices 

controlling the import and intra-community trade of animals, food of animal origin and animal 

feed. Within Italy there are 35 Border Inspection Posts (BIPs) with responsibility for import 

controls on imported animals, food of animal origin and animal feed. There are 12 Seaport, 

Airport and Border Health Offices (USMAF), comprising 35 local units at the main seaports and 

airports, which are responsible for controls on imported food of non-animal origin. The control 
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of intra-community trade of animals, food of animal origin and animal feed is the responsibility 

of 17 Veterinary Offices for Community Affairs (UVAC). The EC Food and Veterinary Office 

(FVO) maintains supervision of these offices. 

Carabinieri Health Protection Unit (NAS)

The Ministry of Health conducts enforcement activities through the Police for Health (NAS), a 

special unit of the Carabinieri, a branch of Italy’s Armed Forces. Although hierarchically linked 

to the Carabinieri, the NAS operates under the supervision and direction of the Ministry of 

Health. The NAS is organized into a central command, 3 field offices, and 35 territorial 

inspection units. The NAS is responsible for investigations and controls on illegal adulteration 

of foodstuffs, fraud, illegal trafficking of medicines, and may be requested by the MOH to 

enforce animal health controls and investigations. NAS officials have the title of health 

inspectors and the authority of judicial police. The NAS is staffed by approximately 1,000 

employees most are warrant officers who are mainly involved with food safety inspections.

Laboratory services

The Istituti Zooprofilattici Sperimentali (IZS) are veterinary public health institutes which 

provide a network of public laboratories at the national and regional level. There are 10 IZS with 

85 field diagnostic units at the provincial level. Each single IZS serves one or more Regions. 

The IZS are subject to control and supervision by the Regions and coordination by the MOH, 

DVPHNFS. The most important tasks of the IZS are:

• Diagnosis of animal and zoonotic diseases

• Epidemiological surveillance in animal health, animal production and food of animal 

origin

• Research on animal health and welfare, infectious animal diseases, zoonoses, food and 

feed safety

• Training of specialized animal health veterinarians and animal health technicians

• Support and assistance in the animal disease control and eradication and with 

development of improvements in animal production

Each IZS serves as a National Reference Laboratory of one or more animal disease or for food 

safety issues and some have been designated as Food and Agriculture Organization of the United 

Nations (FAO), OIE or World Health Organization (WHO) Reference Laboratories. The IZS at 

Brescia, the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia (IZSLER). 

Operating within IZSLER is Italy’s national reference laboratory for vesicular diseases, the 

Centre of Reference for Vesicular Diseases (CERVES). The CERVES is also an OIE reference 

laboratory for SVD and an FAO Reference center for FMD and SVD.3

 

The National Health Institute (Istituto Superiore di Sanita) (ISS) is the leading technical and 

scientific public body of the Italian National Health Services. The ISS supervises the 

laboratories of the Italian National Health Service engaged in food safety. Its activities include 

 3 The EC reference laboratory for SVD is the Institute for Animal Health in Pirbright, England. 
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19

public health research, control, training and consultation. An important activity of ISS, which is 

carried out on behalf of the Minister of Health or the Regions, is inspection and quality control of 

food products and packaging. The ISS includes: the Community Reference Laboratories for 

Escheria coli; for parasites (in particular Trichinella) and for the residues.

Regional veterinary authorities

In 2001, the Italian Constitution was amended so that responsibility for health in general, 

including animal health, food and feed safety and animal welfare, became shared between the 

national and regional governments. Where these authorities are shared, the national and regional 

governments share legislative authority. However, related administrative powers are delegated

to the regional governments. The national authority transposes EC Directives and Decisions for 

the whole country and these are then legislatively adopted by individual Regions. However, the 

MOH maintains the authority and responsibility for international commerce of animals and 

animal products, setting and developing necessary import and export controls. This 

responsibility includes the management of all border inspection posts. The MOH also serves to 

provide national coordination, guidance and inspection of establishments in relation to export to 

other countries. The MOH has the authority to audit regional control activities. 

Italy is subdivided regionally into 19 Regions and 2 Autonomous Provinces each having the 

responsibility for planning, implementing and verifying controls within their respective territory. 

Although there is some regional variation in the internal structure, responsibility for animal 

health, food and feed safety and animal welfare is assigned to the Regional Veterinary Services 

(RVS) which normally are part of the Regional Public Health Services (RPHS). Approximately 

100 veterinarians are employed by the RPHS. While the RPHS functions to provide oversight 

and coordination, implementation of controls is done on a local level by inspectors employed by 

the Local Health Units (AUSL). 

Local veterinary authorities 

The AUSL are public bodies responsible at the local level for the organization and management 

of all public health services. The AUSL have a high degree of managerial, administrative, 

financial and technical autonomy. There are 146 AUSLs in Italy. Within the AUSL, the Local 

Veterinary Services (LVS) is a division of the Department of Prevention. The LVS are 

responsible for animal health, animal welfare, food of animal origin, and animal feed. The 

majority of inspectors in the LVS are veterinarians. There are approximately a total of 5,787

veterinarians employed in AUSLs throughout Italy. 

The State-Regions Conference is a permanent institution to facilitate cooperation between the 

MOH and regional governments.

EU Oversight

The EC maintains oversight of Member State implementation of EC Directives and Decisions 

through periodic audits by the EC Food and Veterinary Office (FVO) in accordance with the 

general provisions of European Community legislation (Article 45 of Regulation EC No. 
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882/2004 of the European Parliament and of the European Council) [9]. In addition, each year 

Italy submits its annual national plan for SVD eradication for Commission and the EC Standing 

Committee on the Food Chain and Animal Health routinely monitors the status of the SVD 

situation in Italy.

Legal Authority for Animal Health Activities [25, 27, 46-49]

Control measures in Italy are required to follow European Commission (EC) regulations that are 

applicable throughout the European Union (EU). These regulations are documented in Council 

Directives and Commission Decisions. The provisions of the EC regulations must be 

incorporated into the Italian regulations. 

General animal health measures

Council Directive 82/894/EEC (December 1982) stipulates that SVD is a notifiable disease in 

accordance with provisions for the notification of animal diseases within the European Union. 

Specific response measures for several animal diseases, including SVD, to be applied whenever 

a disease outbreak occurs in an EU Member State were established by Council Directive 

92/119/EEC (December 1992). Standards for laboratory diagnostic procedures, sampling 

methods and criteria for the evaluation of the results of laboratory tests for the confirmation and 

differential diagnosis of SVD are set out in Commission Decision 2000/428/EC (July 2000). 

This Decision also recognizes the Institute for Animal Health in Pirbright, England as the EC

reference laboratory for SVD. Transposition of these EC requirements into Italian law was 

principally made through Republic Presidential Decree no. 362, May 17, 1996, and Ministerial 

Order of March 28, 2007.

Specific SVD control measures

With the exception of two outbreaks in Portugal (December 2003 and January 2004), Italy is the 

only EU Member State to experience SVD outbreaks in recent years. SVD appears to be 

persisting within limited regions of Italy giving rise to sporadic outbreaks elsewhere in the 

country. Following a significant rise in SVD outbreaks in 2002-2004, the EC issued Decision 

2005/779/EC in November 2005 addressing specific SVD control measures to be applied in

Italy. The provisions were intended to mitigate SVD spread to the free areas of Italy or to other 

Member States. This Decision has been amended four times since originally adopted, 

strengthening certain provisions and revising the lists of regions recognized as being SVD-free 

and SVD-affected.
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Key provisions of Decision 2005/779/EC are:

• Recognition of regions: establishes two lists of regions in Italy, a SVD-free and SVDaffected list. When first adopted in December 2005, the EC considered four regions in 

Italy to be SVD-affected. The Decision has been subsequently amended four times, 

including several amendments to these two lists. Currently the EC considers two regions 

in Italy to be SVD-affected, the Regions of Campania and Calabria. Regional differences 

in the SVD status within Italy are described in more detail in the next section (Section 

4.2).

• Suspension of the recognition of provinces in a region recognized as SVD-free: 

establishes the requirement and process for suspending and subsequently regaining the 

free status of a region or province (a subunit of a region) that is listed as being SVD-free. 

A province must complete the steps to regain its status within 6 months or the recognition 

is revoked. 

• Recognition of individual holdings: provides the criteria for obtaining, maintaining and 

suspending recognition of individual holdings as SVD-free in both SVD-free and affected 

regions. The criteria for recognition of holdings are described in Section 4.4.

• Surveillance: establishes the requirements for surveillance in both SVD-free and SVDaffected regions. Requirements specify, for each list of regions, the type and frequency 

of testing for holdings with breeding pigs and assembly centers in order to detect a 5%

SVD prevalence with a 95% confidence interval. SVD surveillance activity is described 

in more detail in Section 4.9.

• Movement controls for swine: establishes measures restricting the movement of swine 

both within Italy and between Italy and other Member States. Movement of swine from a 

holding not recognized as SVD-free is prohibited, including movement to a 

slaughterhouse. However, Article 8 allows swine from SVD-free holdings within ECdesignated SVD-affected regions to move to SVD-free regions under certain conditions, 

including movement restrictions on the destination herd, until completion of mandatory 

testing of the herd at least 28 days after receiving swine from SVD-affected regions. 

Movement of swine from SVD-affected regions, regardless of the status of the holding, is 

prohibited. Swine may not move from assembly centers (dealer’s premises) until 

obtaining negative results on SVD samples, and that shipment of swine must be sampled 

and negative test results obtained prior to movement from the holding of origin to a 

slaughterhouse. Movement of swine through dealer’s premises had been linked to the 

spread of SVD. 

• Communication to the EC and the Member States: Italy is obligated to report every 

six months through the EC Standing Committee on the Food Chain and Animal Health 

any relevant information on its SVD situation. 

Italy transposed Decision 2005/779/EC into Italian law with the issuance of Ministerial Order 

dated April 12, 2008, Sanitary Measures for the Eradication of Swine Vesicular Disease and 

Surveillance of Classical Swine Fever. The Ministerial Order exceeds the requirements of 

Decision 2005/779/EC in several significant ways: 

• Criteria for recognition of regions: Article 3 of the Ministerial Order defines criteria 

for a region to be recognized as SVD-free; whereas Decision 2005/779/EC lists free and 

not-free regions. For recognition to be granted by the Ministry of Health, Italy requires 

that: all swine holdings in the region are accredited as SVD-free holdings; and that all 
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SVD control activities as set forth in the national SVD eradication and control plan were 

carried out in the previous year. 

• Dealer’s premises: to address an identified risk of SVD spread, Italy restricts the 

movement of swine from dealer’s premises to allow only movements directly to 

slaughter. Furthermore, animals may not be kept on a dealer premises for more than 30 

days. Culled, unthrifty, underweight or diseased pigs are prohibited from being sold 

through dealer’s premises. Dealer’s premises must be emptied every 30 days to allow for 

a period of cleaning and disinfection. Transport vehicles must be washed and sanitized 

after each shipment and records verifying cleaning and disinfection must be maintained 

for 1 year. Minimum standards are set for biosecurity, sanitation, and traceability 

records. Compliance with these measures must be verified by local veterinary authorities 

as a pre-requisite for maintaining the holding registration. 

• Singleton reactors: Article 11 defines a singleton reactor as being suspected when a 

single seropositive case occurs with the following conditions: (1) the absence of clinical 

symptoms of SVD in the holding’s animals, (2) no history of SVD on the holding, and (3) 

no epidemiological correlation of the holding or seropositive animal with an outbreak of 

SVD or another seropositive animal. A singleton reactor is confirmed when there is no 

seroconversion of other swine on the holding and there is no increase in the antibody titer 

of the seropositive animal. 

• Slaughter of seropositive swine: Article 12 stipulates that seropositive animals, 

including singleton reactors, must be slaughtered within 72 hours of being so ordered by 

the local veterinary authorities. Seropositive animals must be transported and slaughtered 

separately without commingling with other swine, the head and viscera must be 

destroyed, and the meat must only be used for the domestic market only. The transport 

and slaughter are conducted under the supervision of the local veterinary authorities.

• Communications: Article 14 describes the required notifications and procedures by 

which local, regional and national veterinary authorities are notified of any serological or 

virological finding of SVD. 

• Biosecurity checklist: The annex to the Ministerial Order includes a biosecurity 

checklist which describes minimum standards and procedures for biosecurity on swine 

holdings and a list of approved disinfectants efficacious against SVD. 

Traceability measures

EC measures regarding the identification and registration of swine were laid down in Council 

Directive 92/102/EEC (November 1992) which was amended several times and eventually 

replaced by Council Directive 2008/71/EC (July 2008). Italy transposed and clarified the 

requirements of Directive 92/102/EEC as amended in Ministerial Order dated April 12, 2008,

Identification and Registration System of holdings, pigs and their movements. Italy has since 

drafted a revision to the Ministerial Order to incorporate changes to the registration system 

necessitated by the replacement Council Directive. The current identification and registration 

system for swine are summarized in this section. 

All swine holdings in Italy are required to be registered (except where a single pig is kept for 

home consumption purposes). Pigs are identified by a left ear tattoo containing a herd number. 

Pigs must be marked within 70 day of birth and in any case before they leave the holding.
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Any keeper of swine is required to keep a register stating the number of pigs present on the 

holding. This register shall include an up-to-date record of all movements, indicating the number 

of swine entering and leaving, origin or destination, and the date of each movement.

A movement document, referred to as Form 4, is required for all movements and subject to 

authorization by the regional veterinary services. Form 4 records detailed information on the 

holding of origin and destination, identification of the animals, means of transport and animal 

health status. 

In accordance with EC requirements, Italy maintains a computerized national swine health 

database which maintains a record of swine holding registrations, including their geospatial 

coordinates, and swine movements. The database is maintained by the Teramo IZS, which also 

functions as the National Reference Center for Epidemiology. The database is a web-based 

application which can be accessed by national, regional and local authorities. Some Regions 

maintain their own computerized database which integrates data with the national database.

The information maintained in the database includes for each registered holding: a unique 

identification number consisting of not more than 12 figures plus the country code (IT for Italy), 

the address and geographic coordinates of the holding, name and address of the person 

responsible for the animals, type of production unit and capacity, and the herd health status for 

the holding.

For swine movements the database captures for each shipment: the identification numbers of the 

holding of departure and of arrival or slaughterhouse (for swine imported from third countries 

the holding of importation), the departure and arrival dates, the number of animals being moved, 

and the number of the transport document and/or health certificate. This information is held on 

the database for three years.

From slaughterhouses, the database captures the following information about each group of 

swine slaughtered: date of slaughter, the number of animals slaughtered, the identification 

number of the holding of departure, the commercial categorization of the herd, and for breeding 

animals, the sex of the animal slaughtered. Additionally for swine originating from outside of 

Italy, the database identifies the country of origin, health certificate information, and if from a 

non-EU Member State, the date and location of inspection carried out by a border inspection post 

(BIP).

Annually, Italy audits compliance with the identification and registration system requirements by 

examining the records for at least 1% of all swine holdings. Penalties may be assessed for the 

following non-compliances: 

• failure to register holding with local official authorities;

• failure to notify changes in details of the holding;

• failure to identify animals;

• alteration of animal identification;

• failure to maintain the holding register;

• failure to update the holding register;
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24

• failure to record data into the national database;

• failure to complete transport document for slaughterhouse;

• failure to record information on slaughtered animal in the national database; and

• failure to record the herd consistency in the national database.

Discussion

During the December 2010 site visit, the APHIS team focused much of its attention on matters 

related to the authority, organization, and infrastructure of the veterinary services in Italy since in 

2007 APHIS identified several concerns related to this factor (see Section 2). The concerns 

identified in 2007 in regards to this factor appear to have been fully addressed for the region of 

Italy under evaluation by APHIS although some differences remain between the different 

Regions.

For the regions under review by APHIS, the Ministerial Order of April 12, 2008 harmonized the 

SVD control framework across the region. Despite some differences among the Regions visited

in regards to the manner in which they implemented the national SVD control plan, the basic 

framework provided by the Ministerial Order appears to have addressed concerns identified by 

APHIS in 2007. Specifically the lines of authority between the national, regional (or provincial), 

and local authorities appeared to more clearly defined. Communication chains between these 

entities had also been improved, especially regarding the improvements in the real-time

integration of local, regional and national databases. The holding registry system significantly 

enhances the traceability capacity of the official veterinary authorities. Enforcement activity 

seemed to be more uniformly applied in accordance with the authority established by the 

Ministerial Order.

The differences observed by APHIS in 2010 relate to enhanced measures that enhanced or 

exceeded the national plan. For example, the Regions of Lombardia, Emilia-Romagna, Veneto, 

Piemonte and the Autonomous Provinces of Tento and Bolzano have adopted a biosecurity 

checklist that is more restrictive than the one described in the national plan, and conduct more 

frequent inspections to ensure the measures are more effectively implemented. 

However, APHIS also observed differences between the major swine producing regions and 

those with less production. It appeared to the APHIS team that regions with less swine 

production (Veneto and Marche) did not assign the SVD control the level of priority as did the 

major swine production regions (Lombardia and Emila-Romagna). This observation is 

consistent with the observations made by APHIS in 2007 and suggests that a similar trend might 

exist in other low swine production areas of Italy. The low swine production areas include the 

other four regions currently recognized by APHIS as being SVD-free (Friuli, Liguria, Marche, 

and Valle d’ Aosta) and the central and southern parts of the country which are not currently 

under review by APHIS. 

Another significant observation in 2010 relates to measures implemented to reduce the risk of 

SVD spread which historically has been associated with dealer’s premises. It appears to APHIS 

that limiting the movement of swine from dealer’s premises exclusively to slaughterhouses, 

along with the other measures imposed upon dealer’s premises, have greatly reduced the risk of 
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25

spreading SVD from dealer’s premises to other swine holdings. APHIS was made aware that 

these measures have also resulted in a reduction of the number of dealer’s premises operating in 

the regions under review by APHIS.4 The impact on the incidence of SVD outbreaks related to 

dealer’s premises will be discussed in the next section. 

Ministry of Health officials explained to the APHIS team the existence of a type of holding 

which had some similar risk characteristics as dealer’s premises. These holdings, referred to as 

“high turnover” holdings, are farms where movements of swine to and from multiple holdings 

occur. Because these type of holdings do not rise quite to the level of turnover as a “traditional 

dealer’s premises” and thus not subject to specific measures imposed upon dealer’s premises, 

they do present similar risks. Several of the regions visited by APHIS conduct increased 

surveillance on these types of farms.

APHIS is concerned about the provision in Article 8, Decision 2005/779/EC which allows 

movement of swine from SVD-free holdings within EC-designated SVD-affected regions to 

holdings in SVD-free regions. As discussed in the next section, SVD outbreaks continue to 

occur in EC-designated SVD-free regions (although none since 2008 in the regions currently 

under review by APHIS). By all indications these outbreaks have resulted from reintroduction of 

SVD-virus into the free regions from affected regions and recently have been often associated 

with the movement of animals or their transport vehicles. Therefore, swine movements present a 

risk pathway for SVD spread that cannot be ruled out under current legal authorities. 

4.2. Disease Status in the Region [10-24, 39, 41, 45, 50-54]

Currently, APHIS considers the Regions of Friuli, Liguria, Marche, and Valle d’ Aosta in 

northern Italy as being SVD-free; the remainder of Italy is considered to be SVD-affected. The

Italian Ministry of Health and the EC currently list only two Regions in southern Italy, Campania 

and Calabria, as being SVD-affected and all other areas of Italy to be SVD-free. 

The last SVD outbreaks in the regions under review by APHIS occurred in the following years:

1998 Trento and Bolzano

2003 Piemonte

2006 Veneto

2007 Lombardia

2008 Emila-Romagna and Marche

SVD was first observed in Italy in 1966 when it appeared clinically as a suspicion of foot and 

mouth disease (FMD). Despite its similar clinical presentation, the SVD virus was found to have 

distinct biological, physical and chemical differences from other swine vesicular viruses. Since 

1973, SVD has been a reportable disease in Italy and beginning in 1995 Italy has conducted SVD 

surveillance and eradication activities. Despite these efforts SVD has proven to be persistent and 

 4 Prior to the restrictions imposed by the April 2008 Ministerial Order, dealer’s premises primarily moved swine to 

and from farms rather than from farms to slaughter. The new restriction eliminated the primary market channel 

involving dealer’s premises and as a result most dealer’s premises ceased operations.
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26

difficult to eradicate in certain areas of Italy giving rise to sporadic outbreaks elsewhere in the 

country. SVD is not very contagious and presents little to no clinical symptoms making rapid 

detection more difficult and resulting in more extensive spread. Detection is primarily the result 

of Italy’s active surveillance program. However, recently implemented control measures are 

having a positive effect and the number of outbreaks and spread seem to be in decline. 

Over the last ten years, numerous SVD outbreaks have occurred in Italy, most notably in 

southern Italy although in 2002, 2006-2007, and 2008 there were series of outbreaks reported in 

northern Italy (see Figure 3). Following a significant rise in SVD outbreaks in 2002-2004, the 

EC issued Decision 2005/779/EC in November 2005 addressing specific SVD control measures 

to be applied in Italy and created lists of regions recognized as either being SVD-free or SVDaffected. 

Figure 3.

Source: Data compiled from CERVES

Soon after Decision 2005/779/EC was issued, Italy experienced a sharp rise in the number of 

SVD outbreaks detected. The outbreaks occurred in both northern and central/southern parts of 

the country. Slight distinctions were found between the viruses circulating in the two areas, 

leading EC and Italian officials to conclude that two separate epidemics were occurring, one in 

the northern Regions of Lombardia and Veneto and the other in the central/southern Regions of 

Lazio, Molise and Calabria. 

The occurrence of outbreaks in the central/southern region was not unexpected as pockets of 

SVD virus persist in some parts of the area. The central/southern part of Italy is not a major 

swine production area with few large commercial swine production facilities. Most swine in this 

region are raised for domestic consumption rather than production of pork and pork products for 

intra-community trade or export. Some traditional practices associated with the domestic market 

carry a higher risk for spreading SVD and may result in the persistence of SVD in this region. 

0

20

40

60

80

100

120

140

160

180

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Italy SVD Outbreaks, 2002-2011

Nationwide Northern Italy
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27

Movement of swine through dealer’s premises is the practice most often implicated due to the 

risk of direct contact with infected swine or indirect contact with the feces of infected swine from 

contaminated holding pens or transport vehicles.

The epidemic in the north was significant because it occurred in the highest density swine 

production area of Italy characterized by numerous large commercial swine facilities. Much of 

the commercial production in this region operates within the vertically-integrated pork 

consortium enterprises, such as the Consorzio del Prosciutto di Parma. Most of Italy’s intracommunity and export of pork and pork products derive from swine produced and processed in 

this region. The northern Italy area had been accredited as SVD-free for some time and is distant 

to the regions of Italy where SVD seems to persist. The financial impact due to the loss in 

production and export markets was significant. Regional and local authorities worked closely 

with the swine production industry to respond to the epidemic. This alliance between 

government and industry resulted in major advances in the development of effective control 

measures to combat SVD.

The epidemic in the north began in November 2006 when SVD was detected during routine SVD 

surveillance at a slaughterhouse. Unfortunately, the disease presented sub-clinically, so by the 

time SVD was confirmed, the infection had spread to multiple holdings in Lombardia and 

Veneto. Once detected, regional authorities responded by implementing quarantine and 

movement controls in accordance with Directive 92/119/EEC. Protection and surveillance zones 

(3 and 10 km respectively) were established around each outbreak and a prohibition imposed on 

movement of live pigs from affected provinces5 to other Member States and third countries. 

The epidemic occurred in two waves, initially from November 2006 to February 2007 then 

followed by a cluster from July through October 2007 concentrated in the Brescia, a province of 

Lombardia. 

The Lombardia regional veterinary authorities concluded that EC disease control measures, 

implemented in compliance with EC Directive 92/119/EEC, would not be enough to control the 

epidemic. This conclusion was based on their consideration of the high density swine population 

in Brescia (2.500 pigs/km2

) and the burden that would be the result of prolonged maintenance of 

restriction zones necessitated by repeated outbreaks. Therefore regional authorities enacted a 

series of extraordinary measures to bring the epidemic under control. These extraordinary 

measures: a prohibition on movement of swine in the provinces where SVD outbreaks had been 

detected, retesting of all farms in the region (statistical sampling calculated for a prevalence of 

5% and confidence interval of 95%), restriction prohibiting all swine movement from dealer’s 

premises except moving directly to slaughter, and standards describing minimum biosecurity 

measures for farms, slaughterhouses and vehicles. 

However more extensive measures were implemented in the Province of Brescia. Extensive 

depopulation was carried out in what was referred to as the “risk area”. All swine located 2 km 

from the center of the protection zone established around outbreaks were destroyed, affecting

about 41.300 pigs on 15 farms. Ordinarily, depopulation is limited to the swine on holdings 

 5 In Italy, a “province” is an administrative sub-unit of a region. 
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where SVD is detected. In addition, a buffer zone was established extending 1 km out from the 

depopulation area (i.e. extending 3 km from the protection zone). Within the buffer zone, 

serologically sampling (P: 5%, I.C. 95%) was conducted upon completion of and 28 days after 

completion of depopulation in the “risk area”. The buffer zone included 13 farms, with about 

38.700 pigs. Restocking of holdings which had been depopulated was allowed after a 6-month 

period, rather than the usual four week period, but only for holdings which met the newly 

established biosecurity standards. During this time the Ministry of Health suspended Brescia’s 

SVD-free accreditation. By March 2008, the suspension was lifted when serological test results 

demonstrated that the SVD had been eradicated in the province. A timeline for the eradication 

control activities for Brescia is described in Table 1.

Table 1: Brescia Eradication Activity Timeline, 2007-2008

Date Activity

July 3, 2007 Outbreak detected in Brescia, beginning of second wave of epidemic

July 16, 2007 Suspension of Lombardia’s SVD-free accreditation by Ministry of 

Health and the EC

October 22, 2007 Last outbreak in Brescia was detected

November 9, 2007 Depopulation began

November 30, 2007 Depopulation completed

December 1, 2007 First serological sampling in “buffer zone”

December 31, 2007 Second serological sampling in “buffer zone”

January 3, 2008 Repeal of protection zone

January 14, 2008 Repeal of surveillance zone; and 

Sampling begins on all farms in Province of Brescia

February 22, 2008 Sampling completed on all farms for Province of Brescia

February 25, 2008 Sampling test results reported, all samples tested negative

March 5, 2008 Brescia regains SVD-free accreditation with Ministry of Health and EC

Source: Ministry of Health 

Discussion

The SVD epidemics of 2006-2007 provide an interesting case study to understand the 

epidemiology of SVD in Italy and the development of the measures employed to bring the 

epidemics under control. 

Both northern and central/southern epidemics share several important characteristics. Primarily,

the disease presented as sub-clinical infections. Extensive secondary spread involved dealer 

visits to multiple farms and movement of animals. Detection in both epidemics was initiated by 

Italy’s active SVD surveillance program. 

Regional differences in the characteristics and practices of swine production in Italy impacted 

the epidemiology of the epidemics. Extraordinary measures were required to bring the epidemic 

under control in the high density swine production area. Furthermore, the effectiveness of 
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29

enhancements to the regular SVD control program were more readily apparent in these high 

density areas, resulting in their permanent incorporation into the EC Decision 200/779/EC and 

the Ministerial Order of April 2008. Those enhancements benefitted disease control activities 

throughout Italy, particularly in regards to measures applied to curtail risky practices associated 

with dealer’s premises. 

The presence of major commercial swine production interests in a region influenced the priority 

given to swine disease control by local and regional authorities as evidenced by the resource 

allocation and enforcement activities. Likewise, the presence of major commercial interests 

likely contributed to the swine producers’ perceived value of compliance with control measures. 

These effects were particularly apparent in Lombardia and Emilia-Romagna, to a lesser extent in 

Veneto, but not very apparent in Marche where swine production is less intense. 

The persistence of SVD in parts of Italy will likely continue to present a risk for reintroduction to 

areas of Italy regionalized for the disease. In subsequent sections of this document APHIS 

discusses the extent to which movement controls and other factors limit the spread of SVD as 

well as Italy’s ability to rapidly detect SVD if reintroduced into region under evaluation.

4.3. Disease Status of Adjacent Regions [10]

Since 2005, SVD has only been confirmed in Italy with the exception of a single outbreak 

detected in Portugal in 2007. APHIS does not consider there to be a risk of SVD release in Italy 

from adjacent regions.

4.4. Extent of Active Disease Control Program [25, 27]

The April 2008 Ministerial Order as amended lays out the framework for Italy’s SVD control 

program (see Appendix 1). This framework fully transposes and in some instances exceeds the 

measures required for SVD control by the EC Decision 2005/779/EC and Council Directive 

2008/71/EC. The measures required by the Ministerial Order are harmonized and implemented 

throughout the regions under review by APHIS (see Table 2). 
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Table 2: Italy’s National SVD Control Program Provisions

• List of Regions recognized as SVD-free and conditions for obtaining recognition 

• Suspension, revocation and reinstatement of provincial recognition

• Requirement for registration of swine holdings

• Requirements for dealer’s premises registration

• Conditions for SVD-free recognition of holdings 

• Retention, suspension and revocation of holding recognition

• Procedures for reinstatement of holding recognition

• Biosecurity standards; checklist for minimum requirements

• List of approved disinfectants active against SVD

• SVD surveillance program; sampling protocols for different type of swine holdings

• Protocols for collection and submission of SVD samples

• Singleton reactor definition

• Requirement for slaughtering of seropositive swine and restriction on the distribution 

of its meat 

• Movement controls, including requirement for transport document (Form 4) and 

certificate of vehicle cleaning and disinfection

• Information captured into national database

• Requirements for cleaning and sanitation of premises and transport vehicles

• Communication requirements

• Program funding and indemnity payments

• Penalties for non-compliance

Source: Ministry of Health 

Movement restrictions for swine are described in Section 4.7. and the SVD surveillance program 

is described in Section 4.9. 

Recognition of SVD-free Regions

The foundation for Italy’s SVD control plan is the recognition of regions and holdings based on 

SVD surveillance, biosecurity standards and risk-reduction practices. A Region in Italy is 

granted SVD-free status by the Ministry of Health if all holdings in the region are accredited as 

being SVD-free and all SVD control activities required by the national SVD eradication and 

control plan were carried out in the previous year. These control activities include: surveillance 

which demonstrates the absence of SVD in accordance with the plan’s sampling protocol, 

adherence to biosecurity standards, sourcing of swine only from SVD-free holdings, and 

integration of animal identification and holding registration information into the national swine

health database system. 

The recognition of a Province within an SVD-free Region shall be immediately suspended or 

revoked by the Ministry of Health when a primary SVD outbreak occurs. A primary outbreak is 

considered to be: the first outbreak in a previously unaffected region/province, an outbreak 

which on the basis of epidemiological investigation is not linked with a previous outbreak, or is 

of unknown origin.
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If the outbreak is determined to be a secondary outbreak then the Province retains its recognition. 

An outbreak is considered a secondary outbreak if it is linked to a primary outbreak in another

already infected region/province based on an epidemiological investigation.

A Province may have its SVD-free recognition reinstated after the outbreak has been 

successfully stamped out in accordance with required procedures of Council Directive 

92/119/EEC (i.e. depopulation, cleaning/disinfection and appropriate restocking of affected 

premises; and quarantine, surveillance and movement restrictions within protection (3 km) and 

surveillance (10 km) zones established around the outbreak premises) and the epidemiological 

investigation have not demonstrated any risk for further spread of SVD. Additionally, all 

holdings within the Province must be sampled twice at an interval of 28 to 40 days, for 

serological testing on a number of pigs sufficient to detect a prevalence of SVD of 5% with a 

confidence interval of 95%, and the results have been negative. Suspension of recognition can 

only last up to six months before recognition status is revoked. If revoked, then the Province 

would have to follow procedures for initially obtaining recognition. 

Accreditation of SVD-free holdings

To be accredited as SVD-free, holdings must be registered in the national database. In addition, 

negative serological test results must be obtained in accordance with the following scheme:

• Holdings in Regions not recognized as SVD-free

o If on two occasions, at an interval of 28 to 40 days, samples for serological testing 

were collected from a number of pigs sufficient to detect a prevalence of SVD in 

the order of 5% with a confidence interval of 95%, and the results were negative. 

• Holding in SVD-free Regions

o Breeding farms: If on two occasions, at an interval of 28 to 40 days, samples for 

serological testing were collected from a number of breeding swine sufficient to 

detect a prevalence of SVD in the order of 5% with a confidence interval of 95%, 

and the results were negative. 

o Fattening farms: all swine are sourced from SVD-free holdings.

To maintain SVD-free accreditation, holdings are subject to periodic inspection and serological 

sampling in accordance with the surveillance (see Section 4.9.).

Dealer’s Premises Restrictions

For the purposes of surveillance, the Italian national SVD plan considers dealer’s premises to be 

assembly centers in accordance to Decision 2005/779/EC. The plan requires that at the time of 

surveillance sample collection, that regional or local veterinary authorities assess whether the 

infrastructure and facility management minimize the spread of disease and ensure traceability if 

disease were to occur. 
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Minimum standards for equipment include: 

• suitable devices for washing, cleaning and disinfecting the premises 

• devices for washing, cleaning and disinfecting the swine transport vehicles before they 

enter the premises

• disinfectants of proven efficacy against the SVD virus are available at the dealer’s

premises and at the entrance 

Management procedures required for dealer’s premises include: 

• sale of swine must take place within 30 days of their purchase 

• swine kept at dealer’s premises are sent solely and directly to slaughter plants

• culled, unthrifty, underweight or diseased pigs are prohibited from being sold through 

dealer’s premises 

• dealer’s premises must be emptied every 30 days to allow for a period of cleaning and 

disinfection

• transport vehicles must be washed and sanitized after each shipment and records 

verifying cleaning and disinfection must be maintained for 1 year

• serological and virological surveillance is conducted according to the plan (see Section 

4.9)

• minimum standards are set for biosecurity, sanitation, and traceability records for which 

Compliance is verified by local veterinary authorities as a pre-requisite for maintaining 

the holding registration

Cleaning and Disinfection

Dealer’s premises, assembly centers, holding pens located at slaughterhouses, and swine 

transport vehicles must be thoroughly cleaned and disinfected using products of proven efficacy 

against SVD virus. The facilities for the cleaning and disinfection of swine transport vehicles 

must be authorized and approved by local veterinary authorities. Furthermore the cleaning and 

disinfection of swine transport vehicles must be inspected and a certificate issued as evidence of 

the process. A description of the cleaning and disinfection certificate is included in the annex to 

the Ministerial Order (see Appendix 1).

Biosecurity Standards for Swine

The Italian veterinary authorities recognize that the epidemiology of SVD, and hence their 

control measures, are strongly influenced by physical and chemical resistance of the virus in the 

environment. Therefore, they considered it to be essential to include in their national SVD 

control plan measures to ensure proper application of biosecurity practices, both on the farm and 

during transport. The April 2008 Ministerial Order includes an annex setting minimum 

biosecurity standards to be implemented on swine holdings in order to maintain their holding 

registration. Local veterinary authorities verify compliance during official visits to the holding.

Based on the type of swine operation, the minimum biosecurity standards include:

• Breeding Operations

o Isolation or quarantine facility for introduction of new breeding animals. During 

quarantine, swine must be subject to clinical observation and serological testing 
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after 28 days and negative results must be obtained before being introduced into 

the holding.

o Parking area for personnel and/or visitors is located outside of the holding’s 

perimeter

o Perimeter barriers, such as fencing, gates, walls, etc., limit and control access by 

personnel, vehicles and animals (from other holdings and wild game). The 

entrance to the holding must have signs prohibiting access by unauthorized 

persons and/or vehicles.

o Shower and changing rooms must be available for use by employees and visitors 

to change clothing or don disposable gowns, suits and shoe covers before entering 

the holding. There should be a container to collect used materials and clothing.

o Vehicle cleaning and disinfection facility preferably located near the entrance to 

the holding. This facility must be kept separated from the holding pens where 

swine are housed. It must be equipped with stationary high-pressure washers for 

cleaning purposes and disinfectants of proven efficacy against the SVD virus in 

compliance with relevant regulations.

o Coolers for storing carcasses preferably located outside the holding perimeter 

with two doors, one from the holding and the other to the outside.

o Loading and unloading of live pigs should be conducted outside of the holding 

perimeter (i.e. the loading/unloading ramp is located along the perimeter barrier). 

Otherwise the loading and unloading can be done inside the perimeter if the swine 

transport vehicle carries only a single load of swine to or from the holding (i.e. no 

commingling of swine from different holdings) and is properly cleaned and 

disinfected with disinfectants of proven efficacy against the SVD virus before 

loading the animals.

o Loading of culled, sick or unthrifty pigs must be conducted outside of the 

perimeter of the holding.

o Dead carcasses must be removed from the swine pens within 24 hours and stored 

in coolers if not immediately disposed. Rendering trucks must not enter the 

perimeter of the holding.

o Unloading of feed must be done outside of the perimeter of the holding unless a 

dedicated holding vehicle is used and has been properly cleaned and disinfected 

with disinfectants of proven efficacy against the SVD virus before loading the 

animals.

o Feeding catering or household waste containing food of swine origin is strictly 

prohibited.

o Manure spreading on land bordering the holding is discouraged; especially 

manure from other swine holdings.

o The holding register must record all movement of pigs to and from the holding 

and this information must also be entered into the national swine health database.

Records on the farm must be maintained a minimum of three years and must 

always include data on the origin of any pig on the farm.

o A record of the entrance of all visitors and vehicles to the farm must be noted in 

the holding register.

o A record of the cleaning and disinfection of vehicles must be noted in the holding 

register.
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o A rodent and pest control plan must be implemented for the holding.

o Swine transport vehicles must be cleaned and disinfected with disinfectants of 

proven efficacy against the SVD virus at facilities approved by the local 

veterinary authority (usually at slaughter plants or other cleaning/disinfection 

facilities). 

o Employees or workers of a swine holding must not keep or contact swine outside 

of the holding.

o Employees or workers of a swine holding must wear clothing used solely at the 

holding.

• Weaning operations

o Same measures as for breeding operations

o Operate as an all-in/all-out system, at least by sectors. Cleaning and disinfection 

operations and biological clearance of at least 2 days must be carried out between 

cycles.

o A record of the cleaning and disinfection operations must be noted in the holding 

register.

• Fattening operations

o Same measures as for breeding operations

o Operate as an all-in/all-out system, at least by sectors. Cleaning and disinfection 

operations and biological clearance of at least 2 days must be carried out between 

cycles.

o A record of the cleaning and disinfection operations must be noted in the holding 

register.

The Regions of Lombardia, Emilia-Romagna, Veneto, Piemonte and the Autonomous Provinces 

of Tento and Bolzano have adopted a biosecurity checklist that is more restrictive than the one 

described in the national plan, and conduct more frequent inspections to ensure the measures are 

more effectively implemented. Regional veterinary officials in Emilia-Romagna have developed 

an extensive biosecurity training program for swine producers.

Compliance

Compliance with official SVD control measures is encouraged in several ways. Only swine 

producers who fully comply with these measures are eligible to collect indemnity payments to 

cover their losses incurred as a result of SVD outbreaks. Producers are eligible to recover 100% 

of the market value of their loss of animals, their products and equipment. Furthermore, civil 

penalties are imposed on swine producers who violate these measures. 

Another incentive encouraging compliance, are the requirements for participation in the 

integrated production and marketing systems of the Italian pork consortiums (see Section 4.8). 

This provides a strong incentive for producers to comply. The consortium requirements address 

quality standards as well as animal health requirements which often exceed those required by the 

national swine health plan. Granted these incentives have a greater impact on commercial pork 

production than on the producers who raise pigs mainly for self-consumption or the domestic 

market.
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Discussion

It is apparent to APHIS that the measures introduced during or modified as a result of lessons 

learned from the SVD outbreaks in 2002-2008 are having a positive effect on controlling SVD in 

Italy. In particular, the emphasis on biosecurity practices and the restrictions on the dealer’s 

premises have significantly reduced the risk of SVD spread in Italy, especially in the major 

swine production area in the northern part of the country. 

Through the April 2008 Ministerial Order and its amendments, Italy has harmonized its SVD 

control framework to implement and to some extent exceed the measures required by the EC 

Decision 2005/779/EC, Council Directive 2008/71/EC and other EC regulations. For some 

Regions, regional and local authorities have enacted more stringent measures to address local 

conditions in order to bring SVD outbreaks under control (described in Section 4.2). APHIS 

recognizes that swine raised to produce pork for the export market are more likely to be reared in 

areas where more stringent measures are practiced. In other Regions, SVD control measures do 

not exceed the Ministerial Order and enforcement activities are impacted by the priority placed 

upon them by the regional and local authorities. For example, during the visit to the Region of 

Marche the APHIS team observed less stringent interpretation of the biosecurity standards than 

was apparent in the other Regions visited. Despite regional differences, APHIS concludes that 

Italy has harmonized a SVD control framework within the region under evaluation that is 

sufficiently robust and the combined effect of incentives and penalties encourage compliance. 

APHIS has reviewed records of Italy’s response to outbreaks throughout the country and 

concludes that Italy has the capacity to quickly respond and eradicate SVD outbreaks once 

detected. Italy’s system to detect SVD outbreaks is discussed in Section 4.9.

4.5. Vaccination Status of the Region [25, 27]

Vaccination for SVD is not practiced in Italy and SVD vaccines are not available. Therefore 

vaccination is not a risk factor for SVD release in Italy.

4.6. Separation from Adjacent Regions of Higher Risk [10]

SVD is only known to exist in Italy. Therefore adjacent regions do not pose a risk of SVD 

release to Italy.

4.7. Movement Controls and Biosecurity from Higher-Risk Regions

Import Movement Controls [10, 55, 56]

APHIS considers a review of Italy’s import movement control system to be unnecessary for this 

evaluation because:

• Currently SVD exists in certain areas within Italy and has not been recently reported
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anywhere outside of Italy.

• APHIS has previously assessed the external movement controls for the European Union 

(EU) in its evaluations of the classical swine fever (CSF) status of various EU Member 

States. For those evaluations, APHIS visited and analyzed the EC controls on the 

movement of swine, pork and pork products into the EU from third countries as well as 

movement controls and processes for intra-community trade of these commodities 

between Member States. APHIS concluded that the border inspection posts (BIPs) with 

third countries consistently conformed to EC standards, regardless of the country of 

location. APHIS did not identify any significant concerns related to the BIPs. APHIS 

was also satisfied with the management and function of movement controls between 

Member States. 

Internal Movement Controls [8, 13-15, 20, 21, 25, 27, 28, 45, 47, 49-51]

Restrictions on the routine movement of swine are imposed by EC Decision 2005/779/EC in 

order to control the spread of SVD within Italy.6

 These restrictions are transposed into Italian 

law by the April 2008 Ministerial Order. 

Movement of swine from a holding not recognized as SVD-free is prohibited, including 

movement to a slaughterhouse, until the holding is recognized as SVD-free. This measure 

mitigates the risk that pork derived from pigs originating from non-accredited SVD herds enters

the commercial pork production market.

Movement of pork and pork products within Italy and between Italy and other Member States is 

not restricted on the basis of SVD control measures per se, except in two situations. Pork 

produced from SVD-seropositive pigs, including singleton reactors, can only be distributed 

locally (restricted by April 2008 Ministerial Order). Pork and pork products produced from 

swine originating and slaughtered within the protection and surveillance zones established 

around outbreaks of SVD cannot be marketed to other Member States or third countries unless 

treated in a manner to inactivate the SVD virus.

Movement of swine from EC-designated SVD-affected regions, regardless of the status of the 

holding, is prohibited except in the following described situation. Decision 2005/779/EC, 

Article 8 allows swine from accredited SVD-free holdings within EC-designated SVD-affected 

regions to move to EC-designated SVD-free regions under certain conditions. Those conditions 

are:

• the holding of origin has been accredited SVD-free for at least two years without 

interruption

• in the 60 days prior to movement, the holding of origin has not been located in a 

protection or surveillance zone established because of an outbreak of SVD

• in the 12 months prior to movement, no pigs were introduced onto the holding of origin 

from holdings where SVD had been suspected

 6 Movement restrictions for emergency response to a SVD outbreak, imposed in accordance with Council Directive 

92/119/EEC, are described in Section 4.11.
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• pigs on the holding of origin are sampled between 20 and 30 days before movement and 

serologically tested is carried out on a number of pigs sufficient to detect prevalence of 

SVD of 5% with a confidence interval of 95%

• sampling and serological testing is carried out as follows:

o pigs on the holding of destination are sampled at least 28 days following the 

movement and serological testing is carried out on a sufficient number of those 

pigs to detect prevalence of SVD of 5% with a confidence interval of 95%; such 

sampling must include the pigs moved into the holding of destination and no pigs 

may be moved from that holding until completion of the testing and negative 

results are reported

o pigs to be moved to a slaughterhouse are sampled within the period of 10 days 

before the movement and serological testing is carried out on a sufficient number 

of those pigs to detect prevalence of SVD of 5% with a confidence interval of 

95%; those pigs may be moved from that holding of origin until completion of the 

testing and negative results are reported

• the animals moved are transported in sealed vehicles under the supervision of local

veterinary authorities 

• movement of pigs is notified at least 48 hours in advance to the local veterinary authority 

responsible for the holding of destination

• the swine transport vehicles used to move the pigs are cleaned and disinfected under 

official supervision before and after movement

A movement document, referred to as Form 4, is required for all swine movements and subject to 

authorization by the regional veterinary services. Form 4 records detailed information on the 

holding of origin and destination, identification of the animals, means of transport and animal 

health status. Information captured on Form 4 is entered into the national swine health database.

Movement of swine through dealer’s premises has been linked to the spread of SVD. In 

response, specific regulations have been imposed on dealer’s premises (also referred to as 

“assembly centers”) in order to reduce this risk. Swine may only move from dealer’s premises 

directly and solely to slaughterhouses. Before these movements can occur, the holding is 

sampled, serologically and virologically, and negative results must be obtained before the swine 

can move from the dealer’s premises to the slaughterhouse. Additional regulations imposed upon 

dealer’s premises are described in Section 4.4. 

Seropositive pigs, including singleton reactors, must be slaughtered within 72 hours of being so 

ordered by the local veterinary authorities. The slaughter must be conducted within the Region 

in which the holding of origin is located. Seropositive animals must be transported and 

slaughtered separately without commingling with other swine, the head and viscera must be 

destroyed, and the meat must only be used for the domestic market only. The transport and 

slaughter are conducted under the supervision of the local veterinary authorities. 

External Movement Restrictions [8, 13-15, 20, 21, 25, 27, 28, 47, 49-51]

The movement of swine from Italy to other Member States is allowed only if the animals 

originate from SVD-free accredited holdings located in EC-designated SVD-free Regions. 
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Movement of swine from EC-designated SVD-affected regions to other EC Member States is 

prohibited regardless of the accreditation status of the holding of origin. 

Health certificates, required in compliance with Council Directive 64/432/EEC, Article 5(1), 

must accompany these shipments. The health certificate must have the following endorsement, 

“Animals in accordance with Commission Decision 2005/779/EC concerning animal health 

protection measures against swine vesicular disease in Italy.”

Movement of pork or pork products to other Member States or third countries is not restricted on 

the basis of EU or Italian SVD control measures except as described in the previous subsection 

(see Internal Movement Controls). Italy has entered into bilateral trade agreements with several 

third countries, including Canada, Chili, and Japan, providing for the export of pork and pork 

products from Italy. 

The agreement with Canada provides a basic guarantee of the origin of swine from which pork 

products are derived. The animals must either since birth: have been in an accredited SVD-free 

holding located within a region recognized as free of SVD in accordance with EC Decision 

2005/779/EC, have been imported from a country recognized by Canada as being SVD-free, or 

have been moved from an SVD-affected region at least 90 days prior to slaughter and the 

movement of animals occurred in accordance with conditions described in Article 8 Decision 

2005/779/EC (movement of swine from accredited SVD-free holdings located in SVD-affected 

holdings to holdings located in SVD-free regions). A second guarantee requires a minimum of 

30 days of curing period for pork products exported from Italy to Canada. A third guarantee 

stipulates that pork and pork products are produced or processed at establishments which are 

approved by the Italy in accordance with Canadian requirements.

Chile only requires that pork is derived from pigs have been born and reared in an SVD-free 

region in accordance to Decision 2005/779/EC. Japan has no restrictions regarding SVD.

Discussion

Controlling the movement of swine from holdings not accredited as being SVD-free and from 

areas around SVD outbreaks is an important component of Italy’s risk-based approach to 

reducing the risk of spreading SVD within Italy and to other Member States and third countries. 

The system of movement controls has multiple verification checks and balances built into the 

process (i.e. holding registers, movement documents, vehicle cleaning and disinfection 

certificates, national database, slaughterhouse registers and logs, etc.) to assist veterinary 

authorities to manage compliance.

The conditional exception to the prohibition of movement of swine from accredited SVD-free 

holdings within EC-designated SVD-affected regions to EC-designated SVD-free regions 

potentially poses additional risk of spreading SVD. This risk would increase by the extent of the 

probability that the testing conducted on the swine to be moved failed to detect infection. Given 

the mitigating effect of the conditions place on these type of movements, the likelihood of failing 

to detect the infection is low, assuming full compliance with all conditions.
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In the past, illegal movements have played a role in SVD spread because they circumvent the 

mitigating effect of movement controls and biosecurity measures regarding the cleaning and 

disinfection of transport vehicles. According to Ministry of Health officials, illegal swine 

movement contributed to the spread of SVD in the 2007 epidemic in central and southern Italy 

and was associated with single outbreak detected in Emilia-Romagna in 2008. However, the role 

of illegal movement is considered low especially for the commercial pork production market, 

given the high level of compliance from swine producers and the level of priority of control and 

enforcement activities by the regional and local authorities in the major commercial production 

areas.

4.8. Livestock demographics and marketing practices in the region [13-15, 20, 21, 24, 28, 

45, 50, 51]

Italian Swine Production

In Italy swine are reared under two very different production systems, commercial production 

and private production for personal consumption. 

Commercial swine are raised through a highly developed, professional system of production 

organized and tightly managed through producer consortiums and associations. This commercial 

production chain operates primarily in northern Italy. About seventy percent of pigs produced in 

Italy are for production of two well-known brands, Prosciutto di Parma and Prosciutto di San 

Daniele. This vertically-integrated production chain tends to involve larger holdings with 

privately-certified control systems that require adherence to standards for good animal disease 

control, biosecurity and record keeping. Over the past two decades, commercial swine 

production in Italy has evolved into a multi-site production necessitating fairly large movements 

of pigs between facilities for farrowing, fattening and slaughter. Nearly every pig in this 

commercial production chain is moved more than once. 

The remaining thirty percent of pigs are raised on small, often family-owned operations where 

pigs are raised for personal consumption or the local domestic market. Most pigs raised in 

southern Italy are raised under this system of production. This system is characterized by small 

number but frequent transport of swine. Typically, piglets are purchased in the spring from 

multiple small breeding operations by dealers who then sell them to individuals and families who 

fatten them for slaughter usually in December. The transport associated with this market chain 

has more often been implicated with the spread of SVD. 

Italy imports a significant number of live swine to supplement its nation’s production, about onemillion head per year from EU Member States such as the Netherlands, Belgium, Spain, 

Germany and the Czech Republic. Very few live pigs are imported from third countries. Italy 

also imports a significant amount of pork, about 40% of its annual consumption, mainly from the 

EU Member States Belgium, Netherlands, and France and very little from third countries. 

Italy primarily exports ham, and some other products like sausage, mainly to EU Member States 

(80%), including the Netherlands, France, Germany and UK, with the remainder (20%) exported 
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

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40

to third countries, including to Australia, Canada, Chile, China, Japan, Korea, Russia and the 

United States. 

Italy exports very few breeding swine and very little swine semen.

Swine Production in Northern Italy 

Italy’s commercial swine production area is centered in the Po River Valley in the northern part 

of the country, principally in the Regions of Lombardia, Emilia-Romagna, Piemonte and Veneto, 

and is included in the regions under review by APHIS. Over 60% of all swine annually 

slaughtered in Italy are slaughtered in Lombardia and Emilia-Romagna. This region has a high 

density swine population (see Table 3 and Figure 4). 

Table 3: Swine populations in northern Italy

Region or 

Province

No. of swine 

holdings

Pig 

population

Lombardia 8,371 4,497,788

Emila 

Romagna 4,857 1,156,714

Veneto 8,288 616,133

Marche 14,270 86,474

Piemonte 2,759 1,143,554

Trento and 

Bolzano 5,216 7,108

 Data Source: Ministry of Health 
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Figure 4: Swine population density in Italy

Data Source: Ministry of Health; map created by: USDA APHIS VS CEAH

The Region of Marche and the Autonomous Provinces of Trento and Bolzano are less involved 

in the commercial swine production. In those areas, swine are principally reared in “backyardtype” holdings. These swine typically are slaughtered at home or in small slaughterhouses and 
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

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the pork meat is used for self-consumption or the local market. Although a specialty ham called 

“Speck” is produced in the Tyrol region of Bolzano and neighboring Austria. This traditional 

smoked ham is produced from pork brought into Bolzano from other regions. In Bolzano there 

are two processing facilities approved to export these hams to the United States.

Live swine movements associated with the commercial pork production in the regions under 

review by APHIS typically involve transporting feeder pigs born in Lombardia, Emilia-Romagna 

to fattening operations located throughout the Po River Valley (Piemonte, Lombardia, EmiliaRomagna, and Veneto) and to a lesser extent to Marche. The Po River Valley area also receives 

feeder pigs from other EU Member States. Breeding swine move in similar patterns with some 

replacement stock coming into Italy from Denmark and the Netherlands. 

Fattened swine are then moved for slaughtering and processing at the large capacity plants 

mainly located in Lombardia and Emilia Romagna. Some fattened pigs are also sent to Lazio in 

central Italy and a more limited number to Campania and Calabria in southern Italy. A 

significant number of swine from other EU Member States are also slaughtered and processed in 

northern Italy. There are numerous slaughtering and processing plants located throughout the Po 

River Valley. However, currently there are only four plants approved to export products to the 

United States, three in Lombardia and one in Emilia-Romagna. 

As described previously, Italy requires that all swine are identified, all holdings to be registered, 

and all movements recorded into the national swine health database. Slaughterhouses track the 

animals as they are slaughtered and the production and processing facilities can track products as 

they move through the production line. These processes support the ability to trace pork and 

pork products as it moves from farm through the market channel. The pork production plants 

visited by APHIS were able to demonstrate this capacity.

Swine raised in backyard operations for self-consumption are purchased mainly from 

neighboring Provinces and Regions in Italy, mainly from Lombardia, Emilia-Romagna, 

Piemonte and Veneto, although in Bolzano occasionally pigs are sourced from Austria and 

Germany. Marche also receives swine from Umbria and other Regions in central Italy. The 

backyard-reared swine tend to be slaughtered locally either at home or in small municipal plants 

and used for self-consumption or the local market. 

Dealer’s premises have almost completely ceased operating in northern Italy. The number of 

traditional dealer’s premises has been on a declining trend for years but Italian officials speculate 

that the measures required by the April 2008 Ministerial Order to be applied to these operations 

have hastened their disappearance. There are a few holdings described as “high-turnover” 

holdings that are operating in northern Italy and because they pose some of the same risks 

associated with dealer’s premises they are similarly sampled monthly for both SVD serological 

and virological testing.

Local fairs exhibiting livestock are held annually and are subject to the authorization and 

monitoring by local veterinary authorities to ensure compliance with appropriate SVD control 

measures.
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Discussion

In this evaluation, APHIS is reviewing the region that includes Italy’s major commercial pork 

production area. Most swine raised here are produced in a vertically-integrated system for which 

producers are required to adhere to a highly developed system of internal industry controls for 

the maintenance of animal health. The Italian pork consortiums provide stringent oversight of 

the producers, slaughterhouses and processing plants to ensure compliance with their standards. 

Often these standards relating to SVD controls exceed those required by Italian national law. For 

example, a more extensive biosecurity review is conducted on holdings that are part of these 

consortiums. Since participation in the consortium is advantageous to the producers in order to 

market swine, the producers have a strong incentive to comply with animal health controls.

The consortiums have an incentive to work closely with national, regional and local veterinary 

officials to develop and modify Italy’s national SVD control plan in order to protect their 

investments and to maintain and expand export market access.

This region benefits from the relatively smaller percentage of swine reared for personal 

consumption since SVD spread has most often been associated with that type of holding. Local 

sourcing of pigs reared for personal consumption also benefits from the higher awareness and 

biosecurity standards associated with swine production in the region. 

Although SVD outbreaks persist mainly in southern Italy, producers in the north must remain 

vigilant and monitor for any reintroduction of the disease in the area. The number of swine 

movements associated with the multi-site production system does increase the potential for 

inadvertent spread of a disease if it were present. The SVD surveillance program and the 

required biosecurity measures, especially in regards to the cleaning and disinfection of swine 

transport vehicles, helps mitigate this risk. 

The traceability capacity associated with the commercial swine production gives APHIS 

confidence of the Ministry of Health’s ability to identify and remove any potentially infected 

pork and pork products from the export market chain if SVD were detected.

4.9. Disease surveillance in the region [17-24, 27, 45]

Italy’s surveillance program is essential to achieve the goals of maintaining SVD-freedom in the 

regions it currently recognizes as free and eradicating SVD in those regions that it considers to 

be affected. Early detection of SVD outbreaks is necessary for both goals and relies nearly 

exclusively on active surveillance activities. Passive surveillance is supported by the required 

notification of any suspicion of SVD and the local presence of official veterinary authorities. 

However, because SVD is increasingly presented as sub-clinical infections, early detection is 

most dependent upon the active surveillance program.

Italy’s SVD active surveillance plan is designed in consideration of risk based on a holding’s 

production characteristics (i.e. breeding vs. fattening, open vs. closed systems) and on the risk 

associated with the frequency of swine movements to and from the holding. The current
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44

surveillance scheme is summarized in Table 4. Italy evaluates and revises the scheme as 

necessary as part of its annual national SVD control plan.

Table 4: Italy’s National SVD Surveillance Program Scheme

Type of Holding

Breeding

(closed cycle)

Breeding

(open cycle) Fattening

High Risk

(dealer’s premises, 

assembly center, or high 

turnover)

SVD

Free

Region

all holdings

serological testing 

every 12 months 

only breeding pigs

P: 10%; CI 95%*

all holdings

serological testing 

every 6 months

only breeding pigs

P: 10%; CI 95%*

representative sample 

of up to 300 holdings

serological testing 

every 6 months

fattening pigs

P: 5%; CI 95%*

all holdings

serological and virological 

testing monthly

all pigs

P: 5%; CI 95%*

SVD

Affected

Region

all holdings

serological testing 

every 12 months 

only breeding pigs

P: 10%; CI 95%*

all holdings

serological testing 

every 6 months

only breeding pigs

P: 10%; CI 95%*

all holdings

serological testing 

every 6 months

fattening pigs

P: 5%; CI 95%*

all holdings

serological and virological 

testing monthly

all pigs

P: 5%; CI 95%*

* sampling for testing shall be carried out on a number of pigs sufficient to detect the specified prevalence (P) of either 5 or 10% with a confidence 

interval (CI) of 95%

Source: Ministry of Health [27]

Surveillance conducted on high risk holdings, such as dealer’s premises, assembly centers, and 

holdings with a high turnover of animals, sampling is conducted monthly for both serology and 

virology testing. The virological samples are environmental samples of pig feces collected from 

the animal holding pens. Swine on these holdings may not be moved until the negative test 

results are received.

The SVD diagnostic assays utilized in Italy for antibody detection are ELISA for screening tests, 

viral neutralization (VNT) for confirmation, and IgG/IgM ELISA for viral characterization. For 

virus detection, the CERVES utilizes PCR (polymerase chain reaction) for screening, virus 

isolation for confirmation and virus sequencing for molecular epidemiology. The CERVES 

developed the OIE reference SVD tests for ELISA and PCR. The CERVES processes all 

serosurveillance samples for the Regions of Lombardia and Emila-Romagna and provides 

confirmation of positive results from the other IZS regional laboratories. The CERVES also 
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45

provides the test kits to these regional laboratories and conducts all SVD virological diagnostics 

for Italy.

For many years Italy has collected a substantial number of samples through its SVD surveillance 

program. The data from the last four years is summarized in Table 5. The number of samples 

collected reflects the baseline surveillance sampling scheme plus the sampling conducted during 

outbreak eradication activities (i.e. greater numbers of samples were collected during 2008-

2009). It is important to note that the serological data in Table 5 includes positive findings in the 

region under evaluation. The MOH conducted case investigations for each positive finding. 

Except for the 6 positive samples listed for Marche in 2009 (samples actually collected in Dec. 

2008 but recorded in 2009 data), the MOH found no evidence of viral activity and therefore 

classified the pigs testing positive as being singleton reactors. 
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Table 5: SVD Serological Surveillance Data

SVD Serological Surveillance, 2008-2011

Checked 

holdings

Positive 

holdings

 Pigs 

tested

Positive 

pigs

Lombardia

2008 2,605 54 217,427 63 *

2009 2,044 22 113,212 24 *

2010 1,361 18 74,327 20 *

2011 1,254 19 68,662 25 *

Emila-Romagna

2008 886 9 39,305 13 *

2009 557 0 25,379 0

2010 488 6 24,912 6 *

2011 466 6 25,863 7 *

Veneto

2008 878 0 28,668 0

2009 420 0 22,858 0

2010 354 0 17,975 0

2011 382 0 21,332 0

Marche

2008 525 0 5,712 0

2009 701 6 13,203 6 ⱡ

2010 582 0 10,933 0

2011 623 0 11,800 0

Piemonte

2008 746 0 28,165 0

2009 568 6 23,564 6 *

2010 523 4 20,040 4 *

2011 539 3 24,721 3 *

Trento and 

Bolzano

2008 78 0 423 0

2009 115 0 519 0

2010 80 0 616 0

2011 210 0 1,035 0

ITALY TOTAL 

2008 16,831 246 589,412 947 **

2009 16,107 162 622,333 1,358 **

2010 12,282 84 356,973 345 **

2011 12,614 122 366,424 450 **

 * Singleton Reactors

** Totals include Singleton Reactors

 ⱡ Positive samples collected in Dec. 2008 but reported in Jan. 2009

data

DATA SOURCE: Ministry of Health

Virological surveillance data for the last four years is summarized in Table 6. Samples collected 

for virological testing were less numerous than for the serological surveys. Fecal and 

environmental samples are routinely collected from high risk holdings (i.e. those which are 

characterized by frequent movements of swine from multiple origins such as dealer’s premises, 

assembly centers, high turnover holdings and slaughterhouses that receive swine from high risk 
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

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47

holdings). Since SVD virus can persist in the environment for a long time and is resistant to 

many routinely used disinfectants, the importance of virological sampling, especially from these 

high risk holdings cannot be understated. 

In the region under evaluation, a single sample collected during this time period produced a 

positive result. The positive sample was collected at a slaughterhouse in Emilio-Romagna which 

led to the detection of the 2008 outbreak. It is interesting to note that none of the swine in this 

herd seroconverted. 

Table 6: SVD Virological Surveillance Data

Virological Surveillance, 2008-2011

Checked 

holdings

Positive 

holdings

Samples 

collected

Positive 

samples

Lombardia

2008 64 0 85 0

2009 69 0 131 0

2010 70 0 181 0

2011 52 0 144 0

Emila-Romagna

2008 55 0 123 1

2009 26 0 52 0

2010 20 0 39 0

2011 25 0 42 0

Veneto

2008 21 0 104 0

2009 17 0 55 0

2010 19 0 54 0

2011 24 0 99 0

Marche

2008 35 0 116 0

2009 19 0 60 0

2010 21 0 78 0

2011 11 0 47 0

Piemonte

2008 4 0 34 0

2009 8 0 27 0

2010 6 0 24 0

2011 7 0 26 0

Trento and 

Bolzano

2008 5 0 36 0

2009 5 0 36 0

2010 5 0 43 0

2011 4 0 36 0

ITALY TOTAL

2008 1,002 16 2,720 24

2009 696 9 2,178 13

2010 665 3 2,523 4

2011 632 21 2,418 27

DATA SOURCE: Ministry of Health
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Discussion

APHIS concludes from the surveillance data that SVD virus is not known to exist in the region 

of Italy under evaluation. However, APHIS is concerned about the potential for reintroduction 

of SVD into this region from residual pockets of virus that persist in southern Italy. Until SVD is 

completely eradicated from Italy, APHIS expects that SVD outbreaks are likely to occur in 

central and southern Italy and rarely in the northern part of the country. APHIS is also 

concerned that detection of reintroduction via passive surveillance would likely be limited due to 

the subclinical presentation of SVD outbreaks as observed in in recent years. Therefore, APHIS 

concludes that a robust active surveillance program, such as that implemented in accordance with 

the April 2008 Ministerial Order, is essential to quickly detect reintroduction of SVD into 

northern Italy and prevent subsequent spread of SVD to the United States through the trade of 

breeding swine, pork and pork products. As a potential enhancement of their surveillance 

system, APHIS recommends that the MOH consider increasing virological surveillance

throughout Italy, especially during times of increased SVD viral activity in central and southern 

Italy.

To further analyze Italy’s surveillance program, at APHIS’ request CERVES prepared an 

analysis of the time period between probable exposure and the time of detection for SVD

outbreaks that occurred in northern Italy. During this time period, which is referred to as the 

“risky period”, an unlikely potential exists for the unintentional export of SVD-infected pork and

pork products if such products were exported before the outbreak was detected (APHIS 

considers that SVD in live swine would be detected during current pre-export and post-import 

testing and quarantine procedures). 

CERVES reviewed the epidemiological investigations from 23 outbreaks in commercial holdings

in northern Italy during 2007-2008 to determine the “risky period” for each outbreak. CERVES 

estimated this period to be 24.1 +/- 11.8 days (mean), with a range from 2-58 days [see Appendix 

2]. It is important to note that Italy implemented enhanced SVD control measures and 

surveillance has a result of lessons learned from the 2007-2008 outbreaks and subsequently only 

6 outbreaks have occurred in the region of Italy under evaluation by APHIS (in Marche during 

2008). 

In reviewing the data collected from many years of SVD sampling and the analysis provided by 

CERVES, APHIS is confident that Italy’s SVD surveillance program will quickly detect SVD in 

the commercial swine sector and reduce the likelihood that undetected SVD-infected swine, pork 

and pork products would be exported to the United States. As discussed in Section 4.2. APHIS 

has concluded that Italy’s animal health infrastructure has the capability to quickly respond and 

eradicate SVD outbreaks once detected and has the traceability mechanisms to ensure that 

potentially infected pork and pork products are removed from the export market channel. 

4.10. Diagnostic laboratory capacity [1, 13-15, 20, 21, 45, 55, 56]

The Istituti Zooprofilattici Sperimentali (IZS) are veterinary public health institutes which 

provide a network of public laboratories at the national and regional level in Italy. The CERVES
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in Brescia is Italy’s SVD national reference laboratory and is also an OIE reference laboratory 

for SVD. The IZS laboratory network is described in more detail in Section 4.1. 

APHIS has previously assessed Italy’s laboratory capacity in previous reviews on swine disease 

in the EU and concluded that it consistently conformed to EC and international standards. 

APHIS did not identify any significant concerns related to the laboratory network, and therefore 

considers a review of Italy’s laboratory capacity to be unnecessary for this evaluation.

4.11. Emergency response capacity [4-6, 8, 13-15, 20, 21, 45, 47]

European legislation, Council Directive 92/119/EEC, established specific response measures for 

several animal diseases, including SVD, which are to be applied whenever a disease outbreak 

occurs in an EU Member State. Italy’s response to SVD outbreaks are in accordance with this 

Directive.

The Directive describes the conditions to confirm the presence of SVD and lays out the measures 

to be applied upon confirmation. 

The measures applied to the affected holding include: 

• mandatory notification of suspicion of SVD to DVPHNFS

• immediate investigation by regional or local veterinary officials of all reports of SVD 

suspicion

• precautionary quarantine placed upon the suspect holding and measures taken to prevent 

potential spread of virus

• depopulation of all susceptible swine if SVD is confirmed

• any substance or waste, such as animal feed, litter, manure or slurry, which is liable to be 

contaminated, shall be destroyed or treated appropriately

• cleaning and disinfection of swine pens and surroundings, vehicles used for swine 

transport and all equipment which may have been contaminated 

• epidemiological investigation is conducted to determine: the earliest date of probable 

infection to estimate the length of time between infection and detection, possible origin of 

the disease on the holding and the identification of other holdings on which there are 

animals of susceptible species which may have become infected or contaminated, and the 

movement of persons, animals, carcasses, vehicles, equipment or any other substances 

likely to have carried the agent of the disease to or from the holdings in question

• measures may be extended to neighboring holdings if contamination suspect due to their 

proximity to or contacts with the affected holding

• restocking of the holding shall be authorized by the competent authority, beginning no 

earlier than 4 weeks following the satisfactory inspection by the official veterinarian of 

the cleaning and disinfection; depending on the type of operation, restocking must 

conform to either:

o in the case of outdoor swine holdings, restocking shall start with the introduction

of a limited number of sentinel piglets which have been checked and found 

negative for the presence of antibodies against SVD virus; the piglets shall be 

placed throughout the infected holding and will be clinically examined and 
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50

serologically tested 28 days after arrival on the holding; if all serology samples 

are negative then full restocking may commence

o for all other forms of swine rearing, the re-introduction of pigs shall take place 

either in accordance with the measures described above for outdoor swine 

holdings or by full restocking, provided that:

 all the pigs arrive within a period of eight days and come from holdings 

situated outside areas restricted as a result of SVD, and are seronegative

 no pig may leave the holding for a period of 60 days after the arrival of the 

last pigs

 repopulated herd is subjected to a clinical and serological examination 

conducted at the earliest 28 days after the arrival of the last pigs

• a protection zone with a minimum radius of 3 km is established around the infected 

holding, which is contained within a surveillance zone with a minimum radius of 10 km; 

establishment of the zones must take account of geographical, administrative, ecological 

and epidemiological factors, and of monitoring facilities

Measures applied to holdings within the 3 km protection zone include:

• identification of all swine holdings within the protection zone 

• periodic visits veterinary officials to these swine holdings to conduct clinical 

examinations on swine; a record of visits and findings must be kept

• serological sampling of all holdings in the protection area 2 times 28-40 days apart to 

detect prevalence of SVD of 5% with a confidence interval of 95%; sampling begins 28 

days after completion of the cleaning and disinfection of the infected holding 

• prohibition of movement and transport of swine unless an exception under specified 

conditions is authorized and supervised by local veterinary authorities in order to move 

swine directly to a local facility for emergency slaughter; the conditions for such 

movement are:

o swine may not be moved from the holding in which they are kept until 21 days 

after completion of the preliminary cleaning and disinfection of the infected 

holding; 

o visual inspection of all swine on the holding has been completed, including a 

clinical examination of the swine to be moved to slaughter 

o identification mark has been applied to each pig in accordance with approved 

methods

o swine are transported to the slaughterhouse under official seal

o swine are kept and slaughtered separately from other swine at the slaughterhouse

o transport vehicle must be cleaned and disinfected before leaving the 

slaughterhouse

o pre- and post-mortem inspections shall inspect for signs suggestive of SVD 

o statistically representative number of blood samples are collected for testing

• an exception to the movement prohibition may also be granted, under exceptional 

circumstances, to move swine directly to other premises located within the protection 

zone, provided that: an inspection of all the pigs on the holdings has been carried out, a 

clinical examination of the pigs to be moved has been carried out, with negative results, 

and each pig has been marked by ear marking or has been identified by any other 

approved method
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51

• pork and pork products derived from the swine slaughtered in the protection zones are 

prohibited from entering into intra-community or international trade

• vehicles used to transport swine, other livestock or material (e.g. feed, manure, slurry, 

etc.) are considered to be contaminated may not leave a holding situated within the 

protection zone, the protection zone, or a slaughterhouse without being cleaned and 

disinfected in accordance with the procedures laid down by the national authority; any 

swine transport vehicle must be inspected by local veterinary authorities before it can 

leave the zone

• measures applied in the protection zone shall remain in force until completion of the 

following measures conducted after a minimum of 28 days (considered by the EC to be 

the maximum incubation period for SVD) following completion of depopulation, carcass 

disposal, and cleaning and disinfection of the SVD-affected holding:

o all holdings in the zone have undergone a clinical examinations conducted on all 

swine without observation of clinical signs suggestive of SVD 

o serological testing of a statistical sample of the swine with negative results

Measures applied to holdings within the 10 km surveillance zone include:

• identification of all swine holdings within the protection zone 

• serological sampling of all holdings in the surveillance area 1 time to detect prevalence of 

SVD of 5% with a confidence interval of 95%; sampling begins 28 days after completion 

of the cleaning and disinfection of the infected holding 

• prohibition of movement and transport of swine unless an exception is authorized and 

supervised by local veterinary authorities provided that:

o inspection of all pigs on the holding has been conducted within the 48 hours 

preceding the movement

o clinical examination of the pigs to be moved has been conducted without 

observation of clinical signs suggestive of SVD in the 48 hours preceding the 

movement

o serological testing of a statistical sample of the pigs to be moved with negative 

results within the 14 days preceding the movement; or in the case of swine 

moving to slaughter, the serological testing may be made on blood samples 

collected at the slaughterhouse by local authorities

o identification mark has been applied to each pig in accordance with approved 

methods

o transport vehicle must be cleaned and disinfected before leaving the 

slaughterhouse

• measures applied in the surveillance zone shall remain in force until all measures 

required for the protection and surveillance zones have been completed

In the event of an SVD outbreak, pork and pork products derived from swine slaughtered during 

the period between the probable introduction of disease to the holding and the implementation of 

official measures is, wherever possible, traced and destroyed under official supervision in such a 

way as to avoid the risk of swine vesicular disease virus spreading. 
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Council Directive 92/119/EEC requires Member States to establish a crisis unit in order to 

provide full coordination of all measures necessary to ensure eradication of the disease as 

quickly as possible and for the purpose of carrying out the epidemiological investigation.

In Italy, a central crisis unit is established within the MOH to facilitate outbreak response 

coordination at a national level. The responsibilities of the central crisis unit are: 

• planning and coordinating disease control and eradication measures for the whole 

national territory

• oversight and facilitation of management of disease prevention activities and control 

measures

• enforcement activities

• facilitation of communication and coordination between MOH central and local offices, 

and crisis units established by regional and local authorities

In the event of an outbreak, crisis units act at central, regional, and local levels in a coordinated 

response. The central crisis unit is the decision-making body, but their decisions are coordinated 

at the regional level and implemented at the local level by the AUSL. The IZS provides 

epidemiological and diagnostic support as needed.

Discussion

Over the last 10 years, Italy has responded to over 591 outbreaks of SVD. Nearly 75% of these 

outbreaks can be accounted for in 3 epidemics of short duration. The high number of outbreaks 

was attributed to the unchecked spread of virus occurring before detection, a problem which was 

potentiated in areas with high-density swine populations. 

Italian veterinary authorities adjusted their disease control strategies as lessons were learned 

from their experiences and implemented extraordinary measures as circumstances necessitated. 

A decline in number of SVD outbreaks appears to be the result of the enhancements to SVD 

prevention and detection control measures. In reviewing records describing the emergency 

response, APHIS could not identify any risk factors associated with Italy’s emergency response 

capacity.

4.12. Release Assessment Conclusions

APHIS concludes that the SVD virus is not known to exist in the region of Italy under 

evaluation. SVD has not been detected in these regions since 2008 despite ongoing surveillance. 

However, APHIS identified risk factors associated with importing breeding swine,7 pork or pork 

products to the United States from the region of Italy under evaluation. APHIS considered these 

risk factors in the context of the potential for counterbalancing circumstances or applying 

appropriate risk mitigations to further reduce the risk of introducing and establishing SVD in the 

United States. 

 7 Since Italy is included in the APHIS-defined EU CSF region, live swine imports are restricted to breeding swine.
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Risk Factors

Persistence of SVD in Italy 

APHIS is primarily concerned about the potential for reintroduction of SVD into the region of 

Italy under evaluation. If reintroduced, the most likely source of SVD virus would be the

residual pockets of virus that persist in southern Italy since SVD outbreaks have not been 

recently reported in other areas of the world. Until SVD is completely eradicated from Italy, 

APHIS expects that SVD outbreaks are likely to occur in central and southern Italy and rarely in 

the northern part of the country. 

APHIS is also concerned that detection of reintroduction via passive surveillance would likely be 

limited due to the subclinical presentation of SVD outbreaks as observed in in recent years. 

Therefore, APHIS concludes that a robust active surveillance program, such as that implemented 

in accordance with the April 2008 Ministerial Order, is essential to quickly detect reintroduction 

of SVD into northern Italy and prevent subsequent spread of SVD to the United States through 

the trade of swine, pork and pork products.

The likelihood of reintroduction is lessened in part by separation in the production of swine 

raised primarily for the export market and swine raised for domestic or personal consumption. 

Commercial swine, from which pork and pork products for the export market are derived, are 

primarily raised in northern Italy; whereas swine raised in central and southern Italy, where SVD 

is known to persist, primarily are intended for personal consumption and the domestic market.

However, as subsequently discussed, this separation is not complete as EU and Italian 

regulations allow limited movement of swine, pork and pork products from central and southern 

Italy to northern Italy.

Italy’s national SVD control plan further mitigates the potential for reintroduction through 

movement control measures, biosecurity standards and surveillance, described earlier in the 

release assessment, which provide additional assurances that the region under review by APHIS 

is protected from SVD reintroduction. 

SVD, unlike FMD, tends to have a limited ability to spread, even within an infected holding. 

The spread of SVD from one pen to another is associated with the movement of infected pigs or 

contaminated material. Similarly, SVD has been known to spread by exposure to viruscontaminated manure on swine transport vehicles. Therefore proper cleaning and disinfection of 

transport vehicles is an important measure to control SVD. Compliance with the truck cleaning 

and disinfection requirements in Italy’s national SVD control plan would mitigate this risk. The 

industry-driven standards and practices required by the pork consortiums provide an additional 

level of assurance that vehicle cleaning and disinfection compliance is high for swine 

movements within the commercial swine production channel. 

APHIS is confident that Italy’s SVD surveillance program will quickly detect SVD in the 

commercial swine sector and reduce the likelihood that undetected SVD-infected swine, pork 

and pork products would be exported to the United States. APHIS is also confident that Italy’s 
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54

swine health infrastructure has the capability to quickly respond and eradicate SVD outbreaks 

once detected and has the traceability mechanisms to ensure that potentially infected pork and 

pork products are removed from the export market channel.

APHIS can further mitigate the risk of introducing SVD into the United States if APHIS 

regionalizes Italy according to SVD risk, allowing exports of breeding swine, pork and pork 

products that originate in or derived from swine originating in regions that it considers to be 

SVD-free and prohibiting exports from regions it considers to be SVD-affected. 

Risky practices associated with dealer’s premises

Dealer’s premises have historically and continue to be associated with the spread of SVD in 

Italy. However, measures restricting movements through dealer’s premises, particularly 

restricting movements only to slaughterhouses, and the level of surveillance conducted at these 

facilities address several risky practices common to these operations. The result may be 

contributing to the decline in the overall number of SVD outbreaks occurring in Italy and have 

also resulted in a decline in numbers of this kind of operation, at least in northern Italy. 

However, other type of swine operations which do not meet the definition of being a dealer’s 

premises continue to exist in limited numbers, even in northern Italy. Italian officials have 

applied the same surveillance sampling regime of dealer’s premises to these so called “high 

turnover holdings.” 

APHIS remains concerned about the risk posed by swine movements associated with dealer’s 

premises and “high turnover holdings.” Although the disease control and surveillance 

requirements imposed on dealer’s premises and high turnover holdings by the April 2008 

Ministerial Order appear to mitigate this risk in the region of Italy under evaluation. However 

any reduction in these controls or level of surveillance would necessitate a re-evaluation by 

APHIS. 

Swine from regions APHIS considers to be SVD-affected

Italian authorities allow swine to enter northern Italy from areas in central and southern Italy, 

including from the regions considered to be affected with SVD, as long as the swine originate 

from accredited SVD-free holdings (Article 8, Decision 2005/779/EC). The risk of reintroducing 

SVD into northern Italy is partially mitigated by the conditions mandated to obtain and maintain 

accreditation as an SVD-free holding, including biosecurity and surveillance requirements and 

restrictions on sourcing and movements. Additional mitigating conditions are required in order 

to move swine from SVD-free holdings in affected regions to holdings in the free areas, 

including serological testing before and after the move. APHIS concludes that the combined 

effect of these measures results in a low likelihood of reintroducing SVD into northern Italy via 

the regulated movement of swine from SVD-free holdings.

In addition, APHIS intends to apply the existing restrictions contained in 9 CFR 94.14 that

prohibit importation of live swine from regions where SVD exists. APHIS considers this

prohibition sufficiently mitigates the risk of importing undetected SVD-infected swine that may 

have legally moved into northern Italy from SVD-affected areas of the country in accordance 
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

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55

with Italian regulations. APHIS has confidence that Italy’s system of animal identification, 

holding registry and movement records provide sufficient basis for Italian authorities to ensure 

compliance with the APHIS prohibition.

Pork from regions APHIS considers to be SVD-affected

SVD virus is known to survive in fresh and cured pork for an extended period of time; however, 

pork meat has not been associated with the spread of the disease. In addition, the EU prohibition 

on the feeding of uncooked garbage to swine limits potential exposure of swine to SVD-infected 

pork via this pathway. However, EU and Italian regulations do not restrict the movement of pork 

and pork products from regions considered to be SVD-affected to SVD-free regions, unless they 

are derived from swine that have tested positive on serology or from swine slaughtered as a 

result of an SVD outbreak. Therefore, a potential exists for undetected SVD-infected pork and 

pork products to move from the affected to the free regions of Italy. Subsequently SVD-infected 

or contaminated fresh pork and pork products might be exported to the United States, however 

unlikely.

To mitigate this risk, APHIS intends to apply the restrictions provided in 9 CFR 94.13 to the 

exports of pork and pork products from Italy which prohibit the importation of fresh pork or pork 

products derived from swine originating in regions considered to be SVD-affected. Furthermore, 

the regulation prohibits the importation of pork or pork products that might have commingled 

with or were contaminated from pork or pork products derived from swine originating in SVDaffected regions. APHIS considers these prohibitions sufficiently mitigate the risk of importing 

undetected SVD-infected fresh pork or pork products from northern Italy. 

Illegal movement of swine

In the past, illegal movements have played a role in SVD spread because they circumvent the 

mitigating effect of movement controls and biosecurity measures regarding the cleaning and 

disinfection of transport vehicles. According to Ministry of Health officials, illegal swine 

movement contributed to the spread of SVD in the 2007 epidemic in central and southern Italy 

and was associated with single outbreak detected in Emilia-Romagna in 2008. However, the role 

of illegal movement is considered by APHIS to be low especially for the commercial pork 

production market, given the high level of compliance from swine producers and the level of 

priority of control and enforcement activities by the regional and local authorities in the major 

commercial production areas. APHIS concludes that existing Italian regulations satisfactorily 

mitigate this risk.
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Conclusions of Release Assessment

APHIS concludes that the risk of exporting SVD-infected breeding swine, pork and pork 

products from the regions of Italy being reviewed by APHIS would be low. 

Based on evaluation of the 11 factors, as well as observations from the site visits, APHIS 

considers that, for the region under evaluation by APHIS, Italy possesses the detection 

capabilities, reporting and traceability systems, and emergency response systems necessary to 

respond to any reintroduction of SVD, to identify and remove exposed or potentially infected 

breeding swine, pork or pork products from the export market channel, and to comply with the 

certification requirements that APHIS intends to impose for exports to the United States from 

Italy. 
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Section 5. Exposure Assessment

An exposure assessment as defined by the OIE describes the biological pathway(s) necessary for 

exposure of animals and humans in an importing country to the hazards released from a given 

risk source, and estimates the likelihood of the exposure(s) occurring [29]. APHIS' regulatory 

authority is limited to animal health, so potential risks to animals are the primary focus of this 

evaluation.

APHIS considers that the most likely pathway of exposure of domestic livestock to SVD virus in 

pork and pork products is through feeding of contaminated food waste to swine [57]. Other 

exposure pathways are more direct and include contact with imported infected live animals or 

contact with infected genetic material. 

5.1. Waste Feeding To Susceptible Swine

The likelihood of exposure of susceptible species to virus-infected meat was evaluated in 

previous APHIS studies. In 1995, APHIS conducted a pathway analysis to estimate the 

likelihood of exposing swine to infected waste [58]. The analysis included two pathways for 

exposure of swine to contaminated waste; namely, exposure associated with illegal imports for 

personal use, and exposure associated with legal imports. The latter is the exposure pathway that 

would be applicable to importing meat or meat products from Italy. With 95% confidence, 

APHIS estimated that 0.023% or less of plate and manufacturing waste would be inadequately 

processed prior to feeding to swine [58]. Based on this fraction, less than 1 part in 4,300 

(reciprocal of 0.023%) of imported meat is likely to be fed to swine as inadequately cooked 

waste.

APHIS conducted a survey in 2001 of the U.S. swine waste-feeding sector to update a similar 

study done in 1994 [57]. Based on this survey, APHIS estimated that the proportion of plate and 

manufacturing waste fed to swine diminished by about 50% between 1994 and 2001 due to a 

significant decrease in the number of waste-feeding premises. The study also found that:

1. Several more U.S. States prohibited feeding food wastes to swine;

2. The number of waste-feeding premises in the continental United States decreased by 

40.5% from 1994-2001, and in Hawaii and Puerto Rico decreased by 37.5% and 52.3%, 

respectively; and

3. Institutions and restaurants provide nearly 90% of all plate waste fed to swine.

APHIS considers that prohibiting the feeding of unprocessed plate waste to swine has further 

contributed to the reduction of waste-feeding to swine. Waste-feeder operations must be licensed 

and inspected regularly by U.S. Department of Agriculture inspectors (9 CFR 166). The 

licensing process requires that producers adequately cook the waste fed to swine using methods 

designed to destroy foreign animal disease agents.

Based on the 1995 estimate that a very small proportion of food waste is inadequately processed 

prior to feeding to swine, and the substantial reduction in waste-feeding operations in recent 

years, APHIS concludes that the likelihood of exposure of susceptible swine to SVD virus 
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

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58

through inadequately processed food waste is low. Based on the results of the release assessment, 

APHIS further regards the likelihood of exposure of susceptible swine to SVD virus through 

inadequately cooked infected meat from Italy as low. 

5.2. Imported Live Animals

The likelihood of exposure of susceptible species to infected live swine was evaluated by briefly 

reviewing virus persistence and shedding in live swine, as well as U.S. standard import 

requirements for this species. This exposure assessment focuses on breeding animals because 

transportation costs are prohibitive for export of other live swine (e.g. feeder pigs) to the United 

States from EU Member States, and because U.S. regulations only allow import of breeding 

swine from the APHIS defined EU CSF region (9 CFR 94.24). APHIS considers exposure of 

U.S. swine to illegally imported infected live swine from Italy to be highly unlikely.

Infected pigs can excrete SVD virus up to 48 hours before showing clinical signs. Excretion of 

SVD virus by infected pigs typically continues for up to 2 weeks from the nose and mouth, and 

for 3 months or longer in the feces [32]. Pigs infected with SVD virus commonly exhibit mild or 

no clinical signs of illness, and therefore, many infections might not be detected unless 

diagnostic testing is performed.

Consequently, APHIS considers this potential pathway for disease introduction to have high 

unmitigated risk. The risk is partially mitigated by current U.S. regulations requiring a minimum 

quarantine period of 15 days for all imported swine (9 CFR 93.510), which increases the 

likelihood of disease detection. Based on the results of the release assessment, APHIS considers 

the likelihood of exposure of U.S. domestic swine to SVD virus via live swine from Italy to be 

low.

5.3. Imported Genetic Material

Genetic material has been implicated in the introduction of foreign animal diseases into 

susceptible populations, as well as the spread of established disease epidemics over considerable 

distances. For example, two semen collection centers became infected during the course of the 

1997-1998 CSF epidemic in the Netherlands [59]. Potentially contaminated semen was 

distributed to 1,680 swine herds over the course of 5 weeks, during which the disease remained 

undetected in the donor boars. Although investigators concluded that only 36 farms had been 

infected through artificial insemination, all suspect farms were subject to quarantine and testing, 

resulting in a tremendous expenditure of resources. 

SVD virus has been isolated from boar semen, and transmission of SVD virus to swine via 

artificial insemination has been demonstrated [60]. However, experimental results indicate the 

likelihood of transmission of SVD via artificial insemination appears to be low. In Italy, there 

has been no reported spread of SVD via artificial insemination. In addition, in consideration of 

the CSF control measures imposed on swine semen collection centers by the EU Decision 

1999/608/EC and APHIS’ swine semen import restrictions described in 9 CFR 98.38, the 

probability of exposure of susceptible swine to SVD viruses via infected semen from Italy is 

very low. 
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Section 6. Consequence Assessment

This consequence assessment, conducted in accordance with OIE guidelines [29] describes the 

consequences of introducing SVD into the United States. The magnitude of the biologic and 

economic consequences following an introduction of SVD would depend on the location of the 

introduction; the virus serotype introduced; the rate of virus spread; the ability to detect the 

disease rapidly; livestock demographics and movement patterns; and the ease of control and 

eradication. Additionally, restrictions imposed by international trading partners may result in 

severe economic losses and other hardship to otherwise unaffected industry segments. 

6.1. Effects on animal health and production

SVD is a transient vesicular disease of swine; its primary significance is clinical similarity to 

foot and mouth disease [31, 32]. Signs include fever, lameness, and vesicular lesions; severity 

varies depending on virus strain, route of infection, age of the animal, and husbandry. 

Production losses are minimal, and SVD causes essentially no mortality [31, 32, 39].

SVD virus generally does not spread as quickly as other foreign animal diseases; even on 

infected premises, spread from one pen to another may not occur in the absence of a common 

open drainage system or of frequent movement of pigs between pens [38]. However, a SVD 

outbreak may not be detected for weeks or even months due to the frequently mild nature of the 

disease, allowing ample time for spread between swine establishments. In addition, the virus is 

extraordinarily stable in the environment, which could lead to disease recurrence on previously 

infected farms. 

6.2. Control and eradication costs

Outbreaks of foreign animal diseases in previously free regions have historically been associated 

with large economic costs, including production and trade losses, as well as the costs of control 

and eradication. The overall costs of control and eradication depend on the magnitude of the 

outbreak and the control options utilized. For SVD-free countries like the United States that 

have a substantial export market for live swine, pork and pork products, the preferred option for 

control and eradication has traditionally been to stamp-out infected herds without the use of 

vaccine. 

Potential costs include disease control measures such as imposing quarantines and movement 

controls, direct costs related to stamping out of affected and contact herds, indemnity payments, 

surveillance and laboratory testing. The total cost of disease control and eradication, however, 

will depend on numerous factors, including the extent of spread and the prevalence of infection 

prior to detection, the density and types of populations of susceptible animals in affected regions, 

and which control and eradication strategies are ultimately implemented. Although the amount 

may be variable, it is likely that the cost of control, eradication, and compensation will be 

significant. 
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Little information exists on the cost of control and eradication of SVD in a previously free 

region. Estimates of control costs for another foreign animal disease of swine, classical swine 

fever (CSF), provide the best available proxy. As discussed, SVD virus generally does not 

spread as quickly as CSF virus, thus APHIS assumes a baseline cost similar to that of a small- to 

medium-sized CSF outbreak.

The most recent outbreak of CSF in the United States occurred in 1976. The cost of a CSF 

eradication program conducted from 1961 to 1976 was approximately $140 million at that time 

[61]. Saatkamp et al (2000) reviewed the economic aspects of control of small and large CSF 

outbreaks in the European Union (EU) from 1990 to 1997. For the largest outbreak, involving 

429 herds over 14 months, the cost of removing affected swine was the equivalent of $401 

million, slaughter for welfare purposes cost $1.1 billion, and program operational costs were 

$126 million. Overall, the outbreak cost pig producers $669 million, the national government 

$217 million, and the EU $760 million [62]. Approximately 10 million pigs were destroyed 

during the outbreak, primarily for welfare reasons (being in overcrowded conditions, or being 

overweight for slaughter) [63]. The total cost of smaller outbreaks ranged from $10.2 million (8 

affected herds over 2 months) to $196 million (113 affected herds over 10 months) [62]. In all of 

these cases, the slaughter of swine, either for welfare reasons or because of infection or high risk, 

accounted for the vast majority of the estimated costs. 

The potential for rapid escalation of costs related to an outbreak is high since many SVD 

infections are mild or subclinical and significant spread could occur prior to detection. Lack of 

sufficient data; the unpredictability of the clinical course and patterns of spread of infections; and 

the complexity of the factors involved in spread, control and eradication make reliable estimation 

of the potential costs of control and eradication of SVD in the United States difficult or 

impossible. Results of this qualitative assessment, however, suggest that the costs would be 

substantial.

6.3. Market Impacts

In 2011 the value of production of hogs and pigs exceeded $20 billion, (NASS), and the value of 

pork exports exceeded $ 6 billion, (ERS). Potential market impacts of a SVD outbreak include 

export losses as a result of trade restrictions, reductions in consumer demand, falling retail prices 

for commodities, and potential alterations to industry structure due to market disruptions [62, 

64]. The impact of a foreign animal disease outbreak on the viability of rural and regional 

economies, including businesses reliant on livestock revenue, could also be substantial. The 

extent of market impacts will depend on a number of factors, including outbreak size, the 

industry segments affected, the efficacy of control measures, and the reaction of trading partners. 

The animal health and production impacts of SVD are less severe than other foreign animal 

diseases of swine, and the disease spreads more slowly. However, clinical signs of SVD appear 

similar to FMD, and countries are interested in maintaining SVD freedom. Thus, an outbreak in 

a previously free region is very likely to result in trade bans. Reports from SVD-affected 

regions indicate that trade restrictions account for the majority of the losses due to SVD [39]. 

Specific estimates of the market impacts of an SVD outbreak in the United States are not 

available. However, estimates based on outbreaks of other foreign animal diseases in swine 
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

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61

(CSF and FMD), highlight the potential for billions of dollars of losses, mainly due to trade 

restrictions [64, 65].

6.4. Effects on public health

Although public health consequences are not issues under APHIS’ regulatory authority, the 

subject is briefly addressed in this assessment. Direct public health consequences are 

insubstantial because the occurrence of SVD infection in humans is quite rare: laboratory 

workers have become infected, but no infections are recorded in farmers or others working with 

infected swine. In fact, the number of cases reported is so small when compared with the number 

of persons exposed to these viruses that the World Health Organization does not consider SVD 

to be a zoonotic threat to humans [66].

A substantial foreign animal disease outbreak can result in severe psychosocial effects on 

farmers and farming communities. The impact of foreign animal diseases on mental health is 

best documented for foot and mouth disease, but would likely be similar following a large 

outbreak of any foreign animal disease. Effects such as grief over losing animals, feelings of 

isolation and loss of control, fear of new outbreaks, disruptions in community life, loss of trust in 

authority, short- and long-term financial stress, and symptoms of depression and post-traumatic 

stress disorder have been documented [67-70]. Animal health emergency responders may also 

experience stress reactions and distress as a result of participating in or witnessing the culling of 

animals or having to deal with distraught owners of the animals [71].

6.5. Effects on the environment

Environmental effects have been considered under all applicable environmental review laws in 

force in the United States. These are considered in a separate, but related, environmental 

assessment. The environmental assessment complies with the National Environmental Policy Act 

(NEPA) and implementing regulations [72].

6.6. Consequence assessment conclusions

The consequences of an introduction of SVD into the United States would vary based on the 

extent of the outbreak at the time of detection, the virus serotype introduced, and movement and 

demographics of affected swine, but could be expected to be substantial. Additionally, 

restrictions imposed by international trading partners could be expected to result in severe 

economic losses to the U.S. livestock industry.
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Section 7. Risk Estimation

Risk estimation consists of integrating the results from the release assessment, exposure 

assessment, and consequence assessment to produce overall measures of risk associated with the 

hazards identified at the outset. Thus, risk estimation takes into account the whole risk pathway 

from hazard identification to the unwanted event [29].

APHIS concludes from the release assessment that, for the region under evaluation by APHIS, 

Italy possesses the detection capabilities, reporting and traceability systems, and emergency 

response systems necessary to respond to any reintroduction of SVD, to identify and remove 

exposed or potentially infected breeding swine, pork or pork products from the export market 

channel, and to comply with the certification requirements that APHIS intends to impose for 

exports to the United States from Italy. 

APHIS concludes from the exposure assessment that the probability of exposure of susceptible 

U.S. livestock to SVD virus via imports of breeding swine, pork and pork products from the 

region of Italy under evaluation by APHIS is low. 

Conversely, APHIS concludes that the animal health and economic consequences of a SVD 

outbreak in the United States would be substantial. Although control and eradication measures 

would be costly, the major economic impact would likely result from export trade losses.

In summary, although the consequences of a SVD outbreak in the United States would be high, 

the findings of the release and exposure assessments lead APHIS to consider the risk of SVDinfected swine, pork or pork products entering the United States from the region of Italy under 

evaluation by APHIS and exposing U.S. swine to the disease to be low.
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63

References

1. APHIS, Evaluation of Risk Factors for Swine Vesicular Disease in Certain Regions of 

Italy, 1999, Animal and Plant Health Inspection Service, Veterinary Services, 

Regionalization Evaluation Services: Riverdale, MD.

2. APHIS, Proposed Rule: Recognition of Animal Disease Status of Regions in the 

European Union. Federal Register, 1999. 64(122): p. 34155-68.

3. APHIS, Final Rule: Recognition of Animal Disease Status of Regions in the European 

Union. Federal Register, 2003. 68(66): p. 16922-41.

4. European Commission, H.a.C.P.D.-G., Director F - Food and Veterinary Office, Final 

Report of an Animal Health Mission to Italy to Evaluate the Implementation of the 

National Contingency Plan for Classical Swine Fever, 14th to 18th June 1999 

[DG(SANCO)/1143/99 - MR - final], 1999.

5. European Commission, H.a.C.P.D.-G., Director F - Food and Veterinary Office, Final 

Report of a Mission Carried Out in Italy from 21 to 25 January 2002 in Order to Monitor 

the Progress of the African Swine Fever, Classical Swine Fever and Swine Vesicular 

Disease Eradication Programmes [DG(SANCO)/8523/2002 – MR Final], 2002.

6. European Commission, H.a.C.P.D.-G., Director F - Food and Veterinary Office, Final 

Report of a Mission Carried Out In Italy from 17 to 21 February 2003 in Order to 

Review Action Taken by the Competent Authorities with Regard to the Contingency Plans 

for Foot-and-Mouth Disease, Classical Swine Fever and Bluetongue 

[DG(SANCO)/9078/2003 – MR final], 2003.

7. European Commission, H.a.C.P.D.-G., Director F - Food and Veterinary Office, Country 

Profile of Italy on Food and Feed Safety, Animal Health, Animal Welfare and Plant 

Health DG(SANCO)/8287/2006 - CP Final), 2006.

8. European Commission, H.a.C.P.D.-G., Director F - Food and Veterinary Office. Final 

report of a mission carried out in Italy from 17 June to 26 June 2008 in order to evaluate 

the situation concerning African swine fever and swine vesicular disease 

(DG(SANCO)/2008-7801 - MR - FINAL). 2008 [cited 2012 July]; Available from: 

http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2070.

9. European Commission, H.a.C.P.D.-G., Director F - Food and Veterinary Office, Country 

Profile of Italy on Food and Feed Safety, Animal Health, Animal Welfare and Plant 

Health (DG(SANCO)/8105/2009 - CP Final), 2009.

10. Health, W.O.f.A. OIE World Animal Health Information Database (WAHID). 2012 

[cited 2012 July ]; Available from: http://web.oie.int/wahis/public.php?page=home.

11. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Outbreak data and information provided in 2005. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2005.

12. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Outbreak data and information provided in 2006. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2006.

13. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Submission documentation supporting request for recognition provided to APHIS in 

February 2007. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2007.
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

64

14. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Presentations given during APHIS site visit to Italy in April 2007. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2007.

15. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Information given during APHIS site visit to Italy in April 2007. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2007.

16. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Outbreak data and information provided in 2007. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2007.

17. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Supplemental surveillance data provided in February 2008. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2008.

18. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Outbreak data and information provided in 2008. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2008.

19. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Outbreak data and information provided in 2009. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2009.

20. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Presentations given during APHIS site visit to Italy in December 2010. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2010.

21. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Information given during APHIS site visit to Italy in December 2010. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2010.

22. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Outbreak data and information provided in 2010. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2010.

23. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Outbreak data and information provided in 2011. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2011.

24. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Supplemental information provided in March 2012. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2012.

25. Commission Decision 2005/779/EC of 8 November 2005 concerning animal health 

protection measures against swine vesicular disease in Italy (as amended), 2009: 

European Union.

26. Clifford, J.R. Letter to Dr. Romano Marabelli regarding APHIS visit in April 2007 to 

Italy for SVD evaluation [Letter] 2007; Available from: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView.

27. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy,,, 

Ministerial Order dated April 12, 2008, Sanitary Measures for the Eradication of Swine 

Vesicular Disease and Surveillance of Classical Swine Fever, 2008.

28. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Supplemental information supporting request for recognition provided in June 2010. 

Available at: https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2010.
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

65

29. OIE. Terrestrial Animal Health Code Chapter 2.1, Import Risk Analysis,. World 

Organization for animal Health 2010 [cited August 2011]; Available from: 

http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.2.1.htm.

30. APHIS, Final Rule: Importation of Swine and Swine Products From the European 

Union [Docket No. 2-046-2]. Federal Register, 2006. 71(97): p. 29061-72.

31. The Center for Food Security and Public Health: Iowa State University. Swine vesicular 

disease. 2007; Available from: 

http://www.cfsph.iastate.edu/Factsheets/pdfs/swine_vesicular_disease.pdf.

32. World Organization for Animal Health (OIE). Swine vesicular disease technical disease 

card. 2009; Available from: 

http://www.oie.int/fileadmin/Home/eng/Animal_Health_in_the_World/docs/pdf/SWINE

_VESICULAR_DISEASE_FINAL.pdf.

33. Escribano-Romero, E., M.A. Jimenez-Clavero, and V. Ley, Swine vesicular disease 

virus. Pathology of the disease and the molecular characteristics of the virion. Anim 

Health Res Rev, 2000. 1(2): p. 119-126.

34. Brocchi, E., et al., Molecular epidemiology of recent outbreaks of swine vesicular 

disease: two genteically and anitgenically distinct variants in Europe, 1987--4.

Epidemiol. Infect., 1997. 118: p. 51-61.

35. Zhang, G., et al., Molecular evolution of swine vesicular disease virus. J Gen Virol, 1999. 

80: p. 639-651.

36. World Organization for Animal Health (OIE), Chapter 2.8.9. Swine Vesicular Disease, in 

Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2011: Available from: 

http://www.oie.int/international-standard-setting/terrestrial-manual/access-online/.

37. Brown, F., D. Goodridge, and R. Burrows, Infection of man by swine vesicular disease 

virus. J Comp Pathol, 1976. 86(3): p. 409-414.

38. Lin, F. and R.P. Kitching, Swine Vesicular Disease: An Overview. Vet J, 2000. 160: p. 

192-201.

39. Bellini, S., et al., Swine vesicular disease in northern Italy; diffusion through densely 

populated pig areas. Rev. sci. tech, 2010. 29(3): p. 639-648.

40. Lin, F., et al., Persistent infection is a rare sequel following infection of pigs with swine 

vesicular disease virus. Epidemiol Infect, 2001. 127: p. 135-145.

41. Brocchi, E., et al. Swine Vesicular Disease in Italy during 2002: epidemiological and 

diagnostic aspects. in 2002 Session of the Research Group of the Standing Techinical 

Committee of EuFMD. 2002. Cesme, Izmir, Turkey.

42. Guerin, B. and N. Pozzi, Viruses in boar semen: detection and clinical as well as 

epidemiological consequences regarding disease transmission by artificial inseminiation.

Theriogenology, 2005. 63: p. 556-572.

43. Maes, D., et al., Diseases in swine transmitted by artificial insemination. Theriogenology, 

2008. 70: p. 1337-1345.

44. Mackay, D.K.J., Swine Vesicular Disease, in Infectious Diseases of Livestock, J. Coetzer 

and T. Tunstin, Editors. 2004, Oxford University Press: Cape Town, South Africa. p. 

1313-1318.

45. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Submission documentation supporting request for recognition of Bolzano, Piemonte and 

Trento provided in March 2011. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2011.
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

66

46. Council Directive 82/894/EEC of 21 December 1982 on the notification of animal 

diseases within the Community, 1982: European Union.

47. Council Directive 92/119/EEC of 17 December 1992 introducing general Community 

measures for the control of certain animal diseases and specific measures relating to 

swine vesicular disease, 1992: European Union.

48. Commission Decision of 4 July 2000 establishing diagnostic procedures, sampling 

methods and criteria for the evaluation of the results of laboratory tests for the 

confirmation and differential diagnosis of swine vesicular disease, 2000: European 

Union.

49. Council Directive 2008/71/EC of 15 July 2008 on the indentification and registration of 

pigs (as amended), 2008: European Union.

50. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Information provided in October 2007 in response to APHIS observations during April 

2007 site visit. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2007.

51. Ministry of Health, D.o.V.P.H., Nutrition and Food Safety, Government of Italy, 

Supplemental information provided in December 2007 in response to APHIS 

observations during April 2007 site visit. Available at: 

https://web01.aphis.usda.gov/db/mtaddr.nsf/WebView?OpenView, 2007.

52. Bellini S, S.U., Zanardi G., Brocchi E., Marabelli R., Swine vesicular disease 

surveillance and eradication activities in Italy. Rev. sci. tech. Off. int. Epiz., 2007. 26(3).

53. Bellini S., Z.G., Ferrarini N., Santucci U., Swine Vesicular Disease: Surveillance and 

Eradication Activities Carried Out in Italy and Considerations on the Measures Adopted 

in Europe for SVD Control on the Basis of the Knowledge Acquired on the Disease, in 

11th International Symposium on Veterinary Epidemiology and Economics2006.

54. CERVES (National Reference Centre for Vesicular Diseases, I., Assessment of the risky 

period in SVD outbreaks in Northern Italy, I.Z.S.d.L.e. dell'Emilia-Romagna, Editor 

2011: Brescia, Italy.

55. APHIS, Risk Analysis for Importation of Classical Swine Fever Virus in Swine and Swine 

Products from the European Union - December 2000. United States Department of 

Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, 2000, U.S. 

Department of Agriculture, Animal and Plant Health Inspection Service, Veterinary 

Services, National Center for Import and Export.

56. APHIS, APHIS Risk Considerations on Importation of Classical Swine Fever (CSF) 

Virus in Breeding Swine, Swine Semen, and Fresh Pork from a European Union Region 

of Fifteen Member States, 2004, U.S. Department of Agriculture, Animal and Plant 

Health Inspection Service, Veterinary Services, National Center for Import and Export.

57. APHIS, 2001 waste-feeder survey (unpublished data). 2002, U.S. Department of 

Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, Center for 

Epidemiology and Animal Health.

58. APHIS, Risk assessment of the practice of feeding recycled commodities to domesticated 

swine in the U.S., 1995, U.S. Department of Agriculture, Animal and Plant Health 

Inspection Service, Veterinary Services, National Center for Import and Export.

59. Hennecken M., J.A.S.e.a., Transmission of classical swine fever virus by artificial 

insemination during the 1997-1998 epidemic in The Netherlands: a descriptive 

epidemiological study. Vet Q, 2000. 22(4): p. 228-33.
APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

67

60. Thibier, M.a.B.G., Hygienic aspects of storage and use of semen for artificial 

insemination. Animal Reproduction Science, 2000. 62: p. 233-251.

61. Paarlberg, P.L., et al., Economic impacts of foreign animal disease. ERR-57, 2008, 

United States Department of Agriculture. Economic Research Service: Washington, DC.

62. Saatkamp, H.W., P.B.M. Berentsen, and H.S. Horst, Economic aspects of the control of 

classical swine fever outbreaks in the European Union. Veterinary microbiology, 2000. 

73(2-3): p. 221-237.

63. Stegeman, A., et al., The 1997-1998 epidemic of classical swine fever in the Netherlands.

Veterinary microbiology, 2000. 73(2-3): p. 183-196.

64. Paarlberg, P.L., et al., Supply reductions, export restrictions, and expectations for hog 

returns in a potential classical swine fever outbreak in the United States. Journal of 

Swine Health and Production, 2009. 17(3): p. 155-162.

65. Garner, M.F., et al., The expected economic impact of selected exotic diseases on the pig 

industry of Australia. Rev Sci Tech Off Int Epiz, 2001. 20(3): p. 671-685.

66. WHO. World Health Organization - Global Early Warning System for Major Animal 

Diseases, including Zoonoses (GLEWS). Available from: 

http://www.who.int/zoonoses/outbreaks/glews/en/index2.html.

67. Hannay, D. and R. Jones, The effects of foot-and-mouth on the health of those involved in 

farming and tourism in Dumfries and Galloway. European Journal of General Practice, 

2002. 8(3): p. 83-89.

68. Mort, M., et al., Psychosocial effects of the 2001 UK foot and mouth disease epidemic in 

a rural population: qualitative diary based study. BMJ, 2005. 331(7527): p. 1234.

69. Olff, M., et al., Impact of a foot and mouth disease crisis on post-traumatic stress 

symptoms in farmers. The British Journal of Psychiatry, 2005. 186(2): p. 165.

70. Van Haaften, E.H., M. Olff, and P.H. Kersten, The psychological impact of the Foot and 

Mouth Disease crisis on Dutch dairy farmers. Njas-Wageningen Journal of Life 

Sciences, 2004. 51(4): p. 339-349.

71. Jenner, M., The psychological impact of responding to agricultural emergencies.

Australian Journal of Emergency Management, The, 2007. 22(2): p. 25.

72. National Environmental Policy Act (NEPA). 1969 [cited 2012 May 15]; Available from: 

http://ceq.hss.doe.gov/.
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Health Ministry

Ministerial Order dated 12 April 2008 

Sanitary measures for the eradication of swine vesicular disease and surveillance of classical swine fever.

Published in the Ordinary Supplement of Italian Official Journal no. 148 of 26 June 2008 (Gazz. Uff. 26 giugno 2008, n. 148, S.O.)

Epigraph

Premises

Article 1. Objectives

Article 2. Definitions

Article 3. Recognition of Regions

Article 4. Recognition of holdings

Article 5. Suspension, revocation and reacquisition of provincial recognition

Article 6. Surveillance activity

Article 7. Retention, suspension and revocation of holding recognition

Article 8. Procedures for reacquisition of holding recognition

Article 9. Tests at holdings

Article 10. Dispatch of samples and forms

Article 11. Singleton reactor

Article 12. Slaughtering of seropositive animals

Article 13. Transportation

Article 14. Information flows

Article 15. Tests on pig consignments from EU Member States

Article 16. Cleaning and sanitation

Article 17. Surveillance of classical swine fever

Article 18. Surveillance of classical swine fever in wild pigs
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Article 19. Transmission of data on the classical swine fever surveillance plan

Article 20. Dispatch of data on activities carried out

Article 21. Financial aspects

Article 22. Penalties

Article 23. Effective date

Annex I - Regions recognized as free from swine vesicular disease

Annex II - Swine vesicular disease surveillance and eradication plan

Annex III - Disinfectants active against the swine vesicular disease virus

Annex IV

Annex V

Annex VI - Swine vesicular disease eradication and surveillance plan -

Accompanying form for samples

Annex VII - Epidemiological survey on swine vesicular disease and classical swine 

fever

Annex VIII - Outbreak communication form

Annex IX

Annex X - Swine vesicular disease (SVD) - Biosafety parameters for pig farms

Annex XI - Swine vesicular disease eradication and surveillance plan - Outline of 

data record to be uploaded on-line with regard to serological surveillance 

activities alone

Ministerial Order, 12 April 2008 (1).

Sanitary measures for the eradication of swine vesicular disease and 

surveillance of classical swine fever. (2)

(1) Published in Ordinary Supplement of the Italian Official Journal no. 148 of 26 

June 2008 (Gazz. Uff. 26 giugno 2008, n. 148, S.O.)

(2) Issued by the Health Ministry.
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THE HEALTH MINISTER

Having regard to the Consolidated Act of sanitary laws enacted by Royal Decree 

no. 1265 dated 27 July 1934 and following amendments;

Having regard to the regulation of veterinary police approved by Presidential 

Decree no. 320 dated 8 February 1954;

Having regard to article 117 of Legislative Decree no. 112 dated 31 March 1998

and following amendments;

Having regard to Law no. 34 dated 23 January 1968 amended by Law no. 

98/1985;

Having regard to article 32 of Law no. 833 dated 23 December 1978 as last 

amended by Legislative Decree no. 229 dated 19 June 1999;

Having regard to Law no. 218 dated 2 June 1988;

Having regard to Decree no. 298 dated 20 July 1988 and following amendments;

Having regard to Decree no. 587 dated 19 August 1996;

Having regard to the Order dated 2 December 1994, published in Official Journal

of the Italian Republic no. 303 dated 29 December 1994;

Having regard to the Order dated 6 February 1997, published in Official Journal of 

the Italian Republic no. 57 dated 10 March 1997;

Having regard to the Order dated 17 September 1998, published in Official 

Journal of the Italian Republic no. 247 dated 22 October 1998;

Having regard to the Order dated 5 August 1999, published in Official Journal of 

the Italian Republic no. 223 dated 22 September 1999;

Having regard to the Order dated 26 July 2001, published in Official Journal of the 

Italian Republic no. 221 dated 22 September 2001;

Having regard to Legislative Decree no. 196 dated 22 May 1999;

Having regard to Presidential Decree no. 317 dated 30 April 1996;

Having regard to Presidential Decree no. 362 dated 17 May 1996;
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Having regard to Legislative Decree no. 55 dated 20 February 2004 on 

«Implementation of Directive 2001/89/EC on Community measures for the 

control of classical swine fever», published in Official Journal of the Italian 

Republic no. 49 dated 28 February 2004 - Ordinary Supplement no. 30;

Having regard to Directive 92/119/EEC introducing general Community measures 

for the control of certain animal diseases and specific measures relating to swine 

vesicular disease;

Having regard to Commission Directive 2007/10/EC dated 21 February 2007 

amending Annex II to Council Directive 92/119/EEC as regards the measures to 

be taken within a protection zone following an outbreak of swine vesicular 

disease, implemented by Ministerial Decree dated 28 March 2007, published in 

the Official Journal of the Italian Republic no. 161 dated 13 July 2007;

Having regard to Commission Decision 2005/779/EC dated 8 November 2005 

introducing new rules on animal health protection measures against swine 

vesicular disease in Italy and following amendments;

Having regard to Commission Decision 2007/9/EC dated 18 December 2006

amending Commission Decision 2005/779/EC on some animal health protection 

measures against swine vesicular disease in Italy;

Having regard to document SANCO/10543/2007, Rev. 1, amending Commission 

Decision 2005/779/EC on some animal health protection measures against swine 

vesicular disease in Italy dated 9 January 2008 and amended on 4 March 2008 by 

document SANCO/10543/2007, Rev. 2, with a unanimous vote of the 

representatives of the Member States during the course of the meeting of the 

Standing Committee on the food chain and animal health;

Having regard to Commission Decision 2007/782/EC dated 30 November 2007

approving annual and multi-annual national programmes and the financial 

contribution from the Community for the eradication, control and surveillance of 

certain animal diseases and zoonoses, presented by the Member States for 2008 

and following years;

Having identified the need and urgency of complying with said regulations;

Whereas in 2006 and 2007 there was a resurgence of swine vesicular disease in 

the Regions of northern Italy recognized as SVD-free and fattening farms were 

the most heavily affected type of production, there is a need to perform checks 

for vesicular disease regardless of the type of production of the holdings;
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Whereas surveillance for classical swine fever is deemed advisable, the disease is 

not currently present on Italian soil, but it is present in some Member States and 

third countries;

Hereby orders:

Article 1. Objectives

1. It is mandatory for Regions and the Autonomous Provinces of Trento and 

Bolzano (hereinafter referred to as «Regions») to implement the swine vesicular 

disease (hereinafter referred to as «SVD») surveillance and eradication plan as 

per Annex II to this Order (hereinafter referred to as «Plan»).

2. The Plan objectives as per paragraph 1 are:

a) maintaining of the accreditation status in the Regions as per Annex I 

hereto;

b) achievement of accreditation status in the Regions lacking recognition as 

per item a);

c) annual implementation of the Plan as per paragraph 1.

3. A Classical Swine Fever Surveillance Plan has been drafted and it is based on 

the detection of any classical swine fever virus circulating in the Italian swine 

population and on the monitoring thereof in the population of wild boars.

Article 2. Definitions

1. For the purpose of this Order the following definitions shall apply:

a) holding: any agricultural premises, building or the like, also outdoors, 

where animals are kept, reared or marketed including dealers’ premises and 

markets;

b) breeding farms: holdings where boars and sows are kept for the 

production of piglets up to weaning; also referred to as Site 1;

c) open breeding farms: holdings where breeders and growing pigs for 

fattening are kept up to the weaning and/or growing phase;

d) closed breeding farms: holdings where breeders and growing pigs raised 

solely for the purpose of slaughtering are kept up to the fattening phase;

e) fattening farms: holdings where growing pigs raised solely for slaughtering 

are kept from the weaning and/or growing phase to the end of the production 

cycle; also referred to as Site 3;

f) dealers’ premises: holdings of a dealer authorized as per article 17 of 

Presidential Decree no. 320 dated 8 February 1954, as set forth by article 11 of 

Legislative Decree no. 196 dated 22 May 1999 where there is a regular turnover

of the animals purchased and sold within 30 days from purchase; for the purpose 
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of the checks all those holdings, which, regardless of the type of production, carry 

out animal turnover like dealers’ premises shall be treated as such. Swine kept at 

dealers’ premises are sent solely and directly to slaughter plants;

g) assembly centers: centers as per article 1, paragraph 2, of Legislative 

Decree no. 196 dated 22 May 1999;

h) Region recognized as free from swine vesicular disease: Region complying 

with the requirements as per article 3 where the conditions for the issue of 

suspension or revocation measures do not subsist;

i) holding recognized as free from swine vesicular disease: holding complying 

with the requirements as per article 4;

l) CERVES: National center of reference for vesicular diseases, Istituto 

zooprofilattico sperimentale (Animal Health Institute) of Lombardy and EmiliaRomagna, based in Brescia;

m) CEREP: National center of reference for swine fever, Istituto 

zooprofilattico sperimentale (Animal Health Institute) of Umbria and Marche, 

based in Perugia;

n) BDN: National database as per Legislative Decree no. 196 dated 22 May 

1999.

Article 3. Recognition of Regions

1. A Region recognized as free from swine vesicular disease is understood as a 

Region where:

a) All the holdings present are accredited as per article 4;

b) All the activities set forth in the Plan were carried out in the previous year;

c) The conditions for the issue of accreditation suspension or revocation 

measures do not subsist.

2. The list of Regions recognized as free from swine vesicular disease in 

compliance with Commission Decision 2005/779/EC and following amendments is 

provided in Annex I.

3. Annex I can be amended by order of the Health Ministry.

4. In the event that primary outbreaks are detected in several provinces 

and/or there is a risk of spreading the infection, the Health Ministry may issue an 

order suspending and/or revoking the regional accreditation if information 

relevant to assessing the epidemiological situation is lacking.

Article 4. Recognition of holdings 

1. For the purpose of recognition, a holding must be registered in the BDN and 

recognized as SVD-free according to the provisions of Annex II hereto. With 

regard to dealers’ premises, the checks set forth in Annex II hereto are to be 

carried out on a regular basis.

Article 5. Suspension, revocation and reacquisition of provincial recognition
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1. The recognition of a province of an SVD-free Region shall be immediately 

suspended/revoked by order of the Health Ministry when an outbreak of disease 

of unknown origin occurs.

2. Recognition is not revoked in the event that it is determined that the outbreak 

as per paragraph 1 is epidemiologically correlated with another and it is proven 

that there is no risk of further spreading the infection. Otherwise the province's 

recognition is revoked.

3. Articles 7, 8 and 9 of Commission Decision 2005/779/EC and following 

amendments shall be applied for provinces whose recognition has been revoked.

4. A no longer SVD-free province can be re-accredited by order of the Health 

Ministry at the following conditions:

a) the envisaged measures are applied in the outbreak protection and 

surveillance zones in compliance with the provisions of Presidential Decree no. 

362 dated 17 May 1996, as amended by Ministerial Decree dated 28 March 2007;

b) serological tests have been carried out twice, at an interval of 28 to 40 

days, at all holdings located in that same province on a number of swine 

adequate to determine a prevalence of 5% with a confidence interval of 95% and 

negative results;

c) the results of the epidemiological survey carried out in compliance with the 

provisions of Presidential Decree no. 362 dated 17 May 1996 have proven that 

there is no risk whatsoever of the further spreading of swine vesicular disease.

5. In compliance with the provisions of Commission Decision 2005/779/EC, the 

Health Ministry shall immediately inform the European Commission of the 

measures adopted in accordance with the provisions of this article and disclose 

the measures adopted.

6. The order of suspension of accreditation can last no more than 6 months. 

Otherwise the suspension order is converted into a revocation order.

Article 6. Surveillance activity 

1. In SVD-free and non-SVD-free Regions surveillance activities are regulated by 

the Plan as per Annex II to this order.

Article 7. Retention, suspension and revocation of holding recognition

1. A holding recognized as SVD-free shall maintain its status if it has complied 

with the provisions set forth in article 4 and:
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a) it has carried out the testing activities set forth in the Plan and the results 

thereof are negative;

b) bought-in pigs come from holdings recognized as SVD-free;

c) it is registered in the national database (BDN) and the relevant sanitary 

recognition is kept up-to-date in the BDN.

2. The holding's recognition as SVD-free is suspended if, during inspections by 

the competent authorities, documentation irregularities are detected in the 

holding's register or in the BDN or in the event that swine, which have not been 

correctly identified, are present. Said status shall last as long as it takes to 

redress the situation.

3. Accreditation as holding recognized as SVD-free is suspended if during the 

course of the Plan's execution a single seropositive case is detected even during 

screening tests carried out at the Istituto zooprofilattico sperimentale (Animal 

Health Institute) having competence over the territory and also before 

confirmation by CERVES. In said case the Azienda sanitaria locale (Local Health 

Authority) shall order:

a) attachment of the holding and block of transportation of animals at the 

holding;

b) collection of a second blood sample from the seropositive animal and from 

a significant number of swine in contact with the pig 7 days after the drawing of 

the previous samples;

c) in the event that seropositivity is confirmed as «singleton reactors» as per 

article 11, the seropositive pig must be slaughtered according to the provisions of 

article 12. In said event, the holding recovers its accreditation immediately after 

the slaughtering of the seropositive animal and the restrictive measures are 

revoked.

4. Accreditation as holding recognized as SVD-free is revoked in the event that 

pigs without certification of their origin or counterfeited documentation or 

identification are found. In said case the local health authority shall order the 

attachment of the holding and the block of the transportation of the animals at 

the holding.

5. If seropositivity is not ascribable to a «singleton reactor», the holding's 

accreditation is revoked and the Local Health Authority applies the measures 

necessary to confirm or rule out the presence of the disease and in said case 

orders:

a) attachment of the holding and block of transportation of animals at the 

holding;

b) collection of a sample of faeces from the holding's various facilities and 

collection of blood samples from pigs:
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- in case of a breeding farm/holding, blood samples from all breeders not 

tested yet and samples from fattening pigs as specified in the table in Annex IV;

- in case of a fattening farm/holding, blood samples from a number of 

animals as specified in the table in Annex IV.

The group of tested animals must include also animals to have come into contact 

with the seropositive animals.

6. If seropositivity alone is detected without any transmission of the swine 

vesicular disease enterovirus, the Local Health Authority shall order, in 

compliance with the provisions of article 12 below, the slaughtering of:

a) the seropositive breeders;

b) all fattening animals,

depending on the type of production affected by seropositivity.

7. In the event that the tests detect the circulation of the swine vesicular disease 

enterovirus, the holding is declared an outbreak and the local health authority 

shall apply the provisions of Presidential Decree no. 362 dated 17 May 1996 and 

following amendments.

Article 8. Procedures for reacquisition of holding recognition

1. In order to re-obtain recognition of:

a) holdings with multiple cases of seropositivity, a number of blood samples 

as specified in the table in Annex IV is to be collected from just as many breeders 

at least 28 days after the slaughtering of the seropositive animals. In the event of 

partial killings (breeding holdings), the animals to be sampled must also include 

those, which had come into contact with the seropositive animals;

b) holdings in protection zones set up as per Presidential Decree no. 362 

dated 17 May 1996, two blood samples are to be drawn. The second is to be 

drawn from a number of animals as specified in the table in Annex IV in a period 

comprised between 28 and 40 days from the first;

c) holdings in surveillance zones set up as per Presidential Decree no. 362 

dated 17 May 1996, a single blood sample is to be drawn in all holdings from a 

number of animals as specified in the table in Annex IV.

2. Holdings pending re-accreditation cannot transport swine to other holdings 

and/or slaughter plants save for the provisions of article 12.

Article 9. Tests at holdings

1. Before sampling, the official veterinarian shall assess the holding's register as 

per article 3, paragraph 3, of Presidential Decree no. 317 dated 30 April 1996 as 
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well as whether the Plan has been implemented correctly. With regard to dealers’ 

premises s/he must also assess compliance with the provisions set forth in the

relevant document attached to the Plan.

2. The inspection of the holding's register is aimed at assessing the movement of 

incoming and outgoing consignments and determine whether the information 

posted in the register actually matched the actual farm stock.

3. At the dealers’ premises the official veterinarian assesses the register of 

disinfection operations as per article 11 of Ministerial Order dated 5 August 1999

(as per the premises), whether it is up-to-date and whether disinfectants have 

been used correctly.

4. The official veterinarian assesses compliance with the provisions on safety as 

per Annex.

Article 10. Dispatch of samples and forms

1. The data of the holding and swine examined and identified as per Presidential 

Decree no. 317 dated 30 April 1996 must be entered correctly into the form in 

Annex VI hereto, which, once duly filled out, must accompany the blood samples 

sent to the Istituto zooprofilattico sperimentale (Animal Health Institute) having 

competence over the territory.

2. Faeces samples can be sent directly by the Azienda sanitaria locale (Local 

Health Authority) to CERVES, provided that a copy of the form as per Annex VI is 

sent to the Istituto zooprofilattico sperimentale (Animal Health Institute) having 

competence over the territory.

3. With regard to dealers’ premises, the samples collected during the 

implementation of this Plan must be sent to the Istituto zooprofilattico 

sperimentale (Animal Health Institute) having competence over the territory or to 

CERVES depending on the type of sample and accompanied by the relevant forms 

duly filled out. The forms must be filled out and sent also when no animals are at 

dealers’ premises and no blood samples can be drawn. In this case enter 0 in the 

«number of animals present» box and «number of samples drawn» box. The 

records for these checks must be entered in the SVD information system.

4. Besides the serological and virological testing for swine vesicular disease and 

classical swine fever, the blood and faeces samples can also be used for other 

tests set forth in other swine disease monitoring plans.

5. The form accompanying the samples (Annex VI) can be downloaded from the 

BDN with the holding's details already filled out. If said Annex downloaded from 

the BDN has data differing from those reported by the official veterinarian during 
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the inspection at the holding, the latter must make the necessary changes by 

updating and/or requiring the update thereof in the BDN.

Article 11. Singleton reactor

1. The presence of a «singleton reactor» is suspected when a single seropositive 

case is matched by:

a) absence of clinical symptoms of the disease among the holding's animals;

b) no prior case of disease at the holding;

c) no epidemiological correlation of the holding or seropositive animal with an 

outbreak of swine vesicular disease or another seropositive holding.

2. The «singleton reactor» is confirmed in the event of:

a) no seroconversion of other animals at the holding;

b) no increase in the antibody titer of the seropositive animal.

Article 12. Slaughtering of seropositive animals

1. Seropositive animals must be slaughtered no later than 72 hours from the 

issue of the slaughter order at a slaughter plant located in the Region's territory.

2. Each single seropositive swine to be slaughtered must be identified.

3. The dispatch of the seropositive animals for slaughter must be notified by the 

Veterinary Dept. of the Azienda sanitaria locale (Local Health Authority) of origin 

to that of destination within 48 hours from departure. The certificate of origin of 

the animals (Form # 4) must bear the wording "swine seropositive for swine 

vesicular disease" in addition to the ID codes of the animals.

4. The official veterinarian in charge of the slaughter plant of destination must 

specify that the animals were slaughtered at the bottom of Form #4 and 

immediately notify the Azienda sanitaria locale (Local Health Authority) of origin 

thereof.

5. Seropositive animals, including the «singleton reactors», must be transported, 

kept and slaughtered separately from other swine and their meat must be 

handled in compliance with Presidential Decree no. 362 dated 17 May 1996 and 

following amendments. The head and viscera of said swine must be destroyed 

and the meat is to be sold on the domestic market only.
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Article 13. Transportation 

1. It is absolutely forbidden to transport live pigs in Italy in the following 

circumstances:

a) from holdings not recognized as SVD-free also to slaughter plants save for 

the provisions of article 12;

b) from Regions not recognized as SVD-free to other Italian Regions.

2. By way of derogation from paragraph 1, item b), the Health Ministry may 

authorize the transfer of swine from holdings located in Regions not recognized as 

SVD-free to other Regions, provided that the conditions set forth in the attached 

Plan and by article 8 of Commission Decision 2005/779/EC and following 

amendments are met.

3. The transportation of live pigs from Italy to other Member States is allowed 

only if the animals come from holdings recognized as SVD-free and located in 

Regions recognized as SVD-free.

4. Swine sent from Italy to other Member States must be accompanied by the 

health certificates as set forth by article 4, para. 1, of Legislative Decree no. 196 

dated 22 May 1999 and the certificate must bear the following wording: «Animals 

in accordance with Commission Decision 2005/779/EC concerning animal health 

protection measures against swine vesicular disease in Italy».

Article 14. Information flows

1. Within the framework of the Plan, the Istituto zooprofilattico sperimentale 

(Animal Health Institute) sends the result of the serological and virological tests 

to the Azienda sanitaria locale (Local Health Authority).

2. In the event that the seropositivity is confirmed by CERVES, the Istituto 

zooprofilattico sperimentale (Animal Health Institute) having competence over 

the territory shall notify the Azienda sanitaria locale (Local Health Authority) and 

the Region by fax and the latter shall notify the Health Ministry.

3. In the case of viral isolation, CERVES shall notify the Health Ministry, Region, 

Istituto zooprofilattico sperimentale (Animal Health Institute) having competence 

over the territory, Azienda sanitaria locale (Local Health Authority) and Istituto 

superiore di sanità (Higher Institute of Health) directly by fax.

4. In case of a seropositive case or viral isolation, the Azienda sanitaria locale 

(local health authority) shall carry out an epidemiological survey within 10 days 

and send the results thereof to the Health Ministry, CERVES and Region using the 

form as per Annex VII.
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5. In order to allow the Health Ministry to inform the European Commission in 

case of an outbreak, the competent Azienda sanitaria locale (Local Health 

Authority) shall send the Health Ministry the data in the form as per Annex VIII 

within 24 hours.

6. The Istituti zooprofilattici sperimentali (Animal Health Institutes) shall send 

CERVES the report of surveillance activities using a record outline attached under 

Annex XI according to the following timeline:

a) on a quarterly basis, for Regions recognized as SVD-free;

b) on a monthly basis, for Regions not recognized as SVD-free;

c) on a monthly basis, in specific cases for which, according to the information 

available and having consulted CERVES, the Health Ministry decides that there is 

an at-risk epidemiological situation.

Article 15. Tests on pig consignments from EU Member States

1. Pig consignments from EU Member States must be subject to nondiscriminatory tests pursuant to Legislative Decree no. 28 dated 30 January 

1993.

2. Sampling shall regard consignments of production/breeding pigs and be 

carried out at the moment of unloading the animals from the truck. Said sampling 

does not include pig consignments for slaughtering.

3. A number of blood samples as per the table in Annex IV together with faeces 

samples taken from the various compartments of the vehicle is collected for each 

consignment.

4. Each blood and faeces sample must be quantitatively adequate to allow the 

Istituto zooprofilattico sperimentale (Animal Health Institute) having competence 

over the territory to obtain two aliquots. Of these one must be kept for at least 

one month in appropriate conditions allowing the use thereof in case of litigation

with the sending Member State.

5. The samples sent to the competent Istituto zooprofilattico sperimentale 

(Animal Health Institute) must be accompanied by the form as per Annex V to the 

Ministerial Order dated 5 August 1999.

6. The Istituti zooprofilattici sperimentali (Animal Health Institutes) shall not 

accept samples to be tested without said form duly filled out.
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Article 16. Cleaning and sanitation 

1. Dealers’ premises, assembly centers, holding pens annexed to slaughter 

plants as well as vehicles used for the transportation of the animals must be 

thoroughly cleaned and sanitized using products of proven efficacy against SVD 

as listed in Annex III and according to the procedures as per the Plan in Annex II. 

The cleaning and sanitation of the trucks must be certified with the relevant 

certificate as per Annex IX.

Article 17. Surveillance of classical swine fever

1. Within the framework of the Plan as per article 1 a classical swine fever 

surveillance programme is to be implemented.

2. The Istituto zooprofilattico sperimentale (Animal Health Institute) having 

competence over the territory shall perform a serological test on 12 samples 

drawn as per article 6 to find the antibodies of classical swine fever.

3. Any positive serological tests must be immediately reported by the Istituto 

zooprofilattico sperimentale (Animal Health Institute) having competence over 

the territory to the Health Ministry, Azienda sanitaria locale (local health 

authority) and Region.

4. Istituti zooprofilattici sperimentali (Animal Health Institutes) shall send the 

CSF-positive samples to CEREP for confirmation testing.

5. If positivity to classical swine fever is confirmed by CEREP, the official 

veterinarian shall immediately apply the official survey procedures aimed at 

confirming or ruling out the presence of the disease in accordance with the 

diagnostics manual.

6. In compliance with the provisions of Commission Decision 2002/102/EC, the 

results of the serological tests for confirmation performed by CEREP are to be 

sent to the Health Ministry, the Istituto zooprofilattico sperimentale (Animal 

Health Institute), the Azienda sanitaria locale (Local Health Authority) and 

Region.

7. The Azienda sanitaria locale (Local Health Authority) shall carry out an 

accurate epidemiological survey as per Annex VII to identify and determine any 

risk factors and send its findings to the Health Ministry and veterinary services of 

the various Regions or Autonomous Provinces.

8. Pending the results of the diagnostic work-up, the Azienda sanitaria locale 

(Local Health Authority) shall apply the measures set forth by Legislative Decree 

no. 55 dated 20 February 2004 to holdings suspected of being infected.
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Article 18. Surveillance of classical swine fever in wild pigs 

1. Regional authorities, in conjunction with CEREP and the Istituto nazionale 

della fauna selvatica (National Wildlife Institute), shall determine the zones where 

serological and virological testing on wild pigs are to be carried out and the 

minimum sampling requirements based on the following risk factors:

a) any evidence over the past five years of outbreaks of classical swine fever 

in areas marked by the presence of wild pigs also in the territory of bordering 

Member States and third countries;

b) size and origin of the flow of wild pigs for re-stocking purposes introduced 

in areas of special wildlife and hunting interest;

c) presence and density of agritourism facilities where swine or wild pigs are 

raised in areas marked by the presence of wild boars.

Article 19. Transmission of data on the surveillance plan for classical swine fever

1. The Istituti zooprofilattici sperimentali (Animal Health Institutes) having 

competence over the territory shall send, once the plan is completed, the data of 

the monitoring activities carried out at holdings to CEREP, which shall collect and 

forward said data to the Health Ministry.

Article 20. Dispatch of data on activities carried out

1. The Health Ministry shall inform the European Commission on the health 

status of the Regions, the state of progress of the Plan, the serological and 

virological tests performed, the outbreaks detected, the holdings and number of 

seropositive animals found and on the indemnities paid out according to existing 

regulations.

2. Regional authorities shall send the Health Ministry the quarterly reports in 

compliance with the last paragraph of article 5 of Law no. 833 dated 23 

December 1978.

3. The Health Ministry, if need be, shall send Regions explanatory instructions on 

Plan implementation.

Article 21. Financial aspects

1. The financial cost of the Plan shall be borne by the National Health Fund 

(section 2700 posted within the framework of the programme «State contribution 

to the funding of health expenditure» of the mission "Financial relations with 

autonomous territorial authorities").
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2. The indemnity due to the owners of the swine slaughtered pursuant to the 

Plan is regulated by Law no. 218 dated 2 June 1988, Ministerial Decree no. 298 

dated 20 July 1989, and Interministerial Decree no. 587 dated 19 August 1996

referred to in the premises.

3. Community financial participation in the Plan shall account for 50% of the 

expenses borne for the serological and virological tests and for the indemnities for 

slaughtered swine.

4. For the purpose of reporting for refund from the European Union, Regions 

shall use the forms as per Commission Decision 2002/677/EC.

5. For the purpose of their relevant obligations, Regions shall send a final report 

on the technical implementation of the Plan along with the receipts of the 

expenses borne with reference to the Plan implemented the prior year by the 1st

of April of the following year.

Article 22. Penalties

1. Without prejudice to the fact that it is not a crime, whoever should fail to 

abide by the provisions herein is subject to the penalties set forth in article 16, 

paragraph 1, of Legislative Decree no. 196 dated 22 May 1999.

Article 23. Effective date

1. This order submitted to the Corte dei conti (National Audit Office) for 

registration shall take effect on the day following publication in the Official Journal

of the Italian Republic and be valid up to 31 December 2009.

2. This order repeals and replaces the Health Ministry order dated 26 July 2001 

concerning the «National Plan for the eradication and surveillance of swine 

vesicular disease and the surveillance of classical swine fever».
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Annex I

Regions recognized as free from swine vesicular disease

Valle d'Aosta

Piedmont

Liguria

Lombardy

Autonomous Provinces of Trento and Bolzano

Veneto

Friuli-Venezia Giulia

Emilia-Romagna

Tuscany

Umbria

Marche

Lazio

Molise

Apulia

Basilicata

Sardinia
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Annex II

Swine vesicular disease surveillance and eradication plan

Description of the plan submitted

The objectives of the 2008 SVD Plan are the following:

- maintaining the state of accreditation in the Regions recognized as SVD-free;

- assessing the epidemiological situation in the Regions recognized as SVD-free, 

which in the 2006-2007 period were the site of SVD outbreaks;

- accreditation of Regions not recognized as SVD-free.

Differentiated forms of surveillance are set forth depending on the regional health 

situation and the epidemiological status in the 2006-2007 period. The events of 

the recent epidemic call for more intense surveillance activities with regard to the 

disease also in Regions recognized as SVD-free.

The National Plan shall also include biosafety guidelines specifying in detail the 

relevant measures to monitor the potential routes by which the infection can

spread and to prevent the contamination of holdings/farms. The provisions set 

forth by legislation are vain if these are not matched by the awareness of the 

sector's operators that, in order to safeguard their own economic and commercial 

interests, it is necessary to safeguard the health of the animal stock also through 

the responsible application of strict biosafety measures.

RECOGNITION OF HOLDINGS 

- In Regions recognized as SVD-free a holding is recognized as free from said 

disease provided that:

- Breeding farms: on two occasions, at an interval of 28 to 40 days, samples for 

serological testing were collected from a number of breeders adequate to detect a 

prevalence of infection in the order of 5% with a confidence interval of 95% and 

the outcome thereof was negative;

- Fattening farms: all swine come from holdings recognized as SVD-free.

- In Regions not recognized as SVD-free, a holding is recognized as free from said 

disease if on two occasions, at an interval of 28 to 40 days, samples for 

serological testing were collected from a number of animals adequate to detect a 

prevalence of infection in the order of 5% with a confidence interval of 95% and 

the outcome thereof was negative;
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SURVEILLANCE ACTIVITY 

Regions recognized as SVD-free

Holdings/farms must be accredited according to the provisions for SVD-free 

Regions under «Recognition of holdings».

Holdings/farms without accreditation cannot transport swine also in the event 

that these are to be sent directly for slaughtering.

Planned Activities:

- Registry of swine holdings/farms;

- Breeding farms:

a. Open farms: serological testing must be carried out every 6 months on all 

breeding farms. Samples for the serological tests must be collected at each 

holding from a number of breeders adequate to detect a prevalence of infection in 

the order of 10% with a confidence interval of 95%.

b) Closed farms: serological testing is to be performed on all breeding farms on 

an annual basis according to the same sampling requirements for open breeding 

farms.

Fattening farms:

- Regions in which in the 2006-2007 period no outbreaks of SVD were detected 

or, in the event of outbreaks, these were secondary outbreaks and the 

surveillance and eradication activities proved that the disease did not spread 

across the Region (Emilia-Romagna): in these Regions a sample of 300 holdings 

(indicative of the regional animal breeding situation) with more than 2 animals 

must be selected.

Samples for the serological tests must be collected every 6 months at the 

holdings selected from a number of animals adequate to detect a prevalence of 

infection in the order of 5% (with a confidence interval of 95%).

- Regions in which in the 2006-2007 period primary outbreaks of SVD were 

detected: in these Regions all fattening farms with more than 2 animals must be 

inspected every 6 months by performing serological tests on a number of animals 

adequate to detect a prevalence of infection in the order of 5% (with a confidence 

interval of 95%).

- Regions not recognized as SVD-free:
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Holdings/farms must be accredited according to the provisions for non-SVD-free 

Regions under «Recognition of holdings».

Holdings/farms without accreditation cannot transport swine also in the event 

that these are to be sent directly for slaughtering.

Planned Activities:

- Registry of swine holdings/farms;

- Breeding farms:

a. Open farms: serological testing must be carried out every 6 months on all 

breeding farms. Samples for the serological tests must be collected at each 

holding from a number of breeders adequate to detect a prevalence of infection in 

the order of 10% (with a confidence interval of 95%);

b. Closed farms: serological testing must be carried out on an annual basis on all 

breeding farms. The number of samples to be drawn is the same as that for open 

breeding farms.

- Fattening farms: all fattening farms with more than 2 animals must be tested 

every 6 months by performing serological tests on a number of animals adequate 

to detect a prevalence of infection in the order of 5% (with a confidence interval 

of 95%).

Activities set forth for dealers’ premises

Without prejudice to the requirements set forth by Legislative Decree no. 196 

dated 22 May 1999, for the purpose of this SVD Plan, the dealers’ premises and 

pens are to be considered as assembly centers and, at the moment of the on-site 

survey for the drawing of the samples required by the national plan, it must be 

assessed whether the infrastructure and management requirements subsist in 

order to minimize the spreading of the disease and ensure traceability if it were 

to occur.

1. Minimum equipment required for dealers’ premises without which it is not 

possible to trade animals:

a) suitable devices for washing, cleaning and sanitizing the dealers’ premises;

a) suitable devices for washing, cleaning and sanitizing trucks before access to 

the dealers’ premises;
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c) availability of disinfectants of proven efficacy against the SVD virus at the 

dealers’ premises and at the entrance to said premises.

2. Management procedures required for dealers’ premises:

a) at dealers’ premises the sale of the animals must take place within 30 days

from their purchase. Swine kept at dealers’ premises are sent solely and directly 

to slaughter plants;

b) discarded animals (underweight animals or animals with diseases or disease 

outcomes requiring their slaughtering) and culled animals (breeders at the end of 

their reproductive years) cannot be sold through dealers’ premises;

c) once the animals are unloaded and anyhow before access to the breeding 

farm, trucks used for the transportation of the pigs must be washed and

sanitized. Records certifying cleaning and sanitation must be kept for 1 year;

d) dealers’ premises must be cleared for sanitary purposes every 30 days and 

cleaned and sanitized using disinfectants of proven efficacy against the swine 

vesicular disease virus. Said clearance periods as well as the cleaning and 

sanitation operations and disinfectants used must be recorded and documented at 

the holding.

3. Sampling required at dealers’ premises/assembly centers: serological and 

virological testing is to be carried out as follows:

a) serological testing: on a number of animals at dealers’ premises equal to that 

specified in the table in Annex IV;

b) virological testing: on faeces scattered in the animals' housing pens.

The blood samples are to be collected at the same time as the faeces samples 

once a month both in Regions recognized as SVD-free and Regions not recognized 

as SVD-free. Pending results, no block of transportation is required for either.

4. When collecting the samples required by the Plan, the competent official 

veterinarians must assess:

a) the flow of the incoming and outgoing consignments (on-farm herd register, 

Form # 4) and compliance of the documents with the animals present at the 

holding;

b) that the production cycles (of no more than 30 days) are duly alternated with 

cycles of clearance and of cleaning and sanitation of the holding's premises;
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c) the proper functioning of the sanitation equipment;

d) the availability of disinfectants of proven efficacy against the SVD virus;

e) the dealers’ premises must always have at hand the documentation specifying: 

the periods of clearance, disinfections with the relevant dates, the commercial 

name, the active ingredient and the quantity of disinfectant used.

The official veterinarian having competence over the territory performing the 

survey of the dealers’ premises must record the date of the survey at the holding 

in the on-farm herd register signing and placing the date on it.

The authorization shall be revoked from dealers’ premises to have been detected 

twice as the primary outbreak of swine vesicular disease.

Cleaning and sanitation measures to be applied at the end of the cycle of ordinary 

activity of the dealers’ premises (30 days)

The efficacy of disinfectants is greatly reduced when these are used in the 

presence of soiling, organic material and grease. Therefore, in order to ensure the 

sanitation's efficacy, the premises must be thoroughly cleaned and washed 

before.

The cleaning and sanitation operations must be carried out once the animals have 

been taken away from the premises and in three separate phases:

1. physical removal of any material present (faeces, feed residues, soiling);

2. washing with water and detergent;

3. sanitation.

Phase 1:

The coarse material in the animal housing, feeding or transit premises is to be 

physically removed: faeces, litter, feed residues and soiling. Deposits of organic 

material must be eliminated using high-pressure washers.

Phase 2:

Once the coarse material has been removed, the surfaces must be wet with a 

degreaser (detergent), which must then be rinsed away with water.

Phase 3:
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During the sanitation phase, a disinfectant of proven efficacy against SVD must 

be used at the relevant concentrations of use and left to rest for an entire night. 

The disinfectant must be applied on dry surfaces.

Animals can be introduced into the dealers’ premises only 2 days after the end of 

the cleaning and sanitation operations. Before their introduction, the animal 

housing and feeding premises are to be rinsed.
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Annex III

Disinfectants active against the swine vesicular disease virus

1. Oxidizing agents:

a) mixtures composed of: inorganic peroxides, inorganic salts, organic acids and

anionic detergents. Commercial products recommended also for machinery and 

vehicles at the concentration specified on the information sheet.

2. Alkalis:

a) Sodium hydroxide with a reference concentration of 2% of the active 

ingredient or anyhow capable of reaching a pH of 12 in the final solution. 

Extremely caustic substance to be used only on resistant materials (walls) or 

materials whose intactness is of no concern;

a) Potassium hydroxide with a reference concentration of 2% of the active 

ingredient or anyhow capable of reaching a pH of 12 in the final solution. 

Extremely caustic substance to be used only on resistant materials (walls) or 

materials whose intactness is of no concern.

3. Aldehydes:

a) Glutaraldehyde with a 2% concentration of active ingredient. It does not 

corrode metals and it is recommended for trucks. Do not use on people or 

animals.

Annex IV

Number of swine to be sampled to obtain a prevalence of seropositivity ≥ 5% 

with a confidence interval of 95%.

Number of animals at holding/farm Number of animals to be tested

≤ 26 All

27-35 26

35-55 35

56-100 47

101-600 56

> 600 59
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Annex V

Statistically significant sample of swine to be tested compared to the number of 

animals at the holding/farm in order to determine a prevalence of seropositivity ≥ 

10% with a confidence interval of 95%.

Number of animals at holding/farm Number of animals to be tested

Up to 10 All

11 10

12 11

13-14 12

15-16 13

17-18 14

19-20 15

21-23 16

24-26 17

27-29 18

30-34 19

35-39 20

40-46 21

47-55 22

56-67 23

68-85 24

86-113 25

114-163 26

164-282 27

283-917 28

918 and more 29
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26 June 2008 Ordinary Supplement to the OFFICIAL JOURNAL General series - no. 148

Annex VI

ERADICATION AND SURVEILLANCE PLAN FOR SWINE VESICULAR DISEASE

ACCOMPANYING FORM FOR SAMPLES

REGION: PROVINCE:

ASL DISTRICT:

TEL: FAX

REASON FOR SAMPLING (PUT A CROSS IN ONE BOX ONLY):

Accreditation - 1st sample [1]

Accreditation - 2nd sample [2]

Confirmation check on SVD-free holding [3]

Check at dealers’ premises [4]

Epidemiological correlation at holding of outbreak (*) [5]

Transfer of outgoing swine (derogation from article 7 of Commission Decision 2005/779/EC) [6]

Code of holding of destination

Transfer of incoming swine (derogation from article 7 of Commission Decision 2005/779/EC) [7]

Code of holding of origin

Following seropositivity detected at the holding [8]

Check of holding in the sector - 1st sample [9]

Check of holding in the sector - 2nd sample [10]

Import [11]

Checks for transportation in provinces subject to restriction [17]

Suspect [18]

Check of animals in quarantine [19]

Reacquisition of accreditation

1st Sample Reacquisition of accreditation [12]

Holding in protection zone (*) [13]

Holding in surveillance zone (*) [14]

2nd Sample Reacquisition of accreditation [15]

Holding in protection zone (*) [16]

(*) specify code of holding of outbreak

Holding of origin of swine (1)

Holding's ID code (DPR 317/96) I_I_I_I_I_I_I_I_I

Type of production [ ] Open breeding farm [ ] Fattening [ ] Closed breeding farm [ ] Dealers’ premises

Owner

Province Municipality Locality No.

Breeders present No. of animals present

Date of collection of samples Type of samples [ ] ] # OF BLOOD SAMPLES

[ ] # OF FAECES SAMPLES

[ ] # OF EPITHELIAL SAMPLES

Other exams to be carried out

[ ] AUJESZKY'S DISEASE [ ] CLASSICAL SWINE FEVER [ ] OTHER
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(1) In case of collection at holding, fill out the entire box with the data of the holding where the samples are collected. In case of samples collected at slaughter 

plant specify the last holding of origin of the animals subject to sampling.

26 June 2008 Ordinary Supplement to the OFFICIAL JOURNAL General series - no. 148

Identification of the swine subject to sampling at the holding

Animal ID code Category (3) Animal ID code Category (3)

1 31

2 32

3 33

4 34

5 35

6 36

7 37

8 38

9 39

10 40

11 41

12 42

13 43

14 44

15 45

16 46

17 47

18 48

19 49

20 50

21 51

22 52

23 53

24 54

25 55

26 56

27 57

28 58

29 59

30 60

Comments

Stamp and signature of sampling veterinarian
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Annex VII 

Epidemiological survey on swine vesicular disease and classical swine 

fever

The disease was diagnosed/suspected following:

CLINICAL/PATHOLOGY SUSPECT [ ]

SEROPOSITIVITY [ ]

VIRAL ISOLATION [ ]

EPIDEMIOLOGICAL CORRELATION [ ]

Holding code to which it is correlated 

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

1. HOLDING/FARM REGISTRY

1.1 HOLDING/FARM CODE: [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

1.2 HOLDING/FARM NAME: .........................................

1.3 OWNER: ........................................

1.4 HOLDER (if other than owner): ..................................

1.5 HOLDING/FARM ADDRESS: ......................................

TOWN/CITY: .................... PROVINCE: ..................................................

1.6 ASL (LOCAL HEALTH AUTHORITY): ............................. DISTRICT: 

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

OFFICIAL VETERINARIAN OF AREA A: .......................

VETERINARIAN PERFORMING THE SURVEY: ..................................

TELEPHONE NUMBER (also mobile): .................../.......................................

GEOGRAPHICAL LOCATION OF OUTBREAK:

Longitude .....................°.....................'................................''

Latitude .....................°.....................'................................''
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2. TYPE OF HOLDING/FARM

2.1 SPECIES BRED: PIG [ ]

WILD BOAR [ ]

MIXED [ ]

2.2 TYPE OF PRODUCTION

CLOSED BREEDING [ ]

OPEN BREEDING [ ]

FATTENING [ ]

GROWING [ ]

DEALERS’ PREMISES [ ]

HOLDING PENS ANNEXED TO A SLAUGHTER PLANT [ ]

3. CENSUS AND DISTRIBUTION OF SWINE AT THE HOLDING/FARM

Facility *: 

Category Number With symptoms/lesions Positive

Sows

Boars

Gilts

Suckling pigs

Weaners

Weaned pigs

Feeder pigs

Fattening pigs

Facility *: 

Category Number With symptoms/lesions Positive

Sows

Boars

Gilts

Suckling pigs

Weaner

Weaned pigs

Feeder pigs

Fattening pigs

Facility *: 

Category Number With symptoms/lesions Positive

Sows

Boars

Gilts

Suckling pigs

Weaner

Weaned pigs

Feeder pigs

Fattening pigs
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* A table must be filled out for each facility of the holding/farm. A facility is to be 

understood as any building where pigs are kept and bred. The facility may be 

identified with consecutive numbers, letters or named in full (e.g., farrowing

room, pregnant sow unit, growing unit, fattening unit, etc.) and it must match 

the description provided in the holding/farm layout.

4. INFORMATION ON HOLDING MANAGEMENT

4.1 Does the holding/farm have barriers to prevent unauthorized access? (gates, 

walls) [ ] Yes [ ] No

4.2 Is there a house at the holding/farm? [ ] Yes [ ] No

4.3 Is there a slaughter plant annexed to the holding? [ ] Yes [ ] No

4.4 The animals are loaded/unloaded:

outside the holding [ ] within the holding [ ] at the entrance of the shed [ ] in a 

loading bay [ ]

4.5 Are bought-in animals put in quarantine? [ ] Yes [ ] No

4.6 Is there an area at the holding devoted to truck sanitation? [ ] Yes [ ] No

4.7 All-in/all-out system (lairage, fattening and growing pens) [ ] Yes [ ] No

4.8 High-pressure washers available (steam cleaners) [ ] Yes [ ] No

4.8 Disinfectants available [ ] Yes [ ] No

If so, specify the active ingredient used: .....................

4.10 Disposable materials available (gowns, suits, shoe covers, etc.) [ ] Yes [ ] 

No

4.11 Where are the culled sows kept? [ ]

In separate pens in the breeding unit

[ ] Mixed with fattening pigs

[ ] Other

Please specify ...................................................
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4.12 Discarded animals are collected:

outside the holding [ ]

within the holding [ ]

at the entrance of the shed [ ]

at a loading bay [ ]

4.13 Carcasses are collected:

outside the holding [ ]

within the holding [ ]

at the entrance of the shed [ ]

at a loading bay [ ]

4.14 Manure collection site:

[ ] Storage tank

[ ] Other (specify) .....................................

4.15 Manure disposal method:

[ ] Fertilization under drip irrigation

[ ] in own fields

[ ] in other fields according to agreements

[ ] other (specify): ......................................

4.16 Method for disposal of feed waste

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

4.17 Does the holding/farm have own vehicles for animal transportation? [ ] Yes 

[ ] No

If so, please specify the type of motor vehicle and the license plate:

..................................................................................................................
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4.18 Do the owners and/or family members and/or employees have relations with 

other swine holdings/farms? [ ] Yes [ ] No

If so, please fill out the following form: 

Name and last name Position

Correlated holding

Code Owner/address

5. TRANSPORTATION

5.1 Bought-in animals

(as of date of the latest negative serological and/or virological test)

Date # of 

animals Category Holding of origin

Holding 

address

Owner of transportation firm 

(name & address)

Truck license 

plate

5.2 Bought-in animals

(as of date of the latest negative serological and/or virological test)

Date # of 

animals Category Holding/slaughter plant of destination

Holding/slaughter 

plant address

Owner of 

transportation firm 

(name & address)

Truck 

license 

plate
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5.3 Motor vehicles 

Type of transportation

Last date of 

access to 

holding

Frequency of 

access to holding

Routine service 

provider and 

address

Truck 

license plate 

*

Whey

Carcasses

Manure

Feed

Discarded animals

Rat control

Other (specify) 

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

* In the event that several trucks carry out transportation, specify the license plate of the truck 

to have last carried out transportation.

5.4 Persons (in the 30 days prior to serological/virological positivity or clinical 

suspect) 

Name and last name Position Address Reason for visit Date of visit

NB. Please take into account: persons performing ultrasounds on sows, traders, 

visitors, veterinarians, inseminators, sanitation teams, etc.

6. CLINICAL HISTORY

6.1 Date of observation of first symptoms: ............../................/.............

6.2 Name, last name and position of the reporting person: 

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

6.3 Description of symptoms and/or lesions:

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

6.4 Estimated start of disease at the holding/farm: 

............../................/.............

(to be filled out also following the detection of positivity alone)
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6.5 Overview of animals suspected of being infected upon clinical/pathology tests

Category * # of animals suspected Holding/farm of origin of animals suspected

* Sows, bows, gilts, suckling pigs, weaners, weaned pigs, feeder pigs, fattening pigs.

7. RECENT CLINICAL HISTORY

7.1 Date of sample: ............../................/.............

7.2 Material collected:

[ ] # of faeces samples: ................................

[ ] # of epithelial samples: ........................

[ ] # of blood samples: .......................

[ ] organs, please specify:

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

7.3 Date of isolation of enterovirus: ............../................/.............

7.4 Date of isolation of CSF virus: ............../................/.............

7.5 Date of positivity result: ............../................/.............

7.6 Overview of serological result: 

Category * Animals sampled Positive 

animals Type of Ig Holding/farm of origin of positive animals

* Sows, bows, gilts, suckling pigs, weaners, weaned pigs, feeder pigs, fattening pigs.
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8. REMOTE CLINICAL HISTORY

8.1 Previous health status:

[ ] Recognized holding

[ ] Positive holding

[ ] Negative holding (pending re-accreditation)

9. NOTES AND CONCLUSIONS

(to be understood as additional information not included in the questionnaire as 

well as the description of one or more hypotheses on the origin of the infection)

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

......

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

......

Date filled out: ............../................/.............

STAMP AND SIGNATURE OF VETERINARIAN

10. LAYOUT OF HOLDING/FARM

(identify existing facilities and indicate where the cases of serological, virological 

and clinical positivity were found)
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Annex VIII

Outbreak communication form

DATA TO BE SENT WITHIN 24 HOURS FROM CONFIRMATION OF OUTBREAK TO 

THE DIREZIONE GENERALE DELLA SANITA' ANIMALE E DEL FARMACO 

VETERINARIO (DIRECTORATE GENERAL OF ANIMAL HEALTH AND VETERINARIAN 

PHARMACOLOGY) FOR REPORTING TO THE EUROPEAN COMMISSION

REGION .......................................................................

PROVINCE ...................................................................

ASL (LOCAL HEALTH AUTHORITY) 

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

DISTRICT ...................................................................

TELEPHONE NUMBER ...............................................................

FAX NUMBER ......................................................................

HEAD OF UNIT .........................................

OFFICIAL VETERINARIAN ................................

HOLDING CODE ......................................................................

CORRELATED WITH (HOLDING CODE) .........................................

HOLDING OWNER ..........................................

TOWN WHERE HOLDING IS BASED ...............................

LOCALITY ......................................................................

DATE DETECTED .........................................................

DATE CONFIRMED .........................................................

DIAGNOSTIC METHOD .............................................

# OF ANIMALS PRESENT ON DATE OF DETECTION ...........................

# ANIMALS WITH CLINICAL SYMPTOMS ..............................
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# OF DECEASED ANIMALS ........................

DATE OF KILLING (ALSO PRESUMED) .........................

# OF ANIMALS KILLED ..................

METHOD FOR DESTRUCTION OF CARCASSES ..........................

Annex IX

Certificate of washing and sanitation for trucks for pig transportation

1. Statement of operator/driver of vehicle

I, the operator/driver of vehicle .............................. (type/license plate #),

hereby state that the latest pig consignment was in:

Province, town/city Date Time

Name of holding

Said information must be provided by the operator/driver

After unloading, the vehicle was cleaned and sanitized. Cleaning and sanitation

involved all truck compartments, the loading ramp, the vehicle's wheels and the 

driver's cab.

Cleaning and sanitation were carried out:

Province, town/city Date Time

Name of sanitation facility Stamp

Said information must be provided by the operator/driver

Disinfectant used: ...........................................

Date Place Signature of operator/driver

Name of operator/driver in block letters:
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Annex X 

Swine vesicular disease (SVD)

Biosafety parameters for pig farms

Within the framework of swine holdings as defined under article 2, the Veterinary 

Services of the competent Aziende sanitarie locali-ASL (Local Health Authorities) 

must evaluate the following prerequisites in advance:

- appropriateness of facility to keep animals also with regard to production

capacity;

- sanitary authorization of the holding;

- correct registration in the BDN including the relevant indication of the type of 

production;

- health status of animals with regard to SVD.

For the purpose of applying the biosafety measures the following factors must be 

taken into account:

1) holding/farm structure;

2) holding/farm management;

2.1) use of equipment and systems;

2.2) animal flows;

2.3) personnel;

2.4) means of transportation.

Holdings are classified according to the following types of production:

1. Breeding (open and closed) or Site 1;

2. Weaning;

3. Fattening or Site 3.

1. BREEDING (open and closed) or SITE 1;

HEALTH STATUS OF ANIMALS WITH REGARD TO SVD: Bought-in swine are to 

come from SVD-free holdings.
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FACILITIES

Quarantine: the holding must have isolated premises (in physical, functional and 

management terms) where bought-in breeders are put in quarantine.

Parking area: the holding must have an area located outside the farm's bounds to 

allow personnel and/or visitors to park vehicles.

Barriers (fencing, gates, rails, walls, etc.) limiting and controlling access by 

personnel, vehicles and animals from other holdings or wild animals. The 

entrance to the holding must have signs prohibiting access by unauthorized 

persons and/or vehicles.

Locker rooms: premises used as locker rooms must be provided to allow holding 

personnel and visitors to put on gowns or shoe covers or change clothing and 

shower before entering the farm.

Area for truck sanitation: preferably located near the entrance to the farm; it 

must be kept separated from the holding pens where animals are housed and 

kept. The area must be equipped with stationary high-pressure washers for 

cleaning purposes and disinfectants of proven efficacy against the SVD virus in 

compliance with the relevant regulations.

Coolers: preferably located outside the farm's perimeter and preferably with two 

entrances, one of which leading outside the farm.

HOLDING MANAGEMENT

Quarantine: During quarantine animals must be subject to clinical observation 

and after 28 days, before being introduced into the holding/farm, serological 

testing for SVD must be carried out on the animals. Quarantine must be carried 

out on an all-in all-out basis; if this is not the case, animals are to be serologically 

tested 28 days after the latest introduction.

Loading/unloading of live pigs: it must be carried out outside farm bounds 

(loading/unloading ramp along perimeter) or it may be carried out inside the farm 

provided that the following requirements are met:

1. The truck must carry only animals to/from the holding (single load) and

2. The truck is cleaned and sanitized with disinfectants of proven efficacy against 

the SVD virus before loading the animals.

Loading of discarded animals: it must be carried out outside the farm premises 

(loading/unloading ramp along perimeter) or the discarded animals must be 
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taken away on board the holding's truck. The truck collecting the discarded 

animals cannot enter the farm.

Loading of dead pigs: pig carcasses must be moved from the housing premises 

within 24 hours; pending disposal, they must be stored in coolers. As an 

alternative, the pig carcasses must be taken away on board the holding's truck. 

The truck collecting the pig carcasses cannot enter the farm.

Feed unloading: it must be carried out outside the farm premises; as an 

alternative, it can be done inside the farm, provided that the truck carries the 

feed for the holding only and that the truck has been cleaned and sanitized with 

disinfectants of proven efficacy against the SVD virus upon entrance to the farm.

Feeding: It is forbidden to feed animals with catering or household wastes 

containing food of swine origin.

Manure spreading: without prejudice to the relevant environmental regulations, it 

is not recommended to spread manure on land bordering on the holding and it is 

extremely hazardous to use the manure of other holdings for the purpose of 

fertilization.

Locker rooms: it must have disposable material (gowns, suits, shoe covers, etc.) 

and containers where to keep the used material and clothing.

Recording of pig consignments: incoming and outgoing pig consignments must be 

recorded in the database (BDN) and in the relevant holding register.

Recording: the entrance of visitors and vehicles to the farm must be documented 

in the relevant register.

Recording of truck sanitation: truck cleaning and sanitation operations are to be 

documented at the holding in a relevant register.

Rat/pest control: a holding plan must be implemented.

MEANS OF TRANSPORTATION

Trucks carrying the animals must be washed and sanitized at facilities fit for the 

purpose (at slaughter plants or washing and sanitation facilities) authorized by 

the Veterinary Service of the Azienda sanitaria locale (Local Health Authority). 

Vehicles used for animal transportation must be cleaned and sanitized with 

disinfectants of proven efficacy against the SVD virus. The washing and sanitation

operations carried out must ensure the efficacy of the disinfectant used (dilution 

of disinfectant, drying of vehicle after washing and disinfectant's time of action).
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PERSONNEL

The personnel tending the animals must not keep any sensitive animals and come 

into contact with other holdings keeping animals belonging to sensitive species.

The holding's personnel must wear clothing used solely at the holding.

2. WEANING

The following measures are envisaged for these types of production:

- same measures for breeding farms;

- all-in/all-out system, at least by sectors. Cleaning and sanitation operations and 

biological clearance of at least 2 (two) days must be carried out between the 

cycles;

- recording of cleaning and sanitation operations at the end of production cycles 

(valid also for the sectors).

3. FATTENING OR SITE 3

The following measures are envisaged for this type:

- same measures for breeding farms;

- all-in/all-out system, at least by sectors. Cleaning and sanitation operations and 

biological clearance of at least 2 (two) days must be carried out between the 

cycles;

- recording of cleaning and sanitation operations at the end of production cycles 

(valid also for the sectors).
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Annex XI

Swine vesicular disease eradication and surveillance plan

Outline of data record to be uploaded on-line with regard to serological 

surveillance activities alone

Name Type Dimension

REGION Text (*) 2

STATO _UE (EU STATE) Text 20

ASL (LOCAL HEALTH AUTHORITY) Text 3

ASL PROVINCE Text 2

DISTRICT Text 50

COD_ALL (FARM CODE) Text 10

OWNER Text 40

LOCALITY Text 40

TOWN/CITY (name) Text 40

PROVINCE Text 2

IND_PRODUTTIVO (PRODUCTION IND) Text 3

NUM_RIPRODUTTORI (# OF BREEDERS) Number 8

NUM_CAPI (# OF ANIMALS) Number 8

COD_MACELLO (SLAUGHTER PLANT CODE) Text 10

DEN_MACELLO (SLAUGHTER PLANT NAME) Text 50

COMUNE_MACELLO (TOWN OF SLAUGHTER 

PLANT) Text 40

PROVINCIA_MACELLO (PROVINCE SLAUGHTER 

PLANT) Text 2

MAC_CEE Yes/No 1

MAC_CAP_LIM Yes/No 1

DATA_PRELIEVO (SAMPLE DATE) Date/time (**) 8

SAMPLE Text 2

COD_AZ_ORIG (CODE OF HOLDING OF 

ORIGIN) Text 8

COD_AZ_DEST (CODE OF HOLDING OF 

DESTINATION) Text 8

COD_AZ_FOCOLAIO (CODE OF HOLDING OF 

OUTBREAK) Text 8

NUM_PRELIEVO (# OF SAMPLE) Number 8

DATA_IZS (DATE IZS) Date/time (**) 8

PROTOCOLLO_IZS (IZS PROTOCOL) Text 10

NUM_POSITIVI (# OF POSITIVE CASES) Number 8

NUM_CONFERMATI (# OF CASES 

CONFIRMED) Number 8

TIT_MIN (MIN TITER) Number 8

TIT_MAX (MAX TITER) Number 8

PROT_CREF Text 6

IG (acceptable values «G»; «GM»; «M») Text 2

MA Yes/No 1

CSF Yes/No 1

OTHER Text 50

NOTES Text 120

OUTBREAK Text 1

BOLD fields are mandatory fields (information must always be filled in).

The file must be in .txt or .csv format and a semicolon must be used as a tabulation 

symbol;

(*) The abbreviation of the relevant Region must be entered in the Region field. For 

this purpose please refer to the table at the next page.

(**) Dates must be written in the DD/MM/YYYY format (e.g., 05/12/2006); no other 

format is allowed.

Any column names must be removed so that the column starts immediately with the 

data to be entered.

In case of sampling reasons entered in the SAMPLE field equal to 5, 6, 7, 13, 14, 
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and 16, it is necessary to enter the values referred to COD_AZ_ORIG, 

COD_AZ_DEST, or COD_AZ_FOCOLAIO.

ABBEVIATION REGION

AB Abruzzo

BA Basilicata

CL Calabria

CM Campania

EM Emilia-Romagna

FR Friuli-Venezia Giulia

LA Lazio

LI Liguria

LO Lombardy

MA Marche

MO Molise

PI Piedmont

PU Apulia

SA Sardinia

SI Sicily

TO Tuscany

TR Trentino Alto Adige

UM Umbria

AO Valle d'Aosta

VE Veneto

Data must be sent to the central database of the National Center of Reference for 

Vesicular Disease - CERVES - only through the www.cerves.it website. Access to 

the website is granted only upon authentication via password and username 

issued to authorized personnel (Regional Veterinary Services and IZS (Animal 

Health Institutes) having competence over the territory).

Access requests are to be sent by e-mail to the following e-mail address 

specifying the institution of belonging as well as one's own personal data (name 

and last name).

supporto@cerves.it

Once the identification parameters have been received, it is possible to gain 

access to the area dedicated to the management of vesicular disease data by 

Region. In particular, after selecting the Region whose surveillance data are to be 

updated from the left menu, press the «Inserimento dati anno» (data entry for 

year) button in the main window. Under year you will see the year of the current 

SVD plan. In the web page that opens, select «Sorveglianza anno» (surveillance 

for year) to gain access to the section to load the information arranged as 

described above.
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ISTITUTO ZOOPROFILATTICO SPERIMENTALE

DELLA LOMBARDIA E DELL’EMILIA-ROMAGNA

NATIONAL REFERENCE CENTRE FOR VESICULAR DISEASES

Assessment of the risky period in SVD outbreaks in Northern Italy 

Methods

Below are the main data on SVD outbreaks in commercial farms in Northern Italy in the 2007-2010

period.

Based on the results of the epidemiological investigations carried out, a risky period was defined for 

each outbreak, that is the difference in days between the probable date of entry of the SVD virus in the 

farm (infection) and the date of outbreak confirmation (detection).

Results 

Table 1 summarises the data collected. 23 SVD outbreaks notified in 2007 and 2008 in two Regions 

(Lombardy and Emilia-Romagna) were examined.

In Northern Italy the SVD average risky period turned out to be 24.1±11.8 days (range: 9-58).

Please consider that the higher value in the range, 58 days, is due to a single outbreak occurred in 

Lombardy Region in the year 2007. Subsequently the passive surveillance was strongly reinforced 

therefore we are confident that no more cases with so long risky period never occur.

Figure 1 and table 2 describe the distribution of the calculated risky period: in Northern Italy 96% of 

outbreaks are identified within 45 days of infection.

Table 1 – Risky period in SVD outbreaks in commercial farms in Northern Italy. Years 2007-2010

Region

SVD outbreaks in 

commercial farms total SVD 

outbreaks

total pigs 

in 

outbreaks

risky period (days)

2007 2008 2009 2010 mean sd min median max

Lombardia 22 0 0 0 22 67,521 24.6 11.9 9 22 58

Emilia-Romagna 0 1 0 0 1 29 15.0 - - - -

Veneto 0 0 0 0 0 0 - - - - -

Trentino - BZ 0 0 0 0 0 0 - - - - -

Trentino - TN 0 0 0 0 0 0 - - - - -

Piemonte 0 0 0 0 0 0 - - - - -

Valle d'Aosta 0 0 0 0 0 0 - - - - -

Liguria 0 0 0 0 0 0 - - - - -

Friuli Venezia 

Giulia 0 0 0 0 0 0 - - - - -

Total 22 1 0 0 23 67,550 24.1 11.8 9 20 58
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Table 2 – Distribution of risky period for SVD outbreaks in commercial farms of Northern Italy. Years 2007-2008

Risky period 

(days)

SVD 

outbreaks

detected

% % cum

1-30 17 74% 74%

31-45 5 22% 96%

46-60 1 4% 100%

Total 23 100% 100%

Fig. 1 – Cumulate distribution of risky period for SVD outbreaks in commercial farms of Northern Italy. 2007-2008