## APHIS Evaluation
of the
Swine Vesicular Disease (SVD) Status of

Northern Italy

July 201 2

United States Department of Agriculture Animal and Plant Health Inspection Service Veterinary Services National Center for Import and Export

Regionalization Evaluation ServicesAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

2 

## 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 region s

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

................................ ................................ ................................ ......................... 64APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

3 

## 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

................................ ................................ 2 6

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

- 201 1

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

- 4 4APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

4 

## 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 H ealth 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 He alth Inspection Service

WHO World Health OrganizationAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

5 

## 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 consider ing Regions in northern Italy as being free of this disease. APH IS 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 th at rule was made final, SVD outbreaks occurred in four of the eight regions:

Abruzzo , Emil ia

- 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 grea ter 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

, althoug h 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 area s of Italy

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

, i n 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 vis it , 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. Proble ms 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 a nd 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

6 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 co nsists 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 Organ ization 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 consequenc e assessment, and a risk estimate [ 29 ] . The hazard under consideration is the SVD virus. The risk assessment provides the basis for an APHIS deci sion on recogniz ing 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 o f 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 re gion 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 S VD, 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 Unite d 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 stud ies 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 Region s 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 curr ently recognized by APHIS as being SVD

- free.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

7 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 bree ding swine, pork or pork products, or swine genetic material from Italy was low.

Consequence A ssessment

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 SVD

infected swine, pork or pork products entering the United States from th e region of Italy under

evaluation by APHIS and exposing U.S. swine to the disease to be low.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

8 

## 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:CEAHAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

9 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

- aff ected areas in Italy [ 2 ] . However before the rule was made final, SVD outbreaks occurred in Abruzzo, Emilia

Romagna, Molise, and Piemonte. So the final rule, published in April 2003, recogn ized 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 Regio ns. Several EU Food and Veterinary Office (FVO) reports raise d 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

app roach 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 b etween 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 h as 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, i n 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 2005/77 9/EC inAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

10 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). Th e 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, howeve r, 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., extraord inary measures). This finding suggested to APH IS 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 anticip ated, 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 th e 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

ultim ately 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 Regi ons 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 p ractices, procedures for cleaning and disinfection of transport vehicles, and even the date of implementation of revisions to Commission Decision 2005/779/EC.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

11 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 earli er 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

perce ived 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 determin e 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

Ministeria l 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 norther n Italy [ 11

, 12

, 16

- 19 ]

. These events are described in subsequent s ections 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 Ri ver 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 Region s currently reco gnized 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 recogni zed 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 te ams 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

.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

12 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 recommende d 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 ris k 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 Trent o and Bolzano, and re

- evaluates the S VD disease status of the Region of Marche. APHIS has previously evaluated all of Italy for CSF in its evaluation of the European Union. I n 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).APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

13 

## Section 3. Hazard Identific ation

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 cli nical similarity to foot and mouth disease [ 31

, 36 ]

. Clinical signs include fever, sudden lameness, and vesicles with subsequent erosions along the snout, feet, and tea ts [ 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 app earance of clinical signs [ 31

, 32 ]

.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

14 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 f ecal 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 inf ected 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 introducti on 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,

a nd 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, a nd 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 f irst 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

r eactors” can be differentiated by retesting the positive animal and its herd mates [ 33

, 36 ]

.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

15 Polymerase chain reaction (PCR) and ELISA are appropriate screening tests for SVD antigen detection, whil e 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 ]

.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

16 

## 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 Novemb er 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 Nut rition 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) Coo rdination

• Office IX

– Audit

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

sections:

• Office I

– General a ffairs

• 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 hygieneAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

17 • 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 a ffairs

• Office II

– Assessment of physical, chemical and biological risk

• Office III

– Consumer rela tions

• 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 t he 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 ani mals, 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 contro lAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

18 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 oper ates 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 foods tuffs, 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 approximat ely 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 Labo ratories. 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 Healt h 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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

carried out on behal f of the Minister of Health or the Regions, is inspection and quality control of food products and packaging. The ISS includes : the Community Reference L aboratories for

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

Regio nal 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 t hese 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 post s. 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 over sight 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 t he 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

20 882/2004 of the Euro pean 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 throu ghout 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 8 2/894/EEC (December 1982) stipulates that SVD is a notifiable disease in

accord ance with provisions for the notification of animal diseases within the European Union

. Specific response measures for several animal diseases, including SVD, to be applied whe never a disease outbreak occurs in an EU Member State were establishe d 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 t he EC reference laboratory for SVD

. Transposition of th ese EC requirements into Italian law was principally made through Republic Presidential Decree n o . 362, May 17, 1996, and Ministerial Order of March 28, 2007.

Specific SVD control measures

With the exception of two outbreaks in Portugal (Dec ember 2003 an d Jan uary 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 ou tbreaks 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 recog nized as being SVD

- free

and SVD

- affected.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

21 Key provisions of Decision 2005/779/EC are:

• Recognition of regions: establishes two lists of regions in Italy, a SVD

- free and SVD

affected list. When first adopted in December 2005, the EC considered four region s 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 dif ferences in the SVD status within Italy are described in more detail in the next section (Section 4.2).

• Suspension of the recognition of p rovinces in a r egion recognized as SVD

- free: establishes the requirement and process for suspending and subsequently r egaining 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: provide s the criteria for obtaining, maintaining and suspending recognition of individual holdings as SVD

- free in both SVD

- free and a ffected

r egio ns. The criteria for recognition of holdings are described in Section 4.4.

• Surveillance: establishes the requiremen ts for surveillance in both SVD

- free and SVD

affected 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% confide nce 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 al lows swine from SVD

- free holdings within EC

designated 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 af ter 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 sampl es, 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 i ssuance of Ministerial Order dated April 12, 2008, Sanitary Measures f or t he Eradication o f Swine Vesicular Disease a nd

Surveillance o f 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 Healt h, Italy requires that: all swine holdings in the region are accredited as SVD

- free holdings; and that allAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

22 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 a ddress 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, underw eight 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 r ecords 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 anim als, (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 ord ered 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 t ransport 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 It aly 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 holdi ng.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

23 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 t he 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 prod uction 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 count ries 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

animal s, 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 loc ation 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 fo r 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;APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

24 • failure to record data into the n ational d atabase;

• failure to complete transport document for slaughterhouse;

• failure to record information on slaughtered animal in the n ational d atabase; and

• failure to record the h erd consistency in the n ational d atabase.

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 bet ween the different Regions.

For the regions under review by APHIS, t he 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 nationa l, 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 dat abases. 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.

T he 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 biose curity 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 produc ing 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

- Romag na). 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 t he 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 premise s, have greatly reduced the risk ofAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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 an d 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 regi ons 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 re sulted 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 can not 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

- affecte d. T he 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 region s under review by APHIS occurr ed 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 othe r 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

26 difficult to eradicate in c ertain 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 i n Italy, most notably in southern Italy although in 2002, 2006

- 2007, and 200 8 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 Novem ber 2005 addressing specific SVD control measures to be applied in Italy and created lists of regions recognized as either being SVD

- free or SVD

affected.

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 circ ulating 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 Region s of Lazio, Molise and Calabria

.

The occur rence 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 ma y 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 ItalyAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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

contaminat ed 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 t his region operates within the vertically

- integrated pork consortium enterprises, such as the Consorzio del Prosciutto di Parma . Most of Italy’s intra

community and export of pork and pork products derive from swine produced and processed in this region. T he 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 Nove mber 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 detect ed, 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

mo vement of live pigs from affected provinces 5 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 Bres cia, 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 t heir consideration of the high density swine population in Brescia (2.500 pigs/km 2 ) and the burden that would be the result of prolonged maintenance of restriction zones necessitated by repeated outbreaks. Therefore regional authorities enacted a

series o f 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 f or 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 m inimum biosecurity measures for farms, slaughterhouses and vehicles.

However more extensive measures were implemented in the Province of Brescia. E xtensive 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

28 where SVD is detected. In addition, a buffer zone was established e xtending 1 km out from the depopulation area (i.e. extending 3 km from th e 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 r eported, 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 surveil lance 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 product ion area. Furthermore, the effectiveness ofAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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 Ap ril 2008. Those enhancements benefitted disease control activities throughout I taly, 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 persi stence 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. APHI S does not consider there to be a risk of SVD release in Italy

from a djacent 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 ( se e 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 ).APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

30 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 registratio n of swine holdings

• Requirements for dealer’s premises registration

• Condition s for SVD

- free recognition of holdings

• Retention, suspension and re vocation of holding recognition

• Procedures for reinstatement of holding recognition

• Biosecurity standards; checklist for minimum requirements

• List of approved disinfectants active aga inst 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 na tional 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 ar e 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 b y 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 standard s, 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 b y the Ministry of Health when a primary SVD outbreak occurs . A primary outbreak is considered to be: the first outbreak in a previously unaffected r egion /province , an outbreak which on the basis of epidemiological investigation is no t linked with a previous outbreak, or is of unknown origin.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

31 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 an othe r 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/E EC (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 e pidemiological 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 f or 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 preva lence 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 serolog ical 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

32 Minimum standards for equipment include:

• suitable devices for washing, cleaning and disinfecting the premises

• devices for washing, cleaning and disinfecting the swine transport ve hicles 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 3 0 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 a nd 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 descri ption 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 meas ures, 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 compl iance 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 testingAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

33 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 Pe rimeter 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. The re should be a container to collect used materials and clothing.

o Vehicle clean ing 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 disi nfectants 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 unload ing 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 onl y 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 o r 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 fr om 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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

o Swine transport v ehicles 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, a t 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 op erations 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 nation al 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 w ith 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 re cover 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 participati on 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

35 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 res trictions 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 harm onized 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 stringe nt 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 eva luation 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 respon d 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

v accination 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 reportedAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

36 anywhere outside of Italy.

• APHIS has previously assessed the external movement contr ols 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, regardles s 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 establishe d

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 prohibite d 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

a re:

• 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

• i n 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

.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

37 • pigs on the holding of origin are sampled between 20 and 30 days before movement and serologically tested is carried out on a n umber 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 com pletion 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 S VD 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, iden tification 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
, spec ific 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.

Seropositi ve 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

38 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 accom pany 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 mu st 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 fr om 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

holdin gs 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 establish ments 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 S VD.

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 M ember 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, slaughte rhouse 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

39 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 centra l 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 pr oducers 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 pe rcent 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 requ ire 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 facil ities 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 consu mption or the local domestic market. Most pigs raised in

s outhern 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 multipl e 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 one

million 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 sau sage, mainly to EU Member States (80%), including the Netherlands, France, Germany and UK, with the remainder (20%) exportedAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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 N orthern Italy

Italy’s commercial swine production area is centered in the Po River Valley in the northern part of the country, principally in t he Regions of Lombardia, Emilia

- Romagna, Piemonte and Veneto, and is included in the region s 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 HealthAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

41 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 “backyard

type” holdings. These swine typically are slaughtered at home or in small slaughterhouses andAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

42 the pork meat is used for self

- consumption or the lo cal 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 facilit ies approved to export these hams to the United States.

L ive 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 oper ations located throughout the Po River Valley (Piemonte, Lombardia, Emilia

Romagna, 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 La zio 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 plan ts 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 identifi ed, 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 produ ction 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

Ge rmany. 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 n orthern 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 n orthern Italy and because they pose some of the same risks associated with dealer’s premises they are similarly sampl ed 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 ap propriate SVD control

measures.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

43 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 devel oped 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 standa rds 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 produce rs 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 c ontrol 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 poten tially 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 detect ion 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 offic ial 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 currentAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

44 surveillance scheme is summarized in Table 4

. Italy ev aluates 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 cond ucted 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 co llected 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 alsoAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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 t hat 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

46 Table 5 : S VD Serological S urveillance 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 riskAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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 s eroconverted

.

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 HealthAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

48 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. U ntil 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 i n 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 subsequ ent 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, espec ially 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”, a n unlikely potential exists for the unintentional export of SVD

- infected pork and pork products if such products were exported before the out break 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 n orthern 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 contr ol 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 S VD

- 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 an d 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 h ealth institutes which provide a network of public laboratories at the national and regional level in Italy. The CERVESAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

49 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 an y 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 respon se 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 c onfirm 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 of ficials 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

• epidem iological 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 ques tion

• 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 andAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

50 serologically tested 28 da ys 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 sw ine 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 afte r 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

h olding, 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 ho ldings 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 holdin g

• 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 s uch

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, includi ng 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 h as 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 methodAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

51 • pork and pork products derived from the swine s laughtered 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 ho lding 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 veterina ry 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 disinfect ion 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 SV D

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 mov ement 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 pig s 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 movem ent; 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 vehic le 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

52 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 centr al 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, I taly has responded to over 5 91 outbreaks of SVD. Nearly 75% of these

outbreaks can be accounted for in 3 epidemics of short duration. The high number of outbreak s

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 em ergency 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 th ese region s 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 counterbalancin g 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

53 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. U ntil 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 Minis terial 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.

C ommercial swine

, from which pork and pork products for the export market are derived, are primarily raised in northern It aly ; 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 regulatio ns 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 th e 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 in fected 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 virus

contaminated manure on swine transport vehicles. Therefore p roper 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 an d 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 surve illance 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’sAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

54 swine health infrastru cture 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 an d 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 move ments 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 decl ine 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 m e et the definition of being a deale r’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

- affect ed

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 2005/7 79/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 mo vement s. 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 t hese 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 accordanceAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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 f eeding 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 posit ive 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 fr ee regions of Italy. Subsequently SVD

- infected or contaminated fresh pork and pork products might be exported to the United States, however unlikely.

To mitigate th is 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 m ight have commingled with or were contaminated from pork or pork products derived from swine originating in SVD

affected regions. APHIS considers these prohibition s sufficiently mitigate the risk of importing

undetected SVD

- infected fresh pork or pork pro ducts 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. Howeve r, 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 a nd local authorities in the major commercial production areas. APHIS concludes that existing Italian regulations satisfactorily mitigate this risk.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

56 Conclusion s 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 posse sses 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 exp ort market channel, and to comply with the certification requirements that APHIS intends to impose for exports to the United States from Italy.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

57 

## 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) occurrin g [ 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 S VD 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 200 1 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 th e 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 virusAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

58 through inadequately processed food waste is low. Based on the results of the release assessment, APHIS further regards the likelihood of exposur e 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 an d 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

State s 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 comm only 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. Th e 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 con siders 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 ce nters 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

59 

## 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 introduc tion 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. Additio nally, 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 w eeks 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

i nfected 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 product s, 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 infec tion 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

60 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 Sta tes 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 f or 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 ca ses, 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 eradic ation 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 c onsumer 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 o utbreak 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 m ore 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 estimat es 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 swineAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

61 (CSF and FMD), highlight the potential for billions of dollars of losses, mainly due to tra de

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 numb er 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 f ollowing 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 financi al stress, and symptoms of depression and post

- traumatic

stress disorder have been documented [ 67

- 70 ] . Animal health emergency responders may a lso 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 th e 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 Envi ronmental 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

62 

## Section 7. Risk Estimation

Risk estimatio n 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 f rom 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 c oncludes 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 s ummary, 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 SVD

infected swine, pork or pork products entering the United States from the re gion of Italy under

evaluation by APHIS and exposing U.S. swine to the disease to be low.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

_____________________________________________________________________________

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 Evalu ate 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 Carr ied 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 Swi ne 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 I taly 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/wah is/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 H ealth, 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 Safe ty, 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 Foo d 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, Gover nment 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 p rovided 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 amende d) , 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., Nutr ition 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 Europe an 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_vesicul ar_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 o utbreaks 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. B ellini, 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

vesicul ar 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 . 2 002. 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:

ht tps://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 in troducing 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 pi gs (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 si te 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. Epi z., 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 Acqui red on the Disease , in 11th International Symposium on Veterinary Epidemiology and Economics 2006.

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 S ervice, 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)

Vi rus 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. APHI S, 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 feve r 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. Anima l 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, a nd 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.

Veter inary 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 Sys tem 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. 2 2 (2): p. 25.

72. National Environmental Policy Act (NEPA). 1969 [cited 2012 May 15]; Available from: http://ceq.hss.doe.gov/

.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 1 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 (Ga zz. Uff. 26 giugno 2008, n. 148, S.O.)

Epigraph

Premi ses

Article 1. Objectives

Article 2. Definitions

Article 3. Recognition of Region s

Article 4. Recognitio n 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 sero positive animals

Article 13. Transportation

Article 14. Information flows

Article 15. Tests on pig consignments from EU Member States

Article 16. Cleaning and sanitatio n

Article 17. Surveillance of classical swine fever

Article 18. Surveillance of classical swine fever in wild pigsAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 2 Article 19. Transmission of data on the classical swine fever surveillance plan

Article 20. Dispatch of data on activities carried out

Arti cle 21. Financial aspects

Article 22. Penalties

Arti cle 23. Effective date

Annex I

- Regions recognized as free from swine vesicular disease

Annex II

- S wine vesicular disease surveillance and eradication plan

Annex III

- Disinfectants active against the swi ne 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 com munication 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 3 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 ;

H aving 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 M arch 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. 22 3 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 ;APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 4 Having regard to Le gislative Decree no. 55 dated 20 February 2004 on «Implementation of Directive 2001/89/EC on Community measures for the control of classical swine fever», publ ished 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 g eneral Community measures

for the control of certain animal diseases and specific measures relating to swine
vesicular disease;

Having regard to Commission Direct ive 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 a n outbreak of swine vesicular disease, implemented by Ministerial Decree dated 28 March 2007 , published in

the Official Journal of the Italian Republic no. 1 61 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

d ocument 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 Region s 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;APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 5 Whereas surveillance f or 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 Provinc es of Trento and Bolzano (hereinafter referred to as « Region s») 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 « P lan»).

2. The Plan ob jectives as per paragraph 1 are:

a) maintaining of the accreditation status in the Region s as per Annex I
hereto; b) achievement of accreditation status in the Region s lacking recognition as per item a); c) annual implementation of the Plan as per parag raph 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 boar s

.

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) breed ing farms: holding s where boars and sows are kept for the production of piglets up to weaning ; also referred to as Site 1; c) open breeding farms: holding s where breeders and growing pigs for fattening are kept up to the weaning and/or growing phase; d) closed breeding farms: holding s where breeders and growing pigs raised solely for the purpose of slaughtering are kept up to the fattening phase; e) fattening farms: holding s 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 : holding s 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 turn over of the animals purchased and sold within 30 days from purchase; for the purposeAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 6 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

dea lers’ premises are sent solely and directly to slaughter plants; g) assembly centers: centers as per article 1, paragraph 2, of Legislative

Decree no. 196 d ated 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 Emilia

Romagna, based in Brescia; m) CEREP: National center of reference for s wine fever, Istituto zooprofilattico sperimentale (Animal Health Institute) of Umbria and Marche, based in Perugia; n) BDN: National database as per Legislat ive Decree no. 196 dated 22 May

1999

.

Article 3. Recognition of Region s

1. A Region recognized as free from swine vesicular disease is understood as a Region where:

a) A ll the holdings present are accredited as per article 4 ; b) A ll the activities set forth in the Plan were carried out in the previous year; c) T he conditions for the issue of accreditation suspension or revocation

measures do not subsist

. 2. The list of Region s 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 r evoking 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 ac cording 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 recognitionAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 7 1. The recognit ion 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

am endments 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 protectio n 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 te sts 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 result s ; 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 mea sures 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 Region s surveillance activi ties 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:APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 8 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 recog nized 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, document ation 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. A ccreditation 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 th e 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

artic le 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 with out 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 seropo sitivity is not ascribable to a «singleton reactor», the holding's

accreditation is revoked and the L ocal H ealth A uthority applies the measures necessary to confirm or rule out the presence of the disease and in said case

orders:

a) attachment of the hold ing 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:APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 9 - in case of a breeding farm/holding, blood samples from all breeders not

test ed 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 hav e come into contact with the seropositive animals.

6. If seropositivity alone is detected without any transmission of the swine
vesicular disease enterovirus, the L ocal H ealth A uthority 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 eve nt 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 sample d 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. 3 62 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 An nex IV.

2. Holdings pending re

- accreditation cannot transport swine to other holdings and/or slaughter plants save for the provisions of article 12

.

Articl e 9. Tests at holdings

1. Before sampling, the official veterinarian shall assess the holding's register as

per article 3, paragraph 3, of Presidential Decre e no. 317 dated 30 April 1996 asAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 10 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 asse sses 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 wheth er 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 in to the form in Annex VI hereto, which, once duly filled out, must accompany the blood sam ples 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 ( L ocal

H ealth A uthority) to CERVES, provided that a copy of the f orm 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 anim als 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 serol ogical 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 d ownloaded 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 duringAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 11 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 holdi ng'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 th e 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

V eterinary De pt. of the Azienda sanitaria locale ( L ocal H ealth A uthority) 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 addi tion 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 ( L ocal H ealth A ut hority) 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

a nd the meat is to be sold on the domestic market only

.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 12 Article 13. Transportat ion

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 Region s not recognized as SVD

- free to other Italian Region s.

2. By way of derogation from paragraph 1, item b), the Health Ministry may authorize the transfer of swine from holdings located in Region s not recognized as

SVD

- free to other Region s, 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 holding s recognized as SVD

- free and located in Region s 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 Hea lth 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 Ins titute) 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 Minist ry, 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 o f 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 13 5. In order to allow the Health Ministry to inform the European Commission in case of an outbreak, the competent Azienda sanitaria locale ( L ocal H ealth

A uthority) 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 Region s recognized as SVD

- free; b) on a monthly basis, for Region s 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 de cides that there is

an at

- risk epidem iological situation.

Article 15. Tests on pig consignments from EU Member States

1. Pig consignments from EU Member States must be subject to non

discriminatory 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 consignm ents for slaughter ing

.

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 ade quate 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 l itigation

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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 14 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 II I 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 Institut e) 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 feve r.

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 Reg ion

.

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 a pply 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 Minist ry and veterinary service s of

the various Region s 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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 15 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 fo r 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 holdi ngs 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 Region s, the state of progress o f 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 Min istry 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, sh all send Regions ex p lan atory 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").APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 16 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 f or 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 1 st
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 (Nationa l 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

concer ning the «National Plan for the eradication and surveillance of swine

vesicular disease and the surveillance of classical swine fever».APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 17 Annex I Regions recognized as free from swine vesicular disease

Valle d'Aosta

Piedmont

Liguria

Lombardy

Autonomous Provi nces of Trento and Bolzano

Veneto

Friuli

- Venezia Giulia

Emilia

- Romagna

Tuscany

Umbria

Marche

Lazio

Molise

Apulia

Basilicata

SardiniaAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 18 Annex II

S wine vesicular disease s urveillance and eradication plan

Description of the plan submitted

The objectives of the 2008 SVD P lan are the following:

- maintaining the state of accreditation in the Region s recognized as SVD

- free;

- assessing the epidemiological situation in the Region s recognized as SVD

- free,

which in the 2006

- 2007 period were the site of SVD outbreaks;

- accreditation of Region s 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 in tense surveillance activities with regard to the

disease also in Region s 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 Region s recognized as SVD

- free a holding is recognized as free from said disease provided that:

- Br eeding 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 ther eof 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 serologic al 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;APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 19 SURVEILLANCE ACTIVITY

Regions recognized as SVD

- free

Holdings/farms must be accredited according to the provisions for SVD

- free Region s under « R ecognition of holdings».

Holdings/farms without accreditation cannot transport swine also in the event that these are to be sent directly for slaughtering.

Planned Activities:

- R egistry 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 detec t 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.

Fatteni ng 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 (E milia

- Romagna): in these Region s 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 n umber 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 Region s all fattening farms with more than 2 a nimals 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:APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 20 Holdings/farms must be accredited according to the provisions for non

- SVD

- free Region s under « R ecognition of holdings».

Holdings/farms without accreditation cannot transport swine also in the event that these are to be sent directly for slaughtering.

Planned Activities:

- Regis try 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 p revalence 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%).

Acti vities 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 th is 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 requir ements 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 a nd sanitizing the dealers’ premises ;

a) suitable devices for washing, cleaning and sanitizing trucks before access to

the dealers’ premises ;APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 21 c) availability of disinfectant s of proven efficacy against the SVD virus at the dealers’ premises and at the entra nce to said premises.

2. Management procedures required for dealers’ premises :

a) at dealers’ premises the sale of the animals must take place within 30 day s from their purchase. Swine kept at dealers’ premises are sent solely and directly to slaughter pl ants;

b) discarded animals (underweight animals or animals with diseases or disease

outcomes requir ing their slaughtering) and culled animals (breeders at the end of their reproductive years ) cannot be sold through dealers’ premises ;

c) once the animals ar e 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 pur poses 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 Ann ex 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 Region s recognized as SVD

- free and Region s not recognized

as SVD

- free. Pendin g 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;APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 22 c) the proper functioning o f 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 her d 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, s oiling);

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 elimin ated 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:APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 23 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 sanita tion operations. Before their introduction, the animal housing and feeding premises are to be rinsed.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 24 Annex III Disinfectants active against the swine vesicular disease virus

1. Oxidizing agents:

a) mixtures composed of: inorganic peroxides, inorganic salt s, organic acids and anionic detergents. Commercial products recommended also for machinery and vehicles at the concentration specified on the information sheet.

2. Alkali s :

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 ac tive 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% concentrati on 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 59APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 25 Annex V

Statistically significant sample of swine to be tested compared to the n umber 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

1 9

- 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 29APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 26 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 dealer s’ 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 q uarantine [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]

Ho lding 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 ’ p remises

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 [ ] OTHERAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 27 (1) In case of collection at holding, fill out the entire box with the data of the holding where the samples are collected. I n case of samples collected at slaughter

pl ant s pecify 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 veterinarianAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 28 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): ............................. DIS TRICT:

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

OFFICIAL VETERINARIAN OF AREA A: .......................

VETERINARIAN PERFORMING THE SURVEY: ..................................

TELEPHONE NUMBER (also mobile): .................../.............................

..........

GEOGRAPHICAL LOCATION OF OUTBREAK:

Longitude .....................°.....................'................................''

Latitude .....................°.....................'................................''APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 29 2. TYPE OF HOLDING/FARM

2.1 SP ECIES 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 SW INE 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 Nu mber 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 pigsAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 30 * 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 .........................

..........................APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 31 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 entranc e 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 acco rding 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:

.............................................................................................. ......... ...... .....APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 32 4.18 Do th e 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 plat e

5.2 B ought

- 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 plateAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 33 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 serol ogical/virological positivity or clinical suspect)

Name and last name Position Address Reason for visit Date of visit

NB. Pleas e 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)APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 34 6.5 Overview of animals suspected of being infected upon clinical/pathology tests

Category * # of animals suspected Holding/f arm 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, b ows, gilts, suckling pigs, weaners, weaned pigs, feeder pigs, fattening pigs.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 35 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. LAY OUT OF HOLDING/FARM

( identify existing facilities and indicate where the cases of serological, virological and clinical positivity were found)APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 36 Annex VIII

Outbreak communication form

DATA TO BE SENT WITHIN 24 HOURS FROM CONFIRMATION OF OUTBREAK TO

THE DIRE ZIONE GENERALE DELLA SANITA' ANIMALE E DEL FARMACO VETERINARIO (DIRECTORATE GENERAL OF ANIMAL HEALTH AND VETERINARIAN PHARMACOLOGY) FOR REPORTING TO THE EUROPEAN COMMISSION

REGION .......................................................................

PROV INCE ...................................................................

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 I S BASED ...............................

LOCALITY ......................................................................

DATE DETECTED .........................................................

DATE CONFIRMED .................................................

........

DIAGNOSTIC METHOD .............................................

# OF ANIMALS PRESENT ON DATE OF DETECTION ...........................

# ANIMALS WITH CLINICAL SYMPTOMS ..............................APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 37 # OF DECEASED ANIMALS ........................

DA TE 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 o perator/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

Nam e of operator/driver in block letters:APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 38 Annex X Swine vesicular disease (SVD) Biosafety parameters for pig farms

Within the framework of swine holdings as defined under article 2 , the V eterinary

S ervice s of the competent Aziende sanitarie locali

- ASL (Local Health Authorities)

must evaluate the follow ing 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 followi ng 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 pr oduction:

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.APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 39 FACILITIES

Quarantine: the hold ing 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 t he 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

an d 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 da ys 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 mu st 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 beAPHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 40 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 carr ied 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 viru s 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 o n land bordering on the holding and it is extremely hazardous to use the manure of other holdings for the purpose of

fertilization.

Locker room s : it must have disposable material (gowns, suits, shoe covers, etc.) and containers where to keep the used mater ial 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 rele vant 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 mus t be washed and sanitized at facilities fit for the purpose (at slaughter plants or washing and sanitation facilities) authorized by

the V eterinary S ervice of the Azienda sanitaria locale (Local Health Authority). Vehicles used for animal transportation mu st 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 disi nfectant's time of action).APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 41 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) da ys 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 breedi ng 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).APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 42 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_RIPROD UTTORI (# 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 TITE R) 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

. c sv 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 form at (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,APHIS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 1

_____________________________________________________________________________

A

- 43 and 16, it is necessa ry 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 Mo lise

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 Service s and IZS (Animal Health Institutes) having competence over the territory).

Access re quests 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 gai n 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 ann o» (surveillance for year) to gain access to the section to load the information arranged as

described above.APH IS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 2

_____________________________________________________________________________

A

- 44 

### I STITUTO 

### Z OOPROFILATTICO 

### S PERIMENTALE

DELLA 

### L OMBARDIA E DELL 

### ’E MILIA



### - R OMAGNA

N ATIONAL R EFERENCE C ENTRE FOR V ESICULAR D ISEASES



### Assessment of the risky period in SVD outbreaks in Northern Italy

Met hods

Below are the main data on SVD outbreaks in comme rcial 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 ).

R esults

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 av erage risky period turned out to be 2 4

. 1 ±1 1

. 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 rein forced

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

.

Tabl e 1

– Risky period in SVD outbreaks in commercial farms in Northern I taly . Years 2007

- 2010

Region SVD outbreaks in

commercial farms total SVD

outbreaks total pigs

in

outbreaks **risky per iod (days)** 

2007 2008 2009 2010 **mean sd**  **min median**  **max**
Lombardia 2 2 0 0 0 2 2 67

, 5 21 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 2 3 6 7

, 550 **2 4** 

**. 1**  **1 1** 

**. 8**  **9 2**  **0 58** APH IS Evaluation of the SVD Status of Northern Italy, July 2012

– APPENDIX 2

_____________________________________________________________________________

A

- 45 Table 2

– Distribution of r isky period for SVD outbreaks in commercial farms of Northern I taly . Years 2007

- 2008

R isky period (days) SVD

outbreaks

detected % % cum

1

- 30 17 74 % 74 %

31

- 45 5 22 % 96 %

46

- 60 1 4% 100 %

Total 2 3 100% 100%

Fig. 1

– Cumulate d istribution of r isky period for SVD outbreaks in commercial farms of Northern I taly . 2007

- 2008