## AP HIS Ev aluation of the Status of the Brazilian State of Santa Catarina Regarding Foot - and - Mouth Disease , Classical Sw ine Fe ver ,

Sw ine Vesicular D isease, and Af rican Sw ine Fever

United States Department of Agriculture An imal and Plant Health Inspection Service

Veterinary

Serv ices January 16 , 2009APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 2 TABLE OF CONTENTS TABLE OF CONTENTS ................................ ................................ ................................ .................... 2 LIST OF FIGURES ................................ ................................ ................................ ............................. 3 LIST OF TABLES ................................ ................................ ................................ ............................... 3 LIST OF ABBREVIATIONS ................................ ................................ ................................ ............. 5 Executive Summary ................................ ................................ ................................ ............................. 9 Background ................................ ................................ ................................ ................................ ........ 1 0 Objective ................................ ................................ ................................ ................................ ........... 1 0 Hazard I dentification ................................ ................................ ................................ ........................ 1 1 Risk A nalysis ................................ ................................ ................................ ................................ ...... 1 2 1. Authority, organization, and infrastructure of the veterinary services .............................. 1 2 2. Disease status in the export region ................................ ................................ .......................... 20 3. Disease status of adjacent regions ................................ ................................ ........................... 2 2 4. Ext ent of an active disease control program ................................ ................................ .......... 2 6 5. Vaccination status of the region ................................ ................................ .............................. 29 6. Separation from adjacent regions of higher risk ................................ ................................ ... 30 7. Movement control, biosecurity, and the extent to which the movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regarding such movements ................................ ................................ ................................ ...... 3 1 8. Livestock demographics and marketing practices in the region ................................ .......... 4 0 9. Disease surveillance in the region ................................ ................................ ........................... 4 7 10. Diagnostic laboratory capability ................................ ................................ ............................. 5 5 11. Policies and infrastructure for animal disea se control in the region ................................ ... 5 8 Release Assessment Conclusions ................................ ................................ ................................ ...... 6 0 Exposure Assessment ................................ ................................ ................................ ......................... 6 3 Consequence Assessment ................................ ................................ ................................ .................. 6 5 Risk Estimation ................................ ................................ ................................ ................................ .. 69 Annex I. Hazard Identification
– Foot - and - Mouth Disease Virus ................................ ............... 7 1 Annex II. Hazard Identification
– Classical Swine Fever Vir us ................................ .................. 7 4 Annex III. Hazard Identification
– Swine Vesicular Disease Virus ................................ ............. 7 5 Annex IV. Hazard Identification
– Af rican Swine Fever Virus ................................ ................... 7 6 Annex V. Epidemiologic Characteristics of Rinderpest ................................ ............................ 77 References ................................ ................................ ................................ ................................ ........... 7 9APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 3 LIST OF FIGURES Figure 1: Map of Brazil and list of States with their acronym s ................................ ................ 8 Figure 2: State of Santa Catarina: Geographic location ................................ ......................... 1 0 Figure 3: Distribution of regional coordination units of CIDASAC, 2006 ............................ 1 5 Figure 4: Distribution of CIDASC LVUs, 2006 ................................ ................................ ..... 1 6 Figure 5: FMD status zones, Brazil , 2008 ................................ ................................ .............. 2 1 Figure 6: CSF
- Free Zone in Brazil, 2008 ................................ ................................ ............... 2 1 Figure 7: Brazil and neighboring countries ................................ ................................ ............ 2 2 Figure 8: Location of permanent inspection stations ................................ .............................. 3 8 Figure 9: Density

distribution of human, swine, cattle sheep and goat populations in Santa Catarin a ................................ ................................ ................................ ........................ 4 2 Figure 10: Bovine density and distribution ................................ ................................ ............. 4 3 Figure 11: Distribution of swine population ................................ ................................ ........... 4 3 Figure 12: Distribution of SIE and SIF slaughterhouses for swine and beef .......................... 4 6 Figure 13: Sampling strata and location of sampling units, Santa Catarina, 20 06 ................. 49APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 4 LIST OF TABLES Table 1. Human resources and infrastructure used in the central and regional coordination activities for animal health in Santa Catarina, 2006 ................................ .................... 1 6 Table 2. Structure and human resources used in animal health field work, Santa Catarin a, 2006 ................................ ................................ ................................ .............................. 1 7 Table 3. Entry

of live animals for breeding in Santa Catarina in 2005 and 2006 ................... 3 3 Table 4. Swine movement into or within Santa Catarina (2007) ................................ ............ 3 4 Table 5. Imports of animals and products from FMD
- susceptible animals into Santa Catarina in 200 5 and 2006 (partial data, until October 2006) ................................ .................... 3 6 Table 6. Results of inspections carried out b y C ID ASC, Santa Catarina, in 2005 and 2006 (first half) ................................ ................................ ................................ ..................... 4 0 Table 7. Information on livestock farms with FMD susceptible animals susceptible, SC, 2006 ................................ ................................ ................................ .............................. 4 1 Table 8 . Animal gathering events involving FMD
- susceptible animals inspected by CIDASC in Santa Catarina, 2005 and 2006 ................................ ................................ ................ 4 4 Table 9. Inspections carried out on rural holdings with FMD
- susceptible animals, Santa Catarina, 2005 and 200 6 ................................ ................................ .............................. 5 2 Table 10. Samples colle cted in 2000 and 2003 for CSF ................................ ......................... 5 3 Table 11. Number of notifications of suspected CSF in Santa Catarina, 2004 to March 2008 ................................ ................................ ................................ ..... 5 4APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 5 LIST OF ABBREVIATIONS ASF : African Swine Fever APHIS: Animal and Plant Health Inspection Service BHK- 21: Bab y hamster ki dney
- 21 cell line BL3: Biosecurity level 3 BSE: Bovine spongiform encephalopathy CFR: United States Code of Federal Regulations CIDASC : Companhia Integrada de Desenvolvimento Agricola de Santa Catarina CONASAN: Comite Nacional de Saude Animal (Natio nal Committee for Animal Health COSALFA: Commisao da America do Sul para a Luta contra e Febre Aftosa ( South

American Commission for the F ight A gainst FMD ) CSF: Classical swine fever CVP: Comite Veterinaria Permanente ( Permanent veterinary comm ittee ) DDA: Department of Animal Health DSA : Animal Health Directors EITB: Enzy

me - linked immunoelectrotransfer blot ELISA: Enzy

me - linked immunosorbent assay ELISA 3ABC: ELISA test for detecting FMDV nonstructural proteins 3ABC END: Exotic Newcas tle disease EPP: Expected percentage of protection EU: European Union FMD: Foot - and
- mouth disease FMDV: Foot - and
- mouth disease virus GTA: Guia de Trans ito Animal (Animal movement permit)APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 6

GRSC Granjas de Reprodutores Suideos Certificadas ( Certifi ed Swine Breeding

Farm) LANAGRO Laboratorio Nacional Agropecuario (national agricultural laboratori e s) LVU: Local veterinary units MAPA: Ministry of Agriculture, Livestock and Food Supply NEPA: National Environmental Policy Act NSP: FMDV nonstructural proteins OIE: World Organization for Animal Health (formerl y Office International des

Epizooties) PANAFTOSA: Pan - American Foot
- and
- Mouth Disease Center PHEFA: Plano Hemisferico de Eradicacao da Febre Aftosa (h emispheric plan for

eradication of FMD ) PNEFA Programa Nacional de Eradicação da Febre Aftosa . (National Program for

Foot - and
- Mouth Disease Eradication) Probang: Test for identifying the FMDV in esophageal
- phary ngeal fluid SDA: State Department of Agriculture (or State Agricultural Secretariat) SFA: Federal Agriculture Supervision SIF: Servicio de Inspecao Federa (Federal plant inspectors) SISBOV: Sistema Brasileiro de Identifação e Certificação de Origem Bovina e Bubalina

(Brazilian System for Identification and Origin Certification f or Bovines and Buffaloes) SVD: Swine Vesicular Disease TB: Tuberculosis TSE: Transmissible spongiform encephalopathies UPL : Piglet Production Unit U.S.: United StatesAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 7

USDA: United States Department of Agriculture VIAA: Virus infection
- associated antigen test VS: Veterinary Services, Animal and Plant Health Inspection ServiceAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 8

Figure 1 : Map of Brazil and list of States with their acrony ms

Acre AC Paraíba PB Lagos AL Pará PA Amapá AP Pernambuco PE Amazonas AM Piauí PI Bahia BA Rio Grande do Norte RN Ceará CE Rio Grande do Sul RS Distrito Federal DF Rio de Janeiro RJ Espírito Santo ES Rondônia RO Goiás GO Roraima RR Maranhão MA Santa Catarina SC Mato Grosso MT Sergipe SE Mato Grosso do Sul MS São Paulo SP Minas Gerais MG Tocantins TO Paraná PRAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 9 EXECUTIVE SUMMARY The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary

Services (VS) conducted a risk anal ys is as a decision
- making tool for a proposal to initiate trade in fresh pork from the Brazilian State of Santa Catarina. Trade in fresh pork and other susceptible animals and products from Santa Catarina has not been allowed because USDA considers all of Brazil to be a country affected with foot
- and
- mouth
- disease (FMD), s wine v esicular disease (SVD), c lassical s wine f ever (CSF), and African s wine f ever (ASF). APHI S has evaluated information submitted by Brazil and conducted a site visit to Santa Catarina in June 2008 to substantiate the in formation reported in the documentation and add any new data. APHI S also conducted three other site visits to other Brazilian States in 2002, 2003, and 2006. The site visit s focused on the veterinary and legal infrastructure, border control procedures, l aboratory and diagnostic capabilities, biosecurity procedures on swine f

arms , animal health recordkeeping sy stems, movement controls, and disease surveillance s ys tems. APHI S ’ analy sis was based on informatio n gathered from the site visits; on information submitted in writing b y the Brazilian Ministry of Agriculture, L ivestock and Food Supply (MAPA) and the Companhia Integrada de Desenvolvimento Agricola de Santa Catarina (CIDASC) ; and on published scientific literature. This document describes the animal health s ys tem and disease control and eradication measures in the Brazilian State of Santa Catarina . It identifies potential areas of risk and discusses how this risk is mitigated. The following factors were considered relevant in determining the disease status of Santa Catarina :
 No FMD outbreaks have occurred in Santa Catarina since 1993 .  Santa Catarina has not vaccinated against FMD since May 2000.  No outbreaks of ASF have occurred in Santa Catarina since 1981 .  No outbreaks of CSF have occurred in Sant a Catarina since 199 0 .  SVD has never occurred in Brazil. Surveillance programs in cattle and swine have not detected the presence of the FMD , CSF, SVD, or ASF virus es in Santa Catarina . There was no e vidence of FMD viral activity in cattle during or after the 2000 - 2001 and 2005
- 2006 outbreaks in other areas of the country . In addition, Santa Catarina does not vaccinate for FMD , so any cattle or swine in that State exposed to the FMD virus can be considered sentinels for the disease . APHI S considers the legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs , and emergency response s ystems within Santa Catarina adequate to detect and control FMD , CSF, SVD, and ASF outbreaks. Although the consequences of FMD , CSF, SVD, and ASF outbreak s are severe, APHI S considers the likelihood of outbreak s occurring in the United States , through exposure of domestic livestock to swine or other susceptible species or their related unprocessed products imp orted from Santa Catarina , to be very low .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 10

I. BACKGROUND Brazil has officially

requested that APHI S review the disease status of Santa Catarina to initiate trade in fresh pork from th at State . Trade in fresh pork or other susceptible animals and produc ts from Santa Catarina has not been allowed because APHI S considers Brazil to be a country affected with FMD, SVD, CSF, and ASF. The last outbreak of FMD in Santa Catarina occurred in 1993 . No new FMD outbreaks have been reported since then , despite the occurrence of FMD in neighboring States in 2000 - 2001 and 2005 - 2006. Brazil has recognized Santa Catarina as free of CSF since 1991, and ASF since 1981. Brazilian authorities report that SVD has never occurred in Brazil. Historically , rinderpest virus has never become established in North America, Central America, the Caribbean Islands, or South America. A brief incursion into Brazil occurred in 1921 but was limited in scope and quickl y eradicated. Figure 2 : State of Santa Catarina: Geographic location (source : FMD free OIE document)

MAPA animal health officials submitted d ocumentation to support their request . APHI S made a site visit to Santa Catarina in June 2008 to verify and complement the information submitted by Brazil . It focused on the legal framework and veterinary infrastructure, border and movement controls, agricultural practices, and laboratory diagnostics and surveillance programs related to Santa Catarina’s animal health program. Objective This is an analy sis of the risk of introducing FMD , CSF, SVD, and ASF into the United States through importation of susceptible species and related unprocessed animal products from Santa Catarina (because rinderpest has never been established within the continent it will not be addressed further within this document) . The risk anal ys is is intended as a decision
- making tool for APHI S Other countries in State of South Other P

AAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 11

m anagers that will allow APHI S to develop appropriate regulatory conditions with mitigations that address disease introduction risks posed by any i nitiation of trade. It also constitutes an information source for APHIS stakeholders, providing justification for the conditions in the rule. The anal ys is focuses on Santa Catarina’s status and control measures for FMD , S VD, CSF, and ASF . Supporting D at a The anal ys is is based on documentation provided by MAPA, observations made by the site visit team s , and published information. The report incorporates data obtained from a site visit to Santa Catarina in 2008 and previous site visits in 2002, 2003, and 2006 to different areas of Brazil . The visits evaluated the risk of importing fresh (chilled or frozen), maturated, deboned beef into the United States . The scope of the 2002 site visit included verification of FMD outbreak controls, an overview of the surveillance program and laboratory capabilities, vaccination practices and eradication activities, and movement and border controls within Brazil. During this visit, APHI S placed p articular focus on the regional FMD situation in Brazil and South America and on the risk of reintroducing FMD into Brazil from neighboring countries. The focus of the 2003 site visit was to collect data that APHIS used in our risk assessment. The focus of the 2006 site visit was to evaluate the FMD situation following the 200 5 and 2006 outbreak s in the States of Mato Grosso do Sul and Paraná . The scope of the 2008 site visit was to evaluate the status of Santa Catarina with respect to freedom from FMD, CSF, ASF, and SVD. Hazard I dentification APHI S has identified several Wo rld Organization for Animal Health (OIE) listed diseases [1] as the primary hazards associated with initiating trade in animals and animal products from foreign region s. APHI S addresses l isted foreign animal diseases of primary concern in our regulations at title 9 , Code of Federal Regulations (9 CFR) , Part 94. APHI S is obligated to evaluat e the status of a given region or country for specific foreign animal diseases before opening trade in susceptible species and related products with that region or country (9 CFR 92.2) [2] . The hazard s identified for this analy sis are FM D, CSF, ASF, and SVD . Epidemiological characteristics of the disease agent s relevant to the import risk s they may pose are described in the Annexes . Risk A nalysis This analy sis has four components : the release assessment, the exposure assessment, the c onsequence assessment, and the risk estimation. These components are defined in OIE guidelines and represent the international recommended components for animal health import risk analy s e s. Release A ssessment For the purpose of this report, release asse ssment refers to the evaluation of the likelihood that FMD , CSF, SVD, and ASF exist in Santa Catarina and, if so, the likelihood that these diseases c ould be introduced into the United States through imports of susceptible animals or their products from SantaAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 12

Catarina . The report includes an in
- depth evaluation of the 11 factors identified by APHI S in 9 CFR section 92.2 t o consider in assessing risk levels of free regions. Those factors are: 1. The authority, organization, and infrastructure of the veterinary services organization in the region . 2. Disease status . 3. The status of adjacent regions with respect to the agent
. 4. The extent of an active disease control program, if any , if the agent is known to exist in the region . 5. The vaccination status of the region . 6. The degree to which the region is separated from adjacent regions of higher risk through phy sical or other barriers . 7. The extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regardin g such movements . 8. Livestock demographics and marketing practices in the region . 9. The ty

pe and extent of disease surveillance in the region . 10. Diagnostic laboratory capacity . 11. Policies and infrastructure for animal disease control in the region , i.e., emergency response capacity . Risk factors are identified from the information gathered on these topics, and applicable mitigations to address those risk factors are discussed. Evalua tion of I nformation P rovided by MAPA and CIDASC Relevant to the 11 F actors O utlin ed in 9 CFR 92.2 Assessing the likelihood of introducing FMD , CSF, SVD , and ASF into the United S tates requires an evaluation of the relevant characteristics of the exporting regions relati ve to the epidemiology of the disease s . The 11 factors in APHI S ’ regionalization rule , described above, provide a context for evaluating the risk of exporting a foreign animal disease from a defined region into the United S tates . This section of the risk anal ys is describes APHI S’ evaluation of these factors for Santa C atarina . Main Findings: 1. Authority, organization and infrastructure of the veterinary services The authority, organization, and infrastructure of the veterinary services must be clearl y documented to provide confidence in the ability of the country

to mo nitor for disease, oversee veterinary activities, and implement disease controls in the region (i.e., control risk). This section is designed to provide a comprehensive view of the human, financial, phy sical, and regulatory resources available within MAPA and CIDASC . The section describes the legal authority for animal health activities in the region, the organizational structure and function of the veterinary services, and the personnel and financial resources available. Legal AuthorityAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 13

Legal authority for animal disease control in Brazil primarily consists of general legal directives and regulations issued by

the Federal g overnment with the States issuing supplementary legal acts. The primary animal health services law in Brazil is contained in Decree No. 24.548, enacted in 1934 [3, 4] . There are several overlapping laws administered at both the Federal and State levels in Santa Catarina which establish , among other things , controls on animal and product imports, disease contro l, farm security, surveillance, risk classification, movement control, animal identification, and funding [4] . The main law that defines the veterinary medicine profession in Brazil is Law N o. 5517. This law established the Federal and regional veterinary medicine councils that govern activities and professional aspects of veterinary medicine . Currently , there are over 40,000 veterinarians in Brazil with the majority

being in the s outhea st (47 percent) and s outh (23 percent) parts of the country . Official services v eterinarians are required to participate in specific training programs for different sanitary programs. More than 50 0 veterinarians have been trained specifically in exotic animal diseases, including FMD [5] . Organization of the Official Veterinary Services Federal and State authorities provide the two main structures for Brazil’s veterinary services. MAPA, through the Department of Animal Health (DDA), is the main Federal authority for all animal health programs and is responsible for coordination of all aspects of the national animal health sy stem. MAPA has regional offices, called the Federal Agriculture Supervi sion (SFA) in all 26 States in Brazil in addition to central offices located in the Federal District. A Federal veterinarian reside s in each regional office and oversee s compliance with all official animal health activities at the State level [4, 6, 7] . The State Veterinary

Services implement s animal health programs with the private sector. The Stat e Agricultural Secretariat (SDA) offices coordinate f ield activities. The coordinating agency directly responsible for administration of field activities is an integrated public company referred to as Companhia Integrada de Desenvolvimento Agricola de Santa Catarina (CIDASC). Field services are carried out by

the staff of the local veterinary units (LVUs), which are further coordinated b y the regional veterinary

offices [8] . At the international level, Brazil has an agreement to form a Permanent Veterinary Committee (Comite Veteri naria Permanente

– CVP) composed of the four Mercosur countries (Argentina, Brazil, Paraguay , and Uruguay) plus Bolivia and Chile. This committee is working to improve international relations and collaboration on disease eradication activities (see www.panaftosa.org.br/GIEFA/documentos/Doc2_Ing.DOC ). Central Competent Authority The Federal Government coordinat es and supervis es the overall animal health programs, develop s disease control strategies, regulat es and control s international commerce in animals and animal products, regist ers and control s vaccines, conducts laboratory diagnosis, audit s State veterinary services, inspect s animals and animal products for import, and conducts train ing . Federal government officials, located primaril y in Brasilia, de velop policies, laws, and regulations that govern all animal health programs and activities [6] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 14

Programs managed b y the Federal authorities include FMD eradication, swine health ( especiall y managing CSF ) , tuberculosis (TB) and brucellosis management , transmissible spongiform encephalo path y ( TSE ) surveillance, biological residue control, and traceability . T o provide effective oversight, MAPA officials travel regularly to the Ministry ’s offices in each State, and to the SDA offices in the field to evaluate programs at the local level [6] . The Federal veterinary

serv ice workforce consists of 1 , 629 veterinarians , 2 , 037 technical assistants, and 358 administrative assistants [9] . State and Local Veterinary Services Federal and State interactions are well defined and structured. State personnel execut e Federal programs, laws, and policies at the State level. Cooperation is achieved by renewal of signed cooperative agreements, which transfer considerable amounts of funding from the Federal budget to State agencies. The Federal program has ultimate authority over conduct of the national eradicati on program. It uses its authority to allocate financial resources to ensure compliance with Federal program policy

and provides oversight to ensure that the resources provided will be effectivel y managed [6, 7, 10] . Responsibilities of State officials for carrying out Federal programs are outlined in standard operating procedures developed with Federal officials . The standard operating procedures appl y to defined regions and reflect local circumstances. In Santa Catarina, CIDASC implement s Federal programs at the field level . It maint ains an up - to - date register of rural holdings, control s intra
- and interstate movement of animals and animal products, provi des assistance to Federal authorities during outbreaks, investigat es suspected notifiable diseases, provides sanitary education to the community , develop s animal disease surveillance and information sy stems, inspect s lives tock events such as fairs, exhibitions, auctions and public sales, and inspect s animals and their products and by products before movement . The SFA of MAPA oversees these activities [4] . Regional and local offices of the official S tate veterinary services are part of the CIDASC organization. The central and regional units of CIDASC overs ee local animal health activities. The work of CIDASC is directly inspected b y MAPA, through its repre sentatives at SFA. Additionally , MAPA carries out audits throughout the S tate, with the last s tatewide evaluation occurring during August and September of 2006. The evaluation was positive overall and the State adopted the auditors’ recommendations (Pers onal communication, Chapeco Office). During the 2008 site visit , the Chapeco Regional Office reported that it had been audited b y either MAPA (for pigs and poultry) or C IDASC three times over the past ye ar. The last FMD audit in Santa Catarina was conduc ted in 2006, with favorable overall results. A few deficiencies were documented, including the need for a single person in charge of sanitary health (since at the time one person oversaw both sanitary and animal health) . These deficiencies have been corrected. Each State in Brazil is administratively divided into municipalities, which comprise the basic units of animal health and surveillance. The field structure of the veterinary services in the country consists of 1, 528 LVU s ; 3, 9 40 municipal offices; 5 , 029 veterinarians; and 13,357 technical and administrative assistants and support personnel [9] . The LVUs consist of one or more municipalitiesAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 15

and implement animal health activities within the area they represent. The local units are administratively

grouped into regional units (19 total in Santa Catarina). Epidemiologic and health data collected b y the LVUs are consolidated and anal yz ed at the local level, used as appropriate, and then forwarded to regional, S tate, and national offices [4] . Geographic distribution of regional and local veterinary

units in Santa Catarina is displayed in F igures 3 and 4 , respectivel y, below. Figure 3 : Distribution of regional coordination units of CIDASC, 2006 [4]APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 16

Figure 4 : Distribution of CIDASC LVU s , 2006 [4]

CIDASC s taffing and infrastructure resources within Santa Catarina are shown below for central and regional units (Table 1 ) and local units (Table 2 ) at 2006 levels. Table 1 . Human resources and infrastructure used in the central and regional coordination activities for animal health in Santa Catarina, 2006 . Coordination Structure SFA CIDASC TO TAL Central Unit 1 1 2 Regional Unit s 9 19 28 Veterinarians 16 45 61 Assistants (technical and administrative) 8 40 48 Vehicles 17 40 57 Telephones 13 76 89 Fax machines 12 35 47 Computers 13 56 69 (S ource : F MD
- free OIE document) UVLAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 17

Table 2 . Structure and human resources used in animal health field work, Santa Catarina , 2006. Field Structure Number of resources Municipalities 293 Local v eterinary units 91 Community service offices 191 Veterinarians 295 Te chnical assistants 147 Administrative assistants 140 Vehicles 295 Telephones 99 Fax machines 55 Computers 277 (S ource : FMD
-

free OIE document) There are 295 official v eterinarians working in Santa Catarina. These professionals participate in the sur veillance s ys tem supporting the official veterinary service , in activities to promote animal health , and in notif

ication of animal disease suspicions , especially vesicular diseases [11] . During the 2008 site visit, the site visit team visited the regional office in Chapeco, along with two LVUs located within this region: Xanx erê and Seara. The Chapeco regional office has jurisdiction over 44 municipalities divided into 18 LVUs. Itincludes 404,000 residents and covers 7,095 square kilo m eters . The livestock population consists of 1,164,000 commercial and 15,000 backyard pigs and 700,000 cattle. Forty
- seven official veterinarians work within this region, most of wh om are stationed at LVUs. Additional staffing within the region includes 22 clerks, 6 field assistants, and 74 personnel stationed at sanitary barriers. Four and three veterinarians, respectively , o perat ed out of the Xanx erê and Seara local offices [11] . Representative State activities administered by LVU personnel include regist ering properties, collectin g and tracking census data, monitoring vaccination and control ling vaccine distribution, animal and animal product movement control, reporting suspicious cases, monitoring and eradicating outbreaks, surveillance activities, monitoring local animal gathering events ( such as fairs, expositions, and auctions), monitoring clinical investigations and sampling, and conducting local training and outrea ch [6, 10] . Personnel wh o observe conditions consistent with FMD or swine diseases, including CSF, SVD, and ASF, must immediately notif y Federal officials . The Federal, State and private sectors exchange i nformation freely . Lo cal and regional offices prepare weekl y and monthl y reports that are shared among the three sectors [6, 10] . Interaction among local, regional, State, and Federal authorities and private and international organizations is structured and effective.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 18

Private coordination/contributions Veterinary

control and infrastructure in Brazil depend on close interaction between Federal and State offices , but their functions are also supported strongl y b y producer groups. In fact, this interaction with producers is defined by regulation and considered by Brazilian officials to be a signific ant factor in control ling FMD. The private sector is strong ly committed to general animal health activities as well as disease eradication and traceability ( identification) s ys tems , and shows its support by

substantial financial contributions [6, 7, 10] . Professionals who work in the private sector are often invited to participate in lectures and technical meetings with representatives of the official veterinary service. Private s ector veterinarians can register with MAPA and CIDASC to issue animal movement forms ( Guia de Trans i t o Animal, or GTA s) for the movement of pigs and poultry , as e ach official veterinarian works in a limited number of municipalities [4] . During the 2008 site visit the team observed strong interactions between CIDASC veterinarians, production company (cooperative) veterinarians, and producers. The cooperative veterinarians trained the producers in basic animal health and production, biosecurity , and disease recognition and reporting requirements. The official veterinary services, in turn, train ed the private veterinarians. On most swine farms, farmers have been trained to diagnose common causes of death , such as volvulus, by

conducting their own necropsies, but appeared willing to contact their company veterinarian if they

detected something unknown or suspicious of a viral infectio n . Company veterinarians are in turn required to contact the local CIDASC office upon suspicion of any notifiable diseases [11] . Indemnity procedures Brazil law requires indemnity . The main indemnity procedures are based on L aw N o. 569, passed December 21, 1948, which establishes measures to safeguard public health or for the sanitary protection of animals. The Federal government pay s indemnity for (1) animals sacrificed due to the presence of FMD or any other exotic disease, (2) all susceptible animals that have the disease, and (3) all susceptible animals that have a history o f contact with affected animals. The Federal government provides money for pay ments ; money also comes from private indemnity funds created and administere d by

producers. Federal funds come from the national treasury and complement indemnity

funds adminis t ered by

producers [12] . Whenever sick animals must be destroyed to safeguard public health, or there is destruction of rural buildings or objects, the proprietor must receive financial compensation . Compensation is paid after the situation is assess ed in accordance with regulations of MAPA and the State g overnment. The producers’ private indemnity fund in various Brazilian States comes from fees paid b y producers and slaughter establishment off icials for authorization to move and slaughter animals. Santa Catarina has public and private funds for compensation during disease emergenc i es. During the 2008 site visit, CIDASC reported a fund for animal health activities of 17,763,757 reales (approxi mately $ 11 million.). Brazil ’s laws require that records of the entire indemnity process beAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 19

kept, with the documentation being available for auditing in the involved States (presentation C ID ASC ). Owners have been dul y compensated i n all animal sanitary e me rgency

activities carried out in Brazil [11] . Garbage control/swill feeding Swill feeding to swine is prohibited in all regions of Brazil by Decree N o. 201, issued May 1998 [5] . State laws in Santa Catarina also prohibit garbage feeding . Although Federal law allows s ome feeding with inactivation of waste, this practice is forbidden by Santa Catarina State law. Official veterinarians at the Seara local office reported that if they identified garbage feeding during a farm visit they would provid e guidance and a verbal warning to stop it . Upon a second finding they would issue a fine ; however, the officials reported that this has never been necessary [11] . Conclusions: APHI S considers that MAPA has sufficient legal authority to carry out official disease control, eradication, and quarantine activities. MAPA has a sy stem of official veterinarian s and support staff in place for carrying out field programs and for import controls and animal quarantine. Review of veterinary

infrastructure with MAPA and CIDASC officials demonstrated an infrastructure adequate for rapid detection of FMD, CSF, ASF, an d SVD and for carrying out surveillance programs in Santa Catarina. The technical infrastructure is adequate, and officials use advanced technologies to conduct animal health programs . Santa Catarina’s LVU offices are adequatel y staffed. Assuming that the offices visited during the site visit are representative of LVUs throughout the S tate, the local contacts, coverage, and control mechanisms are strong. LVU functions observed in relatively high
- risk regions demonstrated close contact with individual premises in the regions and strong local controls. LVU personnel appeared to be adequately

trained in identifying the clinical signs of FMD, SVD, ASF, and CSF. In addition they have a close relationship with animal producers and private/company veterinarians in charge of cooperative farms . All parties are willing to report suspicious incidents to the next level. LVU personnel also regularl y provide information on disease signs and reporting requirements to producers within their coverage area. It is expe cted that producers would suspect any of the diseases under evaluation if they

were to see them. During our site visits to Brazil in 2002, 2003, 2006, and 2008 , APHI S received overviews of the activities and structures of Federal, State and local a uthorities . APHI S reviewed premises registration, census information, vaccination records, and movement control documents . Our personnel visited farms to observe farming practices. Officials o bserv ed that the structure, effectiveness , and organization of the LVU s in Santa Catarina were adequate to perform official animal health functions [6, 11] . With regard to indemnity procedures, APHIS concluded that sufficient funds are available to compensate owners for sacrificed animals. In addition, indemnity provisions can be extended to exposed and contact animals. Livestock producers and other industry groups contribute to and administer private compensatio n funds, which show the level of commitment and participation of the cattle industry

in FMD program activities and of the swine industry to FMD, CSF, SVD , and ASFAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 20

program activities. Availability of indemnity

provisions should encourage disease reporting and complement detection efforts carried out by official veterinary

services. 2. Disease status in the export region Gaining a thorough understanding of the history of FMD, CSF, ASF, and SVD in a region is essential to assessing its existing export risk. A ssessment of risk includes a consideration of the effectiveness of control measures the region implements and revis es as appropriate. Consequentl y, this section focuses on historical outbreaks and eradication efforts in Santa Catarina. FMD FMD vaccinati on became mandatory in Brazil in 1965. The first s ys tematic vaccinations were implemented in 1967 through a joint action of the Federal and State governments. In1992, the policy and strategies against FMD were reviewed; as a result , the vaccinations were enforced regionally

based upon livestock demographics. Stakeholders (producers, agricultural industry , retail, universities, etc . ) were incorporated as a main element in all phases and activities in the National Program for Foot
- and
- Mouth Disease Eradic ation (PNEFA
- Programa Nacional de Erradicação da Febre Aftosa ). Consequently , in 1998, the OIE recognized the first FMD
- free area where vaccination was practiced . The last FMD outbreak in Santa Catarina occurred in 1993. Santa Catarina achieved intern ational recognition in 1998 as FMD
- free with vaccination. In 2000, the year that vaccination ceased in Rio Grande do Sul, an FMD outbreak occurred in that State. No FMD was detected in Santa Catarina. The 2000 Rio Grande do Sul outbreak affected 22 prem ises. The disease was eliminated by stamping out ( destruction of the affected animals ) . Officials suspected that the disease was linked to a Ty pe O1 FMD outbreak in Argentina, which also occurred in 2000. Transit of infected cattle in the border region between Argentina, Brazil , and Uruguay was implicated as the pathway of introduction. At that time, vaccination against FMD remained suspended in Santa Catarina and Rio Grande do Sul. In 2007, OIE recognized Santa Catarina as an FMD
- free zone where vaccination is not practiced (see F igure 5 ).APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 21

Figure 5 : FMD status zones, Brazil, 2008.

( S ource : Presentation, U

. S
. Technical V

isit June 8
- 13, 2008) CSF No outbreaks of CSF have occurred in Santa Catarina since 1990 [13] . In addition, there have been no outbreaks in the CSF
- free portion of Brazil, which comp rises the 12 southernmost Brazilian States, since 1998 (see Figure 6 ). The CSF
- free zone of Brazil was declared in January 2001 according to Normative Instruction SDA 01/2001. It consists of almost half of the Brazilian territory and 80 percent of the national swine population [9] . Figure 6 : CSF - F ree Z one in Brazil, 2008 [9]

Infected Zone Free Zone 2008 Non free Free zone with vaccination Buffer zone Free zone without vaccination Suspended free zoneAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 22

Fifteen outbreaks have been detected since declaration of the free zone in Brazil in 2001, all of which occurred in the non
- free zone. Most occurred in the State of Ceará; one outbreak occurred in Paraíba in 2006 and one in Maranhão in 2008 [9, 14] . ASF No outbreak s of ASF have occurred in Brazil sinc e 1981. As of 1984 [15] , all of Brazil was declared to be ASF - free and continues to be regarded as such [14] . SVD SVD has never occurred in Brazil [14] . Conclusions: Santa Catarina’s last FMD outbreak occurred in 19 93 . No outbreaks of ASF have occurred in Santa Catarina since 1981 and no outbreak s of CSF have occurred in Santa Catarina since 1990. SVD has never occurred in Brazil. There is no evidence of any FMD, CSF, SVD, or ASF infections or outbreaks in Santa Catarina. 3. Disease status of adjacent regions This section describes the disease st atus in other areas of Brazil with respect to FMD, CSF, ASF, and SVD, and in Argentina, which borders Santa Catarina (Figure 7 ). Figure 7 : Brazil and neighboring countriesAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 23

FMD Brazil currently has several different FMD zones. Santa Catarina is the only zone designated by

the OI E as free of FMD without vaccination. At the time of this anal ys is, the area recognized by the OI E as free of FMD with va ccination contains 16 States , mostly located in the southern and central portion of Brazil (OIE reference). Santa C atarina is surrounded b y the States of Rio Grande Do Sul and Paraná , both recognized by the OIE as free of FMD with vaccination. Outbreaks of FMD have occurred in Rio Grande Do Sul (200 0 /2001) and Paraná and Mato Grosso do Sul in 2005 and 2006 . Rio Grande do Sul In 2000, the year that vaccination ceased in Rio Grande do Sul, an FMD outbreak occurred in that State. FMD was not detected in Santa Catarina. The Rio Grande do Sul outbreak affected 22 premises in four neighboring municipalities in the northwestern region of the State. The disease was eliminated by

stamping out. The eradication program involved the destruction of 11,0 1 7 animal s (8,185 bovine, 2,106 swine, 722 ovine , and 4 caprine species). In addition, officials imposed strict movement controls and biosecurity measures [6, 7, 12, 16] . The disease was linked to a Ty pe O1 FMD outbreak in Argentina that occurred in 2000. Transit of infected cattle in the border region between Argentina, Brazil , and Uruguay was implicated as the pathway of introduction. At that time, va ccination against FMD remained suspended in Rio Grande do Sul [16, 17] . In 2001, another outbreak occurred in Rio Grande do Sul affecting 30 premises in six different municipalities. In this outbreak, in addition to implementing a stamping out program, officials car ried out emergency

vaccination for all cattle in the State. A total of 2,348 farms were quarantined and 32,408 animals were slaughtered. No direct epidemiological relationships between the six affected municipalities were identified. Investigation resul ts suggested that the six outbreaks result ed from independent re
- introductions, all coming from Uruguay . Direct epidemiological relationships were established between the owner of an affected herd in one municipality and producers in Uruguay . The observation that the first occurrence of disease was farther away from the border than subsequent occurrences was significant because the owner of the affected herd had been in Uruguay

a few day s before the outbreak erupted in his herd . No direct relationship wa s identified between the outbreaks in the six municipalities and the outbreaks in Argentina since the virus in Argentina was type O and the virus in Uruguay was classified as type A [6] . At th at time, vaccination against FMD was reinstated throughout Rio Grande do Sul [16, 17] . Paraná On October 21, 2005 , Brazilian authorities detected FMD in the State of Paraná. The outbreak was immediately

reported to the OI E. As a result, the affected properties, as well as those located within a 10 - km radius , were immediately quarantine d and interdicted. Paraná reported a total of 11 outbreaks (two outbreaks in Maringá, one in Grandes Rios, four in L oanda and two in Amaporã). Epidemiological investigation revealed that the disease entered Paraná because of the movement of 87 heifers from Mato Grosso do Su l on September 27 , 2005 . These animals originated from aAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 24

property that was later identified as ( 1 ) having had FMD cases, and ( 2 ) being adjacent to two properties with FMD cases. The animals involved remained for 8 day s in the municipality of Bela Vista d o Paraiso in Paran á , and subsequentl y sold at auction in the municipality of Londrina. Clinical and sero epidemiological investigations identified 11 properties with suspected FMD. By April , 2006 a total of 6,781 cattle had been destroyed to fight the outbreak . Officials made s everal attempts to isolate and identify the virus ; however , due to several factors ( such as samples taken not being suitable for virus isolation) , the laboratory staff could not identify

the presence of the FMD virus . Nevertheless , based on the clinical signs and epidemiological links to outbreaks in Mato Grosso do Sul, the episodes were confirmed as FMD, and officials declared a state of sanitary emergency . Argentina Argentina borders the Brazilian States of Rio Grande do Sul, S anta Catarina, and Paraná. In July 2000, officials recorded an outbreak caused b y virus ty pe O. Additional premises were infected with virus ty pe O through December 2000 in multiple provinces, including Corrientes and Misiones. D etection of separate pre mises affected with virus ty pe A between August and December 2000 compounded the situation . Subsequently , multiple outbreaks of virus ty pe A occurred between March 2001 and January

2002 throughout Argentina, including 70 outbreaks in Corrientes near the b order with the Paraná R iver. In addition, in September 2003, a single outbreak of virus typ e O occurred in the northern province of Salta. This outbreak was limited to swine in a single premises and Argentina declared eradication in early October. In 20 06, Argentina reported an outbreak of virus ty p e O in San Luis del Palmar (Corrientes) near the border with Paraguay . This outbreak was quickl y contained and eliminated . Molecular characterization of the virus revealed that the strain was indigenous to the region and shares common similarities with the isolates responsible for the type O outbreak s in South America between 2000 and 2005 [18] . Specifically , studies showed that the virus presented a high degree of hom ology (96 percent) with virus ty

pes isolated in Pozo Hondo (Paraguay) in 2003 and in Tarija (Bolivia) in 2000, and with 92 percent homology with virus isolated in Mato Grosso do Sul (Brazil) in 2005. Brazil appears to have successfull y prevented the intro duction of FMD from Argentina during some but not all outbreaks in that country . Regional approach to FMD eradication in South America A plan to eradicate FMD in all of South America by 2009

– the Plano Hemisferico de Eradicacao da Febre Aftosa , or PHEFA

– was created in the mid
- 1980s. Under this plan, a regional partnership agreement involving Brazil, Argentina, Uruguay , Paraguay , Chile, and Bolivia (the Convention da Barcia do Rio do Prata) was implemented in 1997. This agreement aims to integrate the various national and regional FMD programs and to coordinate sanitary measures for FMD control and eradication, particularl y i n the border regions [16, 17] . As part of the partnership agreement, the veterinary services in the border regions are jointly preparing map s that demonstrate the commercial flow of susceptible animals to pinpoint areas ofAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 25

higher risk. In addition, the local veterinary services of the involved countries meet periodically to discuss available information and conduct joint activities, thereby improving horizontal relationships and disease reporting at the local level. CSF As previously

described, Brazil was declared a CSF - free zone in 2001. Santa Catarina is located within th is CSF
- free zone, as are both of its adjoining Brazilian States. No outbreaks of CSF have occurred in Santa Catarina since 1990 [13] . There have been no CSF cases detected in the CSF
- free portion of Brazil since it was declared. Although CSF outbreaks have occurred in Brazil since this time , the outbreaks have been limited to States in the northeast ern portion of the country , far from Santa Catarina. Movement controls are in place at the border between the CSF
- infected and free zones of Brazil and have prevent ed spread of the disease into the free zone [9] . The last reported case of CSF in Argentina occurred in 1999 [14] . ASF ASF was first reported in Brazil in 1978 in the State of Rio de Janeiro. It is believed that the disease entered via infected food leftovers from an incoming passenger flight from Portugal, which was experiencing outbreaks of ASF at the time. Within Brazil , the outbreaks were concentrated in farms th at produced pigs for their own consumption . These farms were located on the outskirts of Rio de Janiero and had access to food waste [13] . The outbreak was contained through stamping out and increasing biosecurity

to prevent exposure to infective materials and wild boar. Brazil has had n o further outbreaks of ASF since 1981 [14] an d has been declared officiall y free of ASF since 1984 [15] . ASF has never been reported in Argentina [14] . SVD SVD has never been reported in Argentina [14] . Conclusions: There is no evidence that FMD has been transported from surrounding countries or regions of Brazil into Santa Cat arina. CSF has not occurred within Santa Catarina since 1990. Although CSF has been detected in recent years in the CSF
- infected zone of Brazil, movement controls have prevent ed introduction of the disease into the free area. CSF does not appear to be circulating within Argentina at this time; therefore , it is not likely that transmission of disease would occur from this source. ASF has not occurred in Brazil for nearl y 30 years, and it has never been reported in Argentina. Therefore, it is highl y unlikely that the virus exists in areas neighboring Santa Catarina or that these areas pose a risk for disease transmission. SVD has never been reported to occur anywhere within Brazil or in Argentina.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 26

4. Extent of an active d isease control program In this section we describe the disease control program s that led to the eradication of FMD , CSF, ASF, and SVD in Santa Catarina, and review MAPA and C ID ASC program activities. The Brazilian FMD program strategy consists of defining a region based on the livestock circuit or ecos ys tem . Eradication efforts are coordinated by region. The program relies heavil y on community involvement and joint activities with stakeholder groups interested in animal health and production. Brazil has formed local groups that work under the coordination of the States’ regional and central offices. One of the main objectives of the program is to shift decision
- making to the LVU s, wh ich take sanitary

actions and generate technical information. The DDA coordinates and supervises all aspects of the FMD program. The DDA:  Develop s strate gies to combat the disease .  Develop s program rules .  Control s interstate and international movement of animals , products , and by products .  Regist ers , test s , and control s specific vaccines .  Conduct s laboratory

tests for disease diagnosis and virus isolation .  Conducts disease surveillance and information s ys tems at national and international levels .  Audit s State veterinary services .  Conducts s anitary

education and training of program personnel .  Conducts v eterinary

inspection of animals, animal products , and b yp roducts at origin and after importation .  Provi des financial support through cooperative agreements with the States . The States implement program strategies. The States’ secretariats:  Execut e program s at the field level .  M aint ain an updated rural holdings register .  Promot e and monitor the FMD vaccination program for cattle and buffaloes .  Supervis e vaccinations in risky areas or holdings .  Control intra
- and interstate movement of animals and animal products (the interstate control is conducted in partnership with the Federal government) .  Help Federal authorities during outbreaks of the disease and investigation of suspected vesicular disease .  Provide s anitary

education ,  O rganiz e community participation in the programs .  Develop animal disease surveillance and information sy stems .  Inspect livestock events such as fairs, exhibitions, auctions , and public sales .  Inspect animals and their products and by products before movement .  Train program personnel . The participation of the private sector in the national cont ext is through CONASAN and occurs at all levels of administration (national, State , and municipal). The private sector supports the FMD program b y providing financial resources and participating in the program’s planning, financing, implementation , and ev aluation of the technical and managerial actions. According to BrazilianAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 27

officials, the private sector’s participation has also strengthen ed official structures and improve d sanitary actions, mainl y within the local units of the surveillance sy stem. The Brazilian Government has promoted and guaranteed the involvement of various groups of CONASAN into a plan called the National Program for Foot
- and
- Mouth Disease Eradication , or PNEFA . These groups are composed of people interested or involved in livestoc k production or health, such as rural producers, livestock and livestock product industry personnel, trade agents, private veterinarians, and members and officers of farmers’ unions, cooperatives, universities , and town halls. The objective of these alliances is to bring greater awareness, a wider scope, transparency , and credibility to the p rogram. The Federal Government coordinates the implementation of the national plan. Eradication of FMD in Santa Catarina followed the basic strategies implemented b y PNEFA and are summarized here :  Strengthening and maint aining the animal health sy stem, including hiring personnel for the official veterinary

service through public agreements .  Enacting and enforcing compliance with animal health laws .  Registering rural h oldings, herds , and all other establishments linked to the livestock production sy stem .  In its first phase, periodic mass vaccination of bovine animals and buffaloes which can be suspended and followed by actions to strengthen the primary surveillance sy st em .  Working on vesicular disease suspicions and implementing a stamping
- out policy if officials confirm FMD .  Control and surveillance of animal movement and prohibiting the entry of at
- risk animals and animal products .  Strengthening community participation .  Auditing and supervisi ng premises as needed . Main activities of the FMD and other swine notifiable disease program Disease surveillance Brazil’s animal health service has a surveillance sy stem that covers the entire country . The LVU s collect the nece ssary

data and make decisions based on the data . Many official and private sources supply the s ys tem’s information. InSanta Catarina, the field units collect and process surveillance data and forward the information to the regional offices. Santa Catarina’s central unit and a national unit represented b y DDA and the MAPA SDA are located in Brasilia. The DDA official collects data from the State level and forwards the information to the OIE and other parties such as the South American Commission for th e Fight against FMD. Reports are sent :  Weekly for disease notifications .  Monthly for confirmed cases of animal diseases .  Biannual ly

for the results of each phase of vaccination against FMD for each F ederal unit .  Annual ly

for full report s of epidemiological and sanitary information . Notification and investigation of suspected casesAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 28

All official service field staff, community participants, and private sector veterinarians are trained and required to look for signs of notifiable diseases. If any of the lis ted diseases, including FMD, CSF, ASF, or SVD is suspected, the disease must be immediately reported to the local unit or to an authority that would notify

the local unit. Response to a suspected outbreak begins within 12 hours from the time the unit rece ives notification. All actions are carried out as if the herd is infected until proven otherwise. The suspect holding is immediately quarantined , movement of animals is prohibited, and samples are collected and sent to a laboratory

to confirm the diagnos is. Field inspections LVU personnel carry

out special visits to certain herds classified as “risky” by the official service. Risky herds are those owned by rural landless herd owners and Indian tribes, herds in areas densel y populated with backyard and street cattle, or herds that have previousl y been affected by one of the diseases under evaluation . In addition, official veterinarians inspect animals prior to movement into Santa Catarina. Surveillance at abattoirs and meat packing plants Animals are individually

inspected by

personnel from the official service for signs of vesicular disease before slaughtering. Other body parts, including the tongue and feet, are examined during postmortem inspection. Surveillance at animal gathering places All ani mals entering fairs, auctions, or exhibitions are clinically inspected by

official veterinarians. Laboratory diagnosis There are three laboratories for diagnosing FMD. These are located in Recife (Pernambuco State), Para (Belen State), and Pedro Leopold o (Minas Gerais State ) . MAPA supervises the se laboratories. The Pan
- American Foot
- and
- Mouth Disease Center (PANAFTOSA), located in Rio de Janeiro, is the reference laboratory

for FMD in Brazil and neighboring countries. The Recife laboratory performs ro utine serology for CSF , and for SVD and ASF if necessary . Serological monitorin g Serologic studies follow OIE guidelines . (See section 9 . ) Regarding reportable swine diseases, current strategies under MAPA ’s disease prevention and control programs include :  P ermanent sanitary

surveillance .  M andatory

and immediate notification of events or suspicion of occurrence of CSF or other swine diseases .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 29

 Immediate assistance to States for control and eradication of outbreaks .  C ontrol of the transit of swine , their products and by products, and genetic material .  C ontrol of pathological and biological products that are possible vectors of disease .  Control of places where swine concentrate .  D isinfection of vehicles, equipment , and environments .  D estruction of potentiall y infected materials .  Control of stamping
- out policies .  C ontrol and prohibition on the use of vaccines. N one of the diseases under evaluation have been found in Santa Catarina for more than 8 years . A ctivities designed to detect and prevent introduction of any of these diseases and quickl y eradicate the m are all in place and are described in subsequent sections of this document. Conclusions: APHI S considers that Santa Catarina has a control program and a national plan sufficient to respond quickly to any emergencies related to the diseases under evaluation. Santa Catarina has a structure d sy stem of notification and official involvement to investigate all reports of suspect ed vesicular disease. In addition, Santa Catarina maintains a surveillance program at the field level o n farms, in slaughterhouses , and at animal gathering locations. The community

takes an active part in program activities, which has played an integral role in the motivation and strengthening of the program. 5. Vaccination status of th e region Santa Catarina does not v accinat e against FMD . FMD vaccination was last applied in May 2000. Brazil prohibited CSF v accination in 1998. MAPA may

approve emergency

CSF o r FMD vaccin ations if necessary . The vaccinations must be conducted under the strict control of the o fficial v eterinary s ervices [4] . Vaccine has been administered as part of outbreak control measures in the CSF
- infected zone , although this has not occurred sin ce 2003 (OIE). Vaccine has not been used any where within the CSF
- free zone since it was prohibit e d in 1998 [3] . There are currently

no available vaccine s for either SVD or ASF. Conclusions : Santa Catarina does not vaccinate for any of the diseases under evaluation . In the absence of vaccination, it is likely

that clinical signs resulting from an incursion of disease would be quickl y identified.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 30

6. Separation from adjacent regions of higher risk Geographic barriers, such as mountains or expanses of water, impede the natural and human
mediated movements of animals and animal products. Inthis section we highlight the geographical and other barriers that limit introduction of diseases from other Brazilian States into S anta C atarina . Santa Catarina is in the s outh ern region of Brazil, between parallels 25o 56  and 29o 23  S and meridians 48o 20  and 53o 51  W. The State has an area of 95,346 km2 , representing about 1 percent of Brazilian territory . Santa Catarina has two large regions separated by mountains: The coast al area, also referred to as the eastern area, which extend s for approximately 400 km along the Atlantic Ocean ; and the plateau area (or western area), the remaining 66 percent of the S tate ’s territory . The western area is where the greatest livesto ck production occurs ( See Figure 2 ). Santa Catarina is bounded to the east by the Atlantic Ocean, and otherwise borders the States of Paraná and Rio Grande do Sul and the Argentinian Province of Misiones. At the northern border of Santa Catarina, with Paraná, the border is approximately 860 km long, 54 percent of which is rivers . The remainder is formed by the Serra do Mar mountain ridge at the extreme northeast of the State. The south border, with Rio Grande do Sul, is approximately 1,170 km long, 65 p ercent (750 km) of which is formed b y permanent rivers . The west ern border, with the Province of Misiones, Argentina, is 237 km long, 86 percent of which runs along the Rio Peperi
- Guaçú. In Misiones, the border area is formed mainly by protected natural areas, among which is the Yaboti Biosphere Reserve. In addition to the geographical characteristics that control entry of products at risk for FMD into Santa Catarina, the protection sy stem includes 67 fixed inspection posts, strategicall y located at the entry points . These inspection stations employ 429 professionals from the official veterinary service , who work in shifts that provide uninterrupted operation of the posts . In spection station staff members are coordinat ed by an official veterinarian, and have police support. The inspection stations are described in further detail in S ection 7 of this document. In addition, movement controls are in place between Santa Catarina (which is considered free of FMD without vaccination) and areas of Brazil affe cted with FMD or where vaccination against the disease is practiced. Similarly , there are movement controls between the CSF
- free zone and the CSF - infected zone in the northern portion of Brazil [3, 4] . Conclusions: Although some natural barriers to animal movement into Santa Catarina from surrounding areas exist, most of the controls of animal movement and the ir products are administrative. These two factors combined (geographical and administrative separation) have prevent ed th e introduction of the disease s under evaluation into Santa Catarina. In addition, the lack of recent disease history for any of the diseases under evaluation in the adjacent areas further reduce s the likelihood of their introduction into Santa Catarina.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 31

7. Movement control, biosecurity, and the extent to which the movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regarding such movements Border controls, including inspections at ports of entry and other surveillance practices, enable a country to monitor the movement of people, animals, and goods into the country or a particular region . Illegal movements of susceptible commodities or people and equipment can spread disease . A thorough understan ding of animal movement controls helps assess the likelihood of disease introduction. Further, biosecurity measures are critical to minimize the spread of disease should an outbreak occur. In this section we review Santa Catarina ’s border control capabil ities for monitoring and controlling the movement of species and products that could carry the diseases under evaluation into the State . Among general animal health measures carried out by the official veterinary

service in order to protect the animal health status of Santa Catarina, control at the entry points into the State is the primary prevention mechanism . Both international and domestic movement of animals and their products and by products are regulated b y federal rules. MAPA is directly responsible for the control of permanent inspection station s on the border with Argentina, three ports and the international airport in Florianopolis, the State capital, through its International Plant and Animal Surveillance (Vigilância Agropecuária Internacional ). Santa Catarina control s other inspection stations through CIDASC [4] . Animals must be accompanied b y a Zoosanitary Certificate signed b y an official veterinarian from the exporting country , pursuant to the model in Normative Instruction SDA 31 /2002. C ontrols f or international transport and trade are defined b y Normative Instruction SDA 47 /2001, which bans the import of animals and products at risk of FMD from countries where the dis ease has occurred. Normative Instruction SDA 31/2002 and Normative Instruction SDA 54/2002 include i nformation on the extent of control and biosecurity measures on imports from higher risk areas for CSF. The movement from the non
- free zone into Brazil’s free zone of animals or other products capable of introducing CSF is regulated b y Normative Instruction SDA 01 /2001. The requirements for entry of animals, products , and by products at risk for FMD into Santa Catarina are contained in Normative Instruction SDA 0 5 /2003 [3, 4] . All animals and products (plus plant products) must enter and leave Santa Catarina via one of the 67 fixed inspection stations [4] . Domestic movement controls and animal identification Brazil has stringent m ovement controls. MAPA requires that all cattle owners identify their animals with a unique brand. Sheep and swine are identified by an individual brand or notch in the ear. Each LVU keeps a registry of identification s ys tems and a complete registry of the livestock holdings in the region with animal populations listed by age group and sex. The registry must be updated at least twice a year, and whenever animals are moved ( farmers must n otify the LVU of changes to the animal inventory due to birth, death, or movement off premises and must do so within 30 day s [7] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 32

The Brazilian Sy stem for I dentification and Origin Certification for Bovines and Buffaloes (SI SB OV - Sistema Brasileiro de Identifação e Certificação de Origem Bovina e Bubalina ) is currentl y being used in Santa Catarina. Within Santa Catarina , CIDASC has implemented a program for the individual identification of the S tate’s entire herd. This identification is mandatory , with e ar tags issued by the S tate government, as per State Ordinanc e n. 44, issued December 18, 2006 [4] . The LVU must issue an animal movement permit (GTA) before any animal can be moved [6]. Those seeking a GTA must meet certain requirements, such as: balance of animals for the specific age group and sex; vaccination against the diseases listed by the local veterinary

service; obtaining sanitary certificates, when necessary ; and meeting the necessary sanitary condition or status at the origin and at th e destination. A cop y of the GTA is sent to the destination. In addition, the LVU staff must verify

that the vehicle transporting the animals has been cleaned and disinfected as required b y law [4, 7] . The GTA must include a list of the bar codes of all animals in the shipment. If animals are going to slaughter, the slaughter plant must make sure that all of the numbers and animals are accounted for and that the information is record ed in a controlled database [11] . Pigs are sent b y lot to slaughter. Each farmer has a specific farm number which is applied by back tag when the animal is moved to slaughter. Piglets also receive e ar notches. If necessary , a lot of animals can be traced back to the piglet level through the GTA (the lots stay together throughout their lifetime). Some slaughterhouses will slaughter cull animals (i.e. , not shipped by lot); howe ver, these animals are slaughtered last each day and if any problems (such as signs of disease) are noted the plant will stop the line and disinfect the premises and staff clothing [11] . The official veterinary

service controls animal movement within the country . At the request of the potential purchaser, the official service of the destination State anal yz es the risk rating of the origin State [5] . The main factors considered in the risk rating are :  The time passed since the last outbreak  The presence or absence of viral activity  The extent of vaccine coverage  C ontrol and inspection of incoming animals and products  The disease status of adjacent areas  The infrastructure of the official services  The level of surveillance  The degree of community participation [19] If the risk rating is acceptable, and the destination and origination premises are suitable for quarantine purposes, the movement process begins [16]. Animals are isolated at the origin property for at least 30 day s, during which time they are serologicall y tested for FMD. Once moved, the animals are isolated at the destination property for another 14 day s and re
- tested. If a single animal tests positive for FMD, the entire group is denied entry (except for animals moving directl y to slaughter) and the official service conducts an epidemiological investigation [19] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 33

In 2005 , Santa Catarina ’s official veterinary service issued 272 ,000 movement permi ts , which includ ed the movement of 14 million FMD
- susceptible animals. Ninety
- tw o percent of the permits were issued for intrastate movement and the other 8 percent permitted movement to other S tates, especiall y neighboring ones. Ninety- six percent of the ani m als moved were s wine . Fifty- three percent of those were transported to slaughter. Cattle movement s accounted for 3.7 percent of all movements, and small ruminants accounted for less than 1 percent . In the period from January to October 2006, a total of 258 ,000 GTAs were issued allowing the movement of 11 million FMD
susceptibl e animals. Similar percentages were reported in 2005, with swine representing 94 percent of all animal s move d [4] . Table 3 shows the movement of FMD
- susceptible an d nonvaccinated animals into S anta C atarina from other Brazilian States recognized b y MAPA as FMD free or where vaccination is practiced. All movements are recorded by GTAs and the animals were inspected at the point of entry . The entry is regulated by

the Normative Instructio n SDA 0 5 /2003 [4] . In specific cases of swine, in 2005 and 2006, only animals for reproductive purposes from Certified Swine Breeding Farms ( Granjas de Reprodutores Suideos Certificadas

– GRSC) were allowed into Santa Catarina. These farms have a high level of bios ecurity , having been subject to certifi cation by the official veterinary

service every

six months. The farms keep their own permanent veterinary assistance and onl y swine from o ther GRSC s can enter the premises . In 2006, swine that entered S anta C atarina came from 36 GRSC s . Animals from Mato Grosso do Sul and Parana, where FMD outbreaks were reported , c ame from farms not located in the municipalities where the disease occurred. Santa Catarina is a large producer of swine. Of all the animals slaughtered in the State, only 2 percent came from other States [4] . Table 3 . Entry

of live animals for breeding in S anta C atarina in 2005 and 2006 [4] State of Origin 2005 2006

Pigs Sheep and

goats Pigs Farms of Origin Sheep and

g oats Rio Grande Do Sul 4,380 612 5,478 11 843 Paraná 15,920 111 17,45 9 11 0 Minas Gerais 14,450 0 10,747 6 0 Goiás 7,470 0 5,610 2 0 São Paulo 413 0 2,465 4 104 Mato Grosso do Sul 0 0 2,925 1 0 Mato Grosso 100 4 500 1 4 Total 42,733 727 45,184 36 951 *certified Swine Breeding Farms (GRSC), with biosafety level define d by Normative Instruction SDA 19APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 34

Santa Catarina is a large producer of swine. Of all the animals slaughtered in the State, only 2 percent came from other States. The movement of swine during 2007 in Santa Catarina according to purpose is described in T able 4 below. Table 4 . Swine mov ement into or within Santa Catarina (2007) [13] Origin Slaughter Fattening Reproduction Total GO 0 0 73 73 MG 226 300 7,158 7,684 MT 0 0 112 112 PR 0 0 1,271 1,271 RS 19,219 379 914 20,512 SC 1,200,018 1,308,696 27,149 2,535,863 The requirements for entry of animals, animal products and by products at risk for FMD into Santa Catarina are contained in Normative Instruction SDA 0 5 /2003. Any animals, animal products and by products, veterinary

products, material or substances that might transmit the FMD virus cannot enter the State . However, FMD - susceptible animals may enter Santa Catarina if the importer seeks p rior authorization from MAPA. Th is request for authorization must include specific information on the animals’ place of origin, route an d destination, sanitary tests, a place of destination for isolation, and a description of the animals . The authorization must include the date and identification of the issuer. All animals must undergo clinical inspection and quarantine at both their points of origin and their destination [4] . No bovines or other animals vaccinated against FMD are allowed to enter Santa Catarina. However, c ertain animals and animal products originating from FMD
- free zones in Brazil where vaccination is practiced may enter Santa Catarina with certain provisions. Sheep, goats , and pigs destined for immediate slaughter may ent er if they have not been vaccinated and were born in S tates MAPA considers to be FMD - free with vaccination . They must be transported in vehicles that have been sealed b y the official veterinary service of the S tate of origin. Sheep, goats , and pigs may also ent e r for stocking, fattening, breeding, or exhibition if they receive prior authorization from the official veterinary

services of Santa Catarina and if they are subjected to a 30 - day pretransport quarantine approved b y and under the supervision of the official veterinary services, have tested negative for FMD, and are transport ed in sealed vehicles [4] . M aturated boneless beef may ent er if it is obtained from bovines that have remained in the FMD
- free (with vaccination) S tate for the 2 ye ars immediately before sl aughter (or since birth in the case of animals less than 2 ye ars old), were slaughtered in slaughterhouses under F ederal inspection, did not show signs of FMD at the time of being transported , and displayed no FMD lesions on antemortem or postmortem inspec tion. Additional animal products are permitted from FMD
- free (with vaccination) States as long as they are processed in a manner that eliminate s FMD infectivity [4] . Certain products are also permitted from S tates located in a buffer zone or infected zone for FMD with medium or low
- risk FMD classification. These include maturated boneless beef as described above sent directly

to inspected establishments within Santa Catarina where it is processed for internal consumption , or fresh pork that has been treated to inactivate the FMD virus. OtherAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 35

products, such as offal for human consumption that has been heat
- treated to inactivate the FMD virus, raw hides and skins salted with sea salt containing 2 percent sodium carbonate, tanned hides and skins, hoofs, horns, hairs, and manes, processed animal feed, tallow, and beef and dairy products and by products that have been submitted to phy sical and chemical treatment capable of inactivating the FMD virus , are also permitted [4] . Swine from the non
- CSF - free area of Brazil may not ent er the CSF
- free zone (which includes Santa Catarina) with certain exceptions. P igs from non
- CSF free areas may enter for immediate slaughter only , with prior authorization by MAPA and provisions that the pigs have lived o n the farm of origin since birth or are quarantined at the farm of origin with negative serological tests for CSF [9] . International movement controls Internatio nal transport and trade controls are defined by Normative Instruction SDA 47 /2001 . SDA 47 bans the import of animals and products at risk of FMD from countries where the disease has occurred [4] . Information on the extent of control and biosecurity measures on imports from higher risk areas for CSF are included in Normative Instruction SDA 31/2002 and Normative Instruction SDA 54/2002 and are listed in Annex 1 . The movement of animals or other products capable of introducing CSF into the free zone of Brazil from the non
- free area is regulated by Normative Instruction SDA 01 /2001 [3] . The list of countries from which FMD
- susceptible animals and their products and by products may enter is based on O IE recognition a s updated b y DSA (the animal health directors) . Unauthorized countries may

import some products if the produc er s meet specific requirements that en sure sanitary safety. These requirements are similar to those outlined above for products entering Santa Catarina from other Brazilian States [4] . Swine destined for import must originate from a country or region considered free from ASF, SVD, CSF , and other diseases, according to the standards set by the OIE as recognized by MAPA . In addition, the animals must be quarantined at the point of origin and tested (with negative results) for brucellosis, TB , CSF, Aujesky ’s disease, porcine reproductive and respiratory s yndrome ( PRRS ) , transmissible gastroenteritis, enterovirus encephalomyelitis , and leptospirosis . The condition of the country , zone , or establishment as free from a given disease waives the need to test for the disease during quarantine at the point of origin. In addition, a second 14 - day quarantine must be conducted upon entry into Brazil under the supervision of the official v eterinary s ervice. Animals are quarantined in establishments approved b y MAPA and which emplo y a veterinarian to serve as the Technical Offic ial in Charge [3] . Individual identification is required for imported dairy and breeding animals. For slaughter animals, only information on the number, sex, and age of the animals is required , and they must be transport ed in a sealed vehicle. These animals mu st go to a f ederally inspected (SIF) plant and can only be used for the internal market because they have not been in the country for more than 90 day s. If an animal arrives at the border with clinical sy mptoms of disease , it is sent back to the place of origin; however, animals that show signs of FMD are quarantined and sampled [6] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 36

Animal products that enter Brazil must h ave a MAPA import permit , c o mpl y with all sanitary health requirements , o rigin ate from an establishment approved to export to Brazil , and d eclare the port of entry and final destination. Animals must be accompanied by a Zoosanitary

Certificate as required in Normative Instruction SDA 31 /2002 [3] . According to Brazilian officials, 100 percent of animal products entering the country receive a primary and a secondary inspection . An inspection for animal health purposes is conducted, which includes a check for compliance with labeling and packaging requirements. For the secondary inspection, the product is sent to a storage facility registered with MAPA for public health sampling. If a shipment is rejected, Brazil law authorizes a number of actions. The product may be returned to its place of origin, may

be confiscated and incinerated, or may be retained for possible resolution. There was no international importation into Santa C atarina of live animals susceptible to FMD, semen , or embryos from January 2005 to October 2006. All registered imports of products and by products are listed t able 5 [4] . Table 5 . Imports of animals and products from FMD
- susceptible animals into Santa Catarina in 2005 and 2006 (partial data, until October 2006).

Product Country of Origin Quantity (kg) 2006 2005 Fresh or chilled boneless maturated beef Argentina 163,841 192,000 Uruguay 203,200 109,615 Frozen maturated boneless beef Argentina 43,716 104,861 Uruguay 20,200 23,200 Fresh or chilled bone
- in beef cuts Uruguay 1,300 1,000 Frozen bone
- in beef cuts Uruguay 500 0 Frozen boneless lamb Uruguay 29,980 18,500 Frozen bone
- in lamb cuts Uruguay 558,946 318,500 Frozen pork South Africa 51,000 0 Frozen pork edible offals Spain 91,200 412,089 United States 0 101,870 France 0 24,747 Beef casings Australia 72,955 11,520 Pig casings Germany 116,600 0 D enmark 22,400 0 Spain 242,960 241,800 United States 290,899 500,545 Poland 271,850 147,000 Whole cattle hides Paraguay 0 24,130 Pre - tanned cattle hides Uruguay 2,860 0 Whole cattle hides/skins It aly 61 0 Raw sheepskin with wool Argentina 11,853 0 United States 0 19,278 Raw goatskin United States 0 154 Tanned pigskins China 352 0 Source: Foreign Trade Information Analysis System/ Foreign Trade Secretariat (SECEX) / Ministry of Development, Industry and foreign Trade (MDIC).APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 37

Brazilian law proh ibits all transport of animal and plant products from anywhere in the world without proper permits. Airline p assengers are checked for animal and plant products. The ty pe of inspection depends on the origin of the flight. Shipments arriving by sea are also checked for animals and animal products, while ship passengers receive random checks for the presence of animals and animal products. Prohibited items are confiscated, stored, and transported b y the contract company to the incinerator under MAPA super vision. Customs officials X - ray a percentage of arriving luggage and confiscate prohibited products. They increase the percent age of luggage undergoing X - ray for flights arriving from high
- risk areas such as Spain and Portugal, which have small artisan f

arms with no government oversight, or countries with outbreaks. In addition, passengers from high
- risk countries must walk across a disinfectant mat. One hundred percent of luggage from countries having an FMD outbreak goes through X - ray inspection. Ins pection s tations MAPA control s products imported from other countries at the authorized entry points. Prior to importation, the importer must procure authorization from MAPA . MAPA evaluates the s anitary conditions of the exporting country as well as the exporting facility . If MAPA authorizes the importation, the entry

point into Brazil will be specified on the authorization and MAPA’s International Agriculture and Livestock Surveillance Service at the point of entry will receive a copy of the authorization with all the specific sanitary requirements listed. The products must receive inspection and authorization from the official veterinarian at the point of entry to be released into Santa Catarina [4] . Permanent inspection stations are located at strategic points along the border of Santa Catarina. There are 67 permanent inspection stations for import of plants, animals and products into Santa Catarina (see Figure 8 ). These stations are staffed by 429 professionals from the official veterinary services, who work in shifts to provide 24
- hour coverage. Operations at each post are coordinated by an official veterinarian and include police support. The inspection posts have communication s equipment, computers, vehicles, equipment for cleaning and disinfection, and an area for disinfecting and disposing of confiscated material [4] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 38

Figure 8 : Location of p erman ent i nspection s tations

(Source Presentation : CIDASC) Some of the permanent inspection stations are designated as control points for moving animals and products through the S tate. There are 12 of these “sanitary corridors” in Santa Catarina. At thes e posts, vehicles are sealed at the entry point and the person in charge of the transportation signs a liability commitment which identifies the entire route through the State, including the exit inspection station. The exit station, which is in charge of verifying the integrity of the seal and information on the exiting cargo, is notified of the shipment by the official in charge of the entry station. In case of conflicts or the failure of the transiting cargo to arriv e at the destination, the State’s he alth authorities are immediatel y notified, initiating the search and apprehension process with involvement of the official veterinary services at both the origin and destination points of the shipment as well as police [4] . In addition to the permanent inspection stations, there are also a number of mobile inspection stations. These are organized by the LVUs and set up at strategic points without advance notice. They are staffed by

offic ial veterinarians and paraveterinarians and include police support [4] . During the 2008 site visit , the site visit team visited two land interstate border inspection posts with each of th e Brazilian States bordering Santa Catarina (Paraná and Rio Grande do Sul) and the MAPA office at the International Airport Hercilio Luz at Florianopolis. Officials at the sanitaryAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 39

corridor inspection posts that were visited demonstrated working knowledge of requirements for animals and products to enter or transit Santa Catarina. They described the day
- to - day procedures and provided copies of MAPA and CIDASC procedural manuals, personnel logs, and records of activities. They

also outlined the actions th at would be taken if a transiting vehicle did not arrive at the exit point within the appropriate time [11] . The site visit team examined paperwork of exiting vehicles and reviewed seal verification and removal . The p aperwork included the authorization for movement (issued by MAPA), the GTA (provided b y the LVU), and farm certific ation documents (issued by the local MAPA office in the State). The site visit team observed that cargo trucks were properly checked and disinfected. The team also observed that passenger cars are not routinely stopped at border points , but only vehicles that could carry

animals or large amounts of animal product s . These vehicles were stopped and the driver s w ere asked to open all cargo compartments. However, officials reported that during outbreaks in neighboring areas (and a corresponding elevation in the risk status of the affected area), security measures are tightened . Inspectors inspect more passenger vehicles and confiscate more materials , including items for personal use such as sandwiches . In addition, staff clean and disinfect all vehicles, n ot just livestock trucks [11] . Officials at the inspection station reported that any trucks with animals destined to stay in Santa Catarina (as opposed to transiting the State) would be followed to the destination farm b y C IDASC officials who would break the seal on the farm and oversee the required 14 - day quarantine period, after which the animals may be allowed to move. The wheels and undercarriage of all trucks carryi ng animals into Santa Catarina for any reason are disinfected on entry . The disinfection equipment and procedures were demonstrated during the visit [11] . I f confiscated materials exceed the local inspection post ’s ability to properly disin fect and dispose of them on site, the entire shipment will be directed to a local renderer for autoclave sterilization. The official veterinarian on site will issue a seizure document and contact the highway police to escort the truck to the plant. The p lant will issue a document of inactivation, which is returned to the inspection post. The shipper will also be fined. The border post with Rio Grande do Sul had not had t o do this and had no records to show the site visit team. Small er amounts of confis cated material are usuall y inactivated on site with iodine and buried. This process was demonstrated to the site visit team [11] . Actions taken in the case of illegal entry All animals susceptible to FMD, animal products and by products, veterinary

products and materials or substances that can carry the FMD virus coming into Santa Catarina that are not in compliance with current legislation are slaughtered or destro yed at the discretion of the official veterinary service and in accordance with the risk represented by the animal or product (Normative Instruction SDA 0 5 /2003). The results of inspection activities carried out in 2005 and the first half of 2006 are shown in Table 6 .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 40

Table 6 . Results of inspections carried out b y C IDASC, Santa Catarina, in 2005 and 2006 (first half). Non compliance encountered 2005 2006 Fine for tran sporting animals without a GTA 61 33 Fine for transporting products without documentation (meat, dairy , hides , lard) 41 27 Slaughtered bovines 127 132 Slaughtered sheep and goats 192 863 Meat products destro ye d (tons) 20.3 133 Dairy products destroyed (tons) 5 24 Ref [4] Waste destruction Waste of food transported or consumed in air, sea, river , or land travel into Santa Catarina is destroyed under MAPA’s official supervision, b y in cineration at ports and airports (Normative Instruction SDA 05 / 17/200 3) [4] . Conclusions : APHI S concludes that CIADSC has adequate controls at ports of entry for legal importation of spe cies and products that could carry the diseases under evaluation. Santa Catarina also has the legal framework and authority

to deal with the entry

of illegal animal or animal products into the S tate. 8. Livestock demographics and marketing practices in the region Market practices and movements within the S tate could lead to exposure to or spread of diseases. In this section we explain the livestock demographic practices and the type of production systems in different areas of Santa Catarina. General i nformation The livestock population of Santa Catarina is shown in Table 7 . There are currentl y 178,945 rural holdings in the State that are registered in CIDASC and contain one or more species susceptible to FMD. Included among these are over 75,000 holding s that contain domestic pigs or wild boar, both of which are susceptible to FMD, CSF, ASF, and SVD. Eighty percent o f the total number of registered holdings have been georeferenced b y C ID ASC [4] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 41

Table 7. Li vestock farms in Santa Catarina with FMD
- susceptible animals, 2006 [4]
Data Quantity Holdings with FMD
- susceptible animals 178,945 Holdings with bovines 164, 33 Bovine population 2,748,8 Bovines per holding 17 Holdings with buffalo 534 Buffalo population 37,685 Buffalo per holding 71 Holdings with pigs 74,490 Swine population 5,248,9 Swine per holding 70 Holdings with wild boars 794 Wild boar population 16,467 Wild boars per holding 20 Holdings with goats 3,021 Goat population 36,705 Goats per holding 12 Holdings with sheep 7,820 Sheep population 195,78 Sheep per holding 25 The density

distributions of holdings containing various ty pes of livestock within Santa Catarina, broken out b y species , is provided in Figure 9 . The total population of susceptible species within Santa Catarina is 5,250,000 domestic swine; 2,750,000 cattle; 196,000 sheep, 37,000 goats, and 16,000 far med wild boar [4] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 42

Figure 9 : Density distribution of human, swine, cattle, sheep and goat populations in Santa Catarina [4]

Santa Catarina is primarily known for its swine production. The swine population of Santa Catarina is approximately

twice th e size of its cattle population. While the State provides almost 30 percent of Brazil’s por

k industry , it contains less than 3 percent of the country ’s cattle industry . Although the zebu cattle breeds predominate in most of Brazil, European breeds are more common in Santa Catarina [10] . Most of Santa Catarina’s cattle are dairy cattle. The State contains 97 f ederally i nspected and 60 State i nspected dairy facilities. The State produces approximately 1.5 billion liters of pasteurized milk annual ly [4] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 43

Figure 1 0 : Bovine density and distribution [9]

Brazil has the largest swine herd in Latin America, with the majority of the production concentrated in the southern and southeastern regions of the country, primarily Santa Catarina ( F igure 1 1 ). Figure 1 1 . D istribution of swine population [9]APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 44

The majority

of Santa Catarina’s swine industry consists of a verticall y integrated production system from breeding stock to processing (85 percent of the State’s producers operate under such a sy stem according to off

icials interviewed during the 2008 site visit). In this sy stem, a c ertified b reeding f arm, or GRSC , produces breeding animals and distributes them to piglet production units (UPL s). The GRSCs are highly

controlled facilities that produce all of the breeding/grandparent stock for all aspects of production within the cooperative [11, 13] . There are no animals introduced to the GRSCs ; they use thei r own genetics. Biosecurity requirements for GRSCs, as provided in Normative Instruction No. SDA 19 /2002 , include requirements for peripheral fencing , a single entry point for people and vehicles with an appropriate disinfection sy stem, a loading and unlo ading station next to the fence, and disinfection for materials and equipment. In addition, a locker room and shower facility with impermeable floors must be available for visitors to shower in . Visitors must shower twice before entering the facility , on ce at a nearb y hotel and then again within the facility . Visitors must also shower before leaving the facility . Visitors must complete a form describing the date and place of visits to facilities containing pigs (no one can visit such a facility more than once within 24 hours). Clean w ater must be available . Finally , the facility

must be licensed b y the environmental department for treating and disposing of waste . A sy stem must be in place for proper disposal of dead animals. GRSCs must conduct routin e testing for CSF, Aujesky ’s disease, brucellosis, TB , scabies, and leptospirosis every

six months. Additionally , GRSCs will lose their certification if a slaughter plant or feed mill locates too close or i s classified as an at - risk facility for any reaso n . There are 306 GRSCs in Brazil within the CSF
- free zone . The majority o f them (136) are located within Santa Catarina [11] . The cooperative production sy stem is governed by contract, with the parent company guaranteeing the supply

of piglets, feed, and veterinary assistance [13] . The cooperative agencies involved in the production sy stems reviewed during the site visit included many aspects of agriculture, including crop production and the rearing of different livestock species. The parent company has minimum biosecurity

standards, which they

help the small producer to meet and maintain. Additional requirements for participation in the cooperative include m inimum traceability requirements, required reporting of disease or production problems to the company veterinary

representative (plus concurrent notification of CIDASC in the event of a vesicular or hemo rrhagic disease), and the producer’s periodic training in disease and production measures. Cooperative company veterinarians are trained by official veterinarians from CIDASC. During the 2008 site visit, the team visited several individual facilities operating within an integrated sy stem, including farrowing farms, finishing operations, and UPL s. Some of the facilities were involved in all phases of production and some included other species, primarily dairy cattle. All of the farms visited followed (or were implementing ) basic biosecurity measures required by

the cooperative, such as perimeter fencing, footbaths or lime, and vehicle wash s tations at the entry . In addition, representatives of the cooperative provided protective clothing and footwear. T he UPLs and the GRSC facilities maintained more intense biosecurity measures, including showering and additional clothing requirements [11] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 45

The cooperative farm producers kept records of births and mortalities as well as all veterinary visits and all treatments provided. They were willing to contact their company veterinarian with any animal health questions or disease suspicions. The company veterinarians, in turn, expressed close relationships with the LVU veterinarians and would help them should they encounter an issue of concern [11] . During the site visit , official veterinarians and producers reported that producers often relied on official veterinarians rather than private veterinarians to provide diagnostic services because the S tate veterinary

service was free. In addition, since most of the swine farms are integrated, they receive frequent official visits , and when needed, will call the company v eterinarians or paraveterinarians emplo yed by the corporation. During farm visit inspections the official veterinarian or paraveterinarian educat es the producer and staff as necessary regarding the signs of disease and reporting requirements , and check s animal health, records (including copies of GTAs) , and current inventory [11] . The farming of wild boar in Santa Catarina is control led by the Brazilian Institute of Environment and Renewable Natural Resources, which operates under the Ministry of the Environment. The total population of wild boar numbers approximately 16,500 animals, most of which reside in the middle western part of the State [13] . The 2008 site visit team visited a wild boar facility . This facility handled all aspects of pig production. The producer delivered pigs to a local slaughter plant when enough animals became available to warrant the movement. The facility had a perimeter fence of cement block topped with chain link and similar fencing among the houses. The farrowing facilities consisted of open pens with solid block walls separating them and a nursery area for the newborn piglets . Pig rearing areas consisted of solid block foundation with metal bars. Lime was used at the entrances to the pig houses to prevent entry of contaminants [11] . The Brazilian sheep flock consists of approximately 14.8 million animals and is concentrated in the southern region of the country , especiall y in Rio Grande do Sul . The goat population consists of approximately

12.1 million animals and is concentrated in the northeastern region of Brazil. Most small ruminant s are produced for the internal market [5, 10] . Animal identification Brazil is implementing the SI SB OV national identification sy stem for cattle and buffalo. SI SBOV’s goal is to individually

identify and monitor all cattle and buffaloes born or imported into Brazil. The sy stem is designed to trace animals from birth to death. A unique 17
- digit identification code is given to each animal and is registered in a national database managed by MAPA. Additionally , the sy stem includes information on the owner’s registration, date and place of the animal ’s birth, breed characteristics, feeding practices, vaccination data, movement records, death information, and other animal health indicators [6, 12] . MAPA accredits private companies to assign the codes and collect the relevant information. There are eight accredi ted companies . The companies select the type of identification used and certify the status of each animal enrolled. MAPA audits the companies regularl y. A visit by a veterinarian isAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 46

required to register the animals [7, 11]. Participation in the program is voluntary , but Brazilian officials intend to make it mandatory at the national level. At the present time, all farms and animals that export to the European Union (EU) must participate [6, 12] . Id entified animals that move to slaughter are issued a SI SB OV card. The slaughter facility check s the documentation and terminat es the registration of slaughtered animals in the national database. I f the slaughter facility is not f ederal ly inspect ed , the accredited company terminat es the registration of slaughtered animals [12] . Santa Catarina producers use SI SB OV tags (provided by MAPA) for identification . The tags are not registered with the SISBOV sy stem unless the animals are exported. Individual farmers are required to apply tags and maintain an inventory . The LVU distributes the tags along with a listing of tags by number. MAPA is working with the swine industry to define ear tag use in pigs to be export ed to the European Union. Farmers must place the ear tags on the animals, maintain tag inventories , and report all movements, including births, to the LVU within 30 day s. The farmer must also report the loss of a tag, as well as the death or slaughter of an animal (along with its tag number) to the LVU . Santa Catarina ’s animal identification sy stem was fully implemented at the end of 2008 [11] . Slaughter inspection There are 58 slaughterhouses for swine i n Santa Catarina . These include 18 f ederally inspected slaughterhouses (SIF) and 40 using the S tate inspection service (SIE). For cattle, the State has four SIF slaughter

houses and 34 SIE facilities , and for small ruminants, a total of 10 SIE slaughterhouses. The health inspection of these establishments is carried out b y 126 official veterinarians, with 79 official paraveterinarians and 459 hired emplo ye es [4] . (See F igure 1 2 for the location of slaughter plants within Santa Catarina.) Figure 1 2 : Distribution of SIE and SIF slaughterhouses for swine and beef [4]APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 47

Animal gathering point

s In Santa Catarina , CIDASC inspects most fairs, exhibitions, and e vents where animals are gathered. In 2005 and 2006 there were 162 such events, involving 83,449 bovines and 2,949 small ruminants (Table 8 ). All animals are inspected and have their health documents checked on arrival by a representative of the official veterinary service. The representative is present during the entire event [4] . Table 8 . Animal gathering events involving FMD
- susceptible animals inspected by CIDASC in S anta C atarina , 2005 and 2006 [4] . Animal gathering events (auctions, fairs, etc.) involving FMD
susceptible animals Year 2005 2006 Total events inspected b y CIDASC 61 101 Total cattle at the events 46,277 37,222 Total sheep and goats at the events 1,790 1,159 Conclusions: The livestock industry

in Santa Catarina appears to be well organized and knowledgeable of necessary biosecurity

precautions. APHI S finds that different controls and biosecurity measures at commercial swine farms effective ly mitigat e introduction and spread of the diseases under evaluation. The slaughter inspection sy stem is robust. Animal identification sy stems are comprehensive and allow officials to trace the movement of cattle and swine within Santa Catarina. Further, APHI S concludes that S anta C atarina has adequate control of inspection activities within integrated production sy stems, animal concentration points , and slaughter plants. 9. D isease surveillance in the region Documenting surveillance sy stems that ensure early detection of the diseases under consideration is essential for the risk assessment. This section explains the characteristics of the FMD, CSF, SVD, and ASF surveillance program s in S anta C atarina . FMD Brazil employ s both passive and active surveillance strategies designed to demonstrate freedom from FMD . The strategies’ emphases differ depending on the phase of the eradication process within a given State or zone . During the first phase , the zone demonstrat e s its freedom from disease . The second phase consists of monitoring of the zone. The second phase begins once the zone is free from infection and is recognized as free of FMD by the OIE, either with or without vaccination (Santa Catarina is recognized as free without vaccination). The primary goal of the first phase is to document freedom from disease while the second phase prevent s the reintroduction of the disease, maintain s good sanitary

conditions, and provide s technical grounds to demonstrate the continual absence of disease and viral activity in the zone.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 48

The first phase relies on a ctive surveillance while the second phase uses both active and (mainl y) passive surveillance. Active surveillance complements passive surveillance primaril y b y targeting specific “high
- risk” areas within the zone for serological sampling and more in
- depth inves tigations. Santa Catarina is currently in the second phase; therefore, the emphasis is on passive surveillance for FMD. The survey s and monitoring carried out in Brazil follow the guidelines for FMD surveillance contained in Annex 3.8.7 of the Terrestrial Code of the OIE. Brazil uses the I
- ELISA 3ABC ( enzy me - linked immunosorbent assay test for detecting FMDV nonstructural proteins 3ABC ) and the EI TB ( enzy

me - linked immunoelectrotransfer blot ) system developed by PANAFTOSA as the diagnostic method to test for antibodies against non
- structural proteins of the FMD virus . The two tests are conducted consecutively . The I - ELISA 3 ABC screen s for the disease and the EI TB is used for confirmation. As a complementary test in animals testing positive for non
- stru ctural proteins, the ELISA CFL (ELISA liquid phase competition) is used to determine antibody titer s for the three viral strains prevalent in South America and used in the vaccine . S amples of esophageal
- phary ngeal liquid are collected for viral testing [4] . All animals sampled, whether through passive or active surveillance, are individual ly identifi e d and examined by

an official veterinarian. The holding cannot sell sampled animals d uri ng the testing period [4] . Active surveillance Active surveillance for FMD in Brazil consists mainly of targeted serologic survey s conducted primarily in specific “high
- risk” farms withi n the zone under evaluation. Serological testing is also conducted whenever there is a suspicion of disease. High
- risk farms are defined as those that:  H ave a high volume of movement of animals or their products  Are located close to animal or waste
- gath ering facilities, such as o Sla ughterhouses o L ivestock event centers o F eed mills o H ighway s o L andfills o International borders o B orders with States where the disease is present  Engage in a high level of breeding activities  C ontain over 100 cattle or multiple species The first survey

to assess the circulation of the FMDV in Santa Catarina was carried out in 1997 with Rio Grande do Sul to meet the OI E’s requirements for establish ing an FMD - free zone where vaccination is practiced. Another survey was carried out in Santa Catarina in 2002, after an outbreak of the disease in Rio Grande do Sul, and serologic monitoring was performed in 2003 and 2004. In 2006 , a new serological survey was carried out to evaluate viral circulation, so that Santa Catarina could be declared FMD - free without vaccination . S amples were collected during November and December [4] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 49

Three geographical sampling strata were established for the survey . An independent survey was car ried out within each stratum using a two - stage cluster sampling design with the following statistical parameters: 95 percent confidence level; 95 percent sensitivity of the diagnostic s ys tem; 100 percent specificity; expected prevalence among herds of at l east 2 percent ; and expected prevalence within herds of at least 5 percent . About 468 primary sampling units consisting of 1,347 holdings were established throughout the State. A total of 11,059 samples were collected, out of which 48 were determined to be reactors to I - ELISA 3ABC/EITB testing [4] . Figure 1 3 depicts the three sampling strata and the location of primary sampling units, including those where a positive reactor was found in Santa Catarina during the 2006 study . Figure 1 3 : Sampling strata and location of sampling units, Santa Catarina , 2006 [4]

In locations where at least one animal reacted to the serol ogic sampling , a complementary investigation was carried out which included detailed clinical inspection of all sampled and susceptible animals on the farm. None of the animals showed any evidence of vesicular disease. The high susceptibility

of the cattle herd in Santa Catarina coupled with the low number of reactiv e animals , and the absence of clustering as supported in complementary investigations and analy ses, led Brazilian authorities to conclu de that the FMD virus was not circulating in the populati on at the time of the survey [4] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 50

Passive surveillance Passive surveillance is the primary form of evaluation conducted during the second phase of FMD eradication, and involves monitori ng for disease. Many individuals carry

out this phase of surveillance using many different types of activities, including:  Animal movement control activities  F arm inspections  S laughterhouse inspection  Inspections during livestock fairs [6] High
- risk farms receive more visits during passive surveillance. Because passive surveillance relies heavily on community

participation and similar inputs through the LVU, officials try to keep the level of community

participation high and the participants informed of b oth the suspicious signs of disease and its reporting requirements. For example, in 2002, the official service held 9,702 seminars, reaching 213,131 people, with an average of 23 participants per event [7] . Any suspicion of vesicular disease must be immediately reported to the official veterinary services (or in the case of animal owners or handlers , to their private veterinarian , who must then report a continued suspicion to the official service). Animal owners or those responsible for the animals who fail to report suspicious cases of officially notifiable disea ses, such as FMD or SVD, are subject to S tate civil penalties and may also be charged under the Brazilian Penal Code. Veterinarians may also face disciplinary

sanctions by

the Veterinary

Medicine Regional Councils [4] . There are several participants in the vesicular disease surveillance s ys tem in Brazil :  C attle raisers, owners of susceptible animals, and rural workers who handle the animals  O fficial emplo ye es, as part of their duties whil e visiting farms or animal gatherings ( such as shows, auctions, and exhibitions)  C ontracted, approved or official vaccinators  T echnicians  Representatives of rural communities, especially those who work in cattle holdings and receive training from the offic ial veterinary service  S laughterhouse emplo ye es  O fficial emplo ye es who check the movement of animals and their products and by products in permanent inspection stations and on mobile inspection teams  V eterinarians, p araveterinarians and other private sector professionals who work with animal health [4] Records of notifications submitted to the official veterinary service are kept at LVUs and include information about the time of notificatio n, the location of the holding or premises wher e the animals are kept , the species involved, the ty pe of notification (by

owner, veterinarian, or third party), how the notification was made (personally , by phone, or otherwise ), and an initial description o f the event. A fter receiving the notification, o fficial service veterinarians must respond to the suspicion as soon as possible. This response is usually immediate, especially

if the report is made during business hours, but must be made within 12 hours regardless of weekends or holiday s. A vesicular disease suspicion kit is available in all LVU s and includes the necessary equipment to hold the animal, collect samples, take appropriate biosafety measures, and record the collected information. A standard national notification form is used. The kit also includes a manual detailing the steps toAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 51

follow on notification of vesicular disease suspicions, including the appropriate information flow and the technical procedures to be followed. All official veterinarians are trained in carrying out this initial response [4] . After completing the initial records and before leaving the field, the official service veterinarian on site will inform his or her work team, immediate superior , and the regional representative of the emergency

diseases group about the suspicion. Until the investigation has been completed, animals cannot be moved from the holding, from any adjacent holdings , or other holdings that have trad ed animals, products, or equipment with the affected holding [4] . Once the disease suspicion has been ruled out, the official services veterinarian records the final diagno sis, lifts the animal movement restrictions on the affected and related holdings, and communicates the results to his or her immediate superior , work team, and the regional representative of the special group for emergency diseases. Most investigations co ncern false reports, traumatic injuries, intoxication and malnutrition rather than actual OI E reportable disease [4] . If the official veterinarian determines that a disease suspicion is v alid and needs to collect specimens for lab oratory anal ys is, the involved holdings will remain under quarantine until testing is completed and negative results returned . P ositive results would exten d the quarantine until disease control measures are compl eted . The veterinarian immediately sends the laboratory

materials, along with the appropriate submission forms, to a MAPA laboratory . The official veterinary service sends additional teams to provide extra surveillance around the primary holding and inve stigat e the movement of susceptible animals in and out of the affected holding within the 60 day s prior to the most probabl e first occurrence of the disease [4] . If the investigation conf

irms FMD, an animal sanitary emergency

state is established during the completion of the investigation and eradication efforts. I f tests do not detect FMD, differential diagnostic tests are carried out for vesicular stomatitis, bovine viral diarrhea, infe ctio u s bovine rhinotracheitis, and bluetongue. Specific procedures exist for each of these diseases and would be carried out if any of the diseases were detected [4] . Santa Catarina repo rted 83 notifications of reportable disease suspicions in holdings with FMD
susceptible animals in 2005 . These notifications were investigated . Thirty involved a report of possible vesicular disease. Of the vesicular notifications, none were confirmed t o be FMD. Instead, 13 were determined to involve trauma and 17 involved a variety of toxic plant exposures. In 2006 there were 201 notifications of suspicious reportable diseases in holdings containing FMD
susceptible animals. Eighty
- one of these were related to possible vesicular disease with 41 eventuall y determined to involve trauma and the remaining 40 to involve toxicosis [4] . O fficial veterinary

services staff also conduct inspections during their regular duties. These duties include control of animal movement at permanent inspection stations or by mobile inspection teams; antemortem and postmortem activities at slaughterhouses; supervision of livestock congregations; and direct i nspection at rural holdings [4] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 52

In addition to responding to reportable disease suspicions, official veterinary services staff also conduct inspections during routine surveillance activi ties (while updating inventory numbers provided b y the farmer to the local veterinary unit) and certification of holdings as part of specific sanitary programs. N one of these visits detect ed any clinical signs compatible with vesicular or notifiable disea se [4] . Information on the number of rural holdings inspected by the official veterinary

service in 2005 and 2006 is provided in Table 9 . Table 9 . In spections carried out on rural holdings with FMD
- susceptible animals, S anta C atarina , 2005 and 2006 [4] Year Inspected

Holdings Existing susceptible animals

Swine Bovine Sheep Goats 2005 11,445 1,539,937 160,907 23,002 122 2006 13,489 1,626,798 145,991 22,104 142 Total 25,034 3,166,735 306,898 45,106 264 T o ensure that members of the public that have contact with animals know the signs of the diseases under evaluation as well as their obligation to report any suspici on of such diseases , the official veterinary

service held 323 lectures and technical meetings, reaching 42,223 people in 2005, and 325 lectures, involving 44,258 community participants , in 2006. In addition, the official veterinary service is implementing several educational projects, including plans to create and maintain community

support resources b y fostering municipal commissions of animal health , train ing and maintain ing health technicians, and creating a health education plan in schools [4] . Santa Catarina operates a 24
- hour hotline for reporting suspicions of notifiable animal diseases (particularl y for the notification of suspect FMD cases). This service began in May 2001, and from that time until November 2006 community members made 116 reports. All reported incidents have been recorded, including the date and time of the report, history of the report , and actions taken regarding the event [4] . CSF Brazil carries out p assive surveillance for CSF, particularl y at the border between the CSF
- free zone and the infected region ( s ee Figure 6 ) . The border of the CSF
- free zone corresponds to that of the FMD - free zo ne; therefore, sanitary defense staff and programs can control of the entry of susceptible animals and products for both diseases [3] . MAPA coordinated serologic survey s in 2000 and 2003 to delineate and maintain the free zone . The survey s were conducted in acc ordance with the OIE’s statistical parameters. These include a confidence level of 95 percent , specificity of 100 percent , and sensitivity of 95 percent at a prevalence of 1 percent among farms. The target population included the entire hog and wild boar population within the free area, except for those in GRSC farms, which are officiall y and individually

certified as free from diseases. The number of samples collected in each investigation was approximately

28,000 (Table 10 ) [3] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 53

Table 10 . Samples c ollec ted in 200 0 and 2003 for CSF 2000 2003 Ty pe of farm Technologicall y

advanced farms * Other

farms Wild

boar f arm s Technologicall y advanced farms Other

farms Wild boar

f arm s Number of farms sampled 1 , 241 640 182 1,243 1,600 150 Number of farms w ith reac tors 53 28 2 9 13 3 Percentage 4 . 27 4 . 37 1.1 0.72 0.81 2.0 Number of Samples 24,100 3,190 909 19,246 6,514 1,781 Number of reactors 216 59 2 16 15 4 Percentage 0.9 1.85 0.22 0.08 0.23 0.22 * Includes large integrated farms with the exception of GRSC s . Source : Correspondence with MAPA officials, January 16, 2009 Diagnostic tests are conducted at o fficial p ublic s ervice laboratories. Screening tests are performed using an ELISA for the detection of antibodies to the CSF virus (IDEXX). Any reactive or suspicious samples are submitted for differential diagnosis using virus
- neutralization tests in cell cultures for bovine viral diarrhea and CSF. Additionally , if the screening test returns a suspicious result , a confirmatory

test will be performed. The farm that provided the sample will undergo serologic evaluation of additional susceptible animals . The laboratory will also attempt to isolate the virus [3] . Pursuant to Decree N o. 24.548, and as with FMD and other vesicular diseases, every citizen must report the suspicion of CSF to the nearest LVU. If the owner of the animals fails to report the suspicion of disease, he or she will lose a claim to indemnity i f the herd must be destro yed to control the disease. V eterinarians and other field professionals may be subject to legal action before their respective trade guilds [3] . I f a sanitary

emergency

or document ed disease event occurs, blood samples are collected from all animals on the farm, both sick and health y exposed animals, to allow for a comparison of antibody titers. Samples are frozen and sent to the Laboratório Nacional Agropecuário in Recife, in Pernambuco, outside the CSF
- free zone. Sick animals are killed and tonsils, spleen, ly mph nodes, kidney s , and the distal portion of the ileum are collected and s ubmitted for virus isolation [3] . As with FMD, all suspicious cases of CSF or other diseases with similar clinical signs must be investigated b y the official veterinarian. The investigation must be initiated within 12 hours of the report and must be conducted u sing appropriate biosecurity. If the responding official cannotAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 54

dismiss the suspicion of disease on clinical examination of the animals on the farm, he or she must collect the appropriate samples , issue a quarantine , and immediately communicate the event to the higher sanitary

authority [3] . The official veterinarian must also fill out the Initial Disease Investigation Form, collect information on the premises under suspicion, prohibit the movement of hogs, their products and by products from the property , clean and disinfect the equipment and materials used in exam inations and specimen collection, incinerat e expendable work clothes, and keep outsiders out of the facilities [3] . Santa Catarina reported three CSF notifications in 2007 , as shown in the table below. Follo wup tests were negative for CSF and the implicated farms received post - investigation evaluations by the official veterinary

service [13] . Table 11 . Number of notifications of susp ected CSF in Santa Catarina, 2004
- March 2008 [13] 2004 2005 2006 2007 2008 (to March) 0 0 0 3 0 SVD Brazil does not routine ly test for SVD since the disease is exotic to Brazil . H owever, the country carries out passive surveillance in a manner similar to that conducted for other vesicular diseases , as detailed above . If FMD is ruled out as a diagnosis in clinically affected pigs, e valuation for SVD is included as part of the followup testing. In suspicious cases , movement of animals from the involved farms and the region is restricted until a definitive diagnosis is reached [13] . ASF For ASF, which is also an exotic disease, no specific surveillance is conduc ted . Instead, if CSF is ruled out in the susceptible population, ASF is considered as a possibility and investigated as such. As with SVD and other notifiable diseases, any implicated farms as well as those associated with them undergo movement restricti ons until the investigation is completed and a final diagnosis achieved [13] . Conclusions : APHI S concludes that the serologic sampling conducted in Santa Catarina for FMD and CSF is valid and the sampling coverage is adequate. As with FMD, all suspicious cases of CSF or other diseas es with similar clinical signs must be investigated b y the official veterinarian. SVD surveillance is addressed within the passive surveillance s ys tem for other vesicular diseases . ASF surveillance is combined with CSF surveillance. Furthermore, gi ven the historical absence of the diseases under evaluation in the region, quick detection of clinical signs should disease be introduced in the absence of vaccination would provide further evidence of freedom of the diseases under evaluation in Santa Catarina .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 55

10. Diagnostic laboratory capacity The laboratory

s ys tem, including test procedures for the diseases under evaluation, quality assurance measures, and official oversight procedures, must be clearly documented to provide confidence in disease surveill ance activities and the ability to quickly

detect and confirm a disease outbreak. This section explains the laboratory capabilities of Santa Catarina for diagnosi ng and detectin g FMD , CSF, SVD, and ASF . General information Brazil’s Ministry

of Agriculture has three laboratories that perform diagnostic tests for FMD . These laboratories are located in Pedro Leopoldo , Pará, and Recife. The PANAFTOSA laboratory in Rio de Janeiro is the reference laboratory . The laboratory in Recife performs CSF serological testing , and SVD and ASF testing if necessary . Brazil’s laboratories perform the following routine FMD tests:  Virus ty

ping: C omplement fixation and ELI SA test (double antibody s andwich ELISA) .  Assessment of antibody level: ELI SA test in liquid phase (b locking ELISA) and serum neutralization .  Detection of viral activity through the anti
- virus infection associated antigen (VIAA), ELISA 3ABC, and EITB tests .  Id entification of the virus in esophageal
- phary ngeal fluid through the Probang test. Four State la

boratories are part of a network of authorized laboratories that perform certain FMD diagnostics to admit animals into the export region and for serological monitoring. The laboratories perform EITB and VIAA tests and began ELISA 3ABC testing in 2002. On ly MAPA laboratories carry out diagnostic activities in response to suspected outbreaks of vesicular diseases and as a part of viral activity studies to implement free zones. The 2002 site visit team visited three of the abovementioned laboratories [6] and reported the following: Diagnostic laboratory

in Pedro Leopolodo, Minas Gerais:  This Federal laboratory had a biosafety l evel (BSL) 2 facility for bacteriology (b rucellosis and TB testing) and chemistry lab oratory .  The staff had about 94 people.  Behind the B S L - 2 facility , a new B S L - 3 laboratory was under construction.  The laboratory

wa s about 2 , 500 square meters in size and had nine laboratories with a double airlock and a separate air zone for each laboratory . There was a separate animal facility with a separate entrance.  The facili ty

had three rooms for large animals with an individual shower for each room, and three rooms for small animals with a common shower in the hallway .  The necropsy

room ha d two oversized autoclaves for decontaminating carcasses.  HEPA filters and the mechanic al room were located on the third floor.  The basement had three 3 , 000 - gallon tanks for decontaminating effluent by boiling at 100  C. Animal Products Analy sis L aboratory (LAPA/Recife), PernambucoAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 56

 This Federal laboratory conduct ed FMD serology for all of Brazil except the n orth ern part , where FMD wa s considered endemic.  Vaccine efficacy wa s assessed in 5
- to 7 - day
- old mice. FMD vaccine safety testing wa s tested in the bab y hamster kidney
- 21 ( BHK - 21 ) cell line.  At the time of the visit, the laboratory had fiv e professional staff and three technicians. They tested 30,000 serum samples per month for FMD serology .  Criteria for conducting followup on the positive samples seem ed correct and well carried out through EI TB and ELISA confirmatory tests. The laboratory used v irus i solation, ELISA, c omplement f

ixation and IDGA to confirm vesicular disease diagnosis from the regional authorized laboratories .  The laboratory

was also equipped to run the highly sensitive suckling mice inoculation technique for antigen detec tion, which is used for vaccine security tests .  The laboratory

used ELISA, c omplement f ixation, v irus i solation and seroneutralization assay s to diagnose differential diseases such as infectious bovine rhinotracheitis , bovine viral diarrhea virus and vesicular stomatitis virus . The 2008 site visit team visited the Recife laboratory in Pernambuco and found:

 The lab oratory visited provides FMD and CSF serology and FMD vaccine efficacy for all of Brazil except for the n orth ern part , where FMD is endemic.  The lab oratory is working under MAPA Regulation N 0 1 issued January 16, 2007; 2 0 Art.; 5,741 Decree of March 30, 2006, and according to the process n 0 21000.004072/2005
- 19, which defines the criteria for accreditation of MAPA ’s national agricultural laboratories (Laboratorio Nacional Agropecuario, or LANAGRO ) . An independent agency regularly audits facilities under this regulation.  The laboratory

also diagnose s: o FMDV and its differentials vesicular stomatitis virus , bovine viral diarrhea virus, and bovine rh inotracheitis virus ; o CSFV and its differentials Aujes zky ’s disease , s wine c olibacillosis, p orcine ery sipela, p asteurellosis and s almonellosis; and o 17 o ther animal diseases.  Brazil has five FMDV vaccine plants in production. Two are close to Santa Catarina, one in Parana and one in Matto Grosso do Sul. The laboratory visited provided v accine efficacy for each lot of FMDV vaccine produced.  The laboratory tests vaccine efficacy and potency

using inoculation in 5
- to 7 - day
- old mice and seroneutralization ti ters in sera from the vaccinated animals. The animals are not given live virus.  FMD vaccine safety is test ed using the BHK - 21 cell line.  CSFV vaccine is produced only for export. The laboratory visited do es safety

tests in cell cultures and potency

tests with live virus challenge s to vaccinated pigs, in facilities located in endemic areas of the country . Although these techniques differ from OIE recommendations, the site visit team considers them adequate because of the limitations of BS L - 3 agriculture animal facilities and the cost of bovine test techniques .  The laboratory

has 27 professional staff members and 110 technicians or supporting personnel. Seven professionals (v eterinarians and c hemi cal and a gronomic engineers)APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 57 provide CSFV - FMDV diagnostics . These individuals have been working at the laboratory for at least 10 years.  The lab oratory

is old but well maintained and reasonably equipped.  The site visit team found the laboratory personnel highl y qualified and motivated . The team also found that th ey have the equipment necessary to detect disease.  The turnaround time for results is excellent, avoiding the exten sion of quarantine time o n farms and States affected by an epidemiological alert.  The laboratory

has SOPs ( s tandard o perating p rocedures) and QA ( quality a ssurance) control for , at least, the two tests the site visit team scrutinized. The procedures for CSFV and FMDV diagnos is are well established and are suited for both detection and confirmation of the etiologic agent. They are: o FMDV: Surv eillance and transport certificates and sera samples are sent to accredited laboratories in Rio Grande do Sul, Sao Paulo, Minas Gerais and Mato Grosso. Inconclusive E LISA/ITB results go to Recife. I f a clinical case is reported, the DSA direct that the s amples be sent to LANAGRO to perform VIAA or ELI SA 3ABC/EITB. If a case ends up with suspected positive results, an alert is sent to the DSA and CGAL (General Coordination for Animal L aboratories) authorities who in turn will implement their control and eradication policies. o CSFV: The s ame accredited lab oratories perform ELISA for CSFV antibodies in sera . Any

serum - positive or inconclusive result is sent to LANAGRO - Recife for confirmation. I f a clinical case is reported, the samples go to LANAGRO - Recife only , where VIAA , virus neutralization, and/or ELISA are performed. I f the result is confirmed as positive, the authorities take the appropriate measures for control and eradication. Conclusions : APHI S conclude s that Brazil has the diagnostic capability to adequately test samples for the presence of the FMD, CSF, SVD, and ASF virus. The laboratories in Pedro L eopoldo , Pará, and Recife h ave adequate diagnostic capabilities to test samples for the FMD virus, including adequate quality control activities, laboratory equipment, and sufficient staff. Th e Recife laboratory has adequate diagnostic capabilities to test samples for FMD and other swine notifiable diseases. The tests use d to investigate evidence of viral activity are consistent with OIE guidelin es. The staff members at the facilities visited in 2002 and 2008 w ere well trained and motivated. The laboratories have sufficient q

uality control activities, routinely monitor and calibrate laboratory equipment, have suf ficient staff, have an effective and efficient recordkeeping s ys tem for storage and retrieval of data , and turn samples around quickly . 11 . Policies and infrastructure for animal disease control in the region Each country

should have c ontingency plans in place to limit any disease outb reak. In this section we provide an overview of the elements of Santa Catarina’s emergency plan if suspect cases of FMD , CSF, SVD , and ASF are identified. The Brazilian government has developed a Federal contingency plan for FMD and CSF . Each State also drafts a specific contingency plan for immediate, effective action in an emergency . Each StateAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 58

must maintain an organization to handle health emergencies, establish coordinating committees and emergency

animal health technical groups, defin e strategies and plans of action, and, when necessary , carry

out the appropriate control measures within a timeframe compatible with a state of emergency [4, 7] . Santa Catarina ’s contingency plan requires each municipality to have a local operational plan that lists the names and contact informatio n for all entities involved in emergency response . These includ e local police officials and mayors as well as truck washing terminals and technical responders. The emergency plan is triggered by

an official declaration of sanitary emergency

at the State level [11, 16] . The 2008 site visit team reviewed local emergency operational plans while visiting the LVUs. These plans were up to date and included a high level of detail such as assignment of specific individuals to the various emergency

functions. The local contingency plan i s not specific to a particular disease, but is designed to be applied to any animal diseas e emergency [11] . CIDASC has held sanitary emergency training sessions for professionals working in the official veterinary

service . R ecently , CIDASC trained 30 veterinarians in the management of emergenc ies . CIDASC also held two simulations , with the participation of all sectors, institutions and authorities involved in an emerg ency response [4] . Animal owners, veterinarians, transporters, a nd members of the public are required b y law to notify the LVU upon suspicion of a notifiable disease in any livestock. Penalties for noncompliance can include significant fines and/or legal actions. The official service is required by law to respond to reports of disease suspicion within 12 hours. All official veterinarians have been trained in carrying out this response [4] . If the LVU confirms a probable outbreak b y clinical observation, the central offices of the affected State, the SFA and the DSA in Brasilia must be informed immediately . If the suspe cted case occurs in an area bordering another country , the local unit of the neighboring country must also be informed [5, 7] . A vesicular disease suspicion kit, which is available to all LVUs through the regional office, is taken to the susp ect holding b y the official services veterinarian. This kit includes equipment for animal restraint, sample collection, and sanitation as well as disposable clothing and forms to collect information. The kit also includes a disease response manual which lists technical procedures and required reporting hi erarchy . The 2008 site visit team reviewed the emergency response kit at the Chapeco regional office. The team found the kit to be extremely well stocked . It includ ed lab oratory submission materials and forms, protective clothing, cleaning and disinfection materials, and information on appropriate steps in the response, among other items [11] . Once the LVU clinical ly confirm s a notifiable disease, the involved holding and others in close proximity are quarantined and all animal movement is prohibited. Unauthorized movement of peopl e and vehicles onto and off the holding is also prohibited. Officials collect s amples for laboratory

anal ys is and start an epidemiological investigation. At this point additional official veterinary teams are called on to conduct clinical and serologic surveillance around the suspectedAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 59

holding and beg in tracing animal movement on and off the premises during the 60 day s prior to the likely beginning of the sanitary problem (30 day s for CSF) [4, 7] . Following laboratory

confirmation, the LVU declares a state of sanitary emergency and recruit s the civilian defense and military forces to the effort. In addition, other States, neighboring countries, trading partners, and international organizations are notified of the outbreak [19] . Upon confirmation of disease the trace investigation is expanded to include the trans it of people, transportation of products, fairs, abattoirs , and buyers who, before the imposition of the restrictions, had been in contact with the infected establishment. All professionals who work with animals inside the infected zone are informed of th e occurrence of disease and are required to provide the o fficial v eterinary s ervice with a list of all breeding establishments visited during the last 7 day s [3] . Ongoing sanitary

emergency

actions also include defining an emergency area around the affected holding at least 25 km in radius, restricting the transport of animals , animal products , and b yproducts in the emergency

area (as well as those related commercially to the affected holding), and banning agricultural and livestock events (shows, markets, auctio ns , and similar events ) in the emergency area . The emergency

area is subdivided into three areas, which are, in order of decreasing severity, the infected area, the surveillance area, and a buffer or protection area [4] . The infected area includes the affected holding plus all other holdings within a minimum radius of 3 km from the outbreaks. Within this area the movement of animals, people , and vehicles onto and off holdings is prohibi ted . Sick and contact animals must be destroyed (us ing compensation funds), and all places where the sick and contact animals had been held must be clean ed and disinfect ed [4] . The surve illance area includes all holdings located within 7 km of the infected area. Animal movements are banned within this area , although animals may be slaughtered for internal consumption only

(i.e. , in slaughterhouses located within the surveillance zone its elf) following approved biosecurity

measures . S laughter, when authorized, must be supervised by the official veterinarian and the meat boned with the bones incinerated. A ll susceptible animals must receive a clinical inspection, and surveillance and moni toring of this population must be constant . Surveillance must includ e serological evaluation of all susceptible animals within th e infected zone [4] . The buffer area surrounds the infect ed and surveillance area s and extends 15 km beyond the outer limits of the surveillance area. Measures taken with in this zone include restrictions on animal transport, slaughter of animals for internal consumption only (in local abattoirs) as above, and o ngoing surveillance, including clinical inspection of susceptible animals [4] . Cleaning and disinfection of affected premises starts with removal of any excess organic matter. The area i s then clean ed with water under pressure. All the material collected during this stage , including food, excreta , and effluents, must be destroyed (buried or incinerated). The facilities are washed again with detergents, followed b y a preliminary disinfec tion after the facilities and the waste - collecting gutters have dried. The process is repeated as many times as the o fficial s ervice deems necessary . Machinery , equipment , and materials used to end the outbreak are also disinfected [3] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 60

The minimum period required before restocking with sentinel animals after disinfection is 30 day s for FMD and 10 day s for CSF. Sentinel animals (young, weaned, unvaccinated animals) are introduced to the holding and held there for at least 30 day s. The sentinel animals undergo serologic testing on introduction and at 15 day s and 30 days after introduction . They are also subjected to weekl y clinical evaluation, including measurement of body temperature. If both clinical exams and laboratory

testing yi eld negative results at th e end of the 30
- day period , the facility

may gradually carry out a controlled repopulation, under the supervision of the o fficial v eterinary s ervice. If any of the sentinel animals test positive on serologic evaluation, all other animals are killed and th e process s tarts again . The contingency measures applied in protection and surveillance zones are maintained until the property

has been determined to be free of disease [3, 4] . In 2005, Santa Catarina reported and investigated 83 notifications of reportable disease suspicions in holdings with FMD
- s usceptible animals . The State investigated 30 notifications for vesicular disease, 13 of which were due to trauma and 17 of which were due to diverse intoxications. In 2006, Santa Catarina reported and investigated 201 notifications of reportable disease suspicions in holdings with FMD
- susceptible animals , 81 of which were investigated as vesicular disease suspicions . The s e were all found to be unfounded , with 41 due to traumatic injuries and 40 due to intoxication [4] . Santa Catarina did not report any susp ect ed cases of CSF in 2005 and 2006; however three suspect ed cases were reported in 2007. All of these were inves tigated and subsequently determined to be negative for CSF [3] . Conclusions: Brazil has effective disease control and response program s for FMD and other notifiable ruminant and swine diseases . Santa Catarina has develop ed specific contingency plan s for immedi ate action in any emergency

situation. The State handl es animal health emergencies, establish es coordinating committees and emergency animal health technical groups, defin es strategies and plans of action, and, when necessary , carri es out the appropriate control measures within a timeframe compatible with a state of emergency . Quarantine and movement restriction decisions are made b y State officials with input from Federal authorities. There are also sy stems for notification and training that ensure emergency

preparedness and response with a legal framework to authorize needed actions. APHI S concludes CIDASC has the capabilities to respond rapidl y and effectively to an animal disease outbreak and limit the spread of the disease should an outbreak occur. Release Assessment Conclusions APHI S identified risk factors associated with importing FMD
- susceptible species or their products to the United States from Santa Catarina. APHI S discusse d these risk factors in the context of the potential for counterbalancing circumstances or applying appropriate risk mitigations to reduce the risk of introducing and establishing FMD or other swine notifiable diseases under evaluation in the United States. The risk mitigation procedures, which will be defined in the prop osed rule, include various forms of verification and inspection to which APHI S will propose that MAPA certify to p rovide confidence that susceptible animals and their products meet acceptable export criteria.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 61

Likelihood of the introduction of notifiable diseases into Santa Catarina Risk Factor 1. FMD is endemic in some South American countries. CSF outbreaks have been detected in northern Brazil, in S tates located within the CSF
- affected area , as recently as 2008. The FMD or CSF viruses could be reintroduc ed into Santa Catarina from adjacent affected areas. Consequentl y , there is a risk that susceptible species or products from such species bound for the United S tates could originate from or be commingled with animals or animal products from affected neighboring areas . In contrast, ASF and SVD are not present in South America. SVD has never been reported in the countries closest to Santa Catarina (Argentina, Paraguay , and Uruguay), nor has it been reported in Brazil. ASF has been reported in Brazil ; however the last case occurred over 20 years ago. Discussion Santa Catarina authorities allow FMD - susceptible species to enter the S tate from other Brazilian S tates as long as the animals are not vaccinated against FMD, the risk of introduc i n g such ani mals is considered acceptable , and the destination and origination premises are suitable for quarantine purposes . Additionally , Santa Catarina has requirements in place, including serological testing, for susceptible animals ( such as sheep, goats, and pig s) entering S anta C atarina from other S tates . M atured, deboned fresh beef is imported into Santa Catarina from other areas of Brazil for local consumption , since beef is not produced in sufficient quantities for local demand. This meat has a low risk of introducing FMD into Santa Catarina since it must go through a maturation process that kills the FMD virus. Swine entering Santa Catarina must originate from countries considered free of ASF, SVD , and CSF, as well as other swine disease s . The animals are also quarantined and may be tested for swine diseases both before and after import. Live s wine may be imported from areas not considered free of CSF within Brazil if they are destined for immediate slaughter , but only under permit from MAPA . This compri ses a minority of the pigs slaughtered in Santa Catarina. Mitigations Based on site visit observations, APHI S considers that Santa Catarina’s veterinary officials have adequate controls at the ports of entry (including airports) to mitigate risk for comm ercial and legal importation. Santa Catarina prohibits the importation of susceptible animals and animal products from areas considered affected by FMD, CSF, SVD, and ASF . In addition, Santa Catarina has stringent requirements in place, including serolog ical testing, for importing animals from other States susceptible to the diseases under evaluation . Therefore, APHI S concludes that it is unlikely that FMD or other diseases of concern will be introduced through legal importation.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 62

To ensure compliance wi th the appropriate controls for FMD , APHI S will propose in its rule that MAPA certify that FMD
- susceptible animals and products did not originate from and were not commingled with animals or products from areas APHI S considers to be FMD affected. Specific all y, APHIS will require the following certifications for beef or pork products exported to the United S tates from Santa Catarina:  The beef or pork comes from animals that have been born, raised, and slaughtered in Santa Catarina.  The beef or pork comes from animals that originated on premises where FMD has not been present during the lifetime of any of the animals slaughtered. Risk Factor 2. There is a potential risk from illegal introduction of affected animals or animal products fro m affected regions . Santa Catarina contains several inspection posts in internal and external border areas. Even where there are barriers or checkpoints, people and animal products may cross both domestic and international borders illegall y , particularl y b y passenger car . Th is increases the potential for the viruses under evaluation to cross the border . Mitigations APHI S evaluated Santa Catarina’s controls for animals moving into the S tate , as well as its biosecurity

procedures and quarantine procedures, and concluded th at they sufficiently mitigated the risk of illegal importations from affected regions. Risk Factor 3. If FMD or the swine diseases under evaluation were to be reintroduced into Santa Catarina, disease might be spread through animals scavenging unmonitored garbage dumps. Mitigation Brazilian laws prohibit the feeding of untreated garbage to animals, while Santa Catarina prohibits garbage feeding regardless of treatment. These laws are enforced effectively , so that animal garbage feeding is unlikely

to occur in Santa Catarina. Release Assessment
– Conclusion Based on evaluation of the 11 factors as well as observations from the site visits, APHI S considers that Santa Catarina possesses the detection capabilities, reporting s ys tems, and emergency respons e sy stems necessary to combat FMD , CSF, SVD, and ASF .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 63

Exposure A ssessment An exposure assessment as defined b y O IE describes the biological pathway(s) necessary for exposure of animals and humans in an importing country to the hazards of a given risk source, and estimates the probability

of the exposure(s) occurring [20] . APHI S’ regulatory authority is limited to animal health, however, so its evaluation focuses on potential risks to animals. APHI S considers that domestic livestock are most likely to be exposed to FMD, CSF, SVD, and ASF viruses through feeding contaminated food waste to swine [21] . Other exposure pathway s are more direct and include contact with imported infected live animals or contact with infected genetic material. Waste feeding to susceptible swine The likelihood of exposure of susceptible species to virus
- infected meat was evaluated in previous APHI S studies. In 1995, APHI S conducted a pathway anal ys is to estimate the likelihood of e xposing swine to infected waste . The anal ys is included two pathway s for exposure of swine to contaminated waste : E xposure associated with illegal household imports, and exposure associated with legal imports [22] . The latter is the exposure pathway appl icable to meat or meat products imported from Santa Catarina. With 95 percent confidence, APHI S estimated that 0.023 percent or less of plate and manufacturing waste would be inadequatel y processed prior to feeding to swine. Based on this fraction, less than 1 part in 4,300 (reciprocal of 0.023 percent ) of imported meat is likely to be fed to swine as inadequatel y cooked waste [22] . APHI S conducted a survey in 2001 of the U.S. swine waste
- feeding sector to update a similar study done in 1994 [23] . Based on this survey, APHI S estimated that the proportion of plate and manufacturing waste fed to swine diminished by about 50 percent between 1994 and 2001 due to a significant decrease in the number of waste
- feeding premises. The study also found that: 1. Several additional S tates prohibited feeding food wastes to swine . 2. The number of waste
- feeding premises in the continental United States decreased b y 40.5 percent f rom 1994 to 2001, and in Hawaii and Puerto Rico decreased b y 37.5 percent and 52.3 percent , respectively . 3. Institutions and restaurants provide nearl y 90 percent of all plate waste fed to swine. APHI S considers that prohibiting feeding unprocessed plate wa ste to swine has further contributed to the reduction of swine waste - feeding. Waste
- feeding operations must be licensed and inspected regularl y b y USDA inspectors under 9 CFR 166. The licensing process requires that producers adequatel y cook the waste fe d to swine using methods designed to reduce the probability of survival of foreign animal disease agents. Based on the 1995 estimate that a very small proportion of food waste is inadequatel y processed prior to feeding to swine, and the substantial reduction in waste
- feeding operations in recent ye ars, APHI S concludes that the likelihood of exposure of susceptible swine to FMD, CSF, SVD, or ASF viruses through inadequately processed food waste is low.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 64

Imported live animals The likelihood of exposure o f susceptible species to infected live animals was evaluated b y briefl y reviewing virus persistence and shedding in live swine and ruminants, as well as standard import requirements for these species. The exposure assessment focuses on breeding animals be cause of high transportation costs for export of other live animals ( such as feeder pigs or cattle) to the United States from Brazil. APHIS considers exposure of susceptible U.S. animal s to illegall y imported infected live animals from Santa Catarina to b e highl y unlikel y. The survival period of CSF virus within live swine ranges from 1 week to greater than 6 months , depending on various host
- pathogen factors. Similarly , up to 50 percent of ruminant animals m ay become carriers of the FMD virus . The maxi mum reported duration of the carrier state is 3.5 years in cattle, 9 months in sheep, and 4 months in goats. Carrier virus is full y infectious , and consequentl y the carrier state is associated with at least a theoretical risk of introducing FMD into a sus ceptible population. ASF may also exhibit a chronic carrier state, while SVD virus is not known to cause persistent infection . A large percentage of infections are subclinical and therefore may remain undetected without diagnostic testing prior to export [24] . Consequently , APHIS considers this potential pathway to pose a high risk for disease introduction if unmitigated. However, c urrent U.S. regulations require certification that ruminants and swine have been kept in a region entirely free of FMD , CSF, SVD, and ASF for 60 day s prior to export (9 CFR 93.405 and 9 CFR 93.505) . They also require a minimum quarantine of 30 day s for most imported ruminants (9 CFR 93.411) and 1 5 day s for all imported swine (9 CFR 93.510). These requirements serve to partiall y mitigate the risk of exposure b y increasing the likelihood of detection in exported animals . Based on the results of the release assessment, APHI S considers the likelihoo d that animals infected with FMD, CSF , SVD, or ASF virus will enter the United S tates from Santa Catarina to be very low . The resultant likelihood of animal exposure to FMD, SVD, and ASF viruses via this pathway is similarly low. Imported genetic materia l Genetic materials have been implicated in the introduction of foreign animal disease into susceptible populations, as well as the spread of established disease epidemics over considerable distances. For example, two semen collection centers became infe cted during the course of the 1997
- 1998 C SF epidemic in the Netherlands . 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 investigato rs 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 [25] . Survival of CSF virus in semen has been estimated in experimental studies to be 12 to 72 hours at 20  C , but ranges from 1 month to several years at 4  C or below [26] . Survival in embryos and ova is unknown [26, 27] . FMD virus may be present in semen up to 4 day s before clinical signs becomeAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 65

apparent [28] . Survival of both SVD and ASF virus es in genetic material is possible but is not considered t o be a primary mode of transmission [29, 30] . Based on the extended period of survival of CSF and FMD viruses in frozen semen, APHI S considers the likelihood of exposure of susceptible animals to these viruses in infected semen , if it were to be imported into the United S tates , to be high if unmitigated . However, based on the results of the release assessment, APHI S considers the likelihood of release of CSF or FMD viruses via infected semen from Santa Catarina to be very low . The likelihood of exposure of d omestic livestock would be si milarly low. Consequence Assessment A consequence assessment describes the biologic and economic consequences of introducing the hazards under consideration into the United States. This consequence assessment addresses both direct and indirect consequen ces , as recommended by the OIE [20] . The magnitude of the biologic and economic consequences following an introduction of FMD, CSF, SVD, or ASF virus would depend on the location of the introduction , the virus serotype introduced , the rate of virus spread and whether environmental conditions at the introduction site might facilitate this spread , the site’s ability to detect the disease rapidly , livestock demographics and movement patterns , and the eas e of employing eradication procedures. In addition, depending on the extent of export of livestock and animal products, trade restrictions imposed by trading partners may

result in severe economic consequences [31] . Direct consequences include effects of the disea se on animal health and subsequent production losses, the total costs of control and eradication, the effect on the environment, and public health consequences. Indirect consequences include effe cts on international trade and associated domestic consequen ces. Animal health consequences FMD FMD causes significant distress and suffering to animals regardless of the size and sophistication of their livestock unit. Very high mortality

rates in young animals can occur, particularl y among pigs and sheep. Mo rtality

in older animals occurs less frequentl y but may be significant with certain virus strains [24, 32, 33] . FMD also causes significant losses in the production capacity of affected animals. Productivity losses of 10 percent to 20 percent are reported in FMD
- infected livestock if the disea se is allowed to run its course . In addition, FMD can cause a reduction in the growth rate of animals raised for meat. The comparativel y greater severity of FMD in pigs would imply at least similar losses to those described for cattle [31, 34] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 66

CSF CSF has a cute and chronic courses. The severity of the disease depends largel y on the age of the animal and the virulence of the viral strain, with young ani mals usuall y more severel y affected than older animals. In older breeding pigs the course of infection is often mild or even subclinical, whereas mortality

rates may

reach 90 percent in young pigs [35] . L ow virulence strains may manifest primaril y as poo r reproductive performance and birth of piglets with neurologic defects [35] . SVD SVD is ty picall y a transient vesicular disease of pigs. The virus causes essentially no mortality, and infected pigs generall y recover within 1 week ( on occa sion, recovery may take up to 3 weeks). Some strains produce only mild clinic al s ymptoms or are as ymptomatic . Morbidity rates may

be low throughout a whole herd but high in certain pens [29] . ASF ASF is a highl y contagious hemorrhagic disease of pi gs. All age groups are equall y susceptible. With high virulence forms of the virus, ASF is characterized by high fever, loss of appetite, hemorrhages in the skin and internal organs, and death within 2 to 10 day s on average. Herd m ortality rates may

be as high as 100 percent [30] . Economic consequences The overall cost of control and eradication depends on the mitigation or policy options chosen to control and eradicate the disease. Potential costs include costs for disease control measures such as imposing quarantine measures and movement controls, direct costs related to stamping out of affected herds, indemnity pay ments, vaccination costs, and costs for surveillance and laboratory testing. For disease
- free countries like the United States that have a substantial export market for livestock and livestock products, the preferred option for control and eradication has traditionally been to stamp out infected herds without the use of vaccine. The U.S. policy

for most significant foreign animal disease emergencies is to follow strict quarantine measures and stamp out infected and contact herds . Officials also assess the need for strategic vaccination, and carry

out vaccination if necessary . Available data do not allow quantification of the number of herds or farms that c ould be infected if one of the diseases under evaluation were introduced into the United States . Nevertheless, the cost of control, eradication , and compensation is likely to be significant. FMD A few studies have estimated the potential consequences of an FMD outbreak in the United States. Bates et al (2003) used results from an FMD simulation model to estimate the direct costs associated with indemnity, slaughter, cleaning , and disinfecting livestock premises for various vaccination andAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 67

eradication strategies to control transmission of FMDV in a cattle population of 2,238 herds and 5 sale yards located in 3 counties in California. The study found that mean herd indemnity pay ments were $ 2.6 million and $ 110,359 for dairy and non
- dairy herds, respectivel y. Cleaning and disinfection costs ranged from $ 18,062 to $ 60,205 per herd. The mean vaccination cost was $ 2,960 per herd and the total eradication cost ranged from $ 61 million to $ 551 million , depending on eradication strategy [36] . McCauley

et al (1979) conducted a comprehensive study to assess the potential economic impact of FMD in the whole of the United States. The study estimated the direct costs (control and eradication program costs) and increased costs borne by consumers of FMD introduction over a 15
- ye ar period (1976
- 1990). Using the Consumer Price Index to update to 2001, the estimated total cost of a strict quarantine and slaughter policy was $ 34.4 million [31] . CSF Since there have been no CSF outbreaks in the United States from which economic estimates can be derived, estimates of economic effects in other countries are provided as illustrations. Saatkamp et al (2000) reviewed the economic aspects of control of small and large CSF outbreaks in the European Unio n (EU) from 1990 to 1997. For the largest outbreak, involving 429 herds over 14 months, the cost of remov ing affected swine was 426.9 million Euros, slaughter for welfare purposes cost 1.2 billion Euros, and program operational costs were 134.3 million Euros. Overall, the outbreak cost pig producers 712.4 million Euros, the national government 230.5 million Euros, and the EU 807.8 million Euros. Approximately 10 million pigs were destroyed during the outbreak, primarily for welfare reasons (being in overcrowd ed conditions, or being overweight) [37] . The total cost of smaller outbreaks ranged from 10.9 million Euros (8 affected herds over 2 months) to 208.7 million Euros (113 affected herds over 10 months) [38] . Garner et al (2001) estimated the potential economic impact of CSF on the Australian pig industry using a stochastic modeling process. The model estimated a loss in gross income of 28 percent to 37 percent for the pig industry in the affected region, and a 9 percent to 11 percent loss in gross income for the national pig industry [39] . SVD Little information exists on the cost of control and eradication of SVD in a previously free region. SVD virus generally

does not spread as quickl y as CSF viru s , even on infected premises . S pread from one pen to another may not occur in the absence of a common open drainage s ys tem or of frequent movement of pigs between pens . However, an SVD outbreak may not be detected for weeks or even months due to the freq uently mild nature of the disease, allowing ample time for it to spread to other swine establishments. In addition, the virus is extraordinarily stable in the environment, which could lead to disease recurrence on previousl y infected farms [40] . In the absenc e of specific data on the cost of control and eradication, APHI S assumes a baseline cost similar to that of a small
- to medium
- sized CSF outbreak (see above).APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 68

ASF As with SVD, there is l ittle information on the cost of control and eradication of ASF in a previously free region. In the absence of specific data on the cost of control and eradication, APHI S assumes a baseline cost similar to that of a small
- to medium
- sized CSF outbreak (see above). While these examples estimate a more severe outcome of an outbreak, the consequences could be lessened if the outbreak was detected earlier and appropriate controls implemented to quickl y eradicate the disease. Environmental consequences Environmental consequences resulting from introduction of FMD, CSF, SVD , or ASF would primarily occur from disposal of carcasses due to death from disease or depopulation of herds, as well as disposal of contaminated bedding and manure. The methods of disposal employed in response to an outbreak would affect the environment differentl y. Disposal of contaminated materials could potentially affect air, water , and soil quality, as well as potentially releasing live virus into the environment. Disposal options previously employed in other countries in response to large
- scale an imal disease outbreaks include rendering, burial, and incineration. Factors influencing the decision as to which methods of disposal to use include the volume of contaminated material (dependent on the number of animals affected), geographic features ( suc h as soil and surface water) of the areas where outbreaks occur, other environmental considerations such as weather and ambient temperature, and available emergency

resources such as funds, equipment, and personnel. The environmental consequences of an outbreak of one of these diseases in the United States could vary from marginal to extreme depending on factors related to disposal of contaminated carcasses and materials. Public health consequences Although APHIS’ regulatory authority does not cover pub lic health consequences, this assessment briefl y addresses the issue. Direct public health consequences are insubstantial because the occurrence of FMD, CSF, SVD, or ASF virus in humans is quite rare. In fact, the number of cases reported is so small compared with the number of persons exposed to these viruses that the World Health Organization generall y does not consider FMD, CSF, SVD, or ASF to be threat s to humans. Perhaps more importantly , a substantial foreign animal disease outbreak can result in s evere psychosocial effects on farmers and farming communities. Farmers and their families can suffer from grief over losing animals, in some cases bloodlines kept over many generations, as well as loss of control over their lives due to movement restricti ons, disruptions in community life, and short
and long
- term financial stress. Indirect consequences In addition to the direct costs of FMD, CSF, SVD, or ASF introduction, the effect on international trade and related domestic consequences must also be c onsidered. Export losses caused b y tradeAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 69

partners’ restrictions on animals and products susceptible to the diseases under evaluation could run into billions of U.S. dollars. The value of U.S. exports of pork and pork products that would be immediately

lo st if an outbreak of one of these diseases occurred was an estimated $ 1.3 billion in 2003 [41] . Similarly, the value of U.S. exports of beef products that would also be lost in an FMD outbreak was over $ 3 billion in 2001. Since the United States exports only small amounts of lamb and mutton, economic losses associated with these commodities are not likely to be significant compared to cattle and swine. The effe ct of an outbreak of a foreign animal disease on rural and regional economic viability , including businesses r eliant on livestock revenue, could also be substantial. For example, Paarlberg et al. (2002) conducted a study to estimate the potential revenue impact of an FMD outbreak in the United States similar to the one that occurred in the United Kingdom in 2001. This study estimated the gross revenue losses for the animal sector as follows: l ive cattle (17 percent), beef (20 percent), milk (16 percent), live swine (34 percent), pork (24 percent ), live sheep and lambs (14 percent), and sheep and lamb meat (10 percent ) [42] . Indirect economic losses to U.S. firms that support e xport markets for live animals and animal products could also be substantial. For example, such firms c ould lose at least $ 2.5 billion annually if ruminant export markets were lost. More than 33 ,000 full
- time U.S. jobs, accounting for almost $1 billion i n wages annually, could be jeopardized by loss of these markets. In the longer term, if trade restrictions persisted and alternative export markets did not develop, the U.S. ruminant production sector could contract, allowing other supplying countries to establish trade relationships in the absence of U.S. supply . Losses due to restrictions on live swine, pork, and pork products could also be significant [43] . Risk Estimation Risk estimation consists of integrating the results from the release assessment, exposure assessment, and consequence assessment to produce overall measures of risk associated with the hazards identified at the outset. Thus, risk estimation takes into account the whole risk pathway from the hazard identified to the unwanted event [20] . APHI S concludes from the assessment that the surveillance, prevention, and control measures implemented by Santa Catarina are sufficient to min imize the likelihood of introducing FMD , CSF, SVD, and ASF into the United S tates via imports of FMD
- susceptible species or products from such species. Although consequences of an FMD , CSF, SVD, or ASF outbreak are potentiall y substantial, the likelihood of an outbreak occurring via exposure of the domestic livestock population to pork or pork products imported from Santa Catarina is very low. The consequences of a FMD outbreak in the United S tates would be extremely high. The major economic consequence of importing FMD would be export trade losses. The sum of the consumer impacts, direct costs and trade losses over a 15
- ye ar period would be between $ 37 billion and $44 billion ( in 2001 dollars ), depending on the magnitude of the outbreak and eradication strategy . Although the consequences are significant, the results of both the release and exposure assessment indicate that the likelihood of introduction and establishment of FMD is low.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 70

In summary , although the consequences of a FMD outbreak in the Unit ed S tates would be very high, the findings of the release and exposure assessments lead APHI S to consider the risk of FMD
infected animals or products entering the United S tates from Santa Catarina and exposing U.S. livestock to the disease to be low.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 71 ANN EXES Annex 1. Hazard Identification : Foot- and - Mouth Disease Virus Etiologic Agent Family Picornavirida e , Genus Aphthovirus , ty pes O, A, C, SAT1, SAT2, SAT3, and Asia 1. Status in the United States FMD virus was eradicated from the United States in 19 29. Epidemiology FMD is a highly

communicable disease of cloven
- hoofed animals caused by an Aphthovirus of the family Picornaviridae . FMD has seven immunologically distinct serotypes (O, A, C, SAT1, SAT2, SAT3, and Asia 1). The O, A, and C serotypes have historically been found in South America [44] . Research indicates that one serotype does not confer protective immunity against the other six ; thus a disease outbreak can be caused b y one serotype or a combination of serotypes [45] . FMD virus serotyp e O (PanAsia strain) has been isolated in over 60 percent of positive samples received b y the World Reference Laboratory for FMD in the United Kingdom (Institute for Animal Health, Pirbright Laboratory). Along with being the most prevalent type O strain, the PanAsia strain is also the most widely

distributed, causing FMD outbreaks in many parts of Africa, Asia , and South America as well as in Europe since 1998 . This virus strain can infect a wide range of species including cattle, water buffalo, pigs, sheep, goats , and gazelle s . FMD virus can be transmitted by direct or indirect contact or aerosol. Fomites ( items such as feed, drinking water, equipment, anim al products, human clothing, transportation vehicles, rodents, stray dogs, wild animals, and birds) can transmit FMD over long distances. The five main elements that influence the extent of FMD spread are:  The quantity

of virus released  The means b y which the virus enters the environment  The ability

of the virus to survive outside the animal body  The quantities of virus required to initiate infection at primary infection sites  The period of time the virus remains undetected [46, 47] The incubation period of the FMD virus is 2 to 14 day s in cattle, depending on the viral strain and dose and the level of susceptibility of the animal [48] . Morbidity in unvaccinated herds can be high, but mortality

usually does not exceed 5 percent. If an outbreak occurs during the calving season, calf mortality

can be considerable [49] . Young calves may even die before clinical signs appear, because the virus attacks the heart muscles [48] . The respiratory

tract is the usual route of infection in species other than pigs. In fection can also occur through abrasions of the skin or mucous membranes. In cattle and sheep, the earliest sites of virus infection and possibly replication appear to be in the mucosa and the ly mphoid tissues of the phary nx. Following initial replication in the pharynx, the virus then enters the bloodstream. Viremia in cattle lasts for 3 to 5 day s; as a result, the virus spreads throughout the body and establishes sites of secondary infection [50] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 72

The usual route of infection in pigs is through ingestion of FMD
- virus contaminated products, direct contact with infected animals , or occupation of heavily contaminated environments. The i ncubation period in pigs will vary

with the strain, dose , and route of infection. Serotype O, which is highly virulent in pigs, can produce clinical signs within 18 to 24 hours , while pigs with low
- level exposures may

take up to 11 day s to develop clinical signs . Pigs that recover from FMD infection do not become carriers , as was thought with ruminants [51] . FMD virus localizes in various organs, tissues, body fluids, bone marrow, and ly mph nodes [52] . Viral replication may

re ach peak levels as earl y as 2 to 3 days after exposure. Virus titers differ in different organs or tissues. Some tissues, such as the tongue epithelium, have particularly high titers. Recent data indicate that the most viral amplification occurs in the stratified, cornified squamous epithelia of the skin and mouth (including the tongue). Although some viral replication also occurs in the epithelia of the phary nx, the amount of virus produced there is apparently much less than the amount produced in the skin and mouth during the acute phase of the disease. By comparison, the amount of virus (if any) produced in other organs like salivary glands, kidney s, liver, and l ymph nodes is negligible [53, 54] . Immunity to FMD is primarily

mediated by

circulating antibodies [55] . The host reaction, including antibody production, occurs from 3 to 4 day s after exposure. Ininfected pigs, the virus is cleared within 3 to 4 weeks. In contrast, around 50 percent or more of cattle will develop a low
- level persistent infection, localized to the phary nx [56 - 58] . According to Alexandersen (2002), a model for progression of infection starts with virus exposure , then accumulation of virus in the phary ngeal area , followed b y the initial spread through regional ly mph nodes , and then via the bloodstream to epithelial cells. S everal cycles of viral amplification and spread follow [55] . Clinical signs in cattle during acute infection include fever, profuse saliv ation, and mucopurulent nasal discharge. The disease is characterized by development of vesicles on the tongue, hard palate, dental pad, lips, muzzle, gum, coronary band, and interdigital spaces. Vesicles may develop on the teats. Affected animals lose condition rapidly , and there is a dramatic loss of milk production [48] . The animal usuall y recovers b y 14 days post infection provided no secondary infections occur [50] . The most consistent clinical signs in pigs are lesions around the coronary bands and lameness, but fever may be inconsistent. Pigs may develop vesicles on the tongue and snout , but these may be less conspicuous than lesions seen in ruminants. The severity of clinical disease depends on the age of the infected pig. Adult swine may recover or become chronicall y lame while younger pigs, especiall y those less than 8 weeks of age, may die from acute myo carditis without developing other clinical s igns [48, 57] . Diagnosis of the disease relies heavil y on recognizing clinical signs. In unvaccinated cattle and pigs, the clinical signs are obvious. However, in small ruminants the disease is often subclinical or is easily confused with other conditions. Inaddition, in endemic regions, clinical signs in partially immune cattle may

be less obvious and could pass unnoticed [48, 57] . Virus isolation and serotype identification are necessary for confirmatory

diagnosis. The clinical signs of FMD are similar to those seen in other vesicular diseases. Differential diagnosis of vesicular diseases includes vesicular stomatitis, mucosal disease of cattle, bluetongue, rinderpest, and FMD. Serological diagnostic tests include the complement
- fixation test, virus neutralization test, and an enzy me - linked immunosorbentAPHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 73

assay test. Other diagnostic tests include one
- or two - dimensional electrophoresis of the viral DNA, isoelectric focusing of the viral structural proteins, or nucle otide sequencing of the viral RNA [47] . FMD virus is a relatively resilient virus. It can survi ve up to 15 weeks in feed, 4 weeks on cattle hair, and up to 103 day s in wastewater. The survival of the virus in animal tissues is closely associated with the acidity of that tissue. For example, in muscular tissues the acidity of rigor mortis, which oc curs naturally , inactivates the virus. The production of lactic acid in these tissues during maturation is considered the primary factor for inactivation [43] . An acid environment where the pH is less th an 6.0 will destroy the virus quickly [43, 59] . Several studies showed that in tissues where no acidification occurs (e.g., l ymph nodes, bone marrow, fat, and blood), the virus may survive for extended times in cured, uncured, and frozen meat [43, 60, 61] . Heating at 50° C [43] and up to 155° F [59] will inactivate the virus.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 74

Annex 2. Hazard Identification : Classical Swine Fever Virus CSF, also known as hog cholera, is a contagious and economicall y damaging viral disease of domestic s wine and wild boar with worldwide distribution. It is caused by the CSF virus of the family Flaviviridae , genus Pestivirus [62] . CSF virus is quite hardy, being stable between pH 4 and 10 , and is also stable at low temperatures [63, 64] . The virus may remain viable even after carcass maturation, and is unlikely to be destro yed b y transport or cold storage. Laboratory confirmation of infection, essential during an outbreak, is complicated b y the close antigenic relationship of the CSF virus with bovine viral diarrhea virus and border disease virus [62] . The incubation period for CSF is 2 to 14 day s [28] . The virus multiplies in the epithelial cry pts of the tonsils and may

be carried to local l ymph nodes and into the bloodstream for distribution throughout the body [65] . Blood and all tissues, secretions , and excretions of sick and dead animals are sources of infection [28] . CSF virus has been recovered from muscle and lymph nodes of infected pigs, and high titers of viru s have been isolated from bone marrow [66] . The disease may also be introduced or spread via infected semen [67] . CSF can spread in an epidemic form as well as establish enzootic infections in domestic swine and wild boar populations. Infection generall y spreads directly from pig to pig, but products including fresh, frozen, or cured pork can remain infectious to other pigs by mouth [68] . Imported pig products are frequently

implicated in the introduction of CSF virus into previously disease
- free regions, primaril y through the practice of swill feeding [69] . Dahle and Liess (1992) demonstrated that the oral infectious dose of CSF virus is very low [70] . Indirect transmission may occur via movement of people, wild animals, and inanimate objects such as live
- haul trucks [71] . The role of wild boar as a virus reservoir and possible source of infection for domestic swine is well known , and epidemiological links between CSF virus infection in wild boar and domestic swine have be en reported repeatedly in recent years [72, 73] . In countries that are free of CSF in domestic swine, epidemics in wild boar are often started b y feeding the animals infected human food waste ( EC 1999 ). Abnormal mortality and sometimes obviously sick animals are the first indicators of CSF introduction into a wild boar population ( EC 1999 ). Four distinct clinical forms of CSF have been described, including acute, chronic, cong enital, and mild manifestations . The acute form involves a disease progression of 2 to 4 weeks and is characterized b y high fever, generalized illness, hemorrhagic lesions, immunosuppression with secondary infections, and high mortality . The chronic form may last 30 to 90 day s before death and usually involves older swine or congenitall y infected piglets. Congenitall y infected piglets may develop s ymptoms of chronic CSF within 3 to 6 months, or may never develop sy mptoms but continuously

shed virus. Mild CSF is ty pically seen only

in sows and may

result from exposure to a low
- virulent strain. Infected sows may show no overt clinical signs but continuously shed viru s to their young and to other swine they contact [74, 75] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 75

Annex 3. Hazard Identification : Swine Vesicular Disease Virus SVD is a contagious and economicall y damaging disease of dom estic swine and wild boar. The disease has historicall y been recorded in Hong Kong, Japan, and several European countries; however, in 2004 the disease was primaril y limited to Ital y and Portugal (OIE 2005a). The SVD virus belongs to the family Picornaviridae , genus Enterovirus [62] . SVD virus is particularl y hardy, as it is resistant to pH changes between 2.5 and 12 and is very stable under cold conditions [76, 77] . The virus is therefore unlikely to be destroyed b y the postmortem decrease in muscle pH that accompanies carcass maturation. SVD virus is also resistant to fermentation and smoking . It may remain in hams for 180 day s , sausages for over a year, and processed intestinal casings for over 2 ye ars [29] . The incubation period for SVD is 2 to 7 day s. The intestinal tra ct is the primary site of infection; however, all tissues contain virus during the viremic period. Blood and feces of sick animals, as well as epithelium from vesicles and vesicular fluid, are significant sources of virus. Although SVD virus does not app ear to have a tropism for skeletal muscle cells, it is easily isolated from muscle tissue from infected animals after slaughter and bleeding out. SVD may be introduced into a herd by feeding garbage containing infected meat scraps, by introducing infected animals into a herd , or b y contacting infected feces (e.g., an improperly cleaned truck). After the initial introduction the disease spreads through contact of susceptible pigs with infected pigs and infected feces. The clinical signs of SVD are easil y confused with those of FMD and include fever, sudden lameness, and vesicles with subsequent erosions along the snout, feet, and teats. Morbidity rates may be low throughout a whole herd but high in certain pens. SVD causes essentially no mortality, and recovery

usuall y occurs within 1 week ( in some cases, up to 3 weeks). SVD infections seldom persist (Lin et al 2001); however, some strains produce onl y mild clinical symptoms or are asy mptomatic, and are detected onl y through laboratory surveillance [2 9] . For example, a 2002 outbreak of SVD in Italy

involved subclinical infection in all but one of 10,312 affected pigs ( Brocchio et al 2002 ).APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 76

Annex 4. Hazard Identification : African Swine Fever Disease Virus African swine fever (ASF) is a highl y contagious, frequentl y fatal, and economically damaging viral disease of pigs. As specified in 9 CFR 94.8, APHIS believes that ASF exists in all countries of Africa, as well as in Braz il, Cuba, Georgia, Haiti, Malta, an d Sardinia , one of Italy ’s islands . AS F has never been reported in the United States [78] . Natural hosts of ASF virus are members of the s uidae famil y of mammals, including domestic and wild swine [30, 79] . In s ub
- Saharan Africa, ASF is maintained in the wild through a life cycle including wild s uid ae and soft
- bodied ticks ( Ortnithodoros sp . ) [80] . The disease is primaril y spread into previously uninfected areas through feeding improperl y cooked swill containing ASFV to domestic swin e. The virus is generall y spread among domestic pigs b y direct or indirect contact [80] . The virus is present in all secretions and excretions, including blood and oral and nasal secreti ons , and may be spread through semen [79] . Virus is often shed before the onset of clinical signs in acute and subacute disease [81] . The in cubation period following exposure via direct contact is 5 to 19 day s, while the incubation period following tick exposure may be fewer than 5 day s. Depending on the virulence of the strain, ASF can manifest as percute, acute, subacute, chronic, or even inapparent disease. The peracute form generally

causes sudden death. In the acute form, pigs display a multitude of clinical signs, ranging from cyanosis and dy spnea to diarrhea . N earl y all body s ys tems are affected. Death generall y follows in 7 to 10 d ay s. The signs of subacute ASF are similar to those of the acute disease , but are less severe. Low virulent viral strains can cause inapparent, mild, or chronic infections. Abortion may be the onl y clinical sign, but intermittent fevers, emaciation, respiratory problems, swollen joints, skin lesions and potentially

death may

occur [80] . The A S F virus is stable across a wide temperature and pH range [79] . The v irus has been shown to survive in chilled or frozen pork for 104 day s. The virus has also been shown to survive for at least some period at pH s ranging from 3.1 to 11.5. Pork generall y reaches a pH of 5.4
- 5.5 following carcass maturation, but this v aries depending on the speci fic carcass and the temperature. The virus can often survive processes such as curing and salting. Farez and Morley conducted a literature review and reported survival times ranging from 30 day s in salami to 399 day s in Parma ham [82] .APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 77

Annex 5. Epidemiologic Characteristics of Rinderpest Etiologic Agent Family Paramyxoviridae , Genus Morbillivirus Status in the United States The United States has been historically free from rinderpest. Distribution Historically

the virus was widely

distributed throughout Europe, Africa, Asia and West Asia, but never became established in either the Americas or Australia/New Zealand. Rinderpest is an OIE listed disea se. [ 83 ] In Africa it has been eradicated from several countries and sub
- regions, and is normally absent from the northern and southern parts of the continent. Rinderpest occurs in the Middle East and in southwestern and central Asia [ 84 ]. Epidemiology Rinderpest is a highl y fatal viral disease of domestic cattle, buffaloes and yaks. Italso affects sheep, goats and some breeds of pigs (Asian pigs seem more susceptible than African and European pigs). Rinderpest can infect a large variety of wildlife sp ecies, including African buffaloes, eland, kudu, wilde
- beest, various antelopes, bushpigs, warthog and giraffes but is rare among camelids [ 83, 84, 85 ]. Transmission of rinderpest can occur through direct or close indirect contacts. The usual route of i nfection is via the respiratory tract with an incubation period of generally 4 to 5 day s following natural exposures but which may range from 3 to 15 day s. Viral shedding begins 1
- 2 day s before py rexia in tears, nasal secretions, saliva, urine and feces and typicall y continues for 8 to 9 days after the onset of clinical signs. Blood and all tissues are infectious before the appearance of clinical signs. Rinderpest can take several clinical presentations; classic, peracute, subacute and atypical. There is no carrier state following infection. The classic form is characterized b y a 2 - to 3 - day period of high fever, depression, anorexia, reduced rumination, increased respiratory and cardiac rate, congested mucus membranes, intense mucopurulent lachry mati on and excessive salivation. Gastrointestinal signs appear when the fever drops with profuse hemorrhagic diarrhea. Dehydration, abdominal pain, abdominal respiration, weakness, recumbency and death generall y occur within 8
- 12 day s. In rare cases, clinical signs regress by day 10 and recovery

occurs by

day 20 - 25. The peracute form has no prodromal signs and is characterized by high fever (>40
- 42°C) and death. The peracute form occurs in highly susceptible young and newborn animals. The subacute form has a low mortality

rate and a similar clinical presentation to the classic form. The atypical form is characterized b y irregular pyrexia with mild or no diarrhea. Rinderpest virus is relatively resistant and is stable between pH 4.0 and 10.0 but is susceptib le to most common disinfectants including lipid solvents. The virus remains viable for long periods in chilled or frozen tissues. Small amounts of rinderpest virus may survive relatively

high temperatures

— 56°C (133°F) for 60 min or 60°C (140°F) for 30 min.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 78

Differential diagnosis of rinderpest is similar to that of other viral vesicular diseases including FMD, Bovine viral diarrhea/mucosal disease (BVD), Infectious bovine rhinotracheitis (IBR), Malignant catarrhal fever, Vesicular stomatitis, and in small ruminants, peste des petits ruminants.APHIS Evaluation of th e Status of the Brazilian State of Santa Catarina 79 REFE RE NCES
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wine F ever (CSF) in Brazil . 2005. 4 . MAPA. State of Santa Catarina Proposal for R ecognition as a n FMD
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actors G iven in 9 CFR 92.2, Application for R ecognition of the A nimal H ealth S tatus of a R egion . 2003a: Department of Animal Health. 6. APHI S. Observations M ade D uring APHIS' Site V isit to Brazil. October 2002 & August 2003. 2003. 7. MAPA. Regionalization of FMD . 2002b, Department of Animal Health. 8. MAPA . Missao Estados Unidos da America
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resh, C hilled or F

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