## Risk Analysis : Foot

- and

- Mouth Disease Risk from

Importation of Fresh (Chilled or Frozen), Matured, Deboned Beef from Northern Argentina into the United States

Animal and Plant Health Inspection Service

Veterinary Services

National Import Export Services

April 201 4

### 2 

## Table of Contents

List of Figures

................................ ................................ ................................ ................................ .. 3

List of Tables

................................ ................................ ................................ ................................ ... 4

List of A cronyms

................................ ................................ ................................ ............................ 6 Executive Summary

................................ ................................ ................................ ........................ 7

A. RELEASE ASSESSMENT

................................ ................................ ................................ ........ 9 Part I: Eleven factor analysis

................................ ................................ ................................ .......... 9

1. Authority, Organization and Infrastructure

................................ ................................ ............... 9

2. Disease status : Is the restricted disease agent known to exist in the region?

......................... 20

3. The status of adjacent regions with respect to the agent

................................ ......................... 26

4. The extent of an active disease control program, if any, if the agent is known to exist in the region

................................ ................................ ................................ ................................ .. 29

5. The vaccina tion status of the region

................................ ................................ ....................... 31

6. The degree to which the region is separated from adjacent regions of higher risk through physical or other barriers

................................ ................................ ................................ ........ 35

7. The extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regarding such movements

................................ ...... 36

8. Livestock demographics and marketing practices in the region,

................................ ............ 50

9. T HE TYPE AND EXTENT O F DISEASE SURVEILLAN CE IN 

### A RGENTINA



### ..................... .. .... 61

10. Diagnostic laboratory capacity

................................ ................................ ............................... 74 11. Policies and infrastructure for animal disease control in the region

................................ ....... 77

B. EXPOSURE ASSESSMENT

................................ ................................ ................................ . 87

C. CONSEQUENCE ASSESSMENT

................................ ................................ ......................... 88

D. RISK ESTIMATION

................................ ................................ ................................ .............. 91

References

................................ ................................ ................................ ................................ ..... 92 Appendix I (Hazard Identification)

................................ ................................ ................................ 98
Appendix II (11 Factor vs. 8 Factor Comparison)................................................................103

### 3



## List of F igures

Figure 1: Map of Argentina and List of As sociated Provincial Acronyms

................................ ................... 5

Figure 2: Argentina Regional Units

................................ ........................ Error! Bookmark not defined. 13

Figure 3 : SENASA

- Regiona l Operative Offices

................................ ................................ ...................... 15

Figure 4 : Functional Organization Chart of SENASA as of 2007

................................ .............................. 16

Figure 5 : Tartagal outbreak, 2003

................................ ................................ ................................ ............... 22

Figure 6 : Map of San Luis del Palma, Corrientes 2006

................................ ................................ .............. 24

Figure 7 : Focal, perifocal, and surveillance area (San Luis del Palmar, 2006)

................................ .......... 25

Figure 8 : Rincón Navarro outbreak, San Luis del Palma, 2006

................................ ................................ .. 26

Figure 9 : Kilograms of noncommercial animal and vegetable products confiscated in the area north of

parallel 42nd during 2005

................................ ................................ ................................ ........... 40

Figure 10 : Map of the border area, Frontera Norte A

................................ ................................ ................. 45

Figure 11 : Map of the nor theast border, Frontera Norte B

................................ ................................ ......... 46

Figure 12: Argentina’s FMD status as recognized by OIE (May 2013)........................................ 47

Figure 13 : Ear tags used by Argentina (pink), Bolivia (white), and Paraguay (yellow) in the b order area 48

Figure 14: Bovine distribution in different Argentinean areas

................................ ................................ ... 51

Figure 15: Description of the digits in the RENSPA number.................................................... 52

Figure 16: Bovine Identification Example.......................................................................... 54

Figure 17 : Number issued by SENASA after disinfection of trucks

................................ .......................... 56

Figure 1 8 : Epidemiological zoning of Argentina for the purpose of serological sa mpling

........................ 63

Figure 19: Bovine (blue) and Ovine/Caprine (green) premises sampled

....................................... 71

Figure 20 : Organizational c hart of the SENASA laboratory..................................................... 75

### 4 

## List of Tables

Table 1 : SENASA offices in the provinces of Jujuy, Salta, and Formosa (2005)

................................ ...... 18

Table 2 : Vaccinated livestock per area during the 2003 outbreak Tartagal, Salta

................................ ...... 23

Table 3 : Vaccination rates (2001

- 2004)

................................ ................................ ................................ ..... 33

Table 4: SENASA personnel in the provinces of Jujuy, Salta, and Formosa

................................ ............. 38

Table 5: P roducts confiscated from luggage and/or passengers at airports and terrestrial ports ( in kg)

..... 40

Table 6: Number of agents stationed at control points, actions, pertinent information (as of 3/30/2006)

.. 48

Table 7: Emergency active personnel during the 2006 outbreak

................................ ................................ 49

Table 8: Amount of beef Argentina is considering exporting to the United States

................................ .... 57

Table 9: Livestock figures used to construct sampling lists.

................................ ................................ ...... 66

Table 10: Compliance with sampling for viral activity during 2004 and 2005*

................................ ........ 67

Table 11: Results of tests to detect antibodies against NSPs in bovine category

................................ ....... 67

Table 12: Sampling to determine viral activity by region, 2007 and 2008

..................................... 68

Table 13: Interpretation of the LP ELISA according to the percentage protection expectancy

................. 69

Table 14 : ELISA 3ABC and EITB result s from cattle in the areas that vaccinate against FMD

............. 70

Table 15: Sampling Design for 2013 Surveillance Study......................................................

... 73

Table 16: Diagnostic tests for FMD in 2003

................................ ................................ ............................... 77

Table 17: Number of Diagnostic Tests for Vesicular Disease Suspect Cases

................................. 77

Table 18: Vesicular Disease Notifications, 2008

- 2012

............................................................ 79

Table 19 : Reporting source for cases of FMD during the 2000

– 2001 epidemic in the Northern provinces

............ .................................................................................................... . 80

Table 20 : Economic impacts of FMD adjusted from 1976 dollars to March 2001 dollars by Consumer

Price Index 1

................................ ................................ ................................ ................................ . 89

### 5 Figure 1 : Map of Argentina and List of Associated Provincial Acronyms

PROVINCES

BUE Buenos Aires CAT Catamarca CBA Córdoba CHA Chaco CHU Chubut CRR Corrientes DOZ Mendoza ERI Entre Ríos FSA Formosa JUA San Juan JUJ Jujuy LAP La Pampa LAR La Rioja MNE Misiones NEU Neuquén RIN Río Negro SAL Salta SCZ Santa Cruz SDE Santiago del Estero SFE Santa Fé TDF Tierra del Fuego TUC Tucumán UIS San Luis

Used by permission from the Canadian Food Inspection Agency.

### 6 List of A cronyms

APHIS: Animal and Plant Health Inspection Service

B S L: Biosafety level

CCFyC: Quarantine, Borders and Certifications Unit

CFR: United States Code of Federal Regulations

CONALFA: National FMD Eradication Committee

COPROSA: Provincial Commission of Animal Health

DILACOT: Laboratories and Technical Control Office

DILAB National Directorate of Laboratories

DNFA: National Agrifood Inspection Office

DNSA: National Animal Health Office

DT

- e : Animal Transport Document

EITB: Enzyme

- linked Immunoelectrotransfer Blot

ELISA: Enzyme

- linked Immunosorbent Assay

EU: European Union

FMD: Foot

- and

- M outh Disease

INTA: National Farming Technology Institute

NESS: National Epidemiological Surveillance System

OIE: World Organization for Animal Health (Office

International des Epizooties)

PCR: Polymerase Chain Reaction

RENSPA: National Sanitary Registry of Ag

- producers

SENASA: National Health and Agrifood Quality Service

USDA: United States Department of Agriculture

VIAA: Virus Infection Associated Antigen

### 7

Executive Summary

The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has identified several World Organization for Animal Health (OIE) listed diseases as the primary hazards associated with initiating trade in animals and animal products from foreign regions [ 1 ] . Listed foreign animal diseases of primary concern are addressed specifically in APHIS regulations (9 CFR 94) [ 2 ] . F oot and M outh disease (“FMD”) is one of the diseases recognized in APHIS regulations as such a hazard [ 3 ]

. In this regard, before opening or resuming trade in fresh beef under certain conditions with any region or country that is not recognized by APHIS as either free of FMD or as a ble to export such commodity, APHIS routinely conducts an evaluation to support its decision

- making (9 CFR 92.2) [4]

. Accordingly, Veterinary Services (VS) has conducted this risk analysis as a decision

- making tool for a proposal to initiate trade in fres h (chilled or frozen) beef from a region in Argentina located n orth o f Patagonia South and Patagonia North B referred to as “ N orthern Argentina” ( or the “export region”)

. Historically, rinderpest virus has never established itself in North America, Central America, the Caribbean Islands, or South America (and therefore is not addressed further within this document ) . A brief incursion into Brazil occurred in 1921

, but was limited in scope and quickly eradicated. Trade in fresh beef from Argentina has not been allowed since June 2001 because USDA has considered Argentina to be a country affected with foot

- and

- mouth

- disease (FMD)

.

This risk assessment is intended to enable APHIS to develop appropriate regulatory conditions with mitig ations to address potential risks of FMD disease introduction following any initiation of trade in fresh beef from the Northern Argentina. It is also an information source for APHIS stakeholders, providing justification for the conditions in the rule

. The analysis considers the epidemiological characteristics of FMD 1 that are relevant to the risk of introducing FMD virus into the United States through trad e in fresh (chilled or frozen) beef from Northern Argentina and describes the animal health system in Northern Argentina. It ide ntifies potential areas of risk and discusses appropriate mitigations to reduce that risk

. The mitigations under consideration included restrictions on the origin of animals, requirements for maturation and pH testing of carcasse s, ante

- mortem and post

- mortem inspections, and verification by Argentinean officials that the various mitigations were applied appropriately.

APHIS evaluated information provided by Servicio Nacional de Sanidad Animal y Calidad Agroalimentaria (SENASA) a nd conducted site visits to northern Argentina in May 2005

, September 2006 , and November 2013 in order to substantiate the information reported in the documentation and to collect additional data

. In addition, APHIS conducted site visit s to the south of Argentina in December 2003 and February 2009

, to evaluate the Patagonia region

. APHIS also visited the areas near the border with Bolivia and Paraguay to evaluate the zone where limited outbreaks occurred in 2003 and 2006

. The site visits focused on the veterinary and legal infrastructure of SENASA, border control procedures, disease control measures, laboratory and diagnostic capabilities, biosecurity procedures on cattle farms and in slaughter facilities, animal health recordkeeping syste ms, movement controls, and disease surveillance systems

. The visits incorporated an evaluation of outbreaks that had occurred in 2003 and 2006

, and the effectiveness of control measures in these outbreaks

. The final analysis was based upon information obta ined from the site visits, written information provided by SENASA, and published information

.

1 Epidemiological characteristics of the disease agent relevant to the import risk it may pose are described in Appendix 1.

### 8

APHIS acquired no evidence to suggest that FMD is prevalent throughout th e export region

. Although limited outbreaks occurred in both 2003 and 2006, the diseas e was quickly diagnosed, controlled, and eliminated. Observations of these events, taken together with the results of APHIS’ extended evaluation, lead APHIS to conclude that Argentina’s legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs and emergency response systems are adequate to detect and control any future FMD outbreaks within the national boundaries of the exp ort region of consideration

. Although consequences of an FMD outbreak in the United States are potentially substantial, the likelihood of an outbreak occurring via exposure of the domestic livestock population to fresh or frozen beef processed under certai n conditions imported from N orthern Argentina is low

. Therefore, APH IS concludes that fresh (chilled or frozen) , matured and deboned beef can be safely imported from the Northern Argentina region.

### 9

A. RELEASE ASSESSMENT

The r elease assessment is a description of the biological pathway(s) necessary for an importation activity to introduce pathogenic agents into a particular environment, with an estimate of the likelihood of that complete process

. For the purpose of this report, releas e assessment refers to the evaluation of the likelihood that FMD exists in N orthern Argentina

. If FMD does exist, the assessment evaluates how likely the disease is to be introduced into the United States through imports of fresh (chilled or frozen),
matur ated, and deboned beef products from Argentina

.
The release assessment is based on documentation provided by SENASA, APHIS site visits to Argentina, and other published information. Assessing the likelihood of introducing FMD into the United States requir es an evaluation of relevant characteristics of the exporting region in relation to the epidemiology of the disease. The release assessment consists of an in

- depth evaluation of the 11 risk factors identified by APHIS in 9 CFR 92.2 ( prior to 2012 ) as facto rs in assessing the risk of the relevant animal disease posed by a region [ 4 ]

. In 2012, APHIS consolidated the eleven factors listed in 9 C.F.R. § 92.2(b) into eight factors. APHIS introduced this simplification in order to facilitate the application process; however, since the evaluation of N orthern Argentina started before 2012, an d the topics addressed by the 11 factors are encapsulated in the eight, this report follows the 11 factor format. Appendix II describes the consolidation of the 11 factors into ei gh t

. The 11 factors are as follows:

 The authority, organization, and infrast ructure of the veterinary services organization in the region ;

 Disease status ( Is the restricted disease agent known to exist in the region? );

 The status of adjacent regions with respect to the agent ;

 The extent of an active disease control program, if any , if the agent is known to exist in the region ;

 The vaccination status of the region ;

 The degree to which the region is separated from adjacent regions of higher risk through physical or other barriers ;

 The extent to which movement of animals and animal pr oducts is controlled from regions of higher risk, and the level of biosecurity regarding such movements ;

 Livestock demographics and marketing practices in the region ;

 The type and extent of disease surveillance in the region ;

 Diagnostic laboratory capacity ; and

 Policies and infrastructure for animal disease control in the region

. Risk factors are identified from the information gathered on these topics and applicable mitigations are discussed

. This part describes APHIS’ evaluation of these factors for a de signated region in Argentina consisting of the region located north of the 42nd parallel

.

1. Authority, organization and infrastructure

The authority, organization, and infrastructure of veterinary services must be clearly documented to provide confidence in the ability of the country to monitor 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, physical, a nd regulatory resources available within SENASA

. The discussion describes the legal authority for animal health activities in the region, the

### 10

organizational structure and function of veterinary services, and available personnel and financial

resources

.

C entral authority

All regulations related to the control of FMD are based on the General Animal Health Enforcement Law (Law 3959/1903)

. This law, along with its accompanying regulations of 1906, grants authority to the Government to restrict and regulate i ndividual rights to pursue the general welfare and establishes the measures necessary to protect safety and health

. Legal authority for control relative to Argentina ’ s FMD status is provided by several SENASA resolutions and other decrees, laws

, and resolu tions

. National Law 24.305/93, along with Decree No. 643/96, establishes the FMD National Eradication Plan and requires immediate and mandatory reporting of FMD cases in Argentina

. SENASA Resolutions 5/2001, 18/2001, and 58/2001 are additional regulations which complement and provide authorization for the FMD National Eradication Plan

. SENASA Resolution 234/96 implements the National Epidemiological Surveillance System (NESS), authorizing the involvement of certain government and private sector offices and units to work at local, provincial

, and national levels to control reportable animal diseases

. SENASA Resolutions 478/99, 779/99, 192/2001, 370/2001, 383/2001, 510/2001, and 37/2002 and SAGPyA Resolution 378/99 establish measures in controlling FMD outbrea ks

, including sanitary steps with susceptible, ill

, and in

- contact animals in the region of the outbreaks; notification and operative procedur es if FMD is detected on a farm; preventi on of spread of the disease; and implementation of the National Sanitary Emergency System

. A lso

, a large number of resolutions establish procedures and conditions for the import of various animals and animal products, disposal of organic wastes from ships and airplanes, passenger and luggage control procedures, and movement of animals within the country

. SENASA Resolutions 495/2001 and 115/2002 establish requirements for shipping FMD

- susceptible livestock to slaughter for export of meat to the European Union (EU) or from farms approved to export
meat to the EU or marke ts with eq uivalent requirements [ 5

- 14 ]

.
SENASA is divided into several sections, three of which focus on animal health issues: (1) the National Animal Health Office (DNSA); (2) the National Agrifood Inspection Offi ce (DNFA); and (3) the Laboratories and Technical Control Office (DILACOT). These offices report directly to the President of SENASA. This structure reflects organizational changes made in 2001 and 2002 and 2007 [ 11, 12, 14] to address issues and problems identified during the FMD outbreaks that occurred north of the Patagonia Region in 2000/2001.

The DNSA organization and structure is defined in SENASA Resolution No. 274/2002 [ 14 ] . The DNSA is specifically responsible for border controls, animal health co ntrol

, and eradication programs, including the necessary preventive, control

, and eradication actions to ensure compliance with current statutes. The actions of this office a re currently carried out in the region of Northern Argentina by the 14 regional and 360 local offices, respectively [ 82 ]. The Epidemiology Office of DNSA carries out, coordinates, assesses, and oversees the FMD program in Argentina. The DNSA is also responsible for strategic prevention activities, risk analysis, and surveillance and assessment of the vaccination programs [ 1 1]

. Within the DNSA, there is also a department responsible for overall coordination in the area of identification and registration of animals, animal movement controls, and traceability

.

The General Field Coordina tion Unit, which reports to the DNSA, implements its responsibilities through the local offices and regional supervisors. Its duties include [2] :

 Coordination and management of the prevention, control and eradication actions of animal disease control progr ams;

 Control of compliance of sanitary actions and enforcing the Law of Sanitary Police and pertinent regulations; and

 Supervision of livestock movement, premises approval and certification.

### 11

The responsibilities of the local SENASA veterinarians include:

 Implementation of prevention, control, and eradication actions of the animal control programs in their jurisdiction;

 Investigation of notifications, suspicions, and outbreaks;

 Permanent monitoring of diseases of interest and epidemiological tasks;

 Implementation of sanitary police actions and compliance of the regulations in force;

 Control and supervision of livestock movement and transport and issuance of the pertinent certificates; and

 Updating producers’ document registries, establishments, lives tock existences, movements, and sanitary and administrative controls in their jurisdiction.

The responsibilities of the regional supervisors include:

 Supervision of disease prevention, control, and eradication actions in their jurisdictions and epidemiolo gical surveillance actions;

 Supervision of compliance of legal regulations in force;

 Organization and operation of local offices;

 Assessment of the field staff performance; and

 Official representation of SENASA in their zone.

The Directorate of Na tional Q uality and Food Safety , under DNFA, i s responsible for enforcing hygiene and health requirement compliance in slaughtering plants, processing plants, and storage facilities for animal and plant products and byproducts (edible or inedible). The Veterinary I nspection Service performs these controls at slaughtering plants approved for export [1]

.

The DILACOT has two units

– the Laboratory for Animal Products and Byproducts and the Laboratory for Plant Products and Byproducts. This office also operates the Nat ional Reference Laboratory for food safety and animal and plant health. In addition, the DILACOT has regional laboratories and manages a network of laboratories accredited by SENASA (for more information on DILACOT

, please refer to factor ten). The functio ns of the DILACOT are as follows [1] :

 Establish the methods and test protocols that are used at the SENASA c entral l aboratory and the laboratories that participate in the national network;

 Intervene in dispute resolution;

 Confirm positive test results is sued by the laboratories in the network;

 Carry out and participate in interlaboratory tests;

 Audit the network of laboratories;

 Provide assistance to other SENASA offices to assess analytical results; and

 Participate in reviewing regulations pertinent to i ts field of action and participate in international meetings (e.g. Codex Alimentarius, MERCOSUR, and OIE).

Under the 2013 structure, the Quarantine, Borders, and Certifications Unit (CCFyC) falls under DNSA. The CCFyC oversees the Animal and Plant Quarantine Unit, the International Movements Unit, and the Borders and Sanitary Barriers Unit. The Borders and Sani tary Barriers Unit operates the control posts at the inland sanitary barriers and border crossings (fluvial and marine ports, airports, and border crossings) [1, 14]

.

Fourteen regional Directorates report directly to the SENASA’s General Manager. Support for the animal health system comes from a participatory structure based on 360 local animal health offices, 30 of which are located in the Patagonia Region. These local offices represent various local organizations and have

### 12

technical subcommittees chaired by official or private veterinary physicians that practice in the area that work closely with SENASA officials [1] . These offices, as authorized by Law No. 24.305, are part of the Epidemiological Surveillance System (NESS) in accordance with the re sponsibilities and functions spelled out in the legal regulations in force. Officials work at the local, provincial, and national levels and comply with established methodologies, procedures, and operations [2]

. At the regional l evel, 24 Provincial Animal Health Committees (COPROSAS) participate in the National FMD Eradication Committee (CONALFA). CONALFA provides a forum for consensus where the provincial governments, SENASA, and representatives of the farmers associations define the operational strategie s to carry out the zoosanitary policies defined by SENASA [1]

. SENASA’s Reorganization

SENASA’s reorganization focused in three major areas [11] : (1) Structure (2) Financial resources (3) Human resources

Structure:

The first important SENASA reorganization was de fined by Decree 394/2001 [2] . It was intended to increase the efficiency of the existing geopolitical system and address international perception that SENASA had not been transparent with its trading partners about its FMD situation. In fact, in 2000, SENA SA failed to report the first FMD outbreaks for several months after they had been detected [18]

.

In 2001 SENASA was restructured so that the veterinary units were no longer based on political borders and the chain of command was changed to address issues that arose during the 2000/2001 FMD outbreaks, including centralization of command and control of the animal health programs. Prior to the 2006 reorganization, SENASA personnel in each province reported to one of three regional directors, each of which ad ministered huge regions. Resources were not allocated to address the regional workload. Specifically, regions with high levels of activity (large livestock population and movements) were assigned the same number of personnel as regions with lower levels of activity, so the system was inefficient. Also, SENASA concluded that there was too much autonomy given to the regional directors.

The regional directors had too much discretion in carrying out the orders from the central office, and the field people had such a wide range of duties that they had trouble focusing on animal health. In regard to transparency, many of the reorganization elements addressed issues of internal monitoring, accountability, and compliance with national policies. The reorganization a lso addressed international standards, certification requirements, and an increased emphasis on border controls [11]

.

In the 200 7 reorganization, boundaries of regional units were redefined so that personnel were assigned at a level appropriate to the act ivity occurring in the region. For example, the province of Buenos Aires, which constituted a very busy single region before the reorganization, was broken into six separate units. This increased the efficiency of the system by distributing the workload mo re evenly [11] . Region 21 and most of region 22 on the map in F igure 2 make up the Patagonia North B region. Regions 23 and 24 make up Patagonia South.

### 13 Figure 2 . Map of SENASA Regional and Local Units as of 2006

In 2007, SENASA redefined its regional units by issuing Resolutions 225/2006, 335/2007, and 362/2007, and created a Regional Operative Unit (Unidad Regional Operative) within the Central Unit (Vice

P residential Unit) to coordinate activities of the 14 Regional Oper ative Offices (ROs

– Centros Regionales).

### 14

The objective of this structure was to facilitate communications between the central and regional levels and to improve interactions with the local government (e.g., provincial, municipal) and non

- governmental
aut horities.

The Regional Operative Unit (ROU) represents a liaison between SENASA central and regional levels. The regional offices provide the oversight to the local field offices and coordinate regional animal health programs. SENASA assigns a budget to each of the regional offices, based on its needs. For instance, the Buenos Aires Regional Unit is the largest (comprises 13 percent of the total budget), and oversees 43 local SENASA offices. Regional Operative Offices are shown in F igure 3

.

### 15

Figure 3 . Regi onal Operative Offices of SENASA

In 2013, SENASA established the direct reporting between Regional Units and the General Manager of SENASA by issuing Resolution 354/2013. The 2013 Resolution also assigns to the General Manager other responsibilities, su ch as the coordination and monitoring of the Regional Operative Offices. Further, it adds a research component among the SE N ASA’s functions and responsibilities. The diagram of the new structure is represented in Figure 4.

### 16

Figure 4 . SENASA’s Structure

Financial resources:

SENASA reported that its 2013 budget was 1.3 billion pesos (approximately $200.7 million U.S. dollars). SENASA officials described the system as self

- sufficient because user fees are required for almost every service SENASA provide s, including slaughter surveillance, issuances of certificates, and laboratory tests [19]. The budget for the laboratory is 60 million pesos (approximately $12 million U.S. dollars)

Human resources :

In November 2013, SENASA reported a total of over 5, 500 employees, which includes both animal and plant health personnel. Of these, over 80 percent have a professional degree, of which 1,054 are veterinarians. Local and regional offices located in areas with high livestock concentrations have a larger numbe r of veterinarians, animal techni c ians

, and administrative staff

. Rules are in place for employees to address conflict

- of

- interest issues. For example, slaughter plant and field inspectors are not allowed to own livestock or sell beef.

SENASA can expand its staff, when necessary, by hiring contract personnel, including veterinarians and animal health technicians. Contract personnel are hired on the basis of a standardized profile defined by SENASA for four month increments and their contracts are renewabl e. Permanent and contract veterinarians have the same authority.

SENASA can also broaden the scope of its activities through agreements with outside parties. For example, it has entered into agreements with some academic institutions to cooperate in acti vities such as conducting risk analyses. Other agreements have been implemented with enforcement agencies like the border police, who assist with security at border control points along land or water borders. Border police also assist SENASA with enforceme nt of quarantines. They played a significant role in security during

### 17

previous FMD outbreaks. Security forces that work at slaughter facilities also assist in the disease control
program [11] . SENASA can call upon border police and other security forces to help prevent entry of disease into Argentina.

Veterinarian licensure, training and roles in the animal health programs

Veterinarians in Argentina are licensed after obtaining a veterinary degree authenticated at the Ministry of Culture and Education. Th ey must be registered at the National or Provincial Professional Association of Veterinary Physicians in the jurisdiction of employment. The respective association issues their license. National and provincial licensure is mandatory [2]

.

The National Priv ate Veterinary Physician Registry, created by SENASA Resolution No. 470/95, registers private veterinarians that take part in the NESS. Registered veterinarians must notify the local DNSA commission of suspect cases of notifiable diseases, including suspec t cases of FMD. In addition, SENASA Resolutions Nos. 234/96 and 422/03 incorporate Veterinary Physician Professional Associations and Councils into the NESS. Registration must be renewed annually and veterinary licensure must be kept up

- to

- date. SENASA iss ues the Registry Veterinarian certificate and guarantees the necessary training for proper performance of duties. This registry has different sections, according to the areas of responsibility of the corresponding office or unit. These veterinarians must c omply with a continuous training program which includes procedures and standards that are currently in force to control reportable diseases [2]

.

I n 2003, SENASA Resolution No. 181 was enacted. It establishes the requirements to accredit private veterinarians in the FMD eradication program, including verification that the veterinary license is up

- to

date and of compliance with scheduled training goal s. The 2009 and 2013 site visit team verified that the resolution was fully implemented.

Private veterinarians accredited by SENASA also perform FMD vaccinations in some regions of the country and preloading inspection on bovine and ovine animals intended for slaughter to export meat and meat products to the EU. They verify the health status of the animals and the accuracy of the premises ’ documents. If satisfactory, then a health pre

- certificate is issued which is later endorsed by the local SENAS A veterinarian.

Official SENASA veterinarians and private veterinarians accredited by SENASA both must comply with training requirements that are in line with the main strategies in the FMD Eradication Plan. The goal of the Plan is to promote measures to strengthen the national and continental structure of FMD surveillance programs. These measures include training activities for the different participants of the program (technicians and administrative staff) and promotion of the different activities of the Plan. The purpose of the Plan is to provide technical resources to the SENASA staff in important subjects such as FMD control.

Training of official SENASA employees is part of a central theme in the development of national animal health programs. Trainin g programs for all the staff levels are developed within the Bureau of Human Resources and Training of SENASA. Staff is responsible for supervising each activity of the FMD Eradication Plan and their adequate performance is vital to meet the established go als. The content of training courses meets the technical guidelines established by the FMD National Eradication Plan and the specific bibliography of the OIE. Veterinarians must also comply with the guidelines of the Training Operative Plan established by SENASA and the Civil Service National Institute, which includes training on various animal diseases besides FMD. All programs are conducted by experts and teachers from

### 18

SENASA and other institutions through agreements with national universities, research i nstitutes such as INTA (National Institute for Agricultural Technology), and others (FAO, etc.). Training activities for SENASA staff and laboratory were provided during the site visits, including the latest activities in 2013 [20].

Training for staff in the DNFA includes the following subjects: legislation in force (Decree 4238/68 and others), approval of establishments producing products intended for domestic consumption and export, hazard analysis and critical control point principles, good manufacturi ng practices, standard operating procedures (for establishments treating products and by

- products of animal origin of all species, including birds and fish), diseases spread by food, animal welfare, traceability, residues, and hygiene control [1]

.

Provinc ial veterinarians also take an active role in the sanitary commissions that fight against endemic diseases. They work together with SENASA official veterinarians, private veterinarians, cattle farmers, and others, along with the respective COPROSAs of each province as part of the Epidemiological Surveillance Commissions (Resolution 445/95

– Regional Patagonia Plan) [2]

. Field offices

Regional supervisors provide oversight for field offices

. Field offices handle local prevention and control measures, eradi cation, compliance, emergency actions, health actions (e.g., vaccination)

, premises identification

, movement controls

, and record keeping

. Many of these responsibilities are controlled through the registration of and assignment of a unique premises identifi cation number called the Registro Nacional Sanitario de Productores Agropecuarios

- National Sanitary Registry of Ag

- producers (RENSPA) , which, in addition to other information on premises, is maintained in a national database

. The team that visited Argent ina in May 2005 visited regional and/or field offices in the provinces of Salta (Salta, Tartagal, and Ingeniero Salvador Mazza), Buenos Aires (Bran d sen), and Formosa (Formosa and Clorinda)

. The team that visited Argentina in September 2006 visited two loca l offices in the province of Corrientes (Corrientes and San Luis del Palmar). The team that visited Argentina in 2009 and 2013 visited regional office s and local offices in the province of Buenos Aires

Additional veterinary infrastructure components in northern Argentina, along the border with Bolivia and Paraguay

Veterinary infrastructure in the region was enhanced after the 2003 outbreak to address vulnerabilities associ ated with international borders

. Table 1 shows the number of SENASA offices i n the area [ 8 ]

.

Table 1 : SENASA offices in the provinces of Jujuy, Salta, and Formosa (20 13)

Province SENASA Local offices SENASA Regional offices Total

Jujuy 1 1 2 Salta 11 0 11 Formosa 1 7 1 1 8 Total 29 2 31

SENASA provided the local offices with equipment such as em ergency response equipment, gas

- operated coolers, refrigeration units, power generators, computers, etc.

### 19

In order to implement the FMD National Eradication Plan’s strategies, SENASA establish ed new local offices and hire d veterinarians, technicians, and administrators in the border departments

. These offices

were equipped with the following:

a. IT equipment to be able to issue movement permits ( “ DT

- e ” or Animal Transport Document ) ; b. Communica tion equipment including satellite telephones and global positioning system (GPS) devices ;

c. Emergenc y equipment such as disinfectant cans, spraying backpacks, Valle medium, tubes, needles, syringes, and Manuals of Proceedings ; d. Appropriate vehicles fo r field tasks, four

- wheel

- drive vehicles (pick

- ups, etc.)

, and motorcycles ;

e. Gas

- operated ref

rigerating equipments or others ; f. Electric generator equipment ; and
g. Mo vable pens

. Specific FMD control and surveillance a ctions recommended by OIE [ 15 ]

Following the recommendations of the OIE mission that vi sited Argentina, Brazil, and Paraguay in December 2006 [ 16 ] , the heads of the v eterinary s ervices and the Pan American Foot

- and

- Mouth Disease Center (PANAFTOSA) defined an area of high

- level surveillance within the border regions of Argentina, Brazil, Paraguay, and Bolivia

. Initially the program w as intended to last two years and be subject ed to periodic reviews and evaluations. During the 2009 and 2013 site visit s , SENASA reported that the
program was still effectively operating , with a redefinition of the high surveillance area in 2013 to include the border regions of Argentina, Paraguay and Bolivia

. Most of the financing has been obtained from the World Bank a nd the Inter

- American Development bank

. Among others, the general actions include:

 Strengthe ning infrastructure of the veterinary services ;

 Harmonizing procedures for control, prevention, and eradication of FMD;

 Harmonizing vaccination procedures in areas of geographic contiguity; and

 Conducting vaccinations under VS supervision.

Swill feeding

SENASA Resoluti on 225/95 regulates housing and maintenance of pigs

. This Resolution bans feeding pigs with raw viscera of any origin, kitchen garbage, hospital, clinic, or nursing home garbage and garbage from national or international ports and airports

. It authorize s feeding pigs with leftovers of food substances of animal origin coming from stores approved by the competent authority to manufacture or sell food

. Authorization is given after compliance with the following requirements:

 The swill is subjected to a cooking process guaranteeing destruction of pathogenic organisms (Resolution 3456/2001) [ 17 ]

.

 The existence

, on the premises

, of equipment necessary to carry out the requirements of the above cooking process with an operation capacity allowing treatment of all the leftovers in a period of time not longer than eight hours after arrival on the premises

. Compliance with the requirements is verified through daily veterinary inspections.

There are no establishments exclusively approved to process swill

. Swill treatments are carried out by the pig producer in the establishment, or the producer obtains the processed swill from slaughtering establishments [ 18 ]

.

### 20

Compliance is monitored pursuant to regulations that ha ndle other sanitary/hygiene issues

. SENASA Resolution 350/98 sets up a mechanism by which SENASA veterinarians can more easily confiscate animals infected with trichinellosis or that constitute a risk because of inadequate sanitary

- hygienic conditions, due to failure to comply with SENASA Resolution 225/95

. In addition , a regulation combined with 350/98 was developed to regulate pig activity and widen the scope of the current regulations to control trichinellosis infestations

. As a consequence, there will b e safeguards to grant additional sanitary protections against FMD contamination of feed [ 18 ]

.

Conclusions

Argentina has the veterinary and regulatory infrastructure to adequately monitor and control the possible incursion of FMD into the country

. Based on site visits

, observations

, and evaluation of documentation submitted by SENASA, APHIS concluded that veterinary officials in Argentina are able to quickly identify disease events compatible with FMD

. SENASA has a s trong veterinary infrastructure

.

Local v eterinary offices are adequately staffed in Argentina

. The local offices that APHIS visited demonstrated that they had the necessary staffing, training, equipment

, and control mechanisms to implement and manage a reliable FMD program

. During the several site visits to Argentina, APHIS received overviews of the activities and structures of the Federal, r egional, and local level

. APHIS reviewed premises registration, vaccination records, and movement control documents and visited farms to observe farming practices

. Observations indicated that the structure, effectiveness and organization of SENASA were adequate to perform official animal health functions

.

APHIS cons iders that the regions along the northern borders with Bolivia, Brazil, and Paraguay constitute a potential source of vulnerability for Argentina where FMD might be introduced from neighboring regions

. APHIS believes that enhancements in border control act ivities and infrastructure in the provinces of Formosa, Salta, and Jujuy as well as the enhancements in the provinces of Misiones, Chaco, and Corrientes provide adequate monitoring of the disease and control in the event of a potential introduction.



### 2. D isease status : I s the restricted disease agent known to exist in the region?

Gaining a thorough understanding of the history of FMD in the region is essential to assessing the existing export risk

. Assessment of risk includes a consideration of the effect iveness of control measures implemented and revision of those measures as appropriate

. Consequently, this section focuses on historical outbreaks

. The Argentine National FMD Control Program (1990/1997) led to the control and eradication of the disease and the official OIE status of Argentina as FMD

- free with vaccination in 1997 (last outbreak detected in 1994)

. In 1999 vaccination was suspended, and in May 2000 the OIE recognized Argentina as a country free of FMD without vaccination

. In July 2000, 14 months after vaccination was suspended, outbreaks of FMD reappeared

. The epidemic lasted 18 months

, during which more than 2500 premises were affected

. The disease mainly affected regions of major livestock concentration

. Infected animals were mostly cattl e (96.78 percent ) under 2 years of age (80.4 percent )

, while 2.49 percent were sheep

, and 0.65 percent pigs

. Virus serotype O was responsible for only 11 outbreaks at the beginning of the epidemic, while serotype A was responsible for 2

, 552 outbreaks and c irculated until January 2002

. SENASA reported the disease to trade partners, and other international organizations 9 months after the first outbreak (April, 2001) [ 8

, 19 ]

. Subsequent e pidemiological investigations identified the following factors that contribut ed to the entrance and dif fusion of the virus in 2000:

### 21

 Lack of knowledge of the regional epidemiological situation and absence of a regional approach ;

 Insufficient border control and inadequate sanitary infrastructure in the north of the country (border with Paraguay and Bolivia) ;

 Lack of adequate evaluation of risk in relation to movement of animals, production, and other factors ;

 Late detection of the disease and failures in surveillance ; and

 L ack of official declaration of disease with resulting limitations in authority to implement adequate control measures

.

The initial control measures taken by SENASA included stamping out; ring vaccination ; restriction of animal and people movements; estab lishment of disinfection points; and delineation of focal, perifocal

, and surveilla nce area s

. Emergency v accination in the high

- risk areas began long before the FMD declaration was official ; h owever, t here were limitations in vaccine supply

. CONALFA, Provincial Commission of Animal Health ( COPROSA ) , and Entes Sanitarios Locales (the Foun dation unit responsible for vaccine delivery) were not adequately functional, and movement controls were weak

. In the absence of a n official declaration of a disease outbreak , officials had difficulty implementing appropriate control measures

. Declaration made control measures easier to implement and facilitated development of a national plan [ 8

, 19 ]

.

V accine use was prioritized becaus e there was not enough vaccine for complete coverage of the affected

area

. Dairies and feedlots were assigned the top priority, followed by the surveillance and focal areas

. Pigs were not vaccinated during this period

. In fact, vaccination followed the outbreaks, rather than preceding and preventing them [ 20 ]

. The peak of the first epidemic occurred in May and June 2001

. SENASA estimated that the number of diseased animals approached 120,000

. Emergency vaccination was initially implemented with available tetravalent vaccines (O1/Campos, A/Arg/79, A/Arg/87, C3 /Arg/85) and trivalent vaccines (strains of O1/ Campos, A24/Cruzeiro and C3/Inda ial )

. Since January 2001, the virus strain A/Arg/00 was incorporated into this vaccine

, replacing the C3/Indaial strain [ 21 ]

. Systematic twice

- yearly vaccination campaigns started again in A pril 2001

. A tetravalent vaccine was subsequently developed including strains O1/Campos and A24/Cruzeiro and the new strains A/Argentina/00 and A/Argentina/01. The eradication measures included systematic and strategic vaccination, movement controls, surve illance, and cooperation agreements with bordering countries [ 8 ]

. In August 2003, a new FMD outbreak was detected in a local slaughterhouse (subsistence operation) in the district of San Martin (Province of Salta), located 10 km from the town of Tartagal and 40 km from the Bolivian border ( Figure 5 )

. SENASA reported that the affected holding had 37 pigs ( 16 with chronic vesicular lesions and two d ea d )

. T here were no other susceptible species in the holding [ 22 ]

.

### 22

Figure 5 : Tartagal o utbreak, 2003

Subsequent to the report of clinical suspicion of the disease in pigs on August 28

, 2003, and prior to confirmation, a number of preliminary FMD control measures were put in place

. FMD control measures included quarantine, stamping out, and the development of a focal, perifocal

, and surveillance area in line with OIE guidelines

. SENASA reported the suspect case to border ing countries, trade partners, and i nternational organizations on August 29

. On September 5, the Argentinean authorities notified the OIE that the FMD serotype O had been confirmed by laboratory testing

. On August 29

, strategic vaccination in the per i focal area was implemented, including rev accination (within a 30 day interval) of susceptible species. The vaccine used contained A24, A2000, A2001, and O1 Campos subtypes

. On September 10

, contact animals (58 porcines, 2 ovines, and 3 bovines) were slaughtered [ 22 ]

.

### 23

Table 2 : Vaccinated livestock per area during the 2003 outbreak Tartagal, Salta

Area Producers Bovines* Sheep/Goats Pigs Total 1 2 3 4 5 6 Perifocal 43 485 29 169 201 203 1087 225 820 2132 Surveillance 189 936 59 308 552 586 2441 1304 2158 5903 Total 232 1421 88 477 753 789 3528 1529 2978 8035
* 1= cows, 2=bulls, 3=heifers, 4=steers, 5=calves, 6=total

SENASA estimated that the initial infection took place at least 30 days before the clinical diagnosis in pigs was made.

The APHIS site visit team that visited Argentina in 2005 also visited the slaughterhouse in which the 2003 outbreak was detected

. The team observed the biosecurity measures in place after the detection of the case

. During 2004 and up to the date of the site visit (May 2005), the region involved in the 2003 outbreak (North/West of Argentina) reported 16 notifications of vesicular diseases

. None of the noti fications were considered suspect cases for FMD

. T herefore

, no animal restrictions were enforced (e.g., echyma, foot rot, trauma, sarcoptic mange).

Argentina also responded in a timely manner to FMD outbreaks in neighboring countries (Mato Grosso do Sul, Brazil in 2005 and Paraguay 2011/2012 ) by declaring sanitary emergency alerts ( R esolution s SENASA 672, 2005 and 684, 2011 ) and intensifying biosecurity, control, prevention

, a nd surveillance within the high

- risk border area.

The last FMD outbreak in Argentina was detected in February 2006 in a farm located in the district of San Luis del Palma r in the Province of Corrientes ( Figure 6 )

. The outbreak occurred in an area near the border with Paraguay considered endemic for FMD

. This endemic area appears to have active virus present in restricted niches or patches, which could potentially lead to outbreaks in cattle populations with low FMD immunity

. Before 2006, the last outbreaks reported in the area were registered in 2000 (virus O) and 2001 (virus A ) [ 19 ]

.

### 24

Figure 6 : Map of San Luis del Palma r , Corrientes 2006

On February 4
, 2006, a private veterinarian reported suspect cases of vesicular disease in cattle to the local office of San Luis de l Palmar

. The next day, the local SENASA Veterinarian observed the vesicular lesions in the mouth and feet of approximately 70 heifers ( 18 months )

. T he lesions were presumed to be about 10 days old

. Subsequent to the report of clinical suspicion of the disease in cattle, and prior to confirmatio n, a number of preliminary FMD control measures were put in place by SENASA including quarantine, interdiction, and initiation of an epidemiological investigation in accordance with OIE guidelines [ 23 ]

. On February 8, the SENASA c entral l aboratory diagnosed FMD type O virus using the ELISA

- S I technique to identify the virus

. After this confirmation, the following measures were taken:

 The information was officially communicated to the pertinent international organizations (OIE, MERCOSUR Permanent Veterinary Committee [Comité Veterinario Perma nente del MERCOS UR], PANAFTOSA), trading partners, industries, and producers.

 SENASA imposed movement i nterdiction s on all D epartments sharing borders with the Department of San Luis del Palmar

. Only movement of animals to slaughter for local consumption was authorized (S ENASA Resolution 35/06).

 Control and disinfection posts on National highways and other strategic locations were established and checkpoints and disinfection control posts were implemented around restricted areas ( 11 road check points to check products in transit and disinfect vehicles, 1 control post at the airport of the c ity of Corrientes )

. These posts operated 24 hours a day

.

 SENASA conducted s tamping out of contact susceptible species (SENASA Resolution 36/2006 ) and defined a focal, perifocal
, and surveillance area ( Figure 7 )

.
 Active surveillance of susceptible animals in an area of 13 km surrounding the affected holdings was initiated.

 Ring vaccin ation was conducted.

 SENASA imposed a b an on the movement of animal products and by

- products produced and manufactured within the area

. As a result of the emergency, SENASA increased Federal and provincial personnel involved in law enforcement and safety

. By February 12, SENASA personnel participating in the emerg ency included 22

### 25

veterinarians, 10 administrators, 10 vaccinators, and 72 contract employees

. A total of 126 security forces (National Border Police, Argentine Navy, and National Aeronautical Police) were also participating by providing support during the emergency

. Figure 7 : Focal, perifocal, and surveillance area (San Luis del Palmar, 2006)

SENASA reported that the first affected holding housed 4,098 bovine s (70 cattle showing clinical signs of FMD), 100 ovine s , 235 caprine s , and 5 porcine s

. The epidemiological investigation results showed that the index farm registered four cattle movements out of the premises during January 2006

. The first two movements represented cattle sent to two different establishments for slaughter (both located within th e quarantined area)

. The remaining movements represented animals sent to other farms, (one within and the other bordering the quarantined area)

. Such movements were registered in the SENASA database

. The APHIS site visit team that visited Corrientes in 200 6 also visited the index farm and interviewed the veterinarian and the manager of the establishment

. The manager reported that he was able to recognize FMD since he had seen animals showing similar clinical signs in the 1980s

. The veterinarian and the

mana ger did not have enough information to develop a reasonable hypothesis regarding the origin of the disease

. The SENASA team appeared credible and transparent regarding the outbreak

. They hypothesized that the most likely explanation was illegal movement of infected cattle exposing a population with a low immunity level

. Stamping out started on February 8 and concluded on February 21 [ 23 ]

. Molecular characterization of the virus revealed that the strain was indigenous to the region and shared common similarities with all the isolates that caused the typo O outbreak in South America between 2000 and 2005 [ 24 ]

. In particular, the s tudies showed that the virus was Type O, genetically related to regional O viruses (homology between 88 percen t and 96 percent), presenting high homology (96 percent) with virus types isolated in Pozo Hondo (Paraguay) in 2003, Tarija (Bolivia) in 2000 and with virus isolated in Mato Grosso do Sul (Brazil) in 2005 (92 percent)

. Further immunogenic studies showed that the vaccine used in Argentina containing the strain O1 Campos offered high level of protection against the strain responsible for the 2006 outbreak (O/Corrientes/Arg 06) [ 25 ]

. Additional population immunity studies demonstrate that cattle housed in the index farm that did no t show clinical signs at the time of the stamping out had adequate level of protection

. Therefore, it was concluded that the FMD

- positive cattle were either unvaccinated or were vaccinated with an adulterated vaccine [ 23 ]

. On February 20, 2006, a nother outbreak was detected in a neighborhood farm ( Figure 8 )

. The outbreak involved a single steer lacking ownership brand

. According to the SENASA records, the animal was not included in vaccination and inspection records of the perifocal area on February 11, 2006

. Direct contacts

### 26

did not show clinical signs of dise ase and tested negative to FMD non structural proteins

. On February 24, 2006, following confirmation, the affected animal as well as its contacts (415 bovine) were destroyed

.

Figure 8 : Rincón Navarro outbreak, San Luis del Palma r , 2006

All owners whose animals were destroyed received compensation in accordance with SENASA guidelines

. The appraisal was perfor med by a team that consisted of three professional appraisers
, one SENASA representative , one representative of the owners of the animals , one representative of the Provincial Farmers’ Association, and one attorney as l egal r epresentative of SENASA

. Farmers and producers interviewed by the APHIS team reported that the compensation was fair and most were satisfied with the procedures and the amou nt of money received [ 23 ]

.

Serosurveillance within the area, which includes the province of Corrientes [ 26
, 27 ] and the perifocal and surveillance area [ 24 ] , showed absence of viral activity

. SENASA concluded that the lack of viral activity by serology demonstrated that the most likely cause of the 2006 outbreak was the reintroduction of the virus through illegal movements of susceptible animals, and/or animal products

. Mechanical transmission (e.g., trucks) cannot be excluded

.

Conclusions

The last detection of FMD in the export region was in 2006 (8 years ago). APHIS recognizes that there were substantial delays (approximately nine months) in reporting the FMD outbreaks in Argentina in 2000

- 2001 that raised questions in the inter national arena regarding SENASA’ s transparency with regard to disease reporting. For this reason, APHIS has been particularly thorough in its subsequent reviews of Argentina’s veterinary infrastructure. APHIS observe d during site visit s to Argentina, which included the regions where isolated outbreaks were detected in 2003 and 2006 , that Argentina had made changes to its veterinar y infrastructure since the 2000

- 2001 outbreaks. APHIS confirmed that these improvements w ere effectively implemented and maintained in its subsequent visits to Argentina in 2006, 2009 and 2013. Based on these observed changes and the responses SENASA personnel provided to the site visit teams’ questions, despite the earlier reporting problems, APHIS is confident that, in the event of another outbreak, reporting would be prompt and transparent.



### 3. The status of adjacent regions with respect to the agent

### 27

The ability of a region to exclude disease is paramount in the assessment of the risk posed in opening the U.S. market

. Relevant risk factors include the presence of the disease(s) in adjacent regions or regions with epidemiological links with areas report ing outbreaks

, and other threats to the biosecurity of the exporting region

. In this section

, we assess the effectiveness of Argentina’s animal health system in preventing FMD from entering Argentina from adjacent regions where FMD is known to be endemic.

The region south of the 42nd parallel and an area bordering that region (Patagonia North B) have been evaluated by APHIS for FMD

- freedom [ 39, 40, 82 , 83 ] and APHIS’ 2013 risk assessment determined the Patagonia region is FMD

- free. In addition, APHIS notes that i n 2002, 2007

, and 2013

, the OIE recognized (1) the areas south of the 42nd parallel, (2) the region called Patagonia North B, and (3) the the summer pasture zone in the Province of San Juan as free of FMD without vaccination , respectively

. At the time of the 2013 site visit, SENASA was in the process of submitting the FMD dossier to the OIE for FMD freedom re cognition of Patagonia North A

.
Argentina is bordered by Paraguay in the north, Bolivia in the northwest, Uruguay and Brazil in the northeast, and Chile in the west

. Only Chile and Santa Catarina, Brazil are considered by APHIS to be FMD

- free [ 28 ]

.

Chile is recognized by OIE as FMD

- free without vaccination (last o utbreak reported in 1987)

. Uruguay is recognized as a FMD

- free region with vaccination (last outbreak reported in 2001)

. Bolivia is classified as FMD

- free with vaccination in the following region s: Chiquitania , the zone adjacent to the east of Chiquitania, a zone consisting of the regions of Chaco and part of Valles, and the Macro

- region of the Altiplano [ 13 , 14 ]

. Paraguay was listed by OIE as FMD

- free zone with vaccination (outbreak reported in Pozo Ho ndo in J uly 2003 , 3 km from the Argentine border) until 2011 when it reported two o u tbr e a ks of FMD type O in the S a n P e dro r e gion in c a ttle a ppro x i m a

tely 250 mil e s f

r om the Br a zili a n b ord e r

. In November 2013, Paraguay was recognized by the OIE as FMD

- free with vaccination.

At present, the Brazilian States of Rio Grande do Sul and Santa Catarina, which border Argentina, are recognized as FMD

- free regions with and without vaccination, respec tively. As of 2007, OIE recognized the State of Santa Catarina as an FMD

- free zone where vaccination is not practiced

. OIE also recognized the States of Acre, along with two adjacent municipalities of Amazon State, Rio Grande do Sul, Rondonia, and the mid dle southern part of the State of Para, as an FMD

- free zone where vaccination is practiced. In May 2008, the OIE recognized the S tates of Bahia, Espírito Santo, Minas Gerais, Rio de Janeiro, Sergipe, Tocantins, Distrito Federal, Goiás, Mato Grosso, Paraná, São Paulo of Brazil as and FMD

- free zone where vaccination is practiced. [ 29 ]

In October 2005, Brazil reported outbreaks of FMD in the States of Mato Grosso do Sul and Parana . The areas involved in t he outbreak are located approximately 200 km from the Brazil, Paraguay , and Argentine triple border. In response to the se outbreaks , SENASA implemented preventive measures to avoid the introduction of the FMD virus

. These measures included:

 Declaring a s anitary alert in the national territory ;

 Establishing an i mport ban on animals, animal products, and equipment from all of Brazil that could carry FMD ;

 Strengthening epidemiological surveillance ;

 Strengthening biosecurity measures ;

 Reinforcing and accelerating the FMD vaccination campaign ; and

 Increasing the border controls in the Northern region of Argentina

.

### 28

On January 25

, 2007

, the Bolivian Animal Health Service (SENASAG) reported the first of a total of five outbreaks of FMD in farms located near Santa Cruz de la Sierra, about 450 km north of the border with Argentina

. The Hemispheric Program for the Eradication of FMD

Information on the epidemiological situation of the countries in the region around Argentina is acquired through data systematically and periodically submitted by each country to PANAFTOSA, and through bilateral agreements and joint border programs

. Since the regional FMD outbreak in 2001, a program of joint actions and adaptation of strategies among the countries of the region was established within the action plan of the Hemispheric Program for the Eradication of FMD (PHEFA)

. This program comprises border work subprojects, reimplementation of vaccination against FMD, epidemiological surveillance actions

, and improvement in the dissemination of information through the Continental System of Information

. The Hemispheric P rogram for the Eradication of F MD (PHEFA) is coordinated by PANAFTOSA

. As a subprogram of the Hemispheric Plan, the Cuenca del Plata Agreement for the Eradication of FMD coordinates common strateg ies among Argentina, Brazil

, and Uruguay in the fight against FMD

. The initial agreement wa s signed in 1987 in Porto Alegre, Brazil

. The strategic program was developed in 1988 by technicians of the three countries and was implemented in 1989

. Paraguay signed on in 1992 and then Bolivia joined the agreement

. Chile participates as an observer cou ntry

. The agreement works through an Executive Committee made up of the sanitary authorities of each one of the member countries, with a Technical Group advising the Committee

. The Technical Group is comprised of five veterinarians from each country and two permanent consultants, the c oordinator and the epidemiologist, all of which advise the member countries

. The Group meets four times a year

. All of the activities of the Agreement are channeled through this Group.

In response to this effort, Argentina incorporated border programs, guaranteeing full notification of the epidemiological situation in the country, development of the vaccination campaigns, joint training, and reciprocal guarantees strengthening the Regional and National Epidemiological Survei llance Systems [14 ]

. Bolivia and Paraguay have signed an agreement to increase technical cooperation to facilitate the control and eradication of the disease in border areas

. Argentina participated in discussions

. Argentina provides technical assistance t o Bolivia by transferring technology and aiding in technical matters in the fight against FMD. The Bureau of Laboratories of SENASA has trained scientists from Bolivia on performance and standardization of FMD diagnostic serological tests (VIAA and EITB). Argentina also has a bilateral agreement with Paraguay and the Cascos Blancos commission (United Nation program for FMD eradication in the border between Argentina and Paraguay) to “agree on a participation and cooperation mechanism” of the latter on bot h sides of the border, within the framework of the P HEF A

, and supported by the South Farming Council (program information available at www.cascosblancos.org.ar/a_inicio/biblioteca/02/index.htm). Representatives of Argentina, Bolivia and Paraguay meet regularly in an effort to establish an FMD vaccination and a prevention and epidemiological surveillance program in the border area between the three countries

. The aim of the program is to mitigate the risk of an FMD occurrence in the area

. SENASA R esolutions 748/2004 and 622/2006 (enhancements in the Frontera Norte A and B , the area bordering Bolivia, Paraguay and Brazil ) increase FMD prevention efforts within the border area, which mimic control and prevention efforts by neighboring countries.

Co nclusions

### 29

According to SENASA officials, illegal movement of animals from neighboring countries, as well as mechanical transmission of the virus

, introduced the FMD virus into Argentina during the 2000/2001

, 2003

, and 2006 outbreak s

. APHIS does not consider countries of South America to be FMD

- free, with the exception of Chile and the state of Santa Catarina in Brazil

. APHIS has evaluated the Patagonia region and has proposed to recognize it as FMD

- free.

APHIS conclude s that there is a risk of reint roduction of FMD from adjacent areas into the export region

, a s long as the disease is endemic in the overall region in South America

. APHIS acknowledge s, however, many enhancements in border control activities along the northern borders with Bolivia, Para guay, and Brazil

. In addition , APHIS recognizes that

, although there is a potential risk of introduction of FMD f ro m Bolivia , Paraguay, and Brazil , local economic conditions often do not favor the movements of animals in this direction

. It is likely that i f FMD were to be introduced into the n orth w est of Argentina

, the consequences would not be major (as demonstrated in the Tartagal outbreak, 2003) mainly due to the low animal density, low animal movements, and effective veterinary infrastructure in the area

. T he FMD outbreak that occurred in 2006 show s that SENASA is able to immediately notify and contain the disease

, even before confirming diagnosis



### . APHIS acknowledges that SENASA has adopted several measures to prevent the introduction of the FMD virus from the South of Brazil , Bolivia, and Paraguay

.



### 4. The exten t of an active disease control program, if any, if the agent is known to exist in the region

In this section we review the SENASA resolutions that dictate the requirements for reporting FMD outbreaks, establishing vaccination plans and administering vacci nations, and other procedures for controlling the disease should an outbreak occur.

General information

National Law 24.305/93, along with Decree 643/96, establishes the FMD National Eradication Plan and requires immediate and mandatory reporting of FMD cases in Argentina

. The National plan establishes a mechanism for funding the FMD Entes Sanitarios Locales (“local foundations ”) at the local level and integrat ion by local producers

. In a ddition, the private sector takes part i n CONALFA

. CONALFA

, through its representatives (e.g., veterinarians, meat processing industry)

, provides a forum for consensus where the provincial governments, national government (SENASA), and private sector define the operational strategies to carry out the zoosanitary policies defined by SENASA

. These, in turn

, work with the local animal health bodies, the Entes Sanitarios Locales, which are the unit responsible for vaccine delivery

. Together the national, provincial, and local units implement the national strategy at the regional level [ 13

, 18

, 30 ]

. Resolution 181/10 provides for an FMD vaccination strategy following a two

- cycle vaccin ation schedule where young cattle between six months and two years of age

, as well as animals to be moved to a different location , are vaccinated during the first cycle, and all adult cattle are vaccinated during the second cycle. Each local administrative area establishes its own local vaccination plan which is develop ed by the local foundation and approved by COPROSA

. Once the plan is approved, it is sent to CONALFA and SENASA for further approval

. T here are 361 vaccination plans with 5,900 agents responsi ble for the implementation of the vaccination

. SENASA Resolution 623/02 established the scope of responsibilities and functions for each member

. SENASA Resolution 33/02 states the bimonthly audits that SENASA local office should carry out on the local plan

.
SENASA Resolutions 478/99, 779/99, 192/2001, 370/2001, 383/2001, 510/2001, and 37/2002 and SAGPyA Resolution 378/99 establish measures for controlling FMD outbreaks

. These measures include

### 30

sanitary steps with susceptible, ill

, and in

- contact animals in the region of the outbreaks; notification and operative procedur es if FMD is detected on a farm; prevention of spread of the disease ; and implementation of the National Sanitary Emergency System [ 6 ]

. There are also a large number of resolutions that est ablish procedures and conditions for the import of various animals and animal products, disposal of organic wastes from ships and airplanes, passenger and luggage control procedures, and movement of animals within the country

. SENASA Resolutions 495/2001 a nd 115/2002 establish requirements for shipping FMD

- susceptible livestock to slaughter for export of beef to the EU or from farms approved to export to the EU or markets with equivalent requirements [ 20

, 31

, 32 ]

. Federal, provincial

, and municipal authorities, veterinarians in private practice

, and citizens must report any signs of disease, the ex istence of suspect cases of the disease, or positive test results for this disease to the local animal health authorities or to the National Animal Health Office of SENASA (Law 3959/1903, Law 24.305/93, Decree 643/96)

. The law also specifies the penalties that individuals could incur due to failure to notify animal health authorities of a disea se outbreak. N o indemnification for destroyed animals is paid if the disease is not reported

, and the one who fails to report the disease as stated above will be fined [ 18

, 20

, 32 ]

. Private diagnostic laboratories must also immediately report outbreaks, and are subject to severe penalities for failure to comply with statutory requirements [11, 14].

In 2010, Resolution 540.10 updated the requirements for registration and notification of reportable diseases, creating a single uniform system for all reportable diseases. Under the amended resolution, the local office must send a veterinarian to the premises with in twelve hours of receiving notification of a suspect case to collect epidemiological data and initiate the reportable disease reporting forms. OIE is notified within 24 hours of the suspicion or of an outbreak of FMD.

Main activities of the FMD National Eradication Plan

Educational activities : The plan for control and for e radication o f FMD (Law 24. 305) incorporates FMD

awareness into educational and training activities

. SENASA provided a list of educational and training activities conducted during 2004 and the first semester of 2005 i n response to APHIS concerns regarding awareness of farmers, farm workers

, and private veterinarians in the regions of the North, Northwest

, and Northeast of Argentina [ 33 ]

. During the 2013 site visit, SENASA provided updates on the training activities conducted in 2013 as well as the outreach and awareness activities related to FMD [ 8 2 ]. FMD

awareness includes television and radio broadcasts on FMD epidemiological situation, vaccination schedules, identification, and reportin g of vesicular diseases.

Field inspections : Cattle are inspected every six months by vaccinators when the animals are gather ed in corrals for vaccination purposes

. In addition, prior to their movement into slaughter

, official veterinarians inspect animals destined for export to the EU.

Surveillance at abattoirs and meat packing plants : Animals are subjected to ante

- mortem inspection by SENASA personnel for signs of vesicular disease (e.g., excessive salivation, diffi culty walking, etc)

. Other body parts, including the tongue and feet

, are examined during post

- mortem inspection.

Surveillance at animal gathering places : All animals coming into fairs, auctions

, or exhibitions are clinically inspected by the official veterinarians.

Surveillance of animals in transit : The clinical inspection of animals in transit is carried out at checkpoints and border control points by official personnel

. These are strategicall y located, in accordance with the flow, vulnerability of the area, and intensity of animal movement

. The conditions under which animals

### 31

move are based on the sanitary status of the province of origin or the country sharing borders with the export region.

Laboratory d iagnosis : The SENASA laboratory is responsible for the screening and confirmatory diagnosi s of FMD

. It is located in the c ity of Martinez, Buenos Aires

. PANAFTOSA, located in Rio de Janeiro, is the reference laboratory for FMD used by Argentina and neighboring countries

. PANAFTOSA is responsible for the molecular characterization of the virus

. Serological monitorin g : FMD epidemiological surveillance implemented by SENASA is in line with OIE recommendations [ 13, 18, 26, 82

, 83 ]

. Serological s ampling is based on the epidemiological situations of each particular area of the country

, which take into consideration the following parameters:

 Animal density ;

 Composition of cattle population (steer/cow ratio) ;

 Animal movements (movements in and out) ;

 Geographical and political

- administrative characteristics ;

 Effectiveness of vaccination ;

 Risk areas ( Frontera Norte A and B ) ;

 Surveillance zones (in free areas) ; and

 Results of previous serological samplings

. SENASA provided the APHIS site visit team wi th the protocol in place for the 2005 to 2008 serological surveillance [ 27 ] [ 34 ] [ 35

, 36 ]

. During the 2013 site visit, SENASA also provided updates on their serological surveillance activities from 2011 to 2013 [ 91

, 92

, 93

, 94 ]

.

Other measures : All cattle are vaccinated every six months with oil

- adjuvant ed vaccines

. Other susceptible species are not vaccinated except for the area located 25 km south of the border between Argentina/Bolivia and Argentina/Paraguay

, where all susceptible sp ecies are vaccinated twice a year

.

Conclusions

APHIS believes that Argentina has a control program and a national plan sufficient to respond quickly to FMD emergencies through quarantine and testing of suspicious premises

. In addition, Argentina maintains an active surveillance program at the field level in farms, slaughterhouses

, and at animal gathering locations.

APHIS concluded that the FMD program is effective at the local and national levels

. Argentina has a structured system of notification and official involvement to investigate any suspect FMD cases

. 

### 5. The vaccination status of the region

Assessment of risk includes a consideration of the effectiveness of control measures implemented and revision of those measures as approp riate

. In this section we explain how the FMD vaccination program in Argentina works and relate this to the effectiveness of the National FMD Eradication Program and overall control of disease.

General Information

Vaccination of c attle is mandatory in th e area n orth of the 42 nd parallel with the ex c eption of Patagonia North B ( the area adjacent to Patagonia South , a region without vaccination) and recently, Patagonia

### 32

North A

. A recent change in Annex I of Resolution 181/10, Resolution 82/13 , now bans FMD vaccination in Patagonia North A , replacing Annex 1 of Resolution 181/10 [ 82 ]

.

SENASA is the enforcement authority and regulating body for planning, implementing, and controlling actions to eradicate FMD

. SENASA establish es the technical requirements for the vaccination program

. The epidemiological office of DNSA is responsible for the regulatory aspects and the assessments of the record ed information

. The general field office, the regional supervisors, and the local SENASA veterinarians are responsible for the operations

. Responsibility for vaccination delivery lies in the local foundation or with the local SENASA office depending on the area , although vaccination practices are audited at the National SENASA level

. The local foundation is responsible for:

 Purchasing and storage ;

 Management ;

 Administration and scheduling the vaccination campaign to ensure that all the bovines are vaccinated ;

 Keeping a vaccine bank for emergencies ;

 Collecting and managing the revenues generated for the vaccination ;

 R eporting vaccination and non

- compliance to SENASA ; and

 Assessing the progress of the campaign with SENASA and the vaccination team

.

SENASA law 24.305 and SENASA Resolution s 33/02 and 623/02 establish the authority for administration and distribution of the vaccines as well as the creation of the local foundations (Entes Sanitarios Locales) under Resolution Sagpya 108/01. At the time of the November 2013 site visit, there were a total of 310 local foundations that emplo y ed over 6,000 official coordinators, programmers, and vaccinators

. There is also an operating group who administer s FMD vaccines to any susceptible species in an area located along the border of Argentina

- Bolivia and Argentina

- Paraguay [ 20 ]

. According to the law, local foundation personnel are obligated to vac cinate all the bovines on every holding. The vaccinators ’ salary depends on the total number of animal s vaccinated

. T herefore

, the vaccinators make the maximum effort to vaccinate all bovines.

The FMD National Eradication Plan conducts periodic and systematic vaccination of bovines

. The rest of the susceptible species are vaccinated only in strategic situations ( e.g., emergency situations )

. Local SENASA veterinarians certify, control, and audit the vaccination campaigns. In addition, local

, regional

, and central SENASA services are responsible for setting vaccination schedules and the monitoring and follow

- up of the campaigns.

V accination dates differ to accommodate geographic, epidemiological

, and production characteristics including animal movemen ts

. A regionalization strategy is applied according to the ecological features, production types, and movement flow

. The vaccination strategies that are implemented according to the different regions , as amended by Resolution 181/10, are as follows:

 In t he provinces of Buenos Aires, Corrientes, Entre Rios, Chaco, Cordoba, Formosa, La Pampa, San Luis, Santa Fe, Santiago del Estero, Tucuman, Neuquen, Rio Negro, and Misiones, two vaccination campaigns are conducted annually in all bovines. Under Resolution 181/10, i n the se

areas that vaccinate twice a year , young cattle between 6 months and two years of age

, and animals to be moved to other facilities , are vaccinated during the first cycle, while all adult cattle are vaccinated during the second cycle. For the rest of the provinces in the North ( Salta, San Juan, Catamarca, La Rioja, Mendoza and Jujuy ) one vaccination campaign is carried out during which

### 33

all the bovines are vaccinated . A second vaccination campaign is held only for bovines in high

risk holdin gs and bovines which are going to be moved to other premises or livestock market

. High ris k holdings are considered to be holdings located closed to slaughterhouses, holdings with a large number of cattle, holdings with an intense dynamic of cattle movemen ts, and holdings for fattening.

 The exception is the Cordon Fronterizo ( the northern borders, “Frontera Norte A” and “Frontera Norte B”, bordering Bolivia, Paraguay and Brazil ) which continue s to vaccinat e all categories of bovine twice annually.

Vaccination can only be performed by authorized personnel who are trained, registered

, and accredited/ audited by SENASA

. Resolution 368/11 recently allowed private veterinarians to administer FMD vaccinations but they are required to undergo training and b e registered with SENASA as official vaccinators. All vaccinators must be affiliated with a local SENASA office and are only approved to vaccinate within that local office’s jurisdiction.

Before starting the vaccination campaign, each local office establi shes the number of animals to be vaccinated based on data available in the Sanitary Management System such as data from previous vaccination campaigns, registered animal movements, and estimates of newborn calves since the last vaccination [ 13

, 18

, 20

, 32 ] [ 8 2 ]

. Data obtained during the vaccinations are entered in a form called the “vaccination act” ( acta de

v acunación ), which is completed by the official vaccinators after visiting each holding

. Dat a collected throughout and at the end of the vaccination campaign include: (1) daily from each vaccinator, the number of animals vaccinated including categories of animals vaccinated, time of vaccination, compliance of premises with vaccination schedule, and (2) every two weeks from each local vaccination delivery center, the proportion of premises/establishme nts vaccinated and the proportion of vaccinated animals. Vaccinati on campaigns last for 6 0 days

. Under Resolution 181/10, animals cannot be moved out of premises that have not completed the vaccination and registration of animals at the end of a vaccinatio n cycle.

Vaccination coverage rates have been over 97 percent in the region above the 42 nd parallel (with the

ex cept ion of Patagonia North B , and most recently Patagonia North A, in which vaccination is not conducted ) since 2001

. T able 3 provides statistical information on the vaccination schedule and coverage in this region, by campaign

, from 200 8 until 20 12 [ 95 ]

.

Table 3 : Vaccination rates from 200 8 to 2012

Campaigns Vaccinated

Bovine s Vaccination rate

(%) 1

1 st Cycle 200 8 59,261,268 99.34

2 nd Cycle 200 8 57,736,145 102.63

1 st Cycle 200 9 55,803,147 99.24

2 nd Cycle 200 9 51,922,968 99.91

### 34 1 st Cycle 20 10 50,268,465 98.96

2 nd Cycle 20 10 37,434,323 103.01

1 st Cycle 20 11 42,686,107 100.51

2 nd Cycle 20 11 44,486,110 104.50

1 st Cycle 20 12 39,790,151 100.62

2 nd Cycle 20 12 43,389,492 101.92

1 Vaccination rate exceeds 100% in some cases due to vaccination of young bovine ( six months to two years) during the 1 st Cycle that were subsequently revaccinated during the 2 nd Cycle

. All FMD vaccine used within the territory is produced under SENASA oversight

. Production and quality control of the vaccine meet the requirements of the OIE Manual ’s standard for diagnostic tests and the recommendations of the OIE Reference Regional Center , PANAFTOSA

. Vaccine production and diagnosis comply with biosecurity level NBS

- 3 OIE Standards

. A biosafety committee (SENASA Resolutions 104/95

- 472/95

- 507/01

- 117/04) controls the compliance with the standards

.

The tetravalent vaccine in use since 2001 is inactivated and contains an oil

- adjuvant that provides extended immunity [ 96

, 97 ]

. SENASA uses vaccines containing the following serot ypes: O1/Campos, A24/Cruzeiro , A/Argentina/ 20 01 and C 3/ Ind a ial

. All vials are identified with technical and manufactur er brand labels, a sequential number, and an official stamp stating the series and the expiration date

. SENASA conducts audits of the cold chain at all stages. T rucks used for the transportation of the vaccines are equipped with temperature sensors to ensu re a cold chain during transportation [ 37 ]

. The vaccine must be tested for quality and safety by the official SENASA laboratory

. Quality control tests of each batch of the vaccine are conducted and strictly follow international standards

, as set by the OIE

. All series of vaccines are tested for:

 Safety ;

 Sterility ;

 Physical and c hemical stability : v iscosity, conductivity, centrifuge

, and accelerating aging tests to confirm stability of emulsion ;

 Purity ( Non

- structural proteins ) : v accines must not interfere wi th tests that detect antibodie s against non specific proteins with the 3ABC ELISA + e nzyme

- linked i mmunoelectrotransfer b lot ( EITB ) tests are used for detection ; and

 Efficacy or p otency: v accines submitted for registration are tested with direct potency assay following the percentage of protection against foot infection (PGP) method [ 38 ]

. Sixteen antibody

- free bovine s are challenged and tested 90 days after vaccination

. The tested vaccines must provide protection in 81 percent of the challenge animals for each virus type included in the vaccine.

Conclusions

APHIS concluded that Argentina conducts its FMD vaccine pro duction appropriately and in accordance with international standards

. There is a system of controls to ensure compliance with vaccination calendars through matching vaccination records to movement permits and census data (see section on

### 35

disease status) and through field inspections

. The structure and application of the vaccination program, in conjunction with movement controls, fosters close interaction between veterinary officials and farmers and facilitates oversight of animal populations and vaccine cove rage in the field.



### 6. The degree to which the region is separated from adjacent regions of higher risk through physical or other barriers

Geographical barriers, such as mountains or expanses of water and other barriers, impede the natural and human

- med iated movement of animals and animal products

. In this section we look at the geographical barriers that could potentially limit the movement of FMD from endemic neighboring areas into Argentina.

The geographic description of the Argentine borders follows below [ 13

, 18

, 39 ] :

1. Chile (west and s outh) 2. Bolivia (n orth) 3. Paraguay (n ortheast) 4. Brazil (northeast and e ast) 5. Uruguay (e ast)

C hile Total length of the border: 4,591 km Inland border: 4,591 km

 The Andean Range makes up a natural border.

Bolivia Total length of the border: 765 km River coastline border : 385 km

 Along the Pilcomayo River: 40 km (Province of Salta)

 Along the Grande de Tarija River: 120 km (Province of Salta)

 Along the Bermejo River: 125 km (Province of Salta)

 Along smaller rivers: 100 km (Provinces of Salta and Jujuy). Inland border: 380 km

 The altitude along the border with Bolivia decreases from west to e ast (Aver age of 3000 m in the

w est and 400 m in the e ast)

. The climate a nd topography also chang e from more mountainous in the w est t o flatter lowlands towards the e ast.

Paraguay Total length of border: 1,570 km River coastline border: 1,570 km

 Along the Paraná River: 630 km (Provinces of Corrientes and Misiones)

 Along the P araguay River: 290 km (Provinces of Formosa and Chaco)

 Along the Pilcomayo River: 300 km (Province of Formosa)

Inland border, deviated course of the Pilcomayo River: 350 km (La Estrella Lowlands, also know n as the Pantalón System)

### 36

 The inland border lies to the w est

. The flat topography of the Province of Formosa continues into Paraguay with no natural barriers.

 The Pilcomayo River enters Argentina again to the e ast, in the town of Palmar, Salto.

Brazil Total length of the border: 1,079 km River coastline border: 1,021 km

 Along the Uruguay River: 695 km (Provinces of Misiones and Corrientes)

 Along the Pepirí

- Guazú River: 134 km (Province of Misiones)

 Along the San Antonio River: 94 km (Province of Misiones)

 Along the Iguazú River: 129 km (Province of Misi ones)

Inland border: 27 km (Bernardo de Irigoyen area)

 To the n orth, the border with Brazil runs along the Iguazú River and continues s outh along the Uruguay River.

Uruguay Total length of the border: 866 km River coastline border: 866 km

 Along the Uruguay River: 491 km (Provinces of Corrientes and Entre Ríos)

 Along the De la Plata River: 375 km (Province of Buenos Aires)

 The border is clearly defined by the Uruguay River to the n orth and continues along the De la Plata River.

Conclusions

Most of the Argentine border is adequately protected by effective natural barriers to reduce the unrestricted flow of animals and animal products from areas of higher risk

. G overnment control measures compensate for those areas whe re natural barriers do n o t exist

.



### 7. The extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regarding such movements

Border controls enable a country to monitor the movement of people, a nimals, and goods into the country

. Illegal movements of susceptible commodities or people and equipment can spread disease ; therefore, a thorough understanding of the animal movement controls of a country is useful in assessing the risk of introduction of the disease

. Further, biosecurity measures are critical to minimize the spread of disease should an outbreak occur

. I n this section we review Argentina’s border control capabilities in regards to monitoring and controlling the movement of FMD susceptible species and products into Argentina.

International and National b order controls are administered by SENASA's Quarantine, Borders

, and Certifications Unit [ 13

, 40 ]

. Importations of live animals, genetic material, animal products

, and animal by

- products are allowed only under permit issued by SENASA

. Animals an d animal products may enter the country legally by means of 45 authorized border stations which include terrestrial, maritime

, and fluvial ports and airports

. International border crossings authorized by SENASA are listed below:

### 37

Chile Jama Crossing ( Province of Jujuy) Cristo Redentor Crossing (Province of Mendoza) Cardenal Samoré Crossing (Province of Neuquén in Patagonia North B) Huemules Crossing (Province of Chubut in Patagonia South) Coandhaique Crossing (Province of Chubut in Patagonia South) Int egración Austral Crossing (Province of Santa Cruz in Patagonia South)

Bolivia Salvador Mazza Bridge (Province of Salta) Aguas Blancas Bridge (Province of Salta) Horacio Guzmán Bridge (La Quiaca, Province of Jujuy)

Paraguay San Ignacio Loyola Crossing (Fraternidad Portal, San Ignacio Loyola Bridge, and ferry, Clorinda, Province of Formosa) San Roque González de la Cruz Bridge (Posadas, Province of Misiones) Puerto Rico: this crossing is for cross

- border traffic only (Province of Misiones)

Brazil Tancredo Neves Bridge (Port of Iguazú, Province of Misiones) Bernardo de Irigoyen Crossing (Province of Misiones) San Javier Bridge (Province of Misiones) Integración Bridge (Santo Tomé, Province of Corrientes) Port of Alvear (Provinc e of Corrientes) Presidente A. Justo Bridge (Paso de los Libres, Province of Corrientes)

Uruguay Salto Grande Bridge (Concordia, Province of Entre Ríos) José G. Artigas Bridge (Colón, Province of Entre Ríos) Libertador San Martín Bridge (Gualeguaychú, Pro vince of Entre Ríos) Port of Buenos Aires (Ferrylineas and Buquebus) Jorge Newbery Airport (City of Buenos Aires)

SENASA officials are assisted at border control points by various security forces, including the National Border Patrol, the Argentine Coast Guard, and t he National Aeronautical Police [ 89 ]

. National Border Control agents assist along international borders and number around 14,000 in the entire country

. Coast Guard personnel assist at seaports and Aeronautical Police at airports

. Permanent SENASA personnel at border crossing points number 394, including veterinarians, agricultural engineers, and administrative personnel [ 40 ]

. Cooperation with these groups occurs under the terms of official agreements [ 40 ]

. Other groups assisting with border in spections include the National Customs Bureau and p rovincial and l ocal institutions

. SENASA considers agreements with the security forces to be critical to the control program

. Argentina authorities check and confiscate products prohibited for movement int ernationally

. The number of human resources associated with control posts in the border with Paraguay and Bolivia during 2005 [ 41 ] are listed in Table 4

.

### 38

Table 4 : SENASA personnel in the associated with control posts in the border with Paraguay and Bolivia (2005)

SENASA Personnel Province Veterinarians Technicians Administrators Jujuy 1 2 0 Salta 5 5 5 Formosa 7 5 6 Total 13 12 11

Commercial imports

Before allowing such imports into the exporting region

, Argentina requires a risk analysis for all imports of live animals and products of animal origin to determine the epidemiological status of the country or region of origin, the existence of national or regional programs to contr ol exotic diseases, the specific capabilities of the laboratories and quarantine facilities and their staff, and other factors that reduce the risk of importing exotic or high risk diseases into the country. SENASA Resolution 1354/94 defines the
pre

- import ation procedures and the health certificate requirements for live animals and their reproductive material into Northern Argentina

. Argentina follows OIE guidelines in its importation policy for Northern Argentina regarding products of animal origin con sidered as possible carriers of the FMD virus from countries or regions with a lower sanitary status. In certain situations, however, Argentina requires mitigation to minimize the potential risks associated with the importation of these products. Resolut ion 816/02 defines the general pre

importation procedures and controls for animal products and byproducts into N orthern Argentina [ 13

, 18

, 40 ]

.

The procedures and criteria applied by Argentin ean officials for imported live animals, animal genetic material, and animal products and byproducts are based on the principles of risk analysis, regionalization and equivalence in the SPS Agreement of the World Trade Organization (WTO) and the standards set by the OIE

. Permits to import such products are required before the goods arrive in the country

. The importer will be issued an import permit only after all the applicable zoosanitary requirements stated in SENASA regulations are met

. The import permits m ust be approved by the SENASA Central Office.

The procedures to assess the risk and approve processing plants and processing procedures in the region of o rigin are stated in Resolution 816/02

. Import permits may be issued after Argentina conducts a risk

a nalysis of the following [ 11 ] :

 The type of product that will be imported ;

 The health status of the exporting region ;

 Approval of the slaughtering or processing plant in the region of origin ;

 Type of shipment ;

 Transit of the product through other countries ;

 Border post at the point of entry into Argentina ; and

 Expected used of the product

.

### 39

All products and live animals that require app roval from SENASA must meet similar security requirements

. Import requirements are summarized as follows [ 11 ] :

 Pre

- importation authorization

.

 Verification of the health certificate issued by the country of origin

.

 Physical inspection, document control

, and verification of the identity of the imported products

.

 A restricted transit p ermit for shipments of animal products to process ing plants with official SENASA veterinary inspection

. Live a nimals must be placed in quarantine at the official quarantine facility.

 After inspection, the imported products are sampled for the purpose of the National Residue Control in Food Products and Hygiene program, and the release document is issued

. In the case of live animals, the release document is issued at the end of the quarantine period, if no pathology is found

. Once the importer has this document, the imported goods may be collected.

Impor ted animals are placed in SENASA’s q uarantine facility

, “Lazareto Capital” in Buenos Aires

. Animals that require special conditions or treatment are placed in special quarantine facilities (e.g.

, zoo animals, ornamental birds, and fish)

. The quarantine per iod lasts for 15 to 60 days to allow sufficient time for completion of all required testing procedures, depending on the species and the place of origin

. At the end of the quarantine period, the imported animals are placed under observation at the farm of destination for a period of 60 days

. After this period, the local SENASA veterinarian must issue a report certifying that the post

- quarantine period has been completed.

Inspections of imports are carried out in all cases, without exemptions, if they are products under SENASA jurisdiction

. Documents are checked and products or animals are physically inspected and identified

. All imports have to meet the requirements established by the responsible technical area as set by the standards of proc edures in SENA SA Resolution 816/02

. Two inspection modes are used at borders [ 42 ] :

 Direct inspection: questioning, observation

, manual inspection of luggage and vehicles (e.g., trunks, rooms, cabins, boxes) ; and

 Indirect inspection at the most relevant entry p oints: a uxiliary methods used to detect organic products that could be pote ntial carriers of pests or diseases (e.g., organic material scanner, dog squad)

. In case of animal health emergencies in the region or in neighboring countries, additional control mechanisms are activated, such as reinforcement of regulations and personne l, increasing vehicular disinfection

, and strengthening of patrol and control tasks

. Security forces (National Border Police, Argentine Navy, and National Aeronautical Police ) that carry out sanitary supervision tasks at the border will be alerted to be mo re vigilant.

At the inspection posts, shipments into all Argentina are inspected and checked for proper documentation and identification. If the shipment has the proper documents and passes inspection, it is authorized to continue to its destination after resealing the vehicle and recording that the shipment had passed through the check point region [ 14, 20 ]

.

Noncommercial traffic

The proportion of travelers, means of transportation

, and t ypes of luggage inspected varies according to the risk characteristics of the borders or origin of the incoming vehicle

. The risk profile of particular

### 40

products is defined according to the recommendations of the p rocedures m anual and regional characteristics of each control post

. The types of inspection activities that occur depend on the nature of the control posts

. Direct controls are carried out mainly at terrestrial posts and sea ports while indirect methods with detecting scanners are used at the main airports of the region (e .g., Aeroparque Jorge Newbery) and some sea ports.

Sanitary barriers were established to prevent unauthorized crossings at points other than border posts

. Control posts are located in strategic places on the borders

. T rained staff is present all day and t hey interact with security forces, through cooperation agreements, to enforce sanitary regulations

. It is difficult to accurately estimate the amount and frequ ency of unauthorized crossings , but the measures explained above are aim ed at minimizing the risk of introduction of animals or products of risk by informal methods [ 42 ]

. Figure 9 show s the amount s (kg) of noncommercial products (animal) confiscated from 2008 to 2012 by province [ 43 ]

.

Figure 9 : Non commercial animal products confiscated in the terrestrial border posts, by province (Salta, Jujuy, Formosa, Corrientes, and Misiones) 2008

- 2012 (in kg)

Province

Year Misiones Corrientes Salta Jujuy Formosa
2008 57,597 4,919 3,027 140 2,049

2009 30,359 2,497 3,408 106 1,817

2010 119,693 8,133 8,980 2,055 1,095

2011 76,448 8,297 4,397 1,450 2,007

2012 7,096 4,867 4,154 1,809 7,767

Property confiscation and transport infringements

The reports submitted by Argentina show the quantity of products condemned at terrestrial and aerial border posts under SENASA control in all of Argentina (2001, 2002) [ 11

, 42 ]

. Controls applied at the

sa nitary barriers follow F ederal transit standards by prohibiting entry of forbidden and restricted animals and products.

During the period of 2010

- 2012 at the main international Argentine airport

, most of the confiscated products were fruits

. Table 5 shows the total amount of p roducts confiscated between 2010 and 2012

.

Table 5

. P roducts c onfiscated from luggage or passengers at the Ezeiza airport (main international airport) (in kg)

.

Year Amount (kg) 2010 3,5116. 3 2011 42,743. 78 2012 36,090. 7

Airports [20]

### 41

During the several visits to Argentina, the site team s visited several airports that act as control points mainly for tourist traffic. The Jorge Newberry Airport in Buenos Aires handles a significant level of traffic to Argentina in general

. The security measures implemented at the Jorge Newberry Airport are thorough. Aeronautical police assist SENASA in its activities. All carry

- on baggage is put through scanners that can differentiate organic materials from other substances. All checked bag gage and hand carried luggage from international flights is examined by scanner. During the 2009 site visit, Jorge Newberry Airport officials indicated that approximately 35 kg of plant and animal products are confiscated daily during the high tourist seas on. The average volume of confiscations drops to eight kg during the low travel season. This airport employs a staff of ten individuals who work in shifts between 4

a

. m

. and 11 p

. m

. daily.

Passengers are provided with information on prohibited substances and are required to fill out a customs declaration form if arriving on an international flight. Passengers carrying food products are given information on prohibited material regardless of d estination. Any unauthorized cargo is confiscated. In 2003, a new statement was developed to accompany packages stating that certain products are not being shipped in the packages or with a passenger. The statement is used for all airplane and bus traveler s. One side has the declaration statement and signature stating that no prohibited plant or animal products are being carried by the passenger and the other side lists the Resolutions involved and prohibited items. If undeclared prohibited items are found on inspection, SENASA conducts a review to determine if a fine should be levied.

Products shipped as cargo directly from plants must be accompanied by relevant documentation. Air freight of perishable goods is rare but would be checked at the airport of destination and not released until after SENASA approves.

Checked baggage heading for a different destination than Newbery is subject to inspection by the Beagle patrol. A beagle dog is used to sniff for prohibited sub stances in luggage in the baggage cla im area

. Luggage that is suspect is identified, sealed, and inspected at the point of destination. A fax is sent to the destination airport to notify them of the suspect package. The luggage can only be opened with the owner present. Any confiscated materi al is denatured and then treated as waste and sent to the landfill. The destination airport then sends a report back to the airport office from where the package had been shipped.

Members of the site visit team in 2009 observed a beagle that, in the proce ss of inspecting passenger baggage , detected a suspect package. The SENASA official labeled it so officials at the point of destination would investigate the package. They do not open these packages at the airport where the dog detects something suspicious . The package is flown to its destination

, then the owner is notified and SENASA opens the package with the owner present.

International land borders

Permanent SENASA personnel are stationed at each international border port ; however , SENASA is not the o nly group responsible for biosecurity at borders

. The number of personnel available for border control is supplemented through agreements with security forces like the gendarmeri e

. In this regard, 14,000 officials are stationed along 9,370 miles of border [ 20

, 31 ]

. In addition , several designated security forces assist SENASA at import centers

. SENASA officials emphasized the importance of the national forces (i.e., the land, water and border police) in identification of illegal imports [ 20

, 31

, 40 ]

. SENASA also has the authority to call upon local police to as sist i f needed

. SENASA checkpoint officials are notified approximately 15 days before a shipment arrives

. This minimizes potential problems with the customs authority and helps facilitate and expedite the process

. All exporters and importers must be regi stered with SENASA

. The shipment must be accompanied by a

### 42

permit and must originate from an approved location

. Both the origin and the destination of the product appear on the permit

. Shipments can be rejected if documentation is incomplete or if it appe ars to be falsified

. There are no fines for commercial shipments that are rejected because the paperwork is incomplete

. H owever, the shipments are denied entry

. SENASA may confiscate and destroy the product

. In comparison, if SENASA detects deliberate fals ification of documents, a fine of 800 pesos is levied

. This is equivalent to

a one

- month salary [ 31 ]

. Border patrol police on land, water, and at the ports are the primary personnel responsible for identifying illegal shipments. The number of illegal shipments has been reduced significantly since the economic collapse in Argentina in 2001. SENASA has monthly meetings with these border patrols to discuss issues and procedures.

Border with Chile

A s previously mentioned, A rgentina is separated from most of Chile by the Andes Mountains

. In addition, Argentina is working with Chile on joint surveillance for monitoring movement across the border (i.e.

, monitoring transport of prohibited materials/animals by people crossing the border)

. Much of the move ment control focus is directed toward FMD

. In this regard, since the OIE recognizes Chile as FMD

- free without vaccination, SENASA does not consider Chile as a high

- risk region. Chile is also recognized as FMD

- free without vaccination by the United States.

Border with Paraguay and Bolivia

SENASA considers t he most vulnerable borders for the potential introduction of FMD to be the Paraguayan and Bolivian borders

. Animal density is fairly low in the northern region, but history suggests that FMD has been int roduced to Argentina through some of those borders

. Although there are river s along some of these borders, some are navigable, so animals could potentially be brought across in boats

. Additionally, there are dry river beds along some areas which animals co uld cross on foot

. In fact, some farmers own property on both sides of the border

. Therefore, there is some potential for animal movement across these borders

. The province s of Formosa and Salta share borders with Paraguay and Bolivia

, respectively

. The vulnerability of these borders has received the attention of SENASA in the form of enhanced support in the region for surveillance and border control activities

. Currently there are 25 professionals with a total workforce in the provinces of 36 distributed among 15 offices

. These are strategically located near the borders of the provinces, along both the international boundaries and the neighboring provinces of Argentina, and in more interior locations

. SENASA has provided significant support in terms of
eq uipment and facilities, including new offices (trail e rs in areas where there is no building infrastructure), refrigerators, computers, radios, cell phones, and vehicles

. As a consequence of the 2006 outbreak, the borders of the provinces of Corrientes, Cha co, and Misiones have also received attention from SENASA in the form of enhance d control and prev ention for FMD (Frontera Norte B ).

Agreements are in place among SENASA and its counterpart veterinary officials in Paraguay and Bolivia for coordinated bor der control activities such as vaccinations, surveillance, animal census, education, and animal identification

. In 2002, SENASA began holding joint meetings with Paraguay and signed a working agreement

. The three countries developed a m anual of p rocedures for the movement of animals in the border areas [ 44

, 45 ]

. The procedures include quarantine, depopulation , vaccination, disinfection, and final disposition of the animal

, including sanitary slaughter of suspect animals, animals without ID, or animals that do not carry proper identification

. SENASA provided the APHIS site visit team with copies

### 43

of the paperwork that has to be completed in the event animals are fo und within the border areas

. Veterinary officials from the three countries have developed a joint policy to identify the country of origin

o f animals, so that animals that are stolen and imported illegally can be identified

. The animals are identified by a colored earta g ( see F igure 7 )

. F rom 2002 until June 2005, the province of Formosa

re ported nine sanitary slaughter procedures resulting from animal identification issues [ 46 ]

.

i. Border crossing at Clorinda to Paraguay

In 2005, t he APHIS sit e team visited the border crossing point at Clorinda

. This crossing primarily handles passenger traffic

. It is the only road in the area from Paraguay

. Team members observed bus passengers going through a clearance process in which bags are scanned and org anic material (both plant and animal) is removed for destruction

. Luggage from cars is also scanned

. The initial screening is performed by customs officials who call SENASA officials if appropriate

. A SENASA office is on site at the control point from 7 a

. m

. to 9 p

. m

. Border control and customs officials are on site for the remainder of the 24

- hour period.

Confiscated material is separated, sprayed to denature it (phenol, creodine, iodine), and placed into containers marked with green for plant materials and red for animal

.

All actions taken are documented and the passenger receives a written notification

. There is a single form for each confiscation and a separate destruction record

. Manual records are maintained in the SENASA office and collated monthl y for the national SENASA office

. Confiscated material is burned in an incinerator on site each day.

Roadblocks are common on major roads throughout the country

. Although these were established primarily for the purpose of inspecting travelers for drugs, they provide a mechanism for inspection for animal health purposes, if necessary and appropriate.

ii. Border crossing at Salvador Mazza to Bolivia

Traffic at Salvador Mazza consists mainly of pedestrians crossing from Bolivia to work in Argentina

. Most of the passengers traveling into Salta and Jujuy have their carry

- on luggage visually inspected at the border post

. Any prohibited materials found by the inspectors are confiscated and disposed of according to the regulations

. A very small amount of risk p roducts are seized weekly (during 2003, 200 to 400 kg per week)

. The APHIS team visited the border of Bolivia in 2005

. During the site team visit no products were seized.

National Route 34 is the main highway in the area, connecting the city of Salta, Tartagal (2003 outbreak), and Ingeniero Maza (border control)

. Along the route there are several control posts that stop cars and trucks to check for possible drug traffic and illegal movements of animals and animal products between Bolivia and Argentina

. In addition, the route is often blocked by “piqueteros” (group of organized unemployed workers) demanding job opportunities

. During the site visit, SENASA personnel commented that trips on route 34 can take a long time since the blockages by the piqueteros are often unexpected

. Alternative routes take at least double the time

. The APHIS team was told that “piqueteros” usually let vaccinat or s and SENASA veterinarians continue with their activities.

Cooperation with other units and countries

SENASA also has agreements in place with border control officials throughout the province s. There are 1800 border control officers cooperating with SENASA

. The border control units can make helicopters available to SENASA

. SENASA and border control officers take joint tr aining courses.

### 44

Paraguay has assigned additional personnel to the border area

. Under the joint agreement, weekly epidemiology reports are generated on any animal health event and shared

. There is also a regularly scheduled monthly meeting

. In addition, of ficials of the two countries also communicate by radio and telephone . In some areas there is no electricity, so the far western regions can only communicate by radio.

SENASA provided an example of a cooperative action between Paraguayan and Bolivian offic ials and SENASA in 2005

. SENASA located stolen animals that Paraguay reported missing. SENASA corralled them, took serum for testing, vaccinated them twice, observed for clinical signs, and returned them to Paraguay

. SENASA then handed the smuggler over to legal authorities

.

N omads live in the area and are likely to move animals without a DT

- e

. However, other farmers in the area are aware of the need for identification of animals and the DT

- e for movement

. They are likely to report nomads with n on complian t cattle to SENASA because they consider the nomads to be “undesirable.” SENASA will follow up on such reports and send the animals back to their origin, if they belong to nomads

. However, animals that are associated with smugglers are killed.

These coope rative activities also include Bolivian officials

. Officials from the three countries have signed an agreement that requires a joint response to a suspect FMD case

. The cooperative effort began with FMD but is being extended to include other diseases.

A s urvey was conducted to acquire more details on the border region with Boliva and Paraguay to identify vulnerabilities . The survey found that some farmers had susceptible small species that were not cattle

. At the time

, they were cons idered sentinels. Howev er, now all susceptible species are vaccinated.

Notices in English, Spanish, and Portuguese are posted at border crossings and other ports of entry to inform visitors of biologically hazardous materials and products

. A standard certificate for export/import must be presented by shippers at the border crossing. SENASA must be notified so staff can be present when the shipment arrives at the border . However , staff from the Border Patrol can also inspect shipments

. The bo rder posts are staffed 24 hours a day

, seven days a week by Border Patrol officials . They check seals and documents but do not open the seals to inspect cargo

. The seals are inspe cted to ensure that they have not been broken and that they match the entries on the export/import documents.

Customs turns over all contraband products seized to Border Patrol or SENASA officials and makes a record of all seized products

. These products are put in a barrel and sprayed with methylene blue or povidine to render the m inedible

. SENASA has developed an in tensive border control program (SENASA resolution 748/200) ] [ 47 ] . The program, called “Frontera Norte A,” started officially in 2004 with the objective of maintaining the OIE status of FMD free with vaccination for most of the northern region. It established a buffer zone of approximately 25 km wide and 1,200 km long with the purpose of stopping the entrance of the virus from Paraguay or Bolivia [ 8
, 48 ] . Figure 10 describe s the characteristics of the high surveillance area known as

“ F rontera Norte A.”

### 45

Figure 10 : Map of the border a rea , Frontera Norte A

The program includes common strategies at both sides of international borders, ex change of surveys on premises and producers, identification of susceptible animals, joint audit visits during vaccination period, enhanced surveillance, ex change of sanitary i nformation
, and property brand records

. Movement cont rols in the region are strict and include the following:

 For movements out of the area, all susceptible animals must be moved within 30 days of the last vaccination or be revaccinated ;

 Animals can only be transported in sealed vehicles after authorization by the local SENASA office ;

 The local office of destination has to authorize the movement ;

 Both local offices (origin and destination) have to be notified upon arrival to destination ; and

 The animals should remain in the new holding for a minimum of three months.

The APHIS team that visited Argentina in 2006 observed examples of movement permits at the office of San Luis del Palmar, province of Corrientes. As a consequence of the 2006 outb reak and as a way to prevent further introductions of FMD in the country, SENASA drafted the regulation 622/2006 [ 49 ] proposing to include the provinces of Chaco, Corrientes, and Misiones (“Frontera Norte B”) to the buffer

area. Figure 11 describes the characteristics of the high surveillance area know n as “Frontera Norte B

. ”

### 46

Figure 11 : Map of the north east border , Frontera Norte B

In September 2006, SENASA implemented an intensive border control which included the provinces of Jujuy, Salta, and Formosa (SENASA resolution No 748/2004). By October 2006, the Frontera Norte B became functional. SENASA pays for the costs associated with vaccination in most of th e region

, although farmers must build and maintain their own confinement pens for vaccine administration.



###  When OIE once again recognized Argentina’s status as FMD

- free with vaccination following the February 2006 outbreak in Corr ientes, the high surveillance area was excluded from Argentina’s request for recognition

. In 20 1 1, SENASA updated legislation (SENASA resolution No 44/2011) unifying Frontera Norte A (Salta and Formosa provinces) and Frontera Norte B (Chaco, Corrientes and Misiones provinces) into the Cordon Fronterizo high surveillance area and subsequently reapplied to OIE for inclusion of the Cordon Fronterizo in the FMD

- free with vaccination zone of northern Argentina

. Resolution 44/2011 established animal health measure s along the high surveillance area that were agreed upon with the Mercosur P rogram For FMD Freedom (PAMA) including:

o determination of viral activity/circulation and immunity ;

o two annual vaccination cycles in all bovine ;

o intensified epidemiological surveill ance ; and

o strict movement contro ls such as:

### 47  Animals must not have contact with susceptible species for 21 days prior
to movement

.

 Establishment of origin must not have had any new introductions into the herd for 21 days prior to animal movements

.

 In the e vent herd introductions were made, those animals must remain in isolation (quarantined) for 21 days prior to animal movement

.

S ince March 2011, the areas of North Central Argentina

, including the Cordon Fronterizo are considered by OIE as FMD free with va ccination (see Figure 12 ) [ 83 ] while the areas including Patagonia (North B and South) and the summer pastures (zona veranadas) of Calingasta Valleys in the province of San Juan are considered by OIE as FMD free without vaccination.

Figure 12

. Argentina’s FMD status as recognized by OIE (May 2013)

There are also protocols for movement of semen and embryos into Argentina following OIE guidelines. Although a few breeding animals have come from specifically approved premises in Paraguay under permit, most come from the Buenos Aires province

. SENASA also requires that animals be identified by country of origin by eartag

. All FMD

- susceptible species have to be eartag ged in the high surveillance

area of Frontera Norte A and B

. A yellow eartag indicates that the animal originated in Paraguay, a pink Zona libre con vacunación CENTRO NORTE Zona libre con vacunación CORDÓN FRONTERIZO

Zona libr e sin vacunación PATAGONIA Zona libre sin vacunación VALLES DE CALINGASTA

### 48

eartag identifies an animal from Argentina, and a white tag identifies animals from Bolivia

. Eartags facilitate identification of smuggled animals, which are either unlikely to carry the tags or have tags showing that the animals originated in another coun try (see Figure 13) . The APHIS team that visited the border between Bolivia and Argentina in May 2005 observed the movement of FMD

- susceptible species with identifying eartags. In addition, at the office of Ingeniero Maza, province of Salta, the APHIS team observed the list of brands belonging to holdings located in Bolivia as well as documentation of vaccination campaigns [ 20

, 44 ]

.

Figure 13 : Ear tags used by Argentina (pink) , Bolivia (white) , and Paraguay (yellow) in the

border area

In 2007, SENASA improved the FMD program in the export region by including the following enhancements :

 Continuation of sanitary measures provided by SENASA Resolution 748/2004 for the “Subproject for Northern A Border” area which w as extended (25 km) along the provinces of Chaco (Department Bermejo), Corrientes

, and Misiones ;

 Strategic and systematic FMD vaccination, effec tive control of animal movements, and increase epidemiologic surveillance ;

 Improve sanitary barriers in areas ( specificall y at the borders of Paraguay and Bolivia) ; and

 Improve the structure for the control and inspection of animal production, including t ransport, marketing, and slaughter

. Cooperation during the 2006 outbreak

During the 2006 outbreak, 11 road check points were established for inspection and disinfection of vehicles

. Of these, one control post was established at the airport of the c ity o f Corrientes

. These posts operated 24 hours a day and are listed on Table 6 [ 50

, 51 ]

.

Table 6 : A ge nts stationed at control points and actions taken ( February to March 2006)

### 49 Post Agents Vehicles inspected and disinfected

Gral. Belgrano Bridge 18 122,500

San Luis del Palmar 7 19.686

Caa C upe 6 1,118
Laguna Alfonso 4 1,635

Rincón Navarro 2 488
Lomas de Vallejos 6 3,985

Saladas 7 4,994

Santa Rosa 6 3,875

Kilómetro 1111 7 5,897
Tranquera 4 4 389

San Lorenzo 7 1,712 “Camba Punta” International Airport 1 2,000 *

Total 75 168,280 ** * Number of passengers

* * Number of vehicles plus passengers at the airport

Table 7 shows the emergency active personnel during the 2006 outbreak

. Personnel were distributed into three groups: land, strategy and planning, and administrators

.

Table 7 : Emergency personnel active during the 2006 outbreak

Veterinarians (SENASA) 22
Technicians (SENASA) 10

Administrators 10
Vaccinators (ENTE) 36

Contract P ersonal (Movement con trol) 72
Security Forces 40
Navy 34

Provincial Police 50

Other Police 2

Training of personnel

SENASA personnel conduct training of security and other forces working on border security

. A manual of procedures applies at a national level for all types of border crossings [ 13 ]

. The manual includes:

 The legal framework ;

 The national and international zoosanitary disease status ;

 A glossary of terms ;

### 50

 The list of officials who are authorized to sign the international certificates and a list of authorized border control posts throughout the co untry ;

 An epidemiological characterization of the Border Posts (in the process of implementation) ; and

 Import and export procedures

. In addition to the procedures manual

, SENASA has a product manual that lists products allowed to enter the country (Resolutions 295/99 and 299/99 list approved plant and animal products)

. The policies and guidelines in these documents are applicable at a national level and define a standardiz ed approach for border personnel.

FUNBAPA employees receive a one

- day instruction course prior to employment and then are given materials to study at home. At the end of ten days they are required to take written and oral examinations on the materials. If the scores are satisfactory

, they are subjected to an interview before the hiring decision is made. They are also trained in various technical duties

, including recognition of FMD clinical signs and laws and regulations. The probationary period is six mon ths. Employees receive mandatory training once a year in a refresher course that covers any new rules or regulations. All posts are audited monthly by FUNBAPA and every four months by SENASA.

Conclusions

APHIS concludes that SENASA has adequate controls at ports of entry for legal commercial importation of FMD

- susceptible species and livestock products

. Argentina also has the legal framework, proper coverage of borders and emergency areas, and adequate staffing to monitor the influx of animals and produc ts via foot or passenger traffic from adjacent areas of higher risk

. The land and air border control posts visited during the site visits demonstrated adequate staffing levels and knowledge of requirements and procedures by employees who exhibited professi onalism and efficiency in conducting their duties. Staff was well trained and updated on a regular basis, and employed the use of appropriate technology when available. SENASA was able to compensate for the effects of the strike that occurred few weeks be fore the 2005 visit and maintain essential services

. In addition, SENASA was able to mobilize emergency personnel efficiently during the 2006 outbreak

, which stopped the spread of the disease into other areas.



### 8. Livestock demographics and marketing pra ctices in the region

Movement of animals to markets and proces sing could lead to exposure or spread of FMD. Mitigations during slaughter allow detection of animals showing clinical signs of dis ease, removal of bone and lymph nodes which could carry the FMD virus, and maturation of the beef to inactivat e the FMD virus

. In this section we explain the livestock demographics in Argentina, the type of production system in different regions, and the mitigations that take place during the slaughter process

. Livestock production systems in Argentina are divided according to geographic, climatic, productive conditions

, and other economic factors into five agro

- economic regions, as follows:

 The Pampas region, including the provinces of Buenos Aires, Cordoba, E ntre Rios, La Pampa and Santa Fe ;

 The North West Region (NOA) including the provinces of Catamarca, Jujuy, La R ioja, Salta, Santiago del Estero, and Tucuman ;

 The North East Region (NEA), including the provinces of Corrientes, Chaco, Formosa, and Misiones ;

### 51

 The Cuyo Region

, including the provinces of Mendoza, San Juan , and San Luis; and

 The Patagonia Region, including the provinces of Neuquen, Rio Negro, Chubut, Santa Cruz

, and Tierra del Fuego

.

The area n orth of the 42 nd p arallel has 55 million head of catt le distributed in 260,000 livestock establishment s . The Pampas Region is the most develop ed of the livestock areas, accounting for 76.62 percent of the production, with the remainder composed of 14.4 percent in the NEO Region, 4.1 percent in the NOA, 3.04 percent in Cuyo

, and 1.84 percent in Patagonia [ 13

, 39 ]

.

The distribution of bovine production in different provinces is shown on Figure 1 4

. Figu re 1 4 : B ovine distribution in areas of Argentina

Seventy

- five percent of cattle production in Argentina is localized in five provinces

. Fattening and dairy farms are prevalent in the central area of the country

. Cattle come from the north to Buenos Air es for fattening

. The western part of the country primarily contains subsistence farming

. Census information for individual holdings and throughout the country appears to be accurate and up

- to

date

. Prior to each vaccination campaign, a census update is c onducted using a quarterly form

. The number of animals in the previous campaign is corrected for the number of animals shipped, the number of animals acquired, and the number of births and deaths

. In some local offices (e.g., Brandsen located in the provin ce of Buenos Aires )

, an automatic correction to the census occurs when a DT

- e is issued

. The census information is used to estimate the number of doses of vaccine needed for the premises

. A follow

up form is completed 15 days after vaccination

. The foundation (unit conducting the vaccination, in most

### 52

parts of the country) informs the local veterinary office of the number of animals contacted during the week

. There is a monthly report on the number of animals moving to slaughter and fattening

.

T he sheep population is 13 million

, of which 16.72 percent is in the Pampas Region, 17.23 percent in the NE A , 5.89 percent in the NOA, 0.47 percent in Cuyo, and 59.69 percent in Patagonia.

The goat population is 2.3 million

, of which 39.68 percent is in Patagonia, 11.72 percent in Cuyo, 29.61 percent in NOA, 13.12 percent in NEA

, and 5.87 percent in La Pampa

The pig population is 2.3 million , of which 78.19 percent is in the Pampas Region, 9.99 percent in the NE A , 9.25 percent in the NOA, 1.24 percent in Cuyo, and 1.06 percent in Patagonia.

The livestock establishments are classified according to the producti on purpose into:

 Dairy establishments located in urban areas ;

 Establishments for fattening or wintering, mainly in areas with better farming quality ;

 Cow

- calf operations, generally located in areas of poor farming quality, where most of the calves are moved into fattening or wintering ; and

 Subsistence farms

. In Argentina, dairy production is concentrated in the c enter w est of the province of S anta Fe, n orth e ast of Cordoba, c enter s outh of Cordoba, the Parana area in the province of Entre Rios, the province of Buenos Aires, and in La Pampa.

The fattening area includes the provinces of Buenos Aires ( n orth w est), Santa Fe ( s outh), Cordoba ( s outh), La Pampa ( n orth), and Entre Rios ( s outh)

. La Pampa region concentrates 97.54 percent of the dairy industry.

Premises and individual identification

SENASA requires that all premises with agricultural animal production register with SENASA and obtain a RE NSPA (Registro National Sanitario de Productores Agropecuarios or National Sanitary Registry of Agricultural Producers) number

. This is an alphanumeric identifier that encodes information about individual premises and identifies the province, municipality, the premises, and various aspects characterizing particular premises , such as ownership, rental status, or shared occupancy

. For example, if an individual owns multiple premise s or if there are multiple producers owning or sharing a single premise , the number code identifies this . T he number can also be coded to indicate whether a premises is rented, as well as the number of people participating in the ownership or rental [ 11

, 20

, 31

, 32 ] . A diagram of t he digits in the RENSPA number is represented in Figure 15

. Figure 15 . Description of the digits in the RENSPA number.

XX XXX X XXXXX XX Province District Internal Control # Unique Farm #

(unique in province) Possession Type Owner (00) Renter (01) Etc.

The name of a responsible private veterinarian must be included on the application for a RENSPA number and is entered into the database

. The veterinarian is held accountable for failing to report

### 53

problems that he or she might observe on the premises

. Veterinarians named on registration documents are required by law to report problems on the premises, such as unusual numbers of sick and dead livestock

. If the veterinarian does not report and there is a disease outbreak, indemnity will not be paid

. This can be a significant loss, since the indemnity paid is typically the market value of the animal

. In addition, a fine is levied on the veterina rian, the owner, or both

, depending on who fails to notify SENASA.

Records of all farms showing ownership, number

, types of animals, farm name

, location, animal
movements , and RENSPA number are stored on a computer database

. The database is maintained by field officials and includes census information on all species on the premises, permit information showing animal movements, as well as other pertinent data. The database also records the FMD test status of the premises, as defined by the national survei llance program. Monthly statistical reports are generated from this database [ 20

, 32 ]

.

The database software platform has the ability to search for data by any of the previous mentioned parameters

. When shipping farm

- to

- farm, after animals are moved to the point of destination, the animal transport document ( DT

- e ) must be turned in to the local SENASA office in the desti nation department within 15 days

. That office notifies the local SENASA office of origin that the shipment has arrived

. If a particular movement record is not closed out (i.e., the animal does not reach its destination) , no more DT

- e’ s for that RENSPA num ber can be issued.

Compliance with the requirement to register premises is controlled by various mechanisms that provide a system of checks and balances. First, FMD vaccinators visit all premises in the country (north of the 42nd parallel) to administer v accines

. The n, t he premises must be registered to vaccinate

. While on the premises for any other purposes, the vaccinator is expected to update a census of all animal species on the premises and report the information to the field office [ 7

, 11

, 13 ] . C ensus information on premises containing cattle can be updated twice yearly because FM D vaccine s are administered twice yearly. If premises do not have cattle or are located in the non vaccination zone (e.g.

, region south of the 42 nd parallel), census information comes from a private veterinarian [ 31 ]

. SENASA considers current compliance with this requirement to be good.

In addition to the RENSPA number, livestock owners are assigned a unique identifying code called a CUIG number (u nique holding identification code), consisting of a series of four digits . The CUIG number is sho rter and easier to remember than the RENSPA number and is used as a more convenient form of premises identification. Farmers must have a RENSPA and a CUIG number in order to purchase eartags. Both the RENSPA number and the CUIG must be included on eartags of cattle (CUIG on the front and RENSPA on the back), but only the CUIG number is required for sheep tags due to size limitations (cattle require both a flap and a button tag whereas sheep only use a button or small flap tag).

The RENSPA and CUIG codes are linked to the i nt egrated management system for animal health ( Sistema Integrado de Gestión en Sanidad Animal

– SIGSA), which ensures prompt access to all information needed in case of any animal health event, such as the number and individual identific ation of animals (for cattle) present in a particular farm at a certain time, all animal movements in and out and detailed geo

- referenced data that allow for a quick identification of other farm or geographical areas at risk of any possible transmission of a reportable disease. All cattle and sheep movements are individually authorized and registered by the SIGSA through the issuing of the electronic animal movement permit ( Documento de tránsito electrónico or DT

- e), which must accompany all cattle and shee p that are moved in Argentina. The owner can request a DT

- e either electronically or by going to the local office.

In 2007, Argentina instituted a compulsory cattle identification program, requiring that all calves born after September 2007 carry offici al tags (Resolution 754/2006). Resolution 563/2012 requires that

### 54

bovines from the older age groups be individually identified. At the time of the 2013 site visit, SENASA reported that the entire Argentine herd was individually identified. Individual identi fication of bovines is unique and permanent. The number of tags needed is requested by the animal owner and is crosschecked at the local office to the inventory in the SIGSA

. The owner is responsible for applying the tags and then notifying the local office as to which tags have been used. The color of tags issued to cattle holders is determined by the FMD status of the region in which the cattle reside. Green tags are used in regions that

are FMD

- free without vaccination, yellow for regions that are F MD

- free with vaccination, red in buffer areas, and blue tags are used for tag replacement purposes only.

Figure 16 shows the IDs used for bovine :

Figure 16. Bovine Identification Example

Left ear Right ear

For sheep, individual identification is not required; however, in the event the farm is approved for export to the EU, premises identification is required, either by eartag, which includes the CUIG number of the farm, or ear notch. The eartag color and shape may be selected by the farmer (the color is not specific to the FMD status of the region as in cattle). Ear notches are controlled by and registered with SENASA to ensure that they are unique.

Movement controls within Argentina

A movement permit (DT

- e ) is required when animals go to slau ghter, go to market, cross provincial lines

, are exported internationally

, or are moved from one farm to another

. These permits are required to establish that the farm of origin is registered so that tracing can be conducted quickly if necessary. The ident ification numbers of b oth the premises of origin and the premises of destination must be record ed on the DT

- e

. Permit applications are checked against farm inventory in the SIGSA database. Thus, i f a registered farm attempts to ship more animals than are recorded in the inventory, the discrepancy is noted and the permit application is denied. The number of animal s and species are recorded on the permit , the information is entered into the database, and the premises’ inventory is updated. In addition , in order to allow the movement of animals, farms must comply with FMD vaccination campaign provisions . In the event the farm missed the scheduled vaccination, the local SENASA office will not issue the DT

- e for the animals from that particular farm. The team s that visited Argentina in 2005 and 2013 verified that the DT

e could only be issued if the information regarding FMD vaccinations was recorded in the RENSPA.

### 55

The local SENASA office issues a DT

- e to keep track of all animal movements off a farm

. A separate movement permit, a provincial transit certificate or guia is issued by the Provincial Authority to validate ownership and identification of the animals

. There is no charge for work done at the control posts (except for the spraying done at points of first entry into Patagonia North A). There are automatic sprayers at all commercial entry points and handheld sprayers at others. Currently, there is a charge for the DT

- e ( one Argentine peso

, which is equivalent to $0. 5 U.S. dollars ). T he p rovince char ges for the g uia, which includes a fee that is then used for agricultural projects in the p rovince (e.g., herd improvement) and funding for the g uia issuing offices. There is also a fee per kilo of wool shipped that is collected by the
p rovince and used th e same way. It is only the fruit and vegetable industry that funds FUNBAPA via fees collected for spraying at the border and for cargo per ton shipped. The animal industry funds go to the
p rovince, except for the vaccination programs where the farmers must pay for the FMD vaccine and the brucellosis vaccine [ 2 0]

. Movements to slaughter are carried out under the conditions established by SENASA Resolution 178/01

. This resolution requires that livestock movements be accompanied by a DT

- e and the pertinent livestock
g uia , have visible identification marks, and be transported in a vehicle approved by SENASA with a certificate accrediting washing and disinfection of the transport vehicle before loading and seals on each of the vehicle doors

. It also establishes joint liability among the official staff that issues the health certificate, the owners or persons responsible for the animals, the shippers

, and the slaughter plants [ 11

, 18

, 40 ] [ 83 ].

If animals are going to slaughter for domestic consumption, the veterinary inspection is limited to the
ante

- mortem inspection at the slaughter facility

. If the carcasses are going to be exported to the EU, the local SENASA veterinarian goes to the farm and seals the transportation vehicle, which is later opened by the veterinarian responsible for the ante

- mortem inspec tion at the slaughter facility [ 11

, 13

, 20

, 31

, 32 ]

. When animals are shipped from farm

- to

- farm, the DT

- e must be returned within five days to the local office of destination , who in turn contact s the local office of origin to notify them of the shipment arrival ( http://www.senasa.gov.ar/Archivos/File/File1528

- Anexo%20356

- 08.pdf )

. All vehicles carrying commercial shipments must also be registered with and approved by SENASA and issued a n umber

. Former SENASA Resolution No. 809/81 establishes the mandatory washing and disinfe ction of all livestock vehicles ( empty or containing animals) that transport livestock within the country

. Typically, the number issued by SENASA is painted on the truc ks, and the driver must show proof of the authenticity and validity of that number ( F igure 17 )

. Trucks must be cleaned and disinfected before every transportation and must show a proof of truck disinfection in the form of a bill issued by a SENASA

- approved facility [ 20 ]

. There is only one bill per movement

. No dirty animal trucks are allowed on the road or they will be cited

. Disinfection is carried out in all freight transports including farm machinery and is performed at random in automobiles at all entrance points into the country and into the free areas wher e vaccination is not practiced

. These points are approved by SENASA and are located at certain risk borders [ 11

, 18

, 40 ]

.

### 56

Figure 17. Number issued by SENASA after disinfection of trucks

Transport washers must be approved by SENASA and must use products specific for veterinary use and approved by SENASA

. The wash ing and disinfection tasks are performed by official staff or staff hired by SENASA using motor

- propulsion machinery or sprinkler equipment and products appro ved for vehicular disinfection [ 18 ]

.

Livestock m arket

The APHIS site visit team visited the Mercado de Liniers in 2005

. It is the largest cattle market in Buenos Aires

. It handles 55 percent of the animals slaughtered in the province and 20 percent of the animals slaughtered in the country

. Market officials estimated that 48,000 animals are sold per week and 200,000
per month

. The facility handled 2.3 million animals the preceding year

. It handles only animals intended for domestic consumption and c anned products that are not intended for export to the EU

. Animals slaughtered for consumption in the EU go directly to slaughter.

Four full

- time SENASA veterinarians and 13 technicians work at the facility

. SENASA personnel work in three teams, each of w hich is headed by a veterinarian

. The teams focus on animal/cattle health, horse health, and biosecurity

. The team for animal health checks and issues DT

- e s, conducts clinical observations and epidemiological investigations, and checks the destination

. Thi s information goes with the truck to the slaughterhouse

. There is a quarantine station on the grounds for animals displaying suspicious clinical signs of disease. No animals were in the facility when the APHIS team visited.

The horse health unit is respon sible for the status of the 400 horses on the facility

. The biosecurity unit supervises unloading, seals, cleaning and disinfection of trucks, and approval of trucks

.

### 57

The facility is owned by the Secretariat of Agriculture

. The corporation has a concessio n, and management is privatized

. Dealers and stakeholders in the corporation are authorized by the Secretariat and meet special requirements to operate.

The auction is held from 7: 0 0 a.m. to 9 : 0 0 a

. m

. The market has 32 scales that operate simultaneously

. SENASA and market officials check a nimal health and the DT

- e when trucks ar r i v e

. Animals are moved into the corral section where the dealers grade and classify the animals

. The sale is recorded when animals are weighed after the sale

. Once the animals are sold, another DT

- e is issued

. Animals are reloaded on trucks that have been cleaned and disinfected on the premises

. SENASA officials check the seals on incoming and outgoing vehicles

. The DT

- e for the departing shipments include s slaughterhouse identifica tion number, the brands of the animals shipped, and the name of the owner.

A computerized system
, in use at the market since 1992
, ensures traceability from field to slaughter

. It contains detailed
, up

- to

- the minute real

- time sale records that include the guia (owner identification), license number of shipper, number of animals shipped, DT

- e information, corral number, RENSPA number, lot identification number, scale number, and other information

. This information is posted automatically and immediately on the I nternet at the ti me of sale ( www.mercadodeliniers.com.ar/)

. The information has been available on the I nternet since 2001

. Records have been maintained since 1995

. Sales are also broadcast live on television from 6 a.m. to 10 a

. m.

There is information on file in the computer system on 60,000 brands, although 20 ,000 to 30,000 of these are the most commonly used.

Various types of reports can be extracted from the system, such as the volume of animals shipped from each province per day and summaries of t he transa c tions occurring on a daily basis

.

A pproximately 55 percent of the slaughterhouses the Mercado de Liniers serves are close to the market

. Farms providing animals to the market are usually small

- and medium

- sized premises

.

Beef export process

Domestic consumption of beef is approximately 63 kg per person each year, and it has declined in recent
years

. Amounts of beef that Argentina would like to consider export ing into the United States are shown in T able 8 [ 52 ]

.

Table 8 : Amount of beef that Argentina is cons idering for export to the United States

Description Lowest Most likely Highest Source Bovine meat expected to be exported into U.S. 16

, 000 Tn 20

, 000 Tn 24

, 000 Tn GRUPO ABC Consorcio. Cámara de Exportadores

In addition to requirements for movement to slaughter established by Resolution 178/01 and the National mandatory Animal Identification System described on Section I , t here is a mandatory system called “Identification System for Bovine Cattle intended for Export,” creat ed by SENASA Resolution 15/2003 f or bovine species

. All the farms registered in the “Registry of Rural Establishments Supplying Livestock for Slaughter for Export” use this system

. It also applies to establishments registered to fatten bovines that are int ended for slaughter for export

. “Rural Establishments of Origin” are registered as premises that produce and raise cattle that eventually go to the Establishments for Slaughter for Export.

### 58

Animals are transported in special vehicles for transport only

. T he vehicles must comply with SENASA Resolution 97/99

, which requires approval of the vehicle by SENASA and compliance with SENASA Resolution 809/82 which prescribes hygiene and sanitation requirements.

F arms must be registered and have a RENSPA number t o market or move animals

. Shipment of animals to any destination requires a DT

- e and a g uia that is issued by provincial authorities

. The local SENASA offices keep a record of the movements of susceptible animals and report this information on a monthly basi s to the statistics unit of DNSA, the Technical Management Unit

, and the CCFyC.

There are 185 sl aughter plants approved by SENASA in the region north of the 42 nd p arallel that comply with the regulations in force established by SENASA

. All plants approved by SENASA are fed erally inspected

. Fifty

- two eligible plants are certified to export meat to the United States [ 53 ]

. The procedures to approve plants for export are regulated by SAGPyA Resolution 310/04, which updates the requirements of Decree 4238/68 and other previously abolished standards

. The facility must first be registered on a list of establishments authorized to export

. Then the Bureau of Supervision of Products of Animal Origin has to carry out an as sessment of compliance with building

, operative and documentary requirements, in accordance with a procedures i nitiative

. I t must a lso be verified that the requirements of the country of destination and the National Bureau of Agricultur al and Livestock Trade Control ( an agency of the Secretariat of Agriculture, Livestock, Fisheries and Food ) have been met.

The following parameters are taken into account for the evaluation of slaughter plants that wish to export their products :

 Capacity of pens at the e xport area ;

 Daily slaughter numbers intended for export ;

 Slaughter capacity (animal/hour) ;

 Capacity of the maturations chambers, if pertinent ; and

 Capacity of carcasses that can be introdu ced into chambers intended for maturation, complying with the follow ing items in accordance with Decree 4238/68:

o Prohibition of commingling of carcasses coming from areas of different sanitary conditions , and

o Presence of viable technical methods to register environmental temperature in the maturation chambers

. The slaught er establishments must be approved for the activity appropriate to the requested destination and a pre determined volume of production

. The establishment must document procedures to identify and trace the products to be exported and provide the Service of V eterinary Inspection an updated list of livestock suppliers

. They must not have any infringements of the Residues and Food Hygiene Plan and must correct any problems that were observed by auditors of foreign sanitary authorities

. Documentary proof of compl iance with all the requirements of the country of destination must be provided.

According to the regulations, by the authority of Decree 4238/68, biosecurity control s in all the slaughter facilities approved by SENASA are the following:

 Pens: A nimals are kept within pens and cannot go out of the slaughtering plant once they enter the premises.

### 59

 Effluent treatment: A ll effluents from the coldstore (pens, slaughter yard, and water used in all the processes) are treated by separating solids, fats, liquids

, an d chlorinates out before releasing them to the general sewage system.

 Sanitary complex: Effluents from the sanitary complex are individually treated by disinfection before dumping them with the rest of the common, treated effluents

. Fallen animals are slau ghtered at the emergency yard and their meat and products are not used for export

. Dead animals are treated at the necropsy digester after diagnosis, including the skin.

 Raw slaughter wastes: Wastes are sent to processing plants with thermal treatments for non edible uses in closed vehicles approved for the purpose

. They may be processed at the same plant in melters or digesters wit h thermal treatment to make nonedible by products.

 Slaughter pathology wastes : Wastes are processed in digesters with pressurized steam or in melters to obtain by

- products.

Two slaughter facilities

, visited during the 2005 APHIS site visit to Argentina

, buy animals from regional farms and the livestock market

. One of the plants located in La Plata (50 km from Buenos Aires) processes approximat ely 240,000 head per year (700 to 800 per day)

. The slaughterhouse was established in the 1960s

. The plant has 600 employees work ing in different shifts

. The other slaughterhouse visited

, located in Rosario (Santa Fe province)

, process e s over 1,600 animals a day and has 1,000 employees. Both plants are approved for export to the EU, Asia, Africa, and the United States

. The 2009 site visit visited a slaughter facility in Puerto Madryn which has been exporting sheep to MERCOSUR member nati ons and other countries, and since 2004 to the EU

. The SENASA official at the plant checks the DT

- e , g uia n umber, seal integrity , and information; verifies that ear no tches match the CUIG on the DT

- e ; and checks transporter information including the truck cleaning and disinfecting certificate. Animals for EU export are also eartagged prior to slaughter with a button tag bearing the unique farm ID number

. In 2013, the APHIS team visited two other slaughter facilities located in the province of Buenos Aires. All the facilities visited were exporting beef to the EU following EU specific requirments (e.g, pH less than 6.0 and 24 hours maturation process)

As observed during the 2005 and 2013 visits, w hen a shipment arrives, the transport vehicles are washed and sanitized

. The shipper must produce documents, such as the DT

- e and g uia, that have to be signed by the local official veterinarians

, or the shipment i s not unloaded

. The local SENASA office that issued the DT

- e is contacted when the animals arrive

. At arrival, animal s are separated into two different groups, depending on whether the shipment originated at the farm or at the livestock market since the EU does not allow the export of animals that pass though the livestock market.

Upon arrival at the pl ant , each animal lot is given a lot number that is carried through the slaughtering and quartering process

. Slaughter labels and quartering labels are linked to each other and detail the following information: herd number, date of slaughter, weight of cut, type of animal, destination ( domestic or export) and other details

. The tags are prepared after the process and attached to the case and the corresponding tag indicating: the date of slaughter, date of preparation, lot number, expiration date, type of cut , and weight of the product

. A SENASA official does the ante

- mortem inspection and any sick animals are placed in an isolation pen

. Animals from the same ranch are all placed in the same pen

. The number of animals and other information are recorded on a ca rd which is kept in the office

. A post

mortem on any animals that die is performed in a nearby necropsy room.

APHIS site visit t eam s pay particular attention to the following critical control points for FMD: (1) ante

mortem inspection for clinical signs o f FMD, (2) post

- mortem inspection for lesions of FMD, (3) maturation procedure, (4) deboning, and( 5 ) removal of lymph nodes.

### 60

(1) Ante

- mortem inspection : The animals receive their first inspection upon arrival by a SENASA technician /inspector who checks t he paper work (DT

- e ), unloads the trucks, and performs a physical inspection

. If a truck arrives with no paperwork, it cannot be unloaded

. If anything unusual is noted, the animals are moved to the observation corral for the veterinarian to perform a clini cal exam.

The Federal veterinarian performs the ante

- mortem inspections

. Observations are registered on an ante

mortem inspection card that contains basic information on the animals in each pen

. Animals with disease symptoms are separated into observation pens for a closer examination

. Holding pens contain animals from one owner and farm, and multiple pens may contain animals from one owner

. The animals are grouped into lots.

(2) Post

- mortem inspection : After animals are killed, a SENASA inspector examines the carcass and
organs

. Post

- mortem inspection includes inspection of the hooves, the head, associated organs

, and lymph nodes

. T he slaughter operator’s technicians also perform post

- mortem inspections. When a lesion is found, the technician at the particular station stops the line

. The SENASA field veterinarian then investigates more closely

. In particular for FMD, the technicians specifically check the feet, muzzle, and tongue for vesicular lesions

. If the technicians have any doubts, they noti f y the veterinarian immediately

. The veterinarians train technicians to perform these inspections.

(3) Deboning : Deboning consists of removal of bone and blood clots . It is carried out under supervision of the quality control personnel

. All products must pass through the quality control point where a score of acceptability is assigned

.
(4) Maturation and pH testing : The carcasses are matured for a minimum of 24 hours at a temperature of 2 to 10  C

. Temperature is measured when the first carcass enters the cooler and again after the last carcass enters and doors are closed

. After 25 hours, technicians measure the pH of the meat at one point in the loin muscles in each half of the carcass

. In the event the pH is above 5.9, the carcass is separated from th e export beef and only used for domestic consumption (as per EU requirement)

. The facilities visited by the APHIS site visit team have the capacity to segregate and test pH to ensur e that all carcasses that would be destined for exports meet the requiremen ts of the importing countr y (e.g., less than 6.0 for the EU and the United States).

Conclusions

The livestock industry in Argentina appears to be well organized, committed to the production of quality products

, and aware of necessary biosecurity precaut ions

. APHIS considers the biosecurity measures and controls at major production facilities to be effective in the prevention of FMD outbreaks

. There appears to be a high level of awareness and compliance with these measures at large livestock producers and slaughter facilities

. Processing facilities are under adequate official control and inspection

. APHIS concluded that the larger commercial farm

- operations are likely to be the source of beef exports from the export region

. Per APHIS regulations, import ed meat or other animal product must have been been processed, stored, and transported to the means of conveyance that will bring the article to the United States in a manner to preclude its being commingled or otherwise in contact with meat or other anima l products from regions that have not been authorized by APHIS to export such products to the United States. Therefore, cattle could not go directly from Argentina livestock markets (where there would be a risk of such commingling) to slaughter, which is the means by which most smaller commercial operations in Argentina sell their cattle. In that regard, APHIS considers the livestock market system in Argentina to be well organized and tightly controlled by the official service

. APHIS further concluded that the Argentina animal identification system is operational and adequate

.

### 61

APHIS concluded that adequate controls and inspection measures exist at slaughter facilities

. In that regard, ante

- mortem and post

- mortem inspections are carried out satisfactorily

. APHIS verified pH controls, maturation

, and deboning procedures at the plants, which export to the EU and other countries

. APHIS concluded that after maturation, the facilities have the capacity to segregate and test pH , to ensur e that all carcasses that w ould be destined to the United States would have a pH below 6.0

. If greater, the slaughter facilities are able to divert the carcasses to local consumption

. APHIS examined maturation records and verified actual rejected and approved seals.

APHIS concluded that Argentina has adequate control of inspection activities in slaughter plants and can certify complianc e with USDA import requirements to import matured

, deboned beef

. 

### 9. The type and extent of disease surveillance in Argentina

Documenting a surveillance system sufficient to ensure early detection of FMD is essential for the assessment of risk

. Argentina’s surveillance system is a combination of both active surveillance (including ongoing laboratory

- based testing) and passive surveillance ( reporting and/ or testing of animals with clinical signs of disease ). This section explains the characteristics of the FMD surveillance program in place in Argentina 2

. Objective of surveillance

The primary objective of all of Argentina’s FMD epidemiological surveillance activities since the July 2000 epidemic has been to search for and eradicate FMD

. This is done in accordance with the country’s National FMD Eradication Plan, of which serological sampling has been an integral part [30, 90]

. S ENASA conduct ed repeated countrywide serological samplings to monitor the disease during the 2000 /2001 outbre a ks, and subsequent country wide serological samplings have been conducted to measure the progress of the National FMD Eradication Plan [ 26

, 27 ] [88]

. I n particular, serological sampling in Argentina is conducted for the following reasons:

 To detect viral activity (or infection)

, and

 To estimate population immunity given by vaccination against FMD where vaccination is practiced.

FMD surveillance activities in Argentina may be broadly characterized as passive and active surveillance

. These two methods work in a complementary fashion re sulting in efficient and effective surveillance

. P assive surveillance gathers qualitative information about the disease and active surveillance gathers quantitative data

.

Passive surveillance

Passive surveillance is accomplished by a wide variety of activities in Argentina

. The most salient feature of passive surveillance is the education and involvemen t of the entire community to be watching for any

2 The Epidemiology and Risk Analysis Unit of SENASA’s National Animal Health Directorate is responsible for designing the sampling and evaluating the results . It collaborates with and seeks technical assistance from the Epidemiology Advisory Commission

, whose members are experts from SENASA, the National Farm Technology Institute , the Animal Virology Centre of the National Council for Te chnical and Scientific Research

, and s chools of

v eterinary s ciences

. Samples are collected by local SENASA veterinarians and specimens are processed by the Animal Department of the Official Laboratory and Technical Control Directorate of SENASA (Ref: Annex IV_Muestreo 2004 end.pdf)

.

### 62

suspicion of FMD

. Observations and qualitative information gathered under the passiv e surveillance effort are an integral part of the overall surveillance efforts in Argentina

. Information from passive surveillance activities is utilized effectively in the national serological sampling design to help achieve better stratification and to c oncentrate sampling effort where needed the most (i.e., targeted sampling)

. Passive surveillance and follow

- up efforts are further described under Factor 11 (Policies and infrastructure for animal disease control in the region) below.

Active surveillance

Active surveillance in Argentina primarily constitutes sampling of animals for serological testing

. This sampling is conducted under the National FMD Eradication Plan ( see Factor 11

— Policies and infrastructure for animal disease control in the region ). Th e design consists of a two

- stage sampling strategy, at the herd level and the individual animal level, within each region (regions are based on the number and type of herds and animals and the disease history of each zones )

.
As mentioned earlier, northern Argentina vaccinates cattle for FMD , and , in addition to the surveillance sampling described above, SENASA also conducts annual nation

- wide serological samplings to estimate the immunity offered by the FMD vaccine. These samplings, together with o ther surveillance activities, serve to assess the epidemiological status of FMD in the country and collect specific indicators on the evolution of the disease

. Argentina has been conducting serological surveillance on a yearly basis since 2001

, with a fr equency of at least once a year. Additionally, other surveillance studies are conducted frequently for various purposes. Examples of such studies include assessing immunity levels in the young vaccinated cattle population, or in sheep and goats in areas th at do not vaccinate for FMD, or for animal movements out of the Cordon Fronterizo bordering Bolivia, Paraguay and Brazil. During the 2012 FMD outbreak in Paraguay, Argentina also conducted intensive surveillance in the six border provinces. These studies are detailed below

.

Description of the sampling design

The random selection of animals for serological testing is conducted according to a standard stratified
two

- stage probabilistic design

. Under this design, the country

— which has a surface of 2,780, 199 km 2 and 270,000 establishments with a population of 52.5 million bovines and 13.8 million sheep

— is f irst divided into zones and sub zones (i.e., strata) according to several factors such as livestock production systems and animal movement patterns, ge ographical and climatic conditions, and epidemiological characteristics with respect to the history of disease in the region and to the vaccination program (see F igure 1 8 below)

. From each zone, herds (establishments) are randomly selected at the first stage of sampling, and animals within herds are then randomly selected at the second stage of sampling

. The design is flexible enough to permit changes and adjustments to target high

- risk areas based on epidemiological a nd other relevant considerations at the time of sampling and the surveillance goals

. APHIS considers Argentina’s sampling design to be appropriate, efficient

, and scientifically sound.

### 63

Figure 1 8 : Epidemiological zoning of Argentina for the purpose of sero logical sampling

Determining sample size 3

The number of herds to be selected in each region (stratum) at the first stage of sampling is determined according to the followi ng standard statistical formula [ 54 ] :

3 Sample sizerefers to the number of herds n h and the number of animals within herds n w

- h to be selected for serological sampling in each region in a given sampling year. These are determined according to formulae (1.1) and (1.2), respectively.

### 64

Similarly, the number of animals to be selected from each of the selected herds is determined according to the following standard statistical formula [ 81 ]:

Changes in serological sampling from year to year

The objectives, approaches

, and intensity of serological sampling in Argentina might change slightly from year to year but are otherwise the same

. In prior years, t he main objective of surveillance was to estimate the prevalence of the FMD virus in different regions of the country

, 4 and to estimate the level of immunity in the natio nal bovine population of herds with the application of the systematic vaccination for each region

. 5 Since the last outbreak occurred in 2006, the surveillance objectives have been modified to

serve the purpose of early detection of FMDV if it were to be pr esent in the country, and for continuing to evaluat e population immunity in areas that vaccinate.

The sampling approach under the current surveillance objectives remains the same

. T he random selection of animals is always conducted in two stages in accordance with the national sampling design described above

. The country is divided into different regions (strata) from which herds are selected at the first sampling stage

, after which individual animals from within the selected herds are selected for s ampling

. Both targeted and random samplings may be conducted

.

For early detection of FMDV

, a herd prevalence of 5 percent and a statistical confidence level of 95 percent were typically assumed each year through 2010. To determin e the population immunity level, a prevalence ( P ) of protected bovines of 75 percent was assumed, with an acceptable error of six percent and a statistical confidence level of 95 percent

. These were the typical assumptions each year in each region

. Similarly, the number of animals to be selected from within a selected herd was determined for each region using formula (2) above

. For the purpose of determining the within

- herd sample size, the

4 Viral activities were measured in susceptible animals that were recently and/or previously infecte d with the FMD virus, as well as in vaccinated animals. Different species were sampled, including sheep, which were not vaccinated; and bovine, stratified in animals from 1 to 2 years old and animals older than 2 years.

5 The samples from the premises that were completely negative to the detection of viral activity were u sed in order to carry out a sub sampling to determine seroprotection levels in the population.

### 65

typical assumptions were two percent within

- herd prevalence and a 95 percent statistical con fidence.

Finally, each year ’s samples from the premises that were completely negative to the detection of viral activity were used to estimate the sero

- protection levels in the population

. The statistical design typi cally required that at least 80 establishments be sampled in each region and approximately 1200 samples be taken

. This was done each year (approximately) by analyzing 15 bovine sera from each of the 80 establishments (960 from bovines aged one to two years and 240 of bovines older than two years)

. A ll of the sampled farms had complied with both vaccination campaigns corresponding to the current year, established by the 

### National FMD Eradication Plan , with at least 30 days from the last vaccination

.

### 66

The list of herds, as well as all livestock census data in Argentina, are compiled and updated by RENSPA

. Table 1 3 shows some of the demographic information and livestock figures used to construct sampling.

Table 9 : Livestock figures used to construct sampling lis ts.

Province Flocks Total Bovine Total

Sheep Total

Swine Total

Goats

BUENOS AIRES 61

, 742 21

, 050

, 731 1

, 194

, 435 532

, 465 9

, 620
CORDOBA 29

, 444 6
, 508

, 375 98

, 619 444

, 343 45

, 089
ENTRE RIOS 39

, 572 4

, 697

, 308 35

, 8300 42

, 155 3

, 277

LA PAMPA 9

, 351 3

, 342

, 981 12

, 8724 95

, 093 25

, 377
SANTA FE 30

, 252 6
, 968

, 040 55

, 738 695

, 451 47

, 635
CATAMARCA 3

, 690 154

, 575 11

, 388 3

, 159 54

, 695

JUJUY 4

, 032 88

, 918 473

, 463 6
, 518 106

, 126
LA RIOJA 3

, 092 278

, 874 8

, 209 26

, 658 142

, 781
SALTA 3

, 037 447

, 933 46

, 725 34

, 830 70

, 899
SANTIAGO DEL ESTERO 9

, 394 1

, 179

, 385 99

, 813 134

, 939 278

, 428

TUCUMAN 6
, 013 125

, 361 7

, 009 14

, 102 7

, 609
CORRIENTES 10

, 047 4

, 480

, 962 1

, 540

, 590 18

, 956 5

, 314
CHACO 10

, 911 1

, 640

, 889 284

, 351 59

, 811 129

, 262
FORMOSA 8

, 945 1

, 565

, 381 60

, 619 83

, 805 155

, 562
MISIONES 26

, 252 315

, 442 6
, 792 68

, 619 2

, 646
MENDOZA 894 137

, 378 8

, 680 4

, 529 192

, 020
SAN JUAN 733 30

, 727 0 2

, 811 30

, 639
SAN LUIS 5

, 747 1

, 523

, 289 43

, 225 21

, 327 38

, 940 NEUQUEN 3

, 757 133

, 758 194

, 007 6
, 039 568

, 500
RIO NEGRO 5

, 306 697

, 501 1

, 728

, 045 7

, 668 176

, 353
CHUBUT 4

, 095 188

, 347 4

, 633

, 518 10

, 818 140

, 364
SANTA CRUZ 1

, 567 46

, 798 2

, 333

, 526 1

, 481 1

, 250
TIERRA DEL FUEGO 87 30

, 815 520

, 403 432 0
Total 276 , 306 55 , 556 , 155 10 , 982 , 250 2 , 314 , 096 2 , 231 , 136

### 67

Serology results

Compliance with sampling

In some regions, the total number of samples may not be collected for the following reasons:

 Problems submitting the samples (e.g., spills, broken tests tubes, storage

problems, etc)

, and

 Samples not fit for testing (e.g., hemolysis)

.

Table 1 0 demonstrates compliance with sampling by region.

Table 1 0 : Compliance with sampling for viral activity during 2004 and 2005 *
Region Farm

Prevalence % Holdings

required to be sampled Holdings

sampled Percent

sampled Species

Central

– Mesopotamia 1 372 (313) 381 102.4 Bovine

Fattening 1 335(313) 326 97.3 Bovine Border 1 459 (313) 456 99.3 Bovine NOA

– Cuyo 1 459 (300) 455 99.1 Bovine Patagonia North A 1 330 (313) 329 99.7 Bovine

Patagonia South and North B 1 459(313) 459 100 Bovine/sheep/goat

Total 2414(1,865) 2406 99.6 *(2005)

Table 1 1 shows the results of the tests to detect antibodies against nons tructural p roteins in bovine c ategory 1 ( six to 12 month of age) and c ategory 2 (12 to 24 month of age) per region during 2004.

Table 1 1 : Results of tests to detect antibodies against nonstructural proteins in bovine s

Region Holdings

tested Positive

holdings sampled Category 1 Category 2

N

N Positive N

N Positive

N % N % N %

Central

– Mesopotamia 305 10 2.6 2272 2 0.08 1510 1 1 0.7

Fattening 324 5 1.5 1942 2 0.1 1283 3 0.2

Border 455 8 1.7 2717 15 0.5 1818 3 0.16

NOA

– Cuyo 453 5 1.1 2674 2 0.047 1782 3 0.17

North A Patagonia 329 9 2.7 1973 3 0.1 1297 8 0.6

### 68 Total 1941 37 1.9 11578 24 0.2 7690 23 0.3

A ll holdings with animals that tested positive in the first sampling were sampled a second time. Positive holdings were immediately reported to the Epide miology Division and the follow up was based on OIE standards

. From each of the holdings with a positive reactor, 60 cattle, and 60 sheep or goat s were identified by eartags, tested, and retested 21 days later

. In addition, other holdings within the same area were included in the serological testing

. During 2006, there were three positive bovine s age d six to 12 months ( two from Cent ral Mesopotamia/Cuyo/NOA and one from the fattening area) and seven positive bovine s age d 12 to 24 months ( three from Central Mesopotamia/NOA/Cuyo, three from the fattening area, and one from the border area)

. Followup of the positive cases showed no evide nce of clinical disease

. In addition, epidemiological surveys failed to demonstrate any risk situation that could be associated with FMD

. Further, sampling of contacts show that from the three cattle that remained reactive, only one maintained the same

res ults after the initial sampling

. No evidence of viral cir culation was found after follow up of premises with reactive animals.

Table 1 2 summarizes the sampling for 2007 to 2008 by region.

Table 1 2 : S am pling to determine viral activity by region , 200 7 and 2008

.

Zone Year Establishment s Sampled Bovine s

Sample d Ovine s

Sample d Total Animals

Sample d Central

Mesopotamia 2007 312 bovine 222 ovine 8,182 2,183 10,365

2008 300 bovine

238 ovine 8,028 2,307 10,335

Fattening 2007 281 bovine 148 ovine 5,123 1,218 6,341

2008 338 bovine

144 ovine 8,883 1,398 10,281

Border 2007 290 bovine 23 ovine 7,809 283 8,092

2008 289 bovine

62 ovine 8,530 590 9,120

Frontera 2007 290 bovine 23 ovine 7,811 283 8,094

2008 289 bovine

62 ovine 4,573 590 5,163

Patagonia Norte A 2007 301 bovine 129 ovine 5,471 1,094 6,565

2008 340 bovine

154 ovine 8,688 1,536 10,224

Through 2008, the sample design was determined at the regional level. Beginning in 2009, the design is determined at the c entral SENASA level taking into account regional differences, which

en sures a more consistent sampling approach.

In addition to the serological testing, SENASA conducts official inspection of cattle in farms, livestock market, and slaughterhouses. The to tal number of individual bovine and ovine inspections reported in 2009 was 31,333,478 [ 55 ]

.

### 69

Population immunity

To evaluate the population i mmunity, the titre obtained using ELISA LP (ELISA monoclonal

based liquid phase ) from each serum sample was classified into low, medium, and high based on the percentage protection expectancy (PPE) for each of the serotypes under study

. The ranges of each category are described in T able 1 3

.

T able 1 3 : Interpretation of the LP ELISA according to percentage protection expectancy

O1 Campos (titre) A2001 (titre) PPE Result

<1.77 <2.1 <7 5% Low 1.77

- 1.91 2.1

- 2.3 75%

- 85% Medium >1.91 >2.3 >85% High

Animals with PPE over 75 percent are considered to have adequate protection against FMD.

Results of the 2005 studies show ed a PPE with medium

- high immunity level for each category, zone, and type of virus [ 27 ]

. Changes in Surveillance Sampling Design, 2011 [ 91 ]

In 2011, serological sampling was conducted to demonstrate the absence of disease in the Northern region that vaccinates against FMD and the Patagonia region that does not vaccinate

. The surveillance objectives in the Northern region were to evaluate for presence of antibodies against non

- structural proteins (NSP) in cattle and against structural proteins (SP) in other FMD

susceptible species

, and also to assess the population immunity in the vaccinated region by determining presence of antibodies against SP for th e types of viruses present in the administered vaccines in cattle that had tested negative to NSP. Four zones were established for sampling: Zone 1 with the highest bovine population density , Zone 2 which has predominantly extensive production systems, Zo ne 3 which corresponds to Patagonia North A ; and Zone 4 which comprised the areas without vaccination.

The sampling strategy was designed based on detection of FMD if present at 1% prevalence among herds and 10% within individuals in the selected herd

, wi th a 95% confidence level. Based on the sampling design, a minimum of 313 farms were randomly selected in each zone . In Zones 1 to 3, 28 animals were sampled from each farm, 17 of which were from 6

- 12 months and 11 were 12

- 24 months. In addition, sample s were collected from 10 sheep and goats between 6

- 24 months for each farm that also raised these species. In Zone 4, a total of 28 cattle, sheep or goats were sampled from each of 313 farms.

For Zones 1 to 3, a total of 25,421 cattle (15,360 from 6

- 1 2 months old and 10,061 from 12

- 24 months) were sampled from 997 farms, while a total of 5,758 sheep and goats were sampled from 564 farms. No reactors were found among all sheep and goat sampled. Table 14 below show s the results for cattle and sheep/goats , respectively.

### 70

Table 14 . ELISA 3ABC and EITB results from cattle in the area s that vaccinate against FMD.

Cattle 6

- 12 months Cattle 12

- 24 months

Zon e Number of

Samples Reactors
Number of Samples Reactor s

No. %

% No. % %

1 5794 0 0 0 3743 0 0 0

2 4771 1 0
0.02 3294 4 0
0.12

3 4795 0 0
0 3024 1 0
0.03

Total 15360 1 0 0.01 10061 5 0 0.05

Follow

- up activities for all reactors included visits to each of the six premises to collect epidemiological information

, including animal movements in and out of the farm. Complementary serological sampling was conducted on the same animal s initially sampled, their cohorts, and any unvaccinated sheep or goats if available at the farm or in a neighboring ranch. A total of 474 additional samples were collected in the follow

- up studies which identified 1 more reactor to the ELISA EITB test. Esophageal

- pharyngeal fluid (LEP) samples were taken from all reactors for Complement Fixation testing (CFT 50 percent ) in each of two pa ssages in BHK cell culture. Probang sampling was repeated after 21 days. All LEP samples from reactors were negative.

Due to the predominance of sheep production operations in Zone 4 (areas that do not vaccinate against FMD), the majority of samples were collected from sheep and goats in this area. A total of 350 facilities were sampled, 326 of which were primarily sheep/goat operations. Figure 19 shows the geographical distribution of bovine and ovine/caprine farms sampled in Zone 4.

### 71

Figure 19 . Bovine (blue) and Ovine/Caprine (green) premises sampled.

No reactors were found in a total of 9,259 samples tested.

Other Directed Surveillance Efforts, 2011

- 2013

In addition to their routine active surveillance, Argentina has conducted additional serosurveillance studies to assess viral activity or to estimate herd immunity in different subpopulations.

2012 Stud ies [ 92 ] : Subsequent to the FMD outbreak in Paraguay, an enhanced surveillance effort was focused on the Northern provinces with international borders: Salta, Formosa, Corrientes, Misiones, Chaco and Jujuy. A two

- stage stratified random sampling design was based o n a one percent prevalence among herds and ten percent prevalence within individual animals in a herd, with a 94 percent confidence level. A total of 345 premises were selected and 28 cattle were sampled in each premises. Up to ten sheep and goats were als o sampled if present on these premises. Cattle between 6

- 12 and 12

- 24 months of age were sampled, while sheep and goats under 24 months were sampled. ELISA 3ABC/EITB was used to detect non

- structural proteins in cattle, and the liquid

- phase ELISA was used to detect antibodies against structural proteins in sheep and goats.

### 72

A total of 8,336 cattle were sampled. Three reactors (0.06 percent ) were identified out of the 4,800 which were in the six to 12 month age grouping; no reactors were found in the 12

- 24 month
age group. A total of 1,698 sheep and goats from 183 premises were also sampled with no reactors identified. Although the overall percent of reactors (0.03 percent ) from all cattle sampled

wa s in accordance with the specificity of the diagnostic te st used , epidemiological follow

- up of all reactors and cohorts was conducted, which included serological and LEP (repeated after 21 days) sampling of all reactors and serological testing of all cohorts. All follow

- up tests were negative for FMDV

. In a sep arate enhanced surveillance effort focused on the international border, 100 animal movements (transport trucks typically carrying between 40

- 50 cattle) were sampled to detect viral activity and determine the immunity levels for cattle leaving the Cordon Fr onterizo. Animals moved out of this area are considered high risk and these movements are regulated under SENASA Resolution No. 44/11 as described in earlier sections . The objective was to identify animals with inadequate protection with 95 percent confid ence , so level of protection of animals within a single movement grouping was set at 70 percent . Sample size for this objective was set at 15 animals per transport unit or movement. A second sampling stage was conducted

, assuming a 50 percent protection le vel. The focus of sampling was young cattle between six to 12 months of age destined for slaughter.

A total of 104 transport units of cattle were tested with 1,560 individual animals sampled. Test results for FMDV strain immunity showed that 89 percent o f the animals tested showed protective levels against serotype O (the predominant strain in the Paraguay FMD outbreak), while 74 percent and 83 percent were protected against serotype A and C respectively. Five (4.8 percent ) out of 104 transport units had insufficient levels of protection. All sera were tested to detect circulating virus, with all negative results on ELISA 3ABC/EITB.

Additional immunity studies were also conducted by SENASA in 2012 in the same six provinces. A total of 272 farms were randomly selected and a total of 3,521 serum samples from young cattle were tested using liquid

- phase ELISA for detection of antibodies against structural proteins. An Expected Percent of Protection (EPP) of 75 percent was used as a standard for each serot ype. Cattle in the six to 12 month age category would have likely received only one dose of vaccine, while those in the 12

- 24 month age range would have received more than one dose, resulting in higher antibody titers. Results show satisfactory immunity l evels conferred by vaccination, particularly in the older age grouping.

2013 Serological Survey

– Patagonia North A [ 93 ] : This survey was designed to supplement the information needed to apply for recognition of Patagonia North A as an FMD free zone witho ut vaccination following the OIE Terrestrial Code guidelines. Thus the study was designed to demonstrate the absence of FMDV in the provinces of Rio Negro, Buenos Aires and Neuquen. Indicators of infection were evaluated by testing for presence of antibodi es against non

- structural proteins in cattle and against structural proteins (A24/Cruzeiro and O1/Campos) in pigs.

The last vaccination campaign in this area was held in late 2012 with a final date for complete cessation of vaccination set on March 4, 2 013. Subsequently, the surveillance strategy for this area, for which annual surveillance has occurred since 2001, was revised to a risk

- based sampling approach. Factors considered included proximity to waterways, recent herd introductions, and proximity t o slaughterhouses and landfills. T his surveillance effort, designed to detect FMDV if present in the Patagonia North A area, focused on young cattle aged six to 12 months. Fifteen animals in that age category were sampled in each facility. If the farm did not have fifteen cattle

### 73

between six to 12 months of age, cattle up to 24 months were sampled. A total of 247 cattle establishments and of 3,674 animals were sampled, the majority (3,228) of which were in the six
to 12 month age category.

Two complementary studies were conducted involving swine and wild boars. In the serological study conducted in swine, a total of 462 samples were collected from 76 establishments in the Patagonia North A area. The wildlife surveillance consisted of a total of 21 samples. All porcine samples were tested using the LF ELISA test.

All cattle samples were analyzed using the ELISA 3ABC and EITB tests , while all porcine samples were tested using LF ELISA. No reactors were identified in any of the samples collected.

2013 Ongoing Surveillance Efforts [ 9 4 ] : Following an audit by the European Commission’s Food and Veterinary Office (FVO) conducted in 2013, and in collaboration with external animal health experts, Argentina revised its surveillance sampling design , focusi ng on the effectiveness of various vaccination campaign plans as implemented by the local offices. The surveillance objectives to estimate herd immunity of the vaccinated cattle population and to demonstrate the absence of FMDV circulation remain basically unchanged from previous recent years

. The sampling frame included all regions that conduct vaccination campaigns twice annually. Three

- stage random sampling consisted of:

 identifying and selecting the different vaccination campaign plans at the local l evel;

 selecting establishments within each of the local units of consideration; and

 selecting animals to be sampled within each selected establishment.

Thirty three establishments were randomly selected in 2013 for each type of vaccination plan under evaluation. A minimum of 13 samples are to be taken in each establishment, or ten cattle between six to 12 months of age and three cattle between 12

- 24 months of age. A total number of 429 samples are expected to be collected for each vaccination plan. A total of 85 vaccination plans are under evaluation in this study. Table 15 details the number of vaccination plans, farms, and samples to be collected in each province under this sampling design.

Tabl e 15. Sampling D esign for 2013 Surveillance Study to evaluate implementation

of the National Vaccination Plan at the local level. 1

1 The first column represents the coordinating region under which the different vaccination plans are implemented. The second column lists the number of operational vaccination plans in that area. The third and fourth columns list the number of farms to be sampled and the number of samples to be collected from individual animals.

### 74

At the time of APHIS’ November 2013 site visit, over 50 percent of samples had already been collected with only two reactors identified. On completion of the study, SENASA expects to be able to compare effectiveness of operational implementation of the National Vaccination plan at the local level.

Conclusion s
APHIS believes that the design under which serological sampling is conducted in Argentina is both valid and efficient and the sampling coverage is adequate

. APHIS also considers that the serological sampling conducted in Argentina under the nati onal ser ological sampling plan since the July 2000 outbreak is adequate to detect disease and identify and measure viral activity (if any) in the area

. Furthermore, APHIS considers the levels of immunity adequate to stop viral circulation if the virus were to be introduced in the susceptible population.



### 10. Diagnostic laboratory capacity

A country’s laboratory system, including test procedures for the disease(s) under evaluation, quality assurance measures, and procedures for official oversight, must be clearly documented to provide confidence in disease surveillance activities and the ability to quickly detect and confirm a disease outbreak

. This section explain s the laboratory capabilities of Argentina in reference to the diagnosis and detection of FMD.

In Argentina, SENASA has one diagnostic laboratory in Buenos Aires with a biosafety

- level (BSL) NBS3 Ag (equivalent to BSL

- 3) that was approved in 1997

. This SENASA central laboratory is authorized to manipulate FMD virus and other microorganisms that m ust be handled in B S L

- 3 facilities or lower status

. The laboratory meets SENASA and OIE biosafety requirements

. There are no other official or private laboratories that are authorized to perform FMD diagnostic and surveillance techniques

. SENASA Resolution 219/95 does allow accreditation of private laboratories by SENASA to produce FMD vaccines [ 11

, 18 ]

.
In 2000, the SENASA central laboratory was audited by inspectors from the EU and the Pan American FMD Center, among others. The scope of the audits included working procedures, quality programs, and biosafety conditions, and the findings were satisfactory. The Argentinian biosafety requirements to manipulate the FMD virus are stated in former SENASA Resolution 219/95.

The staff of the SENASA central laboratory is trained in manipulating and diagnosing the FMD virus

. Training includes specific laboratory techniques, biosecurity standards and quality

, and laboratory good practice standards

. The Virology Advisory Committee was established in 1992 with members hip includ ing professionals from the INTA and the Animal Virology Center (CEVAN) of the National Council for Technical and Scientific Research . The Advisory Committee provides support to SENASA with the best technical and human resources in the country.

The APHIS site visit team met with the director of th e DILACOT, Dr. Veronica Leedham; director of the general department of animal lab, Dr. Osvaldo Periolo ; and the head of FMD section, Dr. Eduardo Maradei at the SENASA central laboratory in Buenos Aires on December 1, 2003

. Below are some observations from the visit [ 31 ] [ 84

, 85 ]

.

### 75

I. Laboratory structure and organization

The DIL A COT ( F igure 20 ) operates the National Reference Laboratory for food safety and animal and plant health

. The General Department of Animal Laboratory includes the Department of Bacteriology, Department of FMD Virology, Chemistry and Chemical Resources, and Department of Food Products and Related Products

. The Department of FMD Virology consists of Diagnostic Virology, Diagnostic Serology, Ser oepidemiology, and Vaccine Control and Experimental Farm

. The advisory board for Virology includes SENASA, INTA

, and CEVAN laboratories

. The FMD l aboratory within the Department of FMD Virology

, is staffed with 16 professionals (12 veterinarians, 11 docto rates or maters in sciences, one biologist, one chemist, one geneticist, and one engineer), 13 technicians, five administrative, and three cleaning personnel. A list of training activities for DILAB staff has been provided during the site visits, including the latest activities in 2013 [ 84 ].

The laboratory uses an information management system (LIMS) for recoding samples coming in and for typing laboratory results that go out to the epidemiologists

. The site review team did not see the actual worksheets fo r every test being run, but the site visit review team in June 2003 saw similar worksheets in the poultry laboratory

. The system appeared effective and adequate for storing data and efficient in retrieval of data

. The staff was very capable in managing the system.

Figure 20 : Functional organization chart of SENASA laboratory.

II. National R eference L aboratory missions

The main functions of the N ational R eference L aboratory are to establish protocols and validate reference assays for disease control dictated by SENASA, perform quality control testing on FMD vaccines produced by the manufacturers, serve as a reference laboratory in confirming

### 76

positive cases, apply bi osafety standards set by SENASA

, and set forth the sampling strategy for disease control and surveillance.

In 2006, the laboratory was accredited by the Argentine Accreditation Organization under international standards ISO 17025

. The first audit occurre d in November 2004

. The food safety department (residues and food control) as well as th e biological departments (analytical methods) for the different diseases have also been ac c redited

. In addition, DILAB inspects and certifies the biosafety of the FMD vaccine manufacturers in Argentina. DILAB personnel perform on

- site inspections of biologics manufacturing annually. They grant the licenses for the manufacturing of biological products. DILAB tests each serial of FMD vaccine for safety, potency and spec ificity. SENASA issues the Argentinian import and export permits for FMD strains and antigens.

III. Diagnostic samples

Epithelial tissue samples are preserved and transported in Vallee medium composed of phosphate glycerin (pH 7.2) with phenol red

. D iagnostic samples (excluding samples for FMD virus isolation) are checked in at the front desk and logged into the database

. Each submission is barcoded and each specimen is given a serial number within the submission

. Sample history is kept confidential f

rom the technical staff as part of the laboratory quality control standards

. Submission for biocontainment is labeled on the package and opened in the B S L

- 3 lab.

Epithelial tissues for FMD virus isolation are homogenized and frozen immediately upon arriv al. Homogenates are thawed out and screened for FMD virus by antigen ELISA

. If ELISA results are negative, the homogenate is inoculated on to baby hamst er kidney (BHK) cells for 48 hours and then tested by ELISA for the presence of FMD virus

. If the ELISA results are negative on the first passage, a second passage is carried on for another 48 h ours and tested for FMD by ELISA

. If the ELISA results are negative on the second passage the sample is considered negative

. The laboratory receives one or two invest igation(s) a year for suspect vesicular disease

. The primary target of these investigations is FMD.

Argentina follows the OIE guidelines for screening and confirmatory testing of serological suspect cases as well as for active surveillance samples. For de tection of viral activity in vaccinated cattle, random serum samples (with no animal IDs) from vaccinated cattle are screened for antibodies to nonstructural proteins by the 3ABC ELISA. Positive samples are confirmed by EITB tests

. A second set of samples is collected from the farm if EITB is confirmed positive on the first set of samples

. If animals remain positive for antibodies to nonstructural proteins, Probang samples are collected from the suspected herd

. These samples are not necessarily from the sam e animals tested positive by serology

. Probang samples are tested for the presence of FMD virus by carrying out virus isolation on BHK cell lines.

S ince 2006, the SENASA FMD laboratory has had the capability to run PCR for FMD. Consequently, samples subm itted for PCR testing are processed in the B S L

- 3 facility where samples containing live FMD virus can be processed. Table 1 6 summarizes the FMD tests conducted in 2008 and Table 1 7 summarizes the FMD samples analyzed in 2012.

### 77

Table 1 6

. D iagnostic tests for FMD and VS serology 2008 [ 56 ]

Test First S emester Second S emester VIAA 910 252 3ABC ELISA 30,265 15,214 EITB 1,180 830 Structural ELISA 28,280 5,191 Typing ELISA 50 41 Total 60,685 21,528

Table 1 7 . Nu mber of Diagnostic Tests for Vesicular Disease Suspect C ases, 2012 [ 19 ]

Typification

ELISA 3ABC EITB VIAA Structural ELISA Vesicular

suspects Antigen

detection (vaccinated) 33,560 1,259 2,957 15,574 1 41

IV. Diagnostic tests capability

T he following t echnology is available for FMD diagnosis and for ruling out other vesicular diseases : 1. FMD

a. Serology: 3ABC ELISA, EITB, VIAA

, and monoclonal

- based liquid phase ELISA are used for serotyping

. b. Virus detection: Antigen ELISA using reagents produced by the PANAFTOSA laboratory is used

. Virus isolation tests are conducted in BHK cells

. The complement fixation test is used for antigen detection

. Reagents for this test are produced in

house

. PCR is conducted at the B S L

- 3 facility.

2. Vesicular stomatitis

a. Serology: Reagents for the IgG ELISA are purchased from the PANAFTOSA laboratory. Virus neutralization test is also available

. b. A gent detection: Ag ELISA and PCR are used in the central laboratory.

Conclusions

Argentina has the diagnostic capabilities to adequately test samples for the presence of the FMD virus

. Q uality control activities within the laboratories are sufficient, laboratory equipment is routinely monitored and calibrated, sufficient staff is available, and there is an effective and efficient recordkeeping system for storage and retrieval of data.



### 11. Policies and infrastructure for animal disease contr ol in the region

Contingency plans of actions to be taken in the event of a disease outbreak should be in place to limit the spread of the disease should an outbreak occur

. In this section we provide an overview

### 78

of the legal authority of SENASA and elemen ts of the emergency plan that would be initiated if suspect cases of FMD are identified in Argentina.

Elements of Argentina’s FMD disease control program are provided in the Foot and Mouth Disease: Manual of Procedures for Focus Attention [ 6
, 30 ]

. Law 24.305 requires immediate and mandatory reporting of FMD in Argentina

. SENASA has legal authority to apply severe penalties
to an y individual or company that fails to report an FMD case

. The Animal Health Law Enforcement Act (3959/1903) requires all veterinarians in private practice who work in rural

areas to report epizootic diseases

. This law with its amendments specifies the pena lties that a person could incur in various situations as a consequence of not notifying animal health authorities of a disease outbreak so that compliance of the regulations in force can be achieved with the purpose of preventing, detecting

, or applying the measures laid out in the FMD National Eradication Plan

. Private diagnostic laboratories must also immediately report epizootic diseases

. They are also subject to severe penalties for failure to comply with statutory requirements [ 11

, 18 ]

.
In 2010, the registration and notification system for reportable diseases in animals was updated and enhanced under Resolution 5 40/10 , creating a single uniform system for all reportable diseases. This system includes a standardized protocol and establishes forms of communication within and between insitutions to ensure the rapid transmission of consistent, reliable collection of e pidemiological information and follow

- up on suspect cases. Within twelve hours of receiving notification of a suspect case, a veterinarian from the local SENASA office must visit the involved facility, collect the necessary epidemiological information, and fill out a reportable disease form determining the disposition of the suspect case. Necropsy and laboratory samples, where applicable, are linked to the original report by a single case number. A final report summarizes the particular case/incident, and a ll incidents are summarized in an annual report.

Routine examinations of livestock occur during industry

- related activities and official surveillance programs. Animals are also inspected at fairs and before and after slaughter. Many private veterinarians sit on the boards of technical subcommittees of the regional and local Animal Health Committees, so they are highly motivated, informed, and support the national eradication programs.

Identification of outbreaks or suspicious signs of FMD is carried out through passive surveillance

. Observations by the producers, animal caretakers, transporters

, and other individuals who see the animals every day are well aware of FMD or other vesicular disease symptoms, reporting requirements

, and available resources to avoid the disease

. Animals are inspected by the vaccinators twice a year during the FMD vaccination campaigns. Also, the INTA has a network of experimental and extension facilities in rural areas that work with the farmers and r eceive updated information on the health conditions of the herds.

Suspicious cases are reported and investigated

. A fter notification of a suspect case , all actions are carried out as if the herd is infected until proven otherwise

. Immediately, the suspect holding s are isolated

, movement of animals prohibited

, and samples are collected and sent to a laboratory to confirm the diagnosis

. Table 18 shows the total number of notification s of suspect vesicular cases between 200 8 and 20 12 [ 20

, 32

, 57 ]

.

### 79

Table 18 . Vesicular Disease Notifications, 2008

- 2012

PROVINC E Affected Species Diagnosis

2008 SANTA FE Bovin e Foot Rot

SANTA FE Bovin e Bovine Viral Diarrhea (BVD)
SANTA FE Bovin e Trauma ENTRE RIOS Bovin e Trauma CORRIENTES Bovin e Poisoning (Ramaria sp. mushroom)
BUENOS AIRES Equin e Negative for Vesicular Stomatitis
SANTA FE Bovine Foot Rot
ENTRE RIOS Bovine Actinom y cosis
SANTA FE Bovine Foot Rot
JUJUY Porcine Trauma (nail puncture wound)

2009 SALTA Ovin e Toxicity
MISIONES Bovin e Infectious Bovine Rhinotracheitis (IBR)

JUJUY Bovin e Foot Rot
JUJUY Porcin e Trauma (nail puncture wound)
BUENOS AIRES Bovin e Photosensitization

SALTA Ovin e Contagious Echthyma
BUENOS AIRES Bovin e Photosensitization

2010 BUENOS AIRES Bovin e Foot Rot

SALTA Bovin e Foot Rot
SALTA Ovin e Contagious Echthyma
JUJUY Bovin e Babesiosis

SALTA Bovin e Toxicity

SALTA Bovin e Toxicity

JUJUY Bovin e Starvation
SGO DEL ESTERO Caprin e Foot Rot

2011 RIO NEGRO Bovin e BVD

CORRIENTES Bovin e Foot Rot

JUJUY Caprin e Contagious Echthyma

CHACO Caprin e Contagious Echthyma

ENTRE RIOS Bovin e IBR

ENTRE RIOS Bovin e IBR

CORRIENTES Bovin e Parasitic Infestation

CORRIENTES Bovin e Parasitic Infestation

CHACO Caprin e Contagious Echthyma

2012 RIO NEGRO Bovin e Plant toxicity/Photosensitization

CORRIENTES Bovin e Poisoning (Ramaria sp. mushroom)

RIO NEGRO Bovin e IBR/ B V D

### 80 ENTRE RIOS Bovin e IBR/ BVD

BUENOS AIRES Ovin e Contagious Echthyma

During the 2000 / 2001 outbreak, most of the FMD notifications were reported by farmers ( T able 19 ). In fact, 20 of the 26 diseased premises were identified from reports by farmers. This shows a high level of awareness of the disease among farmers in the N orthern area of Argentina

, which is considered an area of high vulnerability to the introduction o f FMD . The 2006 outbreak was reported by a private veterinarian who was contacted by the manager of the index farm.

Table 19. Reporting source for cases of FMD during the 2000

– 2001 epidemic in the Northern provinces [ 33 ]

Province Reporting source for diseased premises (number of premises) Veterinary Officials Not reported by farmers Reported by farmers Misiones

- - 1 Corrientes 1

- 17 Chaco

- - 1 Formosa

- 5 1 Total 1 5 20 Percentage 3.85 19.23 76.92

In the event SENASA determines to follow a stamping

- out policy for an outbreak of exotic or endemic diseases that present a health hazard to the national livestock herd

, SENASA’s actions and level of involvement are defined in Resolutions 1410/2000 and 488 /2002

. The actions are listed in Resolution 779/1999 through which the National Animal Health Emergency System (SINAESA) was created as authorized by Law 24.305, Act 3959/1903 and Decree 1585/1996 and 643/1996

. By Decree 394/2001 that updated Decree No. 15 85/1996, the president of SENASA has authority to take prompt actions to respond to emergency situations involving animal health

. SENASA has special policies, logistics

, and a budget for zoosanitary and phytosanitary emergency situations.

The SENASA defin es the responsibilities and functions to control FMD in emergency situations

. It operates at the c entral, r egional

, and l ocal levels

. At the central level, the Central Animal Health Emergency Committee is responsible for describing the emergency scenario, defining the control measures with input of local authorities , financing mechanisms and responsibilities

, and assigning the human and other resources required for the eradication operations.

At the regional level, the actions required by the SINAESA are carried out by SENASA’s regional resources

. The Regional Animal Health Emergency Team is the functional unit of the system

. It is coordinated by the Epidemiology Office of DNSA at SENASA headquarters

. The team includes SENASA professionals, technicians and administrative staff specialized in responding to emergency situations

. The members of the team are specifically selected for their technical and psychophysical profile because they must be continuously available to respond

### 81

immediately in cases of emergen cy

. An alternate is available for each person in case a member is unable to respond.

At the local level, the staff of the l ocal SENASA o ffice in the affected area collaborates with the field technicians to provide support

. The responsibilities of the l oca l o ffice include the following:

 Provide a primary response to suspect cases (collection and remittance of samples, description of the operation, and implementation of preliminary measures) ;

 Notify the Regional Supervisor ;

 Submit a status report to the l oc al An imal Health Emergency Committee ;

 Carry out the actions def ined by the chief of operations ;

 Supply updated maps of the local area, including cadastre drawings ;

 Keep updated records on the characteristics of the production system in their area, includin g a geographic description ;

 Keep updated information on local suppliers and service suppliers

, su ch as mobile telephone companies, equipment suppliers, transportation and rental companies of equipment, trucks, etc. ;

 Keep updated information on the livestoc k population, inventory of other products, shippers of animal products and byproducts, cattle dealers, and other professionals related to the farming sector (veterinarians, agronomists, cattle buyers, dairy farm inspectors, etc.) ;

 Keep updated records of t he local authorities , such as municipal officials, law enforcement authorities, fire brigade, veterinarians in private practice , and others in the

area ; and

 Oversee the surveillance and rep opulation of farming operations

.

The main control measure in the c ase of a confirmed FMD outbreak is stamping out, ring vaccination, restriction of animal and people movements, establishment of disinfection points, and delineation of focal, perifocal

, and surveillance area s

. The definition of the quarantine areas are sim ilar to those used in other countries and in line with international standards

. The quarantine area is subdivided into two areas: (1) a high

- risk zone extending for at least three km beyond all known infected herds, and (2) a buffer zone extending from the periphery of the high

risk zone to the outer perimeter of the quarantine area at least ten km from the affected premises

. In addition, local and central veterinary authorities implement s ecurity checkpoints on rural roads where vehicles enter the quarantine zone

. A ll vehicles suspected of containing farm

- related products, materials, or animals are stopped a t these checkpoints

. Checkpoints are generally maintained for 30 days after the last infected animal is depopulated or until the situation indic ates they are no longer needed

. Examples of the types of activity in the outbreak area are discussed in the disease status section of thi s document, beginning on page 26

.
At the international level, although it did not do so during the 2000/2001 FMD outbr eak

, Argentina has subsequently given rapid and regular notification of diseases according to the time and conditions agreed upon with the world health entities

. The Bureau of Epidemiology of SENASA develops weekly and monthly reports of animal health news

. These reports are written using the information collected through the different levels of epidemiological surveillance and are submitted through the Coordination of International and Institutional Affairs of SENASA to international entities such as the O IE, the European Community

, and the OPS/WHO Continental System for Vesicular Disease Surveillance

. Likewise, a system of reciprocal systematic information was established through bilateral agreements with bordering countries

. This system would allow immedi ate notification of any reportable disease detected in the country that could

### 82

represent a sanitary potential risk for a neighboring country

. One such bilateral agreement is the Cuenca del Plata Agreement between Argentina, Brazil, Uruguay, Paraguay, Bolivi a , and Chile.

Emergency Response During 2011 Paraguay Outbreak:

In 2011, upon receiving official communication from the veterinary authority of Paraguay about an FMD outbreak in the province of San Pedro, Paraguay, SENASA immediately mobilized into action declaring a state of animal health alert throughout the country and strengthening all existing measures to prevent the entry of the FMDV into Argentina (Resolution No. 684/11 of October 19, 2011). Emergency measures included temporary suspension of imports and transit of all commodities from FMD

- susceptible species; ve hicle disinfection and tighter control of air, land, and water transportation inspections; increased staff and control activities at border posts; enhanced cooperation between SENASA, Customs and Security Forces ( Fuerzas de Seguridad ); strengthened biosec urity in slaughterhouses, landfills; and increased auditing for compliance with swill feeding requirements. The FMD vaccination cycle was also advanced in the provinces of Salta, Formosa, Chaco, Corrientes, Misiones, and Entre Rios, and included bovine of all ages. As described earlier under Factor 9 (Surveillance), additional active surveillance was also conducted to assess viral activity and herd immunity in these six provinces bordering Paraguay, as well as in cattle leaving the border area.

Training of Emergency Response Personnel

There is a training and promotion program for the staff of SENASA

, including the performance of drills

. The training is carried out by the Bureau of Epidemiology

. In addition, the Field General Coordination carries out permanent meetings on updating of information, methodology

, and standards that the local veterinarians should know.

Training records are maintained by the Bureau of Human Resources and Training

, in which official agents get credits for the various classes they attend

. The credits are added up in a score which is used towards promotions in the organization

. The Bureau coordinates the training activities of each of the National Bureaus through training consultants

. In the case of the National Bureau of Anima l Health , two professionals who work as consultants will lead the 22 training delegates of the provinces and will coordinate, audit and guide the process of teaching the official veterinarians

. This program is under implementation

. The training legal frame work includes SAGPyA Resolutions 51/2003 and 02/2002 and SENASA Resolution 166/2003.

All local offices maintain copies of a SENASA issued manual on procedures related to FMD outbreaks (Manual de Procedimientos para la Atencion de un Foco). Additionally, S ENASA developed a containment plan ( p lan de contencion) in 2007, a copy of which is maintained at each local office. Veterinarians in local offices were well versed in the procedures contained in both documents.

Conclusions

Argentina has the infrastruct ure and legal authority to declare an emergency and take appr opriate action in case of an FMD outbreak

. SENASA has a n effective disease control program included in the Foot and Mouth Disease: Manual of Procedures for Focus Attention

. The manual sets forth operating standards and is legally authorized by several SENASA Resolutions and Regulations

. Quarantine and restriction decisions are made by the Central A nimal Health Emergency authority

### 83

with input from the local authorities

. S ystems for notification and training ensure emergency preparedness and response with a legal framework to authorize needed actions.

Release Assessmen t Conclusions

APHIS identified risk factors that might be associated with importing fresh (chilled or frozen) matured, deboned beef from a region of Argentina

. APHIS discusses these risk factors in the context of the potential for counterbalancing circumstances or by applying appropriate risk mitigations to reduce the risk of introducing and establishing FMD in the U nited States

.

I. Likelihood of FMD introduction into the export region

Risk factor : FMD is endemic in few countries in South America

. Consequently, there is an ongoing risk of reintroduction of FMDV from adjacent affected areas into the export region

. Therefore, there i s a risk that beef destined to the United States could originate from or be commingled with animals or animal products from affected neighboring areas

. Mitigations : Based on site visit observations

, discussions with the SENASA officials, and documentary evidence, APHIS believes that veterinary officials in Argentina have adequate controls at the ports of entry for commercial and legal importation and sufficient controls exist at international airports to mitigate risk

. Argentina follows OI E standards in its importation policy regarding products of animal origin considered as possible carriers of the FMD virus from countries or regions with a lower sanitary status. In addition, there are also has stringement requirements for animals movement s within the exporting area. Therefore, APHIS concludes that the likelihood that FMD will be introduced via legal importation is low

. In order to ensure compliance with the appropriate controls, APHIS will propose in its rule that SENASA certify that th e animals and products originated from th e export region and were not com mingled with animals or products from areas APHIS considers to be FMD

- affected

. Specifically, APHIS will require certifications that beef exported to the United States from Northern A rgentina meets the foillowing requirements :

 The beef comes from bovines that have been born, raised, and s laughtered in the export region.

 The beef comes from bovines that originated on premises where FMD has not been present during the lifetime of any b ovines that are slaughtere d for export of meat to the United States.

 The beef comes from bovines moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.

 The beef has not been in contact with meat from regions other than the region of origin or those considered as FMD

- free by APHIS (listed under 9 CFR 94.1(a)(2)) [ 31 ]

.

 The beef meets additional certification requirements under 9 CFR 94.11(c) [ 31 ]

. Gene rally speaking, these restrictions prohibit the export

- approved slaughter establishment from receiving FMD

- susceptible animals or animal products that originated, transported, or commingled with animals or animal products from regions that APHIS does not c onsider as FMD

- free.

### 84 Risk factor : There is a potential risk posed by illegal importations of FMD

- affected animals or animal products from affected regions

. Argentina has several internal and external border areas with few or no natural barriers

. Even where there are barriers or checkpoints, people, cars, and animal products could cross both domestic and international borders illegally

. Th us, th e potential for the FMD virus to transit the border

, particularly via passenger car or foot traffic , remains

. Mitigations : SENASA controls, biosecurity procedures, and quarantine operations have been successful in mitigating this risk

. APHIS evaluated SENASA controls for anim als moving into export channels and concluded that risk of exporting contaminated fresh beef from illegal importations from affected regions to be sufficiently mitigated

. The certification requirements mentioned above will further ensure that beef derived from animals illegally imported into Argentina will not enter U.S. export channel s.

II. Likelihood of detection of FMD if reintroduced

Risk factor s : Cattle in Argentina are primarily grass

- fed, and, depending upon the pasture rotation scheme in use, may not be subject to routine supervision

. Because some of the farms are extremely large, animals are distant from human contact for significant periods of time

. Therefore, close observation of animals might be infrequent, and clinical signs might be missed.

Mitigations : APHIS considers that inspection procedures in Argentinean export channel s , such as ante

- mortem examinations

, are sufficient to mitigate this risk for animals exhibiting FMD clinical signs

. To ensure that the inspection procedures are followed , APHIS will propose that SENASA certify the following :

 The beef come s fro m bovines that received both ante

- mortem and post

- mortem veterinary inspection s, which include inspection of the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease.

 FMD has not been diagnosed in the export region within 12 months prior to exportation of the beef.

III. Likelihood of exporting FMD

- infected beef to the U.S.

Risk factors : Cattle could be early in the incubation period and no t show clinical signs of FMD but still be viremic.

Mitigations : Based on published literature and data provided by SENASA, APHIS assessed the effectiveness of maturation, pH testing, deboning of carcasses , and removal of lymph nodes.

 The FMD virus is rapidly inactivated at pH 6.0 or lower

. At pH 6.0, the inactivat ion rate is 90 percent per minute [ 58 ]

.

 Scientific evidence has shown that the virus is totally inact ivated at pH 6 or below after 24 hou rs at a temperature of 4  C [ 59 ]

. At higher maturation temperatures, the pH drop rate is faster

.

 The pH changes may occur at different rates in different musc les, a measurement

### 85 of pH lower than 6.0 in the longissimus dorsi muscle is acceptable as indicating

non survi val of FMDV in the carcass [ 60 ]

.

 Failure with the pH reading is likely to be very low because periodic calibration of pH meters is carried out at the slaughter plants

.

 All carcasses intended for export must be deboned and lymph nodes must be removed

. The deboning process is manually conducted and consists of removing all bones, major lymph nodes

, and blood clots

.

In accordanc e with the risk mitigation effects, the processes evaluated in the risk assessment will be incorporated into the proposed rule

. APHIS will propose to require SENASA to certify that :

 The beef con sists of bovine parts from bovine animals that have been born,

ra ised, and slaughtered in Northern Ar gentina

.

 Foot

- and

- mouth disease has not been diagnosed in Northern Argentina within the previous 12 months.

 The beef comes from bovines that originate from premises where foot

- and

- mouth disease has not been present during the lifetime of any bovines slaug htered for the export of beef t o the United States.

 The beef comes from bovines that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.

 The beef comes from bovines that received ante

- mo rtem and post

- mortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease.

 The beef consists only of bovine parts that are, by standard practice, part of th e animal's carcass that is placed in a chiller for maturation after slaughter. The bovine and ovine parts that may not be imported include all parts of the head, feet, hump, hooves, and internal organs.

 All bone and visually identifiable blood clots and lymphoid tissue have been removed from the meat.

 The beef has not been in contact with meat from regions other than the export region or those listed as free of foot

- and

- mouth disease and rinderpest under § 94.1(a).

 The beef comes from carcasses that were allowed to maturate at 40 to 50°F (4 to 10°C) for a minimum of 24 hours after slaughter and that reached a pH below 6.0 in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both longissimus dorsi muscle s. Any carcass in which the pH does not reach less than 6.0 may be allowed to maturate an additional 24 hours and be retested, and, if the carcass still has not reached a pH of less t han 6.0 after 48 hours, the beef from the carcass may not be exported to the United States.Show citation box

 The beef meets additional certification requirements under 9 CFR 94.11(c) [ 31 ]

. Generally speaking, these restrictions prohibit the export

- approved slaughter establishment from receiving FMD

- susceptible an imals or animal products that originated, transported, or commingled with animals or animal products from regions that APHIS does not consider as FMD

- free.

 An authorized veterinary offici al of the Government of Argentina certifies on the foreign meat inspe ction certificate that the above conditions have been met.

### 86  The establishment in which the bovines are slaughtered allows periodic on

- site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS representative.

Based on i ts evaluation of the 11 factors and observations from several site visits, APHIS considers that Argentina possesses the detection capabilities, reporting systems, and emergency response systems that are necessary for combating and controlling FMD in the export region should it be reintroduced

. Furthermore, the region’s veterinary authority is capable of complying with the requirements specified in the CFR to prevent the commingling of FMD susceptible animals or products from regions with lower FMD status. Moreover, the region’s veterinary authority has sufficient oversight of the slaughter mitigations

. APHIS also believes that the potential of cattle not showing clinical signs and shedding t h e virus is effectively mitigated through appropriate processing p rocedures

.

### 87

B. EXPOSURE ASSESSMENT

Exposure assessment describes the biological pathway(s) necessary for exposure of animals and humans in an importing country to the hazards released from a given risk source

, and estimates the probability of the exposure(s) occurring, either qualitatively or quantitatively.

APHIS believes that the most likely pathway of exposure of domestic livestock to FMDV in beef is through feeding of contaminated food waste to swine [ 61 ]

. The likelihood of exposure of FMD

susceptible species to FMD

- infected beef was evaluated by reviewing previous VS studies

. In 1995, VS conducted a pathway analysis to estimate the likelihood of exposing swine to infected
waste [ 62 ]

. The analysis included two pathways for exposure of swine to contaminated waste: exposure associa ted with illegal household imports and exposure associated with legal imports. With 95 percent confidence, VS estimated that 0.023 percent or less of plate and manufacturing waste would be inadequately processed prior to feeding to swine [ 63 ]

. Based on this fraction, less than 1 part in 4,300 of imported beef that are f ed to swine as plate or manufacturing waste is likely to be inadequately cooked.

I n 2001

, VS conducted a survey of the U.S. swine waste

- feeding sector to update a similar study done in 1994 [ 63 ]

. Based on this survey, VS estimated that the proportion of plate and manufacturing waste fed to swine diminished by about 50 percent between 1994 and 2001 due to a decrease in the number of waste

- feeding premises

. The study also found that:

 The number of waste

- feeding premises has decreased significantly since 1994 ;

 Several states have prohibited feedin g food wastes to swine ;

 The continental United States saw a 40.5 percent decrease in the number of waste

- feeding premises, Hawaii a 37.5 percent decrease and Puerto Rico a 52.3 percent decrease ; and

 Institutions and restaurants provide nearly 90 percent of all plate waste fed to swine.

APHIS believe s that prohibiting the feeding of unprocessed plate waste to swine has further reduced this practice of feeding unprocessed waste to swine

. W aste

- feeder operations must be licensed and inspected regularly by U SDA inspectors (9 CFR 166) [ 31 ]

. The licensing process requires that producers adequately cook the waste fed to swine according to methods designed to reduce the probability of survival of foreign animal disease agents in the waste

.

Based on the 1995 estimate that a very small proportion of food waste is inadequately proc essed prior to feeding to swine and the substantial reduction in waste

- feeding operations in recent years, APHIS considers the likelihood of exposure of susceptible swine t o FMDV through inadequately processed food waste to be low

. Based on the results of the release assessment, APHIS further considers the likelihood of exposure of susceptible swine to the FMDV through inadequately cooked infected beef imported from the expo rt region to be low.

### 88

C. CONSEQUENCE ASSESSMENT

A consequence assessment describes the biologic and economic consequences of FMD introduction into the United States

. This consequence assessment addresses both direct and indirect consequences as recommended by the OIE [ 39 ]

. The magnitude of the biologic and economic consequences following an introduction of FMD would depend on the location of the introduction, the serotype introduced, the rate of spread of FMD virus

, and whether other environmental conditions at the introduction site might facilitate th e spread, the ability to detect the disease rapidly, livestock demographics and movement patterns, and ease of employing eradication procedures [ 64

, 65 ]

. In addition, depending on the extent of export of livestock and their products, trade restrictions imposed by trading partners often result in severe economic consequences.

Direct c onsequences
Direct consequences include effects of the disease on animal health, the subsequent production losses, the total costs of control and eradication, the effect on the environment, and public health
consequences.
Effects on animal health and production : 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, particularly among pigs and sheep

. In pigs, Dunn and Donaldson (1997) estimated a general mortality rate of 40 percent for two outbreaks in Taiwan in 1997 [ 65 ]

. Geering (1967) cites mortality rates of 40, 45, and 94 percent of lambs in several outbreaks [ 66 ]

. Mortality in older animals occurs less frequent ly but may be significant with certain virus strains. FMD causes significant losses in the production capacity of affected animals. Productivity losses of ten to 20 percent are reported in FMD

- infected livestock if the disease is allowed to run its

course [ 64 ]

. For example, the drop in milk yield of dairy cattle averages approximately 25 percent per year [ 67 ]

. In addition, FMD can cause reduction in the growth rate of animals raised for meat

. According t o Doel (2003) [ 68 ] , estimates vary considerably, but one study has indicated that cattle would require approximately ten to 20 percent longer to reach maturity

. The comparatively greater severity of FMD in pigs would imply at least similar losses to those described for cattle.

Control and eradication costs : The overall cost of control and eradication depends on the mitiga tion or policy option chosen to control and eradicate the disease

. Potential costs include disease control measures such as imposing quarantine measures and movement controls, direct costs related to stamping out of affected and other herds, indemnity paym ents, vaccination costs, surveillance and laboratory testing.

The preferred option for control and eradication for disease

- free countries like the United States that have a substantial export market for livestock and livestock products has traditionally been to stamp

- out infected herds without the use of vaccine

. In fact, the U.S. policy for FMD emergencies is to follow strict quarantine measures and stamping

- out of infected herds and contact herds with ongoing assessment of the need for implementation of strategic vaccination.

Published studies indicate that FMD eradication without vaccination is feasible

. It is the least

- cost policy option, even allowing for the costs of prevention and emergency preparedness, and the risk of outbreaks

. However, if the extent of the outbreak were large or if the disease were spreading at a fast rate, vac cination might be beneficial to protect high

- producing livestock [ 67 ]

. A recent

### 89

study using a stochastic simulation model showed that ring vaccination decreased the duration of outbreaks

. However, depending on the magnitude of the outbreak and the number of herds involved, the time and cost needed to dispose of vaccinated animals could be substantial [ 69 ]

.

Available data do not all ow quantification of the number of herds/farms that would be infected if FMD were introduced

. Nevertheless, the cost of control, eradication, and compensation is likely to be significant

. Bates et al (20 03) [ 70 ] used results from a FMD simulation model to estimate the direct costs associated with indemnity, slaughter, cleaning and disinfecting livestock premises for various vaccination and eradication strategies to control transmission of FMDV in a cattle population of 2,238 herds and five sale yards located in three counties of California

. The study found that mean herd indemnity payments were $2.6 million and $110,359 for dairy and nondairy herds, respectively

. 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

. At the national level, McCauley et al. (1979) [ 64 ] 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 eradicati on program costs) and increased costs borne by consumers of FMD introduct ion over a 15

- year period (1976 to 1990)

. The study examined several control and eradication options

. Relevant to this assessment are strategies employed to eradicate the disease by s tamping out or area vaccination

. In the extreme event of endemic FMD in the United States, the impact of compulsory or voluntary control programs was also considered

. A summary of the findings are shown in T able 20

. The results were updated using the diffe rence in the Implicit Price Deflator (DPI) in 2011[73].

Table 20: Economic impacts of FMD

1., Source: 1976: 34.8 IPD, 2011: 111.668 (3.2 = ratio IPD start 1976) 1/IPD = Gross Domestic Product Implicit Price Deflator

- U.S. Department of Commerce: Bureau of Economic Analysis http://research.stlouisfed.org/fred2/data/GDPDEF.txt Source: Adapted, McDowell 2011, personal communication.



### In a 2008 study modeling the economic impact and disease

- spread effects from a hypothetical outbreak of FMD arising from feeding garbage in small farrow

- to

- finish operations, McCauley Estimates Consumer Impacts Program Costs Totals

---------------------------- millions of dollars

--------------------------

-------- 1976 $ 2011 $ 1976 $ 2011 $ 1976 $ 2011 $

Endemic FMD w/ voluntary control $11,600 $37,215 N a na $11,60 0 $37,21 5

Eradication by strict slaughter & quarantine $10,600 $34,007 $539 $1,729 $11,13 9 $ 35,736

Eradication by area vaccination $11,600 $37,215 $690 $2,214 $12,29 0 $ 39,429

Compulsory vaccination program w/ endemic FMD $8,900 $28,553 $4,200 $13,474 $13,10 0 $ 42,027

### 90

the t otal trade losses plus other disease

- related costs to capital and management, totaled between $2,773 million and $4,062 m illion compared with the 2001

- 2004 disease

- free baseline 

### [ 98 ].

Effect on the e nvironment : Environmental effects have been considered under all applicable environmental review laws in force in the United States

. The se are considered in a separate but related environmental assessment (APHIS proposed rule)

. The environmental assessment complies with the National Environmental Policy Act (NEPA) and implementing regulations [ 72 ]

.
Effect on public health : Although public health consequences are not issues under APHIS’ regulatory authority, we address the issue in this assessment

. FMD may affect humans; however, its occurrence is quite rare

. The number of cases reported is so small when compared with the number of persons exposed that FMD is generally not considered a threat to humans

. FMDV h as been isolated and typed in only 40 patients during the last century

. Symptoms in humans are mostly mild and include fever, and blisters on the hands, feet, mouth, and tongue

. Patients usually recover within a week after the last blister formation [ 3 ]

.
Perhaps more importantly, an FMD outbreak of the magnitude observed in the United Kingdom can result in severe psychosocial effects on farmers and farming communities

. Farmers and their families can suffer from grief over losing animals, in some cases blood lines kept over many generations, as well as loss of control over their lives due to mo vement restrictions, disruptions in community life, and short

- and long

- term stress over their financial future

. Researchers from Lancaster University in the United Kingdom conducted a new study into the social consequences of FMD in the Cumbria community and it revealed high rates of depression, alcohol consumption, and mortality among farmers during the crisis [ 73 ]

.
Indirect consequences

In a ddition to the direct costs of FMD introduction, impacts on international trade and related domestic consequences need to be considered

. Export losses due to restrictions imposed by trade partners on FMD

- susceptible animals and products can run into billio ns of U.S. dollars

. The value of U.S. exports of beef products alone, which would be immediately lost, was over $3 .98 billion in 20 14

. The impact of an outbreak of FMD on the rural and regional economic viability, including businesses reliant on livestock revenue, could also be substantial

. In 2002, Paarlberg et al. [ 67 ] 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

. The study suggested that the greatest impact on farm income would be due to loss of export markets and the decrease in demand by consumers

. For example, losses of gross revenue for the animal sector were as follow: cattle (17 percent), beef (20 percent), milk (16 percent), swine (34 percent), pork (24 percen t), sheep and lambs (14 percent), and sheep and lamb meat ( ten percent)

. Thompson et al

. (2002) [ 74 ] estimated the loss of about 20 percent of the estimated total income from farming in 2001 because of the FMD outbreak in the United Kingdom.

### 91

D. RISK ESTIMATION

Risk estimation consists of integra ting 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

. Risk estimation takes into account the whole risk pathway from hazard id entified to the unwanted event [ 1 ]

.

APHIS concludes from the assessment s that the surveillance, prevention, and control measures implemented by Argentina are sufficient to minimize the likelihood of importing FMD into the United States, provided that additional mitigation measures are implemented as described earlier

. Furtherm ore, APHIS concludes that fresh (chilled or frozen), maturated, and deboned beef under cons ideration in this analysis is of low risk in view of the certification requirements that will be implemented

.
The likelihood of exposure of FMD

- susceptible species to FMD

- infected beef was not evaluated quantitatively in this risk assessment

. However, as noted above, in a 1995 study [1], VS determined that 0.023 percent of plate and manufacturing waste is not adequately processed prior to feeding to swine

. This is a three orders of magnitude reduction in the risk at the release level

. Therefore, combining the likelihood of importing FMD

- infected beef and exposure of susceptible species to uncooked infected beef scraps would result in an estimate that is at least three orders of magnitude less than the 95th percentile release rate of 1.73  10

- 4

.
The consequences of an FMD outbreak in the United States 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

- year period would be between US$37 billion to US$42 billion (in 2011 dollars) depending on the magnitude of the outbreak and eradication strategy. Although such consequences are significant, it is i mportant to note that the results of both the release and exposure assessment indicated that the likelihood of introduction and establishment of FMD is low.

In summary, although the consequences of an FMD outbreak in the United States would be very high, given the findings of the release and exposure assessments, APHIS considers the risk of deboned, maturated FMD

- infected beef entering the United States from the export region and infecting U.S. livestock with FMD through feeding of infected materials to s usceptible animals, to be low.

### 92

References

1. World Organization for Animal Health, OIE. International Animal Health Code: mammals, birds and bees. 2013. 2. Code of Federal Regulations 9 CFR 94, Rinderpest, foot

- and

- mouth disease, fow l pest (fowl plague), exotic newcastle disease, african swine fever, classical swine fever, and bovine spongiform encephalopathy; prohibited and restricted importations. 2004. 3. Mann, J., and Sellers, R.F. Foot and Mouth Disease , in Virus Infections of Ve rtebrates

, D.a.B. Morein, Editor. 1990, Elsevier. p. 903

- 12. 4. Code of Federal Regulations 9 CFR 92.2. Application for recognition of the animal health status of a region. 2004. 5. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Anima l Health and Agrifood Quality Service, SENASA. Laws and regulations covering FMD eradication (In Spanish). 2000. 6. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Fiebre Aftosa, Man ual de procedemientos para la atencion de un foco 2002. 7. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Information provided by SENASA to attain recognition of Argentina as a region, as defined in section 92.2, title 9, of the Code of Federal Regulations . 2004. 8. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Infraestructura Agropecuaria y Ganadera de la Republica Argentina

- FMD outbreaks (audiovisual

- power point presentation) (Spanish)

. 2005. 9. Secretariat of Agriculture, Livestock, Fisheries and Food. National Animal Health and Agrifood Quality Service. SENASA. Gaston Funes, Informacion solicitada por APHIS

- SENASA Infrastucture . 2005. 10. Secretariat of Agriculture, Livestock, Fisheri es and Food. National Animal Health and Agrifood Quality Service. SENASA. Informacion Adicional solicitada por APHIS durante la visita de mayo/junio 2005. Dec 2005. 11. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Information provided by SENASA to attain recognition of Argentina's Patagonia as a region, as defined in section 92.2, Title 9, of the Code of Federal Regulations for foot and mouth disease (FMD) July 2003. 12. Secretaria t of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Clarification to the information requested for recognition as region: Newcastle disease. June 2003. 13. Secretariat of Agriculture, Livestock, F isheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Information provided by SENASA to attain recognition of Argentina as a region, as defined in section 92.2, title 9, of the Code of Federal Regulations for foot and mouth dise ase (FMD). November 2002. 14. Secretariat of Agriculture, Livestock, Fisheries and Food. National Animal Health and Agrifood Quality Service. SENASA. Further information requested by USDA

- APHIS of the information provided by SENASA to attain recognition of Argentina's Patagonia as a region, as defined in section 92.2, title 9, of the Code of Federal Regulations for foot and mouth disease (FMD) . November 2004. 15. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Border control system presentation. (Audiovisual

- power point presentation) (Spanish) 2003.

### 93

16. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. SENASA Infr aestructure (Audiovisual

- power point presentation) (Spanish) 2006. 17. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Further information requested by USDA

- APHIS during December 20 03 visit to support Patagonian region status for foot and mouth disease (FMD) . November 2004. 18. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Informacion solicitada por APHIS

- S ENASA Infrastucture . 2006. 19. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Further Information requested by USDA, APHIS of the information provided by SENASA to attain recognitio n of Argentina's Patagonia as a region as define in the section 92.2, title 9, of the Code of Federal Regulations for Foot and Mouth Disease (FMD) . November 2004. 20. Discussions with SENASA officials and observations during the 2003 site visit . December 2 003. 21. Discussions with SENASA officials and observations during the 2005 site visit . May 2005. 22. Discussions with SENASA officials and observations during the 2006 site visit

. September 2006. 23. Secretariat of Agriculture, Livestock, Fisheries, and F ood; National Animal Health and Agrifood Quality Service

- SENASA. Resolution 748/2004 . 2004. 24. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Subproyecto de Frontera Norte A

- Pr ovincias of Jujuy, Salta, y Formosa . 2004. 25. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Resolution 644/06

- Frontera Norte B . 2006. 26. Ministerio de Asuntos Campesinos y Agro pecuarios (MACA), S.d.I.A.e.I.A.S., Programa de Erradicacion de la Fiebre Aftosa (PRONEFA), Informe de Actividades dentro del area de 25 km de Frontera (Spanish) . 2005. 27. Committee Veterinary Permanent South Cone and PANAFTOSA, Specific Foot and Mouth Di sease Control and Surveillance Activities in the Border Regions . 2007. 28. Panaftosa, S.C.P.V.C., Specific FMD Control and Surveillance Actions in the Border Region (Brazil, Argentina, Paraguay). 2006. 29. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Esterilization Control and protocol

- Circular 4356 . 2001. 30. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Report of the 2000

- 2001 FMD outbreaks actions adopted and contingency program in case of FMD risks . 2002. 31. Mattion N, K.G., Seki C, Smitsaart E, Maradei E, Robiolo B, Duffy S, Leon E, Piccone M, Sadir A, Bottini R, Cosentino B, Falczuk A, Maresca R, Periolo O, Bellinzoni R, Espinoza A, Torre JL, Palma EL. Reintroduction of foot

- and

- mouth disease in Argentina: characterisation of the isolates and development of tools for the control and eradication of the disease. Vaccine, 2004. 22 (31

- 32): p. 4149

- 62. 32. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Sanitary Emergency in the Province of Salta

- Report on the Sanitary actions taken in response to the Foot and Mouth Disease outbr eaks in Tartagal, province of Salta . 2003.

### 94

33. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Epidemiological Report

- 2006 Corrientes outbreak . 2006. 34. Secretariat of Agriculture , Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Anex IV

- FMD

- Sero Epidemiological Surveillance, San Luis del Palmar, Corrientes . 2006. 35. Secretariat of Agriculture, Livestock, Fisheries, and Food. National Animal Health and Agrifood Quality Service. SENASA., Annex V, Diagnostic Tests performed

- Epidemiological investigation, San Luis del Palmar, Corrientes . 2005. 36. Secretariat of Agricul ture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Sero Epidemiological Surveillance Serological Sampling 2004 2005. 37. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Sero Epidemiological Surveillance Serological Sampling 2005 2006. 38. Code of Federal Regulations title 9 section 94.1. Region where foot and mouth disease exisits; importation prohibited 2004. 2004. 39. USDA APHIS VS, C hange in the Status of Patagonia South Region of Argentina with Regards to Rinderpest and Foot and Mouth Disease. 2006. 40. Secretariat of Agriculture, L., Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA). , Report on Confo rmance with Article 2.2.10.4. of the OIE Animal Health Code for the territory of Patagonia. . 2007. 41. World Organization for Animal Health, OIE

- FMD

- Change in status. May 27, 2008 [Available from http://www.oie.int/Eng/info/en_fmd.htm] 42. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. FMD Eradication Manual . 2001. 43. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Answer to USDA

- APHIS. 2006. 44. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Notification of vesicular diseases (excel file). 2005. 45. Secretariat of Agriculture, Liv estock, Fisheries, and Food. National Animal Health and Agrifood Quality Service. SENASA. Sero Epidemiological Surveillance Serological Sampling 2005. 2006. 46. Secretariat of Agriculture, Livestock, Fisheries, and Food. National Animal Health and Agrifood Quality Service. SENASA. Epidemiolological Surveillance Serological Samppling 2007. 2008. 47. Secretariat of Agriculture, Livestock, Fisheries, and Food. Nation al Animal Health and Agrifood Quality Service. SENASA. Epidemiological Surveillance Serological Sampling 2008. 2009. 48. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Additional In formation Solicited by USDA

- APHIS before 2005 site visit (Spanish) 2005. 49. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Fiebre Aftosa Republica Argentina (audiovisual

- power po int presentation) (Spanish) . 2005. 50. World Organization for Animal Health, OIE, New chapter on guidelines for international standards for vaccine banks, adopted in May 2005, guidelines for international standards for vaccine banks. 2006. 51. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. OIE report to request freedom from FMD. 2004.

### 95

52. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Programa Frontera Norte "A" (Audiovisual

- power point presentation) (Spanish). 2005. 53. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Spreadsheet amount of animal and vegetable products confiscated in 2005. 2006. 54. Voluntarios de las Naciones Unidas, C.B., Cascos Blancos en el Mercosur, Apoyo a la lucha contra la Fiebre Aftosa en la Frontera con Argentina y Paraguay (Spanish). 2004. 55. Discussions with SENASA officials and observations during the 2005 site visit . May

- June 2005. 56. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Annex II: Quarantining of the Area and Establishmen t of Control and Disinfection Posts . 2006. 57. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Aftosa, Emergency, San Luis del Palmar . 2006. 58. USDA APHIS VS. Follow up letter after 2005 site visit. August 2005. 59. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. SENASA response to the APHIS request (letter August 3, 2005) 2005. 60. USDA FSIS. USDA, Food Safety and Inspection Service Argentina

- Eligible Plants Certified to Export Meat to the United States. 2006. 61. Anonymous. 2004, Lancaster University, United Kingdom. 62. Secretariat of Agriculture, Livestock, Fisheries, and Food. National Animal Health and Agrifood Quality Service. SENASA. Situation de Aftosa en la Patagonia Argentina. 2009. 63. Secretariat of Agriculture, Livestock, Fisheries, and Food

- National Animal H ealth and Agrifood Quality Service (SENASA). Additional Information received. 2009. 64. Bachrach HL. Breese SS. Callis JJ. Hess WR. Patty RE, Inactivation of foot

- and

- mouth disease virus by pH and temperature changes and by formaldehyde. Proceedings of the Society of Experimental Biology and Medicine. 1957. 95 : p. 147

- 152. 65. Pharo H, Foot

- and

- mouth disease: an assessment of the risks facing New Zealand. New Zealand Veterinary Journal. 2002. 50 (2): p. 46

- 55. 66. CEC, investigation on the possible effect of electrical stimulation on pH and survival of foot

- and

- mouth disease virus in meat and offals from experimentally infected animals. Commission of the European Communities. 1986. 10048 : p. 44. 67. USDA APHIS VS CEAH. Pathway assessment of foot

- and

- mouth dis ease (FMD) risk to the United States: an evaluation in response to international FMD outbreaks in 2001. 2001. 68. USDA APHIS VS CEAH. Risk Assessment of the Practice of Feeding Recycled Commodities to Domesticated Swine in the U.S. . 1995. 69. USDA APHIS V S CEAH. Waste

- feeder survey . 2002. 70. McCauley, E.H., et al., Potential economic impact of foot

- and

- mouth disease in the United States. 1979. St. Paul, Minnesota: U.S. Government Printing Office, Potential Economic Impact of foot and mouth disease in the United States US Government Printing Office, St Paul, Minesota, 1979. 71. Dunn CS. Donaldson AI, Natural adaption to pigs of a Taiwanese isolate of foot and mouth disease virus. Vet Rec. 1997. 141 : p. 174

- 75. 72. Geering, W.A. Foot and mouth disease in she ep. Aust Vet J, 1967(43:): p. 485

- 89. 73. Paarlberg, P.L., Lee , J.G., and Seitzinger , A.H. Potential revenue impact of an outbreak of foot

- and

- mouth disease in the United States. J Am Vet Med Assoc, 2002. 220 (7): p. 988

- 92.

### 96

74. Doel, T.R. FMD Vaccines. Vir us Res, 2003. 91 (1): p. 81

- 99. 75. USDA APHIS VS CEAH. Economic impact of alternative management strategies for regulating Canadian ruminant/product imports . 2003. 76. Bates TW, Carpenter TE, and Thurmond MC. Benefit

- cost analysis of vaccination and
preem ptive slaughter as a means of eradicating foot

- and

- mouth disease. Am J Vet Res, 2003. 64 (7): p. 805

- 12. 77. McDowell, R., Economic impacts of FMD adjusted from 1976 dollars to March 2001 dollars by Consumer Price Index . 2002. 78. National Environmental Pol icy Act (NEPA) of 1969, as amended (40 US 4321 et seq) AND regulation of council on environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500

- 1508) and USDA regulations implementing NEPA (7CFR part 1b) and APHIS NEPA imp lementing procedures (7CFR part 372) 1969 1969. 79. Anonymous. Unpublished report. Lancaster University, United Kingdom, 2004. 80. Thomson G. Foot and Mouth Disease . Infectious diseases of livestock, ed. T. Coetzer, and Tustin. 1994, Cape Town, South Afric a: Oxford University Press 825

- 52. 81. Cannon RM, and Roe RT. 1982. Livestock Disease Surveys: A Field Manual for Veterinarians. Australian Bureau of Animal Health, Canberra. 82. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA) PowerPoint Presentation ( Institucional SENASA nov.pdf) and Personal Communication: discussions held with SENASA officials and observat ions made during the site visit

. November 2013. 83. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA). Additional information requested by USDA

APHIS. November 2013. 84. Secretari at of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA). Direccion General de Laboratorios y Control Tecnico. Control of Vaccinations

– APHIS 2013 (Powerpoint Presentation). November 2013. 85. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA). Direccion General de Laboratorios y Control Tecnico. Institutional Structure of DILAB

– APHIS 2013 (Powerpoint Presentation). Novem ber 2013. 86. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA) Personal Communication: discussions held with SENASA officials and observations made during the site visit. May 2005. 87. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA) Personal Communication: discussions held with SENASA officials and observations made during the site visit. September 2006. 88. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. Sero Epidemiological Surveillance Serological Sampling 2004 2005. 89. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA

- Clarification to the information Requested for Recognition as Region, Newcastle Disease, June 2003, Part 4, Annex V. 90. Secretariat of Agriculture, Livestock, Fisheries, and Food; National Animal Health and Agrifood Quality Service

- SENASA. FMD Eradication Manual . 2001. 91. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA). Additional information requested by USDA

APHI S. Annex VI

– Epidemiological Surveillance for FMD, Serological Survey 2011. November 2013.

### 97

92. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA). Additional information requested by USDA

APHIS. Annex III

– Epidemiological Surveillance for FMD, Serological Surveys 2012. November 2013. 93. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENASA). Additional information re quested by USDA

APHIS. Annex VIII

– Epidemiological Surveillance for FMD, Patagonia North A Serological Surveys 2013. November 2013. 94. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Service (SENA SA). Additional information requested by USDA

APHIS. Annex VIII

– Epidemiological Surveillance for FMD, Serological Survey 2013. November 2013. 95. Secretariat of Agriculture, Livestock, Fisheries and Food

- National Animal Health and Agrifood Quality Se rvice (SENASA). Additional information requested by USDA

APHIS.

– FMD Vaccination Coverage Achieved by Province, 2008

- 2012. November 2013. 96. Auge de Mello P., Astudillo V., Gomes I. and Campos Garcia J.T., 1975. Field application of inactivated oil adjuvanted foot

- and

- mouth disease virus vaccine: vaccination and revaccination of young cattle. Bol. Centr. Panam. Fiebre Aftosa, 19/20, pp 31

- 38. 97. Gomes, I., Sutmoller, P., Casas Olascoaga, R., 1980. Response of cattle to foot

- and

mouth disease (FMD) virus exposure one year after inmunization with oil adjuvanted FMD vaccine. Bol. Centr. Panam. Fiebre Aftosa 37 / 38, pp 31

- 35. 98. Philip L. Paarlberg, A nn Hillberg Seitzinger, John G. Lee, and Kenneth H. Mathews, Jr. Economic Impact of Foreign Animal Diseases Economic Research Report No. (ERR

57) 80 pp, May 2008 http://www.ers.usda.gov/publications/err57/ 2008

### 98 Appendix 1



## Hazard identification

— Foot a nd Mouth Disease

The World Organization for Animal Health (OIE) lists several animal diseases that are considered primary hazards associated with trade of animals and animal products. APHIS regulations mitigate the risk of introduction of these foreign animal diseases in t o the United States. As such, APHIS conducts an import risk analysis addressing hazards of primary concern prior to initiating or resuming trade of animal commodities. APHIS considers foot and mouth disease (FMD) virus to be a potential hazard associated w ith trade of live ruminants and swine, as well as certain products and by

- products derived from these species. FMD virus was eradicated from the United States in 1929.



### Causative agent FMD is a highly communicable disease caused by an Aphthovirus of the family Picornaviridae

. FMD has seven immunologically distinct serotypes

— O, A, C, SAT1, SAT2, SAT3, and Asia 1

— which do not confer cross immunity [1] . FMD virus serotype O (PanAsia strain) is the most prevalent and widely distributed, causing outbrea ks in many parts of Africa, Asia, South America, and Europe since 1998 [2

- 4]

. 

### Host range The range of domestic hosts includes all cloven

- hoofed animals such as cattle, swine, sheep, goats, water buffalo, and yaks [2

- 5] . All cloven

- hoofed wild animals are also susceptible, including buffalo, deer, impala, and gazelles; hedgehogs, armadillos, nutrias, elephants, rats, and mice are also susceptible. Camels may be affected by some FMD strains whereas llamas, alpacas, and vicuñas have low susceptibility [5]

. 

### Incubation period The incubation period of the FMD virus is two to 14 days in cattle, depending on the viral strain and dose and the level of susceptibility of the animal [6] . The incubation period in pigs also varies with the strain, dose, and route of in fection [7] . Serotype O

—highly virulent in pigs

— can produce clinical signs within 18 to 24 hours, while pigs with low

- level exposures may take up to 11 days to develop clinical signs.



### Morbidity and mortality Clinical signs in cattle during acute infectio n include fever, profuse salivation, and mucopurulent nasal discharge [6] . 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 th e teats. Affected animals lose condition rapidly, and there is a dramatic loss of milk production. The animal usually recovers by 14 days post infection provided no secondary infections occur [8] . Morbidity in unvaccinated herds can be high, but mortality usually does not exceed five percent. If an outbreak occurs during the calving season, calf mortality can be considerable [9] . Young calves may even die before the development of clinical signs usually because the virus attacks the heart muscles [6]

.

The most consistent clinical signs in pigs are lesions around the coronary bands and lameness; fever may be inconsistent [7, 10] . 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

### 99

on the age of the infected pig. Adult swine may recover or become chronically lame while younger pigs, especially those less than eight weeks of age, may die from acute myocarditis without developing other clinical signs.

FMD infection in sheep and goats is often subclinical or produces only mild clinical signs that may go unrecognized [11] . Reduced milk production may be seen in milking animals and death of young stock may occur without clinical signs.



### Sources of virus and t ransmission Sources of FMD virus include (1) incubating and clinically affected animals; (2) breath, saliva, feces, and urine; (3) milk and semen (up to four days before clinical signs); and (4) meat and by

products in which pH has remained above 6.0 [11, 12] . Transmission occurs by direct or indirect contact or by aerosol. Fomites such as feed, drinking water, equipment, animal products, as well as human clothing, transportation vehicles, rodents, stray dogs, wild animals, and birds can transmit FMD over l ong distances. The five main elements that influence the extent of FMD spread are :

 The quantity of virus released;

 The means by which the virus enters the environment;

 The ability of the agent to survive outside the animal body;

 The quantities of virus required to initiate infection at primary infection sites; and

 The period of time the virus remains undetected [13, 14]

. The respiratory tract is the usual route of infection, particularly in environments that are heavily contamin ated with FMD virus. Infection can also occur through abrasions of the skin or mucous membranes. Pigs may become infected through ingestion of FMD virus

- contaminated products [7, 11]

. In cattle and sheep, the earliest sites of virus infection and possibl y replication appear to be in the mucosa and the lymphoid tissues of the pharynx [8, 15

- 17] . Following initial replication in the pharynx, the virus enters the bloodstream. Viremia in cattle lasts for three to five days, during which the virus spreads throughout the body and establishes sites of secondary infection, localizing in various organs, tissues, body fluids, bone marrow, and lymph nodes.

Viral replication in cattle may reach peak levels as early as two to three days after exposure [15, 16] . Recent data indicate that the most viral amplification occurs in the epithelia of the skin and mouth, including the tongue [18, 19] . Although some viral replication also occurs in the epithelia of the pharynx, the amoun t 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, kidneys, liver, and lymph nod es is negligible.

Immunity to FMD is primarily mediated by circulating antibodies [17] . The host reaction, including antibody production, occurs from three to four days after exposure. In infected pigs, the virus is cleared in less than three to four wee ks. In contrast, around 50 percent or more of cattle will develop a low

- level persistent infection, localized to the pharynx [10, 20, 21]

.



### Inactivation and survival FMD virus is a relatively resilient virus. It can survive up to 15 weeks in feed, four we eks on cattle hair, and up to 103 days in wastewater. The survival of the virus in animal tissues is closely associated with the acidity of that tissue [22, 23] . For example, in muscular tissues the acidity of

### 100

rigor mortis, which occurs naturally, inactiva tes the virus. The production of lactic acid in these tissues during maturation is considered the primary factor for inactivation. An acid environment where the pH is less than 6.0 will destroy the virus quickly. Several studies showed that in tissues wher e no acidification occurs (e.g., lymph nodes, bone marrow, fat, and blood), the virus may survive for extended times in cured, uncured, and frozen meat [16, 22

- 25] . Heating at 50° C [26] and up to 155° F [27] will inactivate the virus.



### Vaccination Inact ivated virus vaccines of varying composition are available commercially [12] . Many FMD vaccines are multivalent to provide protection against the different serotypes likely to be encountered in a given field situation. The finished vaccine must be shown to be free from residual live virus. Live attenuated vaccines are not suitable due to danger of reversion to virulence.

Inactivated FMD vaccines may be classified as either standard potency (commercial vaccines) or higher potency (emergency vaccines) [12]

. Standard potency vaccines are formulated with sufficient antigen to have a minimum potency level of 3 PD 50 and provide six months of immunity after two initial vaccinations given one month apart. Higher potency vaccines are formulated with sufficient antig en to have a minimum potency level of 6 PD 50 to provide for more rapid onset and a wider spectrum of immunity against relevant field viruses.



### Laboratory diagnostics Field diagnosis of FMD relies heavily on recognition of clinical signs, which are similar to those seen in other vesicular diseases such as vesicular stomatitis, mucosal disease of cattle, bluetongue, and rinderpest. Virus isolation or demonstration of FMD viral antigen or nucleic acid in samples of tissue or fluid is therefore necessary for c onfirmatory diagnosis.

Enzyme

- linked immunosorbent assays (ELISA) can be used to detect FMD viral antigens and for serotyping [12, 14] . Lateral flow devices can also be used to detect FMD viral antigens. The ELISA has replaced complement fixation in most laboratories as it is more specific and sensitive; in addition, it is not affected by pro

- or anti

- complement factors. If the sample is inadequate or the diagnosis remains uncertain, sample materials can be tested by reverse transcription polymerase chain reaction and/or virus isolation.

Demonstration of specific antibodies to structural proteins in non

- vaccinated animals is indicative of prior infection with FMD virus [12, 14] . Virus neutralization tests (VNTs) and ELISAs for antibodies to structural proteins are used as serotype

- specific serological tests. Tests for antibodies to some nonstructural proteins (NSPs) of FMD virus are useful in providing evidence of previous or current viral replication in the host, irrespective of vaccination status. Unl ike structural proteins, NSPs are highly conserved and therefore are not serotype specific, so detection of antibodies to NSPs is not serotype restricted.



### References

1. Kitching, R., et al, Development of foot

- and

- mouth disease virus strain characterization

- a review. Trop An Health Prod, 1989. 21 : p. 153

- 166. 2. Knowles, N.J., et al., Pandemic strain of foot

- and

- mouth disease virus serotype O. Emerging Infectious Diseases, 2005. 21 (12): p. 1887

- 1893. 3. Knowles, N.J. and A.R. Samuel, Molecu lar epidemiology of foot

- and

- mouth disease virus. Virus Research, 2003. 91 : p. 65

- 80.

### 101

4. Sakamoto, K. and K. Yoshida, Recent outbreaks of foot and mouth disease in countries of East Asia. Rev Sci Tech, 2002. 21 (3): p. 459

- 463. 5. Torres, A., Foot and mouth disease , in Foreign Animal Diseases, 7th edition , C. Brown and A. Torres, Editors. 2008, Committee on Foreign and Emerging Diseases of the United States Animal Health Association. Boca Publications Group, Inc: Boca Raton, Florida. p. 261

- 276. 6. Kitching, R.P., Clinical variation in foot and mouth disease; cattle. Rev Sci Tech, 2002. 21 (3): p. 499

- 504. 7. Kitching, R.P. and S. Alexandersen, Clinical variation in foot and mouth disease; pigs. Rev Sci Tech, 2002. 21 (3): p. 513

- 518. 8. Woodbury, E.L., A revie w of the possible mechanisms for the persistence of foot

- and

mouth disease virus. Epidemiol Infect, 1995. 114 (1): p. 1

- 13. 9. Seifert, H., Foot

- and

- mouth disease , in Tropical Animal Health 1996, Kluwer Academic Publishers: London, Massachusetts. p. 418

- 431. 10. Kitching, R.P., Identification of foot and mouth disease virus carrier and subclinically infected animals and differentiation from vaccinated animals. Rev Sci Tech, 2002. 21 (3): p. 531

- 538. 11. Alexandersen, S., et al., The pathogenesis and diagnosis of foot

- and

- mouth disease. J Comp Pathol, 2003. 129 : p. 1

- 36. 12. World Organization for Animal Health (OIE), Chapter 2.1.5 Foot and mouth disease , in Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2011: Available from

: http://www.oie.int/ international

- standard

- setting/terrestrial

- manual/access

- online/

. 13. Mann, J. and R.F. Sellers, Foot and mouth disease , in Virus Infections of Vertebrates , Z. Dinter and B. Morein, Editors. 1990, Elsevier. p. 903

- 912. 14. Thomson, G., Foot

- and

- mouth disea se , in Infectious Diseases of Livestock , Coetzer, Thomson, and Tustin, Editors. 1994, Oxford University Press: Cape Town, South Africa. p. 825

- 852. 15. Sellers, R.F., Quantitative aspects of the spread of foot

- and

- mouth disease. Vet Bull, 1971. 41 (6): p. 431

- 439. 16. Cottral, G.E., Persistence of foot

- and

- mouth disease virus in animals, their products and the environment. Bull Off Int Epizoot, 1969. 70 (3): p. 549

- 568. 17. Alexandersen, S., Z. Zhang, and A.I. Donaldson, Aspects of the persistence of foot

- an d

mouth disease virus in animals; the carrier problem. Microbes Infect, 2002. 4 (10): p. 1099

- 1110. 18. Alexandersen, S., M.B. Oleksiewicz, and A.I. Donaldson, The early pathogenesis of foot

and

- mouth disease in pigs infected by contact; a quantitative time

- course study using TaqMan RT

- PCR. J Gen Virol, 2001. 82 (4): p. 747

- 755. 19. Oleksiewicz, M.B., A.I. Donaldson, and S. Alexandersen, Development of a novel real

time RT

- PCR assay for quantitation of foot

- and

- mouth disease virus in diverse porcine tissues. J Virol Methods, 2001. 92 (1): p. 23

- 35. 20. Salt, J.S., The carrier state in foot and mouth disease; an immunological review. Br Vet, 1993. 149 (3): p. 207

- 223. 21. Zhang, Z. and R.P. Kitching, The localization of persistent foot and mouth disease virus in the epithelial cells of the soft palate and pharynx. J Comp Pathol, 2001. 124 : p. 89

- 94. 22. Cottral, G.E., B.F. Cox, and D.E. Baldwin, The survival of foot

- and

- mouth disease virus in cured and uncured meat. Am J Vet Res, 1960. 21 : p. 288

- 97. 23. Henderson , W.M. and J.B. Broodsby, The survival of foot and mouth disease virus in meat and offal. J Hyg (Lond), 1948. 46 (4): p. 394

- 402. 24. Cox, B.F., G.E. Cottral, and D.E. Baldwin, Further studies on the survival of foot and mouth disease virus in meat. Am J Ve t Res, 1961. 22 : p. 224

- 226.

### 102

25. Lasta, R., et al, Combined treatment of heat, irradiation, and pH effects on the infectivity of foot

- and

- mouth disease virus in bovine tissues. J Food Sci, 1992. 57 (1): p. 36

- 39. 26. Green, W. and J.L. Grannis, Economic imp act of alternative management strategies for regulating Canadian ruminant/product imports. 2003: p. Unpublished report, Center for Epidemiology and Animal Health. 27. Heidelbaugh, N. and J. Graves, Effects of some techniques applicable in food processing

o n the infectivity of foot and mouth disease virus. Food Tech, 1968. 22 : p. 120.

### 103 Appendix II.

11 factors described under 9CFR 94.2 before 2012 8 factors described under 9CFR 94.2 after 2012 Scope of the evaluation Scope of the evaluation
The extent of an active disease control program, if any, if the agent is known to exist in the region. Veterinary control and oversight The authority, organization, and infrastructure of the veterinary services organization in the region.
Disease status

—

i.e., is the restricted disease agent known to exist in the region? If “yes,” at what prevalence? If “no,” when was the most recent diagnosis? Disease history and vaccination practices The vaccination status of the region. When was the last vaccination? What is the extent of vaccination if it is currently used, and what vaccine is being used? The degree to which the region is separated from adjacent regions of higher risk through physical or other barriers. Epidemiological separation from potential sources of infection The extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regarding such movements. The status of adjacent regions with respect to the agent. Livestock demographics and marketing practices in the region. Livestock demographics and traceability

The type and extent of disease surveillance in the region

— e.g., is it passive and/or active; what is the quantity and quality of sampling and testing? Surveillance practices

Diagnostic laboratory capabilities. Diagnostic laboratory capabilities
Policies and infrastructure for animal disease control in the region

—

i.e., emergency response capacity. Emergency preparedness and response