### 1 

## RESTORATION OF FMD FREE STATUS ZONE

WHERE VACCINATION IS PRACTISED

Report of a country requesting, according to the provisions of Chapter 2.2.10.5. of the Terrestrial Animal

Health Code , that an area of its territory be recognized as Foot and Mouth Disease free zone with

vaccination

Please follow thoroughly the instructions hereinafter stated. It is recommended to mention and attach national regulations and rules issued by the Veterinary Administration which are considered relevant

Restoration of FMD free status zo ne where vaccination is practised

Countries requesting the restoration of FMD free status with vaccination shall comply with the provisions of Article 2.2.10.7 of the Terrestrial Animal Health Code and provide the information specified in sections 3.1, 3.2, 3.3 and 5.2 of this present report. The information specified in other sections will be supplied if considered relevant.

Extension and limits

The area of the Argentine Republic for which the restoration of the status of “FMD free zone where vaccination is practised” is being requested, is located to the north of Parallel 42o South Latitude, geographical limit between Chubut and Rio Negro provinces.

It includes Buenos Aires, Catamarca, Córdoba, Corrientes, Chaco, Entre Ríos, Formosa, Jujuy, La Pampa, La Rioja, Mendoza, Misiones, Neuquén, Rio Negro, Salta, San Juan, San Luis, Santa Fe, Santiago del Estero and Tucumán provinces.

### 2 Map 1

It is important to mention that in the interior of the area described there is a zone Free from Foot and Mouth Disease where vaccination is not practised, located between the parallel 42o and the Rio Negro in the Rio Negro province and Neuquén province (with the exception of the areas of Confluencia and Valle Azul), zone called Northern B

### 3 Patagonia, that never required vaccination as a control strategy due to the fact that it is an area naturally free from FMD. This zone acts as a “buffer zone” protecting Southern Patagonia, composed of Chubut, Santa Cruz and Tierra del Fuego provinces, Antarctica and South Atlantic Islands, which was recognized as “Free from FMD without vaccination” by OIE in May 2002.

In the Northern limit a “border protection zone” was established, the Northern A Border Subproject, which comprises a stretch of territory 25 Km. wide along the borders with Bolivia and Paraguay Republics, including Jujuy, Salta and Formosa provinces. This zone is under a process of expansion, extending to the rest of the border with Paraguay and the border with Brazil (Northern B Border Subproject – See Annex I – Northern B Border Subproject ) including Chaco, Corrientes and Misiones provinces up to General Manuel Belgrano department in Misiones province.

3. Eradication of Foot and Mouth Disease

3.1. History: describe the history of FMD in th e country and zone (date of first detection of disease, origin of the infection, date of era dication in zone, types and subtypes present).

Historically, the presence of FMD in Argentina was related to two ecosystems; a) free zone (Patagonia) with very low incidence due to the introduction of animals or products from endemic zones and b) endemic zone (under vaccination program), with frequent

incidence until 1994.

FMD National Eradication Plan initiated in 1990 eradicated this disease and allowed interrupting the vaccination program in 1999 obtaining the OIE recognition as “Country

Free of Foot and Mouth Disease without Vaccination” in 2000.

Reintroduction of disease made it necessary to design and implement the Eradication

Plan in 2001.

In May 2002, OIE recognized as ”Free Zone Without Vaccination” the territory located to the South of Parallel 42o, and in July 2003 as “Zone Free of FMD where Vaccination is practised” to the territory located to the North of Parallel 42o.

The status as “Free Zone where Vaccination is Practised” was suspended in August 2003 due to the only outbreak at the town of Tartagal, Salta Province which affected an establishment located at 40 Km. from the border, it was epidemiologically related to the presence of the disease in Paraguay (Pozo Hondo, Department of Boquerón 7/2003) and in Bolivia (Chuquisaca, La Paz, Potosí, Tarija, 7/2003); this status was recovered in January 18, 2005

In October 2005, notifications were received on the presence of outbreaks in Brazil, initially in the State of Mato Grosso do Sul (official information confirmed 10 outbreaks), which then extended to the State of Paraná, where the presence of other 9 outbreaks was confirmed. These facts gave rise to the declaration of sanitary alert through SENASA Resolution No 672 dated on October 25, 2005.

The first days of February 2006, private veterinarians working for Farming Establishment “San Juan” (Outbreak No 1) located at 25 Km from the border with Paraguay, in the Department of de San Luis del Palmar, Corrientes Province, reported to SENASA Local Veterinary bovines with vesicular lesions in such premises. The Official Veterinary verified the presence of 70 bovines with clinical signs without mortality records.

Map 2

### 4 Immediately, the following measures were taken: clinical inspection of animals, immobilization of animals, taking and submission of samples to the laboratory, fencing of eventual focal-perifocal-surveillance zones and call of the Regional Emergency

Team.

The Official Laboratory of SENASA performed the primary diagnoses through the tests ELISA SI and Complement Fixation 50 % (epithelial tissue and EITB (serology) confirming FMD virus “O” type on February 8, later completed by tests for characterization, immunological and molecular. After the confirmation, this was reported officially to International Organisms (OIE - CVP – PANAFTOSA), farming entities, agrifood industry, neighbor countries and countries having a trading relationship.

The SANITARY EMERGENCY was declared (SENASA Resolution No 35/06) and the sanitary slaughter of diseased and contact animals was decided (SENASA Resolution No 36/06).

On February 21 (Outbreak No 2), a bovine was detected with cicatricial lesion in mouth and feet, compatible with FMD at a neighboring establishment to the affected lot of Outbreak No 1. It was the only one bovine without brand indicating ownership. The owner of the establishment did not recognize it as his property and there were no records of its existence in vaccination documents and inspection of perifocal zone carried out on February 11, 2006.

### 5 Cicatricial lesions did not allow taking epithelial samples but LEF- Probang samples were taken from the affected bovine (and three of its contact animals), none of which gave evidence of virus recovery. Serum proved reactive to tests for Non-Capsidal Proteins (NCP) ELISA 3 ABC/EITB. No anim al in the premises had disease clinical signs and at the serological sampling in the establishment no reactors to NCP have

been detected. The sanitary slaughter of the affected animal and its direct contact animals was carried out (SENASA Resolution No 91/06).

Disease is considered eradicated on March 1, 2006, day on which sanitary slaughter of

affected animals finished.

Outbreak Origin and Causes

Simultaneously with carrying out control and eradication measures, SENASA began an investigation in order to know the outbreak origin and causes.

The investigation was oriented to evaluate the necessary and concurrent causes for

FMD reintroduction:

1. Presence of susceptible animals

• Due to vaccine failures (inappropriate or low quality vaccine strain)

• Due to vaccination failures

2. Origin of virus source

• Endemism

• Introduction from outside

1. Presence of Susceptible Animals:

Vaccine Failures:

Studies on molecular characterization and phylogenetic relationships revealed that acting “O”-type virus was genetically related with other virus isolated in the last regional

occurrences.

Immunologic studies on protection of isolated vi rus in relation to vaccine strain (vaccine matching) determined high Expectation Percentage of Protection of vaccine strain O1 Campos, component of the vaccine used in systematic vaccination.

See Annex II: PANAFTOSA Reports

Protocols of production and quality control of vaccine batches used in recent vaccination campaigns in focal zone were verified, and no findings challenged their quality, what was confirmed assessing the immune response of animals vaccinated at

the same time than the affected animals with these same vaccine batches.

For the above mentioned reasons, very low probability was assigned to a failure in

vaccines as cause for outbreaks.

### 6 Failures in Vaccination

The study on population dynamics at the establishment (movement exit-entry-birthsvaccination-etc.) recorded at SENASA registries comparing the actual existence at the time of intervention and slaughter did not reveal differences showing undervaccination.

Serology performed at establishment “San Juan” in animals not affected by disease shows high Expectation Percentage of Protection compatible with a correct systematic

vaccination.

For the above mentioned reasons, very low probability was assigned to a failure in

vaccination as cause for outbreaks.

2.- Virus Source Origin

Endemism

In order to evaluate the probability of endemism, the following facts were analyzed:

• Clinical surveillance performed had not detected FMD cases since September 2003 in the country. In Corrientes province, the last outbreak recorded had been in 2001;

• Serological surveillance through samplings for FMD carried out from 2003 to 2006 throughout the country had not detected viral activity;

• Vaccine coverage achieved after 10 continuous campaigns in 2001, and results from serological samplings to estimate population immunity show population protection immunity levels enough to restrain virus circulation;

• Isolated virus phylogenetic characterization shows a 10% difference with last isolation of “O”-type virus in Argentina (year 2000) and minor differences with recent regional isolations.

See Annex II: PANAFTOSA Reports

• Serological sampling performed in perifocal and surveillance areas did not detect viral activity;

• During last FMD epidemic (2000-2001) only eleven (11) outbreaks of O-type virus were diagnosed (all of them during 2000) and more than 2,500 outbreaks of A-type virus (from August 2000 until January 2002). Therefore if endemism had been the outbreak cause, probabilistically it would be more expectable that they were A.-type virus

For the above mentioned reasons, very low probability was assigned to endemism as

cause for the outbreak.

Introduction from abroad

In this sense, research was oriented, at first to the study of documents on livestock and movements of susceptible animals that could explain the introduction of the disease due to illegal entry of animals and products. It was compared the existence of livestock on farming establishments, recorded in the SENASA Sanitary Management System

### 7 (SGS) with vaccine documents of two last campaigns as well as definite livestock at premises at the time of sanitary slaughter.

This investigation was extended with a formal and documented inquiry questionnaire to the persons related to the affected establishment. There also, the analysis of the compiled information did not contribute elements that could give a formal and effective explanation of what happened.

Analyzed information did not offer us relevant evidence that could explain the source and origin of virus and therefore a final decision could not be concluded, however introduction from abroad seems to be the most probable cause.

SENASA, surpassed in relation to its competence as to investigation on suspected irregular movements of animals that could have introduced FMD virus, derived proceedings to the courts. The investigation continues in this area.



### 3.2. Strategy: describe how FMD has been controlled and eradicated in the zone (sanitary slaughter, modified sanitary slaughter, etc.) and mention how long eradication has

taken

.

For the eradication, guidelines established by Article 2.2.10.7 paragraph 2 item a) of

the Terrestrial Animal Health Code were followed.

Measures taken as from the detection were the following:

• Clinical inspection of animals at the affected establishment,

• Immobilization of cattle,

• Taking and submission of samples to be diagnosed and

• Delimitation of focal, perifocal and surveillance areas as well as call to the

Emergency Regional Team.

After the disease had been confirmed, the following measures were implemented:

a) Sanitary slaughter of diseased and contact animals which were buried b) Strategic vaccination and revaccination c) Interdiction Zone and establishment of disinfection and control stations d) Epidemiologic surveillances (clinical and serological).

a) Sanitary slaughter

Sanitary slaughter of Outbreak 1: After disease had been confirmed, the strategy of sanitary slaughter and burial of diseased animals and contacts in order to eliminate the virus source and its spread.

Sanitary slaughter began on February 10 and finished on February 21.

For sanitary slaughter and burial of 4,636 animals, 8 sanitary landfills were made with an overall extension of 2,200 meters long and 3 meters deep.

It is important to mention that on February 10, animals’ source of infection had been slaughtered and buried (affected lot). Then, other animal lots were slaughtered beginning with the closest animals to the primary outbreak.

### 8 During this operation a total of 4,636 susceptible animals were slaughtered according to the details in the following table:

Table 1: “Sanitary slaughter Outbreak 1”

Date Bovine Swine Ovine - Caprine

02/10/06 246 * 0 0

02/12/06 604 0 0

02/15/06 672 0 0

02/16/06 1015 0 0

02/17/06 871 0 0

02/18/06 641 5 335

02/19/06 49 0 0

02/21/06 0 0 198

TOTAL 4098 5 533

*Lot where disease was detected.

Sanitary slaughter Outbreak 2: After the disease has been confirmed, the strategy of sanitary slaughter and burial of disease and contact animals was continued.

Table 2: Sanitary slaughter Outbreak 2

Date Bovine

02/26/2006 134

03/01/2006 281

Total 415

b) Strategic vaccination in the area

Ring-strategic vaccination and revaccination was implemented on all susceptible species in perifocal area (3 Km around outbreak), and only bovines in surveillance area (10 Km around perifocal area).

At the time when the outbreak was detected, the area had begun the first systematic

vaccination in 2006.

Table 3: Premises and vaccinated and revaccinated animals according to species, in perifocal and surveillance areas

Vaccinated premises Vaccinated animales

### 9 Bovine Ovine/

Caprine Swine Total

Perifocal 175 32,595 2,638 158 35,391

Surveillance 406 60,561 - - 60,561

TOTAL 581 93,156 2,638 158 95,952

c) Interdiction area and establishment of disinfection and control stations

After the Sanitary Emergency Status had been officially declared throughout the country under SENASA Resolution No 35/2006, affected department was interdicted - San Luis del Palmar- and seven neighboring departments, all of them located in Corrientes province (see Map Page 4).

A survey on cattle stocks was carried out in the interdicted area. In the following table bovine stock in involved departments are detailed.

Table 4: Number of producers and bovine stock in interdicted area

Departments Producers Bovine

San Luis del Palmar 847 119,961
San Cosme 239 34,482
Itatí 139 47,897
Berón de Astrada 38 30,964
Gral. Paz 410 120,591 Mburucuyá 242 59,058
Empedrado 677 116,861 Capital 363 22,787

TOTAL 2,955 552,601

Land control stations have been established and river controls have been reinforced to ensure quarantine measures.

### 10 River Stations:

Within interdicted area, 4 river border control stations are established.

1. Paso de la Patria

2. Itatí 3. Yahape

4. Ita Ibate

Each one has 2 permanent official agents who perform control on packages and luggage as well as disinfection of shoes of persons on entry to the country.

During establishment of emergency, a total of 5,040 persons have been controlled in all 4 stations. 161 violation documents were issued and risk products were seized.

Land stations

11 road stations were established for the control of goods and disinfection of vehicles and 1 station in the airport of Corrientes city, on duty 24 hours a day as detailed:

### 11 Table 5: Staff appointed at land stations and measures taken

Station Agents Inspected and disinfected 1.-Puente Gral. Belgrano 18 122,500
2.-San Luis del Palmar 7 19,686 3.-Caa Cupe 6 1,118 4.-Laguna Alfonso 4 1,635

5.- Rincón Navarro 2 488 6.-Lomas de Vallejos 6 3,985
7.- Saladas 7 4,994
8.- Santa Rosa 6 3,875
9.- Kilómetro 1111 7 5,897 10.- Tranquera 4 4 389
11.- San Lorenzo 7 1,712 12.- “Camba Punta” Airport 1 2,000 *

Total 75 168,279 ** * It refers to passengers ** It refers to the addition of vehicles plus airport passengers.

At Camba Punta Airport, preventive measures for disinfection and reinforcement of luggage control have been implemented through equipment for detecting organic

material.

d) Epidemiologic surveillance.

After having confirmed the outbreak, teams of official professionals and vaccinators were formed in order to perform clinical-serological surveillance and vaccination, respectively, in perifocal and surveillance areas; serological studies have been also performed in premises related with the outbreak (retrospective tracing).

Work methodology consisted in visits to all perifocal area premises to perform their general inspection, interview owners (epidemiological survey) and clinical inspection of animals and sample taking.

Visits and inspections to premises at perifocal and surveillance areas have been repeated during revaccination.

Serological surveillance

Samplings performed in perifocal and surveillance areas were intended to detect virus activity through tests for detection of Ac against non capsidal proteins (NCP) of foot and mouth disease virus (FMDV).

At the affected premise tests for structural proteins (SP) to estimate population vaccine immunity were also carried out.

Diagnostic tests (NCP) used to detect virus activity:

Bovine: ELISA 3ABC – EITB (PANAFTOSA kit) Other species: VIAA-IDGA (Ag DILAB-SENASA)

Diagnostic test (SP) to estimate population immunity:

ELISA Fl, for strains A 2001, O1 Campos and C3 Indaial.

### 12 Blood samples were taken to bovines 6 to 24 months of age.

The number of sampled premises and number of samples analyzed.

Table 6: Sampled premises and animals by species and area

Animals Area Premises

Bovine Ovine/ Caprine Swine Total

Perifocal 161 1.639 114 15 1,768

Surveillance 139 1.419 4 5 1,428

Tracing 3 126 0 0 126

TOTAL 303 3184 118 20 3,322

Results of surveillance measures:

It was not detected clinical disease or evidence of virus circulation in susceptible population in perifocal and surveillance areas.

Herd tracing: Destination of susceptible animals was investigated from 8 interdicted departments which moved out of interdiction area from January 1 to February 8.

When the destination of animals was the slaughter (slaughter houses / abattoirs): herd list was submitted to slaughter establishments in order to certify movement and lack of sanitary news.

When the destination of the herd was other farm, clinical inspection and preventive

interdiction was carried out in the destination establishment until the end of the investigation at origin.

Measures in origin consisted in clinical inspection to confirm sanitary status with Confirmation Reports “Actas de Constatación” and epidemiologic survey.

Exits from the interdicted area to farms as from January 1 2006, are detailed.

### 13 Outgoing herds and animals from interdicted zone

as from January 1 to February 8, 2006

Source: SENASA Sanitary Management System

From the interdiction zone, 79 herds (2439 animals) from 25 premises moved out with destination to 27 premises located in other provinces and 89 herds (4033 animals) to 29 premises in Corrientes province but outside from the interdiction zone.

In the tracing performed within the premises of origin/destination, no sanitary news has

been detected.

In 3 establishments that had received animals from San Juan establishment, (Outbreak 1), investigation included clinical inspection and serological study of a representative number of animals of destination establishments to detect virus activity. In any of these premises, evidence of disease or virus circulation has not been detected.

After disease control and eradiation measures have finished and based on the results on clinical and serological surveillance showing absence of virus activity, by virtue of SENASA Resolution No 194/06 the Sanitary Emergency Status was lifted by SENASA Resolution No 35/06, progressively releasing restrictive measures imposed on the zone as from April 1, 2006.

Outbreaks have been considered eradicated on March 1, 2006, day of sanitary slaughter of last involved animals. Therefore, from notice of outbreak until eradication 21 days elapsed.

Legal framework related to the Sanitary Emergency

Resolution issued by SENASA No 672 dated on February 25, 2005:



### • Declaration of sanitary alert in the Argentine Republic due to occurrence of foot

and mouth disease in Brazil



### .

Resolution issued by SENASA No 35 dated on February 8, 2006:



### • Establishes the SANITARY EMERGENCY Status throughout the National Territory



### .

• Calls upon the Central Committee on Sanitary Emergencies and the corresponding Regional Teams of the National System of Sanitary Emergencies (SINAESA) established under Resolution No. 779 dated on July Corrientes Province

Interdiction zone Other p rovinces

29 p remises 45 p remises 25 premises 27
premises 7 9 h e r d s 2 4 3 9

a n i m a l s

89 herds 4033

animals

### 14 26, 1999 issued by SENASA, in order to assess the situation and implement the appropriate sanitary measures

• Interdicts Department of San Luis del Palmar, and adjacent Departments (San Cosme, Itatí, Berón de Astrada, General Paz, Mburucuyá, Empedrado and Capital), all of them located in the Province of CORRIENTES, forbidding all movements of animals susceptible to FMD to any destination, both entries into and exits from the mentioned Departments, except for those intended to immediate slaughter with official author ization at a Slaughter House located in the interdicted area and for domestic consumption.

• Forbids the exit from the interdicted area of products and byproducts of animal origin that could transmit FMD virus, originated, produced and manufactured in that area as from January 5, 2006



### • Forbids export of products and byproducts of animal origin that could vehicle FMD virus, originated, produced and manufactured in the interdicted area as from January 5, 2006



### .

Resolution issued by SENASA No 36 dated on February 8, 2006

• Directs the seizure and sanitary slaughter of animals receptive to FMD existing at the Establishment located at LS 27° 30’ 24,2’’; LW 58° 22’ 59,6’’, located at Department San Luis del Palmar of the Province of CORRIENTES.

• Proceed to interdict and destruction of products, byproducts and elements capable of transmitting FMD virus at the same establishment.

Resolution issued by SENASA No. 47 dated on February 16, 2006

• Established that products, byproducts and derivatives of animal origin or products with animal component under SENASA jurisdiction, originated from species susceptible to FMD that are “in transit” among third countries, they shall have previous authorization by the National Directorate of Agrifood Inspection.

Resolution issued by SENASA No 91 dated on February 24, 2006

• Established the seizure and sanitary slaughter of animals susceptible to FMD existing at the production unit located at Paraje Rincón Navarro (Focus 2), in the manner directed by the Team for Sanitary Emergencies as to quantity, condition, time and place

Resolution issued by SENASA No 194 dated on April 7, 2006



### • Repeal Resolution No. 35/2006, which declared the Sanitary Emergency Status in certain departments of the province of Corrientes



### .

See Annex III- REGULATIONS.



### 3.3. Vaccines and Vaccination 

### :

Which type of vaccine is used? Which species is it administered to?

The National Program includes periodic and systematic vaccination of bovine and bubaline species. Other susceptible species are vaccinated only in strategic or emergency situations. The vaccine used is formulated with oil adjuvant and saponin (long immunity); inactivated by binary ethylenimine (BEI); quadrivalent: containing strains O1 Campos, A24 Cruzeiro, A Argentina 2001, C3 Indaial; of 2ml/dosis produced by private national laboratories under SENASA control.

### 15 Provide tests of conformity of vaccine used according to provisions of Chapter 2.1.1. of Terrestrial

Animal Health Code Manual of OIE



### .

All vaccine batches produced in the country are controlled by the General Coordination of Animal Laboratory under SENASA Directorate of Laboratories and Technical Control (DILACOT), according to the provisions of SENASA Resolution No 351/06, pursuant to recommendations of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE (Chapter 2.1.1) and recommendations of the Regional Center of Reference OIE, PANAFTOSA. The Argentina Republic has 3 laboratories authorized to manufacture FMD vaccines with enough production capacity as to satisfy the country vaccine demand. Vaccine manufacture as well as diagnosis complies with NBS-3 Agriculture biosafety standards. A committee on biosafety (SENASA Resolutions N° 104/95-472/95-507/01-117/04) controls compliance with standards. For virus multiplication, BHK cells in suspension and primary cellular tissue are used. Antigens, according manufacturing laboratory, are concentrated by ultracentrifuge and

/or PEG. All bottles composing a vaccine batch are identified with technical labels as well as brand labels and with an official correlatively numbered stamp specifying batch number and expiration date of product. To control cold chain all along transport, thermal sensors are placed within transport refrigerating containers in order to verify that temperature is maintained within specified

range. Manufacturing laboratory performs own quality controls which minimally include: identity, antigenic mass, inactivation kinetics, safety, stability and sterility. SENASA performs audits to manufacture process at critical points. Each vaccine batch is packed, labeled and stamped, before being submitted to official control for use and marketing authorization. Random samples of finished product are taken to carry out the official controls. Each batch, prior to use authorization, is submitted to the following controls:

• Safety: prior to emulsion rupture, passages in BHK cells are performed from aqueous phase and complete vaccine inoculation in lactating mice.

• Sterility: common laboratory media are cultivated to ensure absence of bacterial and fungical contaminants.

• Stability: emulsion stability is controlled at different room temperatures (room, 37o C), drop and centrifuge tests are performed and viscosity and conductivity are measured.

• Purity: vaccines must not interfere with tests used in epidemiologic surveillance (NCP test). First-vaccinated bovine sera (bovines used in efficiency control tests) must not react to ELISA 3 ABC/EITB tests.

• Efficiency or Potency:

a) Record vaccines or first batch to be controlled: Direct Podal Generalization Protection (PGP) is carried out. For that purpose, 16 bovines born and raised in free zone without vaccination (Patagonia) free of specific antibodies, which are challenged at 90 DPV, with 10000 DIB. Protection of seventy-five percent (75%) of challenged animals is required. (This test is considered as Gold Standard).

b) Vaccines after record. Batches are controlled by indirect methods after product registration has been approved. For indirect efficiency control, per batch under control 16 bovines free of specific antibodies born and raised in free zones without vaccination (Patagonia). To develop this control, SENASA has an experimental field located

### 16 at Colonia 25 de Mayo, La Pampa province. Animals are bled at 0-30 and 60- DPV. Obtained sera are analyzed at 60 DPV through ELISA Fl, to evaluate the level of specific antibodies obtained for each of vaccine strain component of the vaccine (SENASA Resolution No 351/06).

Describe vaccine schedule implemented in the country and in the zone, included established registries, and to submit tests proving its efficiency (vaccine cover, serological surveillance, etc.).

Within the framework of FMD Eradication Plan, SENASA Resolution No 5/01, SENASA implemented as one of its main strategies periodic and systematic vaccination oriented to bovine/bubaline cattle according to a regionalization which defines application zone with active participation of farmers.

Farmers take part both in Local Sanitary Agencies of their jurisdictions and National Committee for the Fight against FMD (CONALFA) at highest decision level.

CONALFA is chaired by SENASA President and within this entity different stakeholders of the livestock business (official and private) take part in the analysis and definition of fight policies.

In the provinces, Provincial Committees on Animal Health (COPROSAs) have the mission to adequate strategies established by SENASA and to carry out technical proposals at provincial level. Their activiti es include coordination of Local Sanitary Agencies in their jurisdiction and submission of reports and proposal to the National Committee in relation to technical and administrative aspects according to the established proceedings and frequency or when officials so recommend.

Each department -or any other political subdivision in provinces- located in the systematic vaccination area through local Sanitary Agency draws up its own Local Vaccination Program pursuant the general strategy established by SENASA. Then it is submitted to COPROSA approval which finally submits for final approval to CONALFA

and SENASA.

Operation Strategies :

Vaccination objective is to achieve an adequate population immunity level of bovine and bubaline cattle and sustain it over time in order to prevent the disease and virus

circulation.

In two annual campaigns, all animals of bovine and bubaline species (bubalus bubalis) are vaccinated, except for the areas included in the Subproject Resolution for the Northern Border where all susceptible species are vaccinated.

All age categories are vaccinated in each campaign.

Movements of bovine are not authorized in vaccination area, when they have received at least two vaccinations with no more than 180 days between them. In order to comply with this requirement, strategic vaccinations are carried out during the campaign and intercampaign periods as applicable.

Vaccine cold chain is controlled from manufacturing laboratory until its application.

Vaccine acquisition is performed by local sanitary agencies or local veterinarians authorized by them, to manufacturing laboratories which are in charge of distribution and responsible for the appropriate cold chain maintenance.

### 17 Vaccination implementation is under the responsibility of operation teams of Local Sanitary Agencies, except for the Subproject Resolution for the Northern Border where vaccination is carried out by SENASA.

Campaign Implementation

The responsibility for the implementation of vaccination campaigns relies on Local Sanitary Agencies, function that has been delegated under SAGPYA Resolution No

108/01. Such activities include planning, implementation and evaluation of campaigns and submission of reports and proposals to the respective Provincial Committee (COPROSA), in relation to technical and administrative issues of the Plan.

These Agencies are composed of representatives of farmers associations, national organisms (SENASA Local Veterinary) and provin cial Animal Health agencies as well as other institutions working in the zone.

Its structure is composed of commissions that address administrative and technical aspects as well as an operation team (coordinators, programmers and vaccinators).

Responsibilities of operation team members are listed by SENASA Resolution No

623/02

SENASA local veterinary, apart from being the Technical Reference Official of Local Vaccination Plan (Chair of Technical Commission) performs the follow up and monitoring of campaigns at local level and he is the direct responsible for audit, control and inspection of Local Plan (Resolution No 33/02).

Registration System for FMD Vacccination

Vaccination is registered through a document considered as affidavit. The vaccinator, member of the Operation Team of Local Sanitary Agency, after performing vaccination, previously agreed with animal owners, prepares Vaccination Record Document “Acta de Vacunación” where brand, batch and expiration date of vaccine used, number of vaccinated animals per category, owner data and date are

recorded. These vaccination documents are issued in triplicate, the original copy is given to owner and/or responsible person for the animals, the duplicate is for the Local Office and the third copy is for the Local Sanitary Agency. With data recorded, the respective Data Sheet on Bimonthly Advancement according to the “System for the Follow-up and Advance of Vaccination Campaigns”. This system has been implemented pursuant to SENASA Resolution No 815/02 and has 8 data sheet which are submitted every two weeks by the Local Veterinarian responsible for each Local Vaccination Program to the Directorate for Epidemiology within seven days after closing of reported period. At the beginning of each vaccination period, “Data Sheet No 1” is submitted indicating start date and estimated number of bovine/bubaline to be vaccinated during campaign and in the case of vaccination programs for the Northern Border, ovine, caprine and swine are also reported.

Campaign evolution is followed in the Follow-up Data Sheets No 2 to 7, submitted every two weeks until the end of the campaign.

When vaccination has finished, (Closing) Data Sheet No 8 is submitted in which all data reported in follow-up data sheet is summarized, disaggregated by department, if program jurisdiction includes more than one.

### 18 The Directorate for Epidemiology, through the “System for the Follow-up and Evolution of Vaccination Campaign”, evaluates local programs and Local Sanitary Agencies in order to know their performance and to implement corrective measures, if applicable.

Table 7: Vaccine Cover Percentage – Campaigns 2005 and 1 st 2006

Campaign Estimated animals to be vaccinated (*) Vaccinated

animals Percentage

1 st - 2005 59,107,158 58,417,829 99

2 nd - 2005 58,854,684 59,983,991 101

1 st - 2006 59,552,376 59,460,351 100

Vaccinated animals include bovine and bubaline (Bubalus bubalis) species of the area where systematic vaccination is practised

(*) Number recorded at SGS +/- birth and death estimation among campaigns

### 19 Table 8: Other vaccinated susceptible species - Campaigns 2005 and 1 st 2006 Subproject Resolution for Border North A

Campaign Vaccinated swine Vaccinated ovine Vaccinated caprine

1 st - 2005 27,415 23,756 93,236

2 nd - 2005 32,770 26,277 91,466

1 st - 2006 31,126 23,959 87,699

Vaccination Schedule

Prior to the beginning of each campaign, SENASA, Local Sanitary Agencies and COPROSAs adequate the schedule for each local program (368 in total).

Vaccination dates vary according to the different regions, being adapted to production systems, geographical and epidemiological characteristics, with an extension from 60 to 90 days.

5. FMD surveillance

5.2 Surveillance:

Are serological and viral controls performed, especially those established by Article 3.8.7.5?

It they are performed, submit data on targets (confidence level, size of sample, stratification)

How often are they performed?

Are wild susceptible species included in controls?

Submit a chart indicating the number of samples submitted to tests to detect FMD, FMD virus, species of the sample, type of sample, test(s) used and results obtained (differential diagnoses included) during the last two years. Give details on measures taken including all results: suspected and positives.

Annually, systematic serological samplings are carried out in order to detect FMD virus circulation on susceptible population and es timate population vaccine immunity in bovine/bubaline population. They are performed according to the recommendations established by Article 3.8.7.5 of the Terrestrial Animal Health Code. It consists of an initial sampling which is probabilistic, at random, stratified and of the follow-up of positive cases. In the zones with and without vaccination. The zone with vaccination was divided in regions, according to their production, geographical and political characteristics. Premise selection to be sampled is performed at random at the Central Level (Directorate for Epidemiology); taking of samples is carried out by SENASA local veterinaries and samples are processed at the Official Laboratory.

See Annex IV- 

### FOOT AND MOUTH DISEASE SERO-EPIDEMIOLOGICAL

SURVEILLANCE - SEROLOGICAL SAMPLING 2005-2006.

In addition to the systematic annual sampling, an additional sampling is carried out in the border zone corresponding to the Subproject Resolution on Border North A. The taking of samples is carried out simultaneously with the second vaccination campaign, for this reason, at the moment the present year sampling is under process.

See Annex V 

### FOOT AND MOUTH DISEASE SERO-EPIDEMIOLOGICAL

SURVEILLANCE - SEROLOGICAL SAMPLING 2005.

### 20 In order to comply with OIE requirements for restoration of status of free zone after the occurrence of an outbreak, an additional serological sampling has been carried out in the affected area of the Province of Corrientes, in the following departments: Beron de Astrada, Capital, Empedrado, General Paz, Itati, Mburucuya, San Cosme and San Luis

del Palmar.

See Annex VI- SAMPLING CONDUCTED IN AREAS UNDER RESTRICTIONS DUE

TO FOOT AND MOUTH DISEASE OUTBREAKS, CORRIENTES PROVINCE - 2006.

In relation to wild susceptible species, during this year, joint measures were implemented with the Directorate for Wild Fauna and Flora under the Secretariat of Natural Resources and Sustainable Development, provincial Directorates for Fauna, Directorates for National Parks, NGOs devoted to research and conservation of wild fauna, private veterinarians, private hunting lodges owners, etc.

Standards for SENASA local veterinarians have also been established in order to make

clearer the role of the official veterinarian in relation to the intervention and communication of disease cases in wild fauna, taking of samples and their submission to laboratory, etc.

The main objective of these joint tasks with other agencies and organizations is to obtain information on disease cases in wild animals and to get parties closer to the official service as well as obtaining samples for monitoring of diseases.

In relation to deer, the first attempts to obtain samples of wild animals were oriented to areas with the greater number of big game hunting lodges, populated with deer as those located in the Provinces of La Pampa and Neuquen. In these provinces, big game enterprises have developed favored by the geographical and wildlife characteristics as well as by the favorable economic relationship of the country for foreign hunters as from 2001. In the case of La Pampa, there are large farms that supplementary to cattle production and favored by particular characteristics of their lands and by the existence of red deer and other hunting interest like pumas and boars, have opened their premises as private hunting lodges.

This year the provincial Directorate for Wild Fauna of La Pampa has registered and

authorized 49 private big game hunting lodges (some of them are also authorized for small game), with an average surface of 5,800 hectares. This situation also happens in the province of Neuquén, but in this case there are also large extensions of fiscal land belonging to National Parks that have been authorized as big game hunting areas. In this province, the Directorate for Wild Fauna has registered 80 big game hunting areas (equivalent to big game hunting lodges in other provinces), with an average surface of approximately 11,000 ha.

Sampling of these animals is more feasible in the following cases:

1. Selection hunting or sex compensation hunting: this activity is carried out in some big game hunting lodges areas (Neuquén), in order to control super population of animals or to regulate the stock of individuals of different sex. This year, serum samples have been obtained from 30 deer from two big game hunting lodges located at Department of Utracán, Province of La Pampa, which have been recently submitted to the laboratory (DILAB). These resulted non

### 21 reactive to detection of PNC though VIAA method. Also samples from 30 deer in a hunting lodge located at the Department of Guatraché, in the same province, which have equally resulted no reactive. In the case of the Province of Neuquén, this modality is regulated by provincial fauna authorities and it is carried out annually until the month of September. It is planned for this year, if weather so allows, coordinating these actions with those of premise owners or persons in charge thereof, in order to obtain blood samples during animal shooting.

2. Sport hunting: in this manner a great number of pieces are shot throughout this season. However, it is not easy to obtain good samples in theses cases, especially of serum samples; a plan to improve communication and collaboration with hunting guides and hunters is being implemented as well as a plan to train them as to taking and submitting samples.

3. Conservationist organizations (NGOs) that perform research on wildlife animals and capture animals. In this case, the contact is closer with members of “Wildlife Conservation Society” (WCS), and particularly with those that are working on projects involving some native deer species (huemul deer and pampa deer, for example). Thanks to them, some serum samples from deer originating from Bariloche area (Río Negro) have been obtained, it is planned that in these months the axis deer capture in the province of Buenos Aires, used as sentinel pampa deer, to study diseases affecting this specie in danger

of extinction.

### 22 Map: distribution of hunting lodges and y deer rearing establishments in the Provinces of La Pampa and Neuquen.