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####### **Risk Analysis:** ![](media/image1.png){width="1.4770833333333333in" height="0.8270833333333333in"}![](media/image2.wmf){width="1.163888888888889in" height="0.9861111111111112in"}

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####### **Risk of Exporting Foot-and-Mouth Disease (FMD) in FMD-Susceptible Species from Argentina, South of the 42° Parallel (Patagonia South), to the United States**

> **Evaluation of the FMD Status of**
>
> **Argentina, South of the 42° Parallel**

**Veterinary Services**

**National Center for Import and Export**

**Regionalization Evaluation Services**

**(June 2005)**

[]{#__RefHeading___Toc111609750 .anchor}**TABLE OF CONTENTS**

[**TABLE OF CONTENTS** 2](#__RefHeading___Toc111609750)

[**LIST OF TABLES** 3](#__RefHeading___Toc111609751)

[**LIST OF FIGURES** 3](#__RefHeading___Toc111609752)

[**LIST OF ABBREVIATIONS** 4](#__RefHeading___Toc111609753)

[**Executive Summary** 6](#__RefHeading___Toc111609754)

[**Background** 7](#__RefHeading___Toc111609755)

[**Objectives** 8](#__RefHeading___Toc111609756)

[**Hazard identification** 8](#__RefHeading___Toc111609757)

[**Risk analysis** 8](#__RefHeading___Toc111609758)

[**Release assessment** 8](#__RefHeading___Toc111609759)

[**Eleven factor analysis** 9](#__RefHeading___Toc111609760)

[**1. The authority, organization, and infrastructure of the veterinary
services organization in the region** 9](#__RefHeading___Toc111609761)

[**2. Disease status-i.e., is the restricted disease agent known to
exist in the region?** 23](#__RefHeading___Toc111609762)

[**3. The status of adjacent regions with respect to the agent**
25](#__RefHeading___Toc111609763)

[**4. The extent of an active disease control program, if any, if the
agent is known to exist in the region**
27](#__RefHeading___Toc111609764)

[**5. The vaccination status of the region**
27](#__RefHeading___Toc111609765)

[**6. The degree to which the region is separated from adjacent regions
of higher risk through physical or other barriers**
28](#__RefHeading___Toc111609766)

[**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** 30](#__RefHeading___Toc111609767)

[**8. Livestock demographics and marketing practices in the region**
44](#__RefHeading___Toc111609768)

[**9. The type and extent of disease surveillance in the region**
47](#__RefHeading___Toc111609769)

[**10. Diagnostic laboratory capacity**
62](#__RefHeading___Toc111609770)

[**11. Policies and infrastructure for animal disease control in the
region** 67](#__RefHeading___Toc111609771)

[**Release Assessment -- Summary of risk factors and mitigations
considered** 69](#__RefHeading___Toc111609772)

[**Likelihood of FMD introduction into the Argentina Patagonia South
region** 70](#__RefHeading___Toc111609773)

[**Likelihood of detection of FMD if reintroduced into the Argentina
Patagonia South region** 70](#__RefHeading___Toc111609774)

[**Release Assessment -- Conclusion** 71](#__RefHeading___Toc111609775)

[**Exposure Assessment** 71](#__RefHeading___Toc111609776)

[**Consequence Assessment** 72](#__RefHeading___Toc111609777)

[**Risk Estimation** 75](#__RefHeading___Toc111609778)

[**References** 77](#__RefHeading___Toc111609779)

[**Appendix 1: Epidemiologic characteristics of foot-and-mouth disease
(FMD)** 81](#__RefHeading___Toc111609780)

[]{#__RefHeading___Toc111609751 .anchor}**LIST OF TABLES**

[Table 1. Animal Health Personnel in the Patagonia South Region
16](#__RefHeading___Toc103570779)

[Table 2. Human Resources at Strategic Control Posts in the Three
Patagonia Sanitary Regions 32](#__RefHeading___Toc103570780)

[Table 3. Airports with Sanitary Inspection in Patagonia South and North
A and B. 38](#__RefHeading___Toc103570781)

[Table 4. Total number of livestock producers and establishments and
number of bovine and sheep livestock and establishments in Patagonia
South in 2003. 44](#__RefHeading___Toc103570782)

[Table 5. Number of pig and goat livestock and establishments in
Patagonia South in 2003. 44](#__RefHeading___Toc103570783)

[Table 6. Livestock figures used to construct sampling lists.
52](#__RefHeading___Toc103570784)

[Table 7. Livestock figures used to construct sampling lists by province
in Patagonia South. 53](#__RefHeading___Toc103570785)

[Table 8. Sampled establishments, collected samples and results of the
population sampling of Patagonia in 2001.
54](#__RefHeading___Toc103570786)

[Table 9. Sampled establishments, collected samples and results of the
targeted sampling of Patagonia in 2001.
55](#__RefHeading___Toc103570787)

[Table 10. Number of samples required by the two-stage sampling design
in 2002. 58](#__RefHeading___Toc103570788)

[Table 11. Number of samples actually analyzed in each zone in 2002.
58](#__RefHeading___Toc103570789)

[Table 12. Number of establishments with at least one positive animal of
any species in Zone C . 58](#__RefHeading___Toc103570790)

[Table 13. Results of viral activity in sheep/goats for each sub-zone in
Zone C. 59](#__RefHeading___Toc103570791)

[Table 14. Number of deer establishments and deer sampled in 2002.
59](#__RefHeading___Toc103570792)

[Table 15. Sampling 2003. Number of premises sampled and collected and
processed samples to determine viral activity by region.
61](#__RefHeading___Toc103570793)

[Table 16. Number of ovine premises sampled and processed samples to
determine viral activity in the Patagonia South and North B regions per
province and their results. 62](#__RefHeading___Toc103570794)

[Table 17. Number of diagnostic tests for FMD and VS serology 2003.
66](#__RefHeading___Toc103570795)

[Table 18. Economic impacts of FMD adjusted from 1976 dollars to March
2001 dollars by Consumer Price Index. 74](#__RefHeading___Toc103570796)

[]{#__RefHeading___Toc111609752 .anchor}**LIST OF FIGURES**

[Figure 1. Map of Argentina and List of Associated Provincial Acronyms
5](#__RefHeading___Toc111365949)

[Figure 2: Map of the epidemiological zones of Patagonia
7](#__RefHeading___Toc111365950)

[Figure 3. Map of SENASA Regional and Local Units
12](#__RefHeading___Toc111365951)

[Figure 4. Functional Organization Chart of SENASA
15](#__RefHeading___Toc111365952)

[Figure 5. Epidemiological zoning of Argentina for the purpose of
serological sampling 50](#__RefHeading___Toc111365953)

[Figure 6. Areas with and without vaccination
51](#__RefHeading___Toc111365954)

[Figure 7. 2002 zoning map for serological sampling
56](#__RefHeading___Toc111365955)

[Figure 8. 2002 further sub-zoning of Zone C in Map 2 above
57](#__RefHeading___Toc111365956)

[Figure 9. Functional Organization Chart of SENASA Laboratory
64](#__RefHeading___Toc111365957)

[]{#__RefHeading___Toc111609753 .anchor}**LIST OF ABBREVIATIONS**

> **APHIS:** Animal and Plant Health Inspection Service
>
> **BL2:** Biosafety level 2
>
> **BL3:** Biosafety level 3
>
> **CCFyC:** Quarantine, Borders and Certifications Unit
>
> **CFR:** United States Code of Federal Regulations
>
> **DILACOT:** Laboratories and Technical Control Office
>
> **DNFA:** National Agrifood Inspection Office
>
> **DNSA:** National Animal Health Office
>
> **DTA:** Animal Transport Document
>
> **EITB:** Enzyme-linked Immunoelectrotransfer Blot
>
> **ELISA:** Enzyme-linked Immunosorbent Assay
>
> **EU:** European Union
>
> **FUNBAPA:** Patagonian Barrier Foundation
>
> **FMD:** Foot-and-mouth 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

[]{#__RefHeading___Toc111365949 .anchor}Figure 1. Map of Argentina and
List of Associated Provincial Acronyms

> ![](media/image3.png){width="3.4611111111111112in"
> height="7.304166666666666in"}

**PROVINCES**

BUE BUENOS AIRES

CAT CATAMARCA

CBA CORDOBA

CHA CHACO

CHU CHUBUT

CRR CORRIENTES

DOZ MENDOZA

ERI ENTRE RIOS

FSA FORMOSA

JUA SAN JUAN

JUJ JUJUY

LAP LA PAMPA

LAR LA RIOJA

MNE MISIONES

NEU NEUQUEN

RIN RIO NEGRO

SAL SALTA

SCZ SANTA CRUZ

SDE SANTIAGO DEL ESTERO

SFE SANTA FE

TDF TIERRA DEL FUEGO

TUC TUCUMAN

UIS SAN LUIS

Used by permission from the Canadian

Food Inspection Agency.

[]{#__RefHeading___Toc111609754 .anchor}**Executive Summary**

Argentina has officially requested the United States Department of
Agriculture (USDA)/Animal Health and Plant Inspection Service (APHIS) to
conduct an evaluation to recognize the Patagonia region of Argentina
south of the 42° Parallel (Patagonia South) as Free from Foot-and-mouth
Disease (FMD). The last outbreak in Patagonia South occurred in October
1976. No new outbreaks have been reported since then. Due to the
historic lack of FMD occurrence in Patagonia South, APHIS has decided to
conduct a qualitative risk assessment to determine the FMD status of
Argentina south of the 42° Parallel.

Argentina's Servicio Nacional de Sanidad y Calidad Agroalimentaria
(SENASA) has submitted information to support the request for
recognition of FMD freedom. APHIS has evaluated the submission and has
conducted a site visit to Argentina in December 2003 in order to
substantiate the information reported in the documentation and add any
new data. The site visit focused on the veterinary and legal
infrastructure of SENASA, border control procedures, laboratory and
diagnostic capabilities, biosecurity procedures on sheep farms and in
slaughter facilities, animal health recordkeeping systems, movement
controls, and disease surveillance systems. The final analysis was based
upon information obtained from the site visit, the information submitted
in writing from Argentina and from published reports.

This document describes the animal health system in Patagonia South and
the adjacent surveillance and buffer zones of Patagonia North B and
North A, respectively. It identifies potential areas of risk, and
discusses how this risk is mitigated. The following factors were
considered of relevant importance in determining the FMD status of
Patagonia South:

No new FMD outbreaks have occurred in Patagonia South since October
1976.

Surveillance programs in sheep and goat herds have not detected the
presence of the FMD virus in the region under consideration. Neither was
there evidence of viral activity in the cattle, sheep or goats in the
surveillance zone, Patagonia North B, during or since the outbreaks in
the rest of the country in 2001 and 2002.

No vaccination is carried out in Patagonia South, so any cattle or swine
in that region exposed to the FMD virus would act as good sentinels of
an outbreak.

APHIS considers the legal framework, animal health infrastructure,
movement and border controls, diagnostic capabilities, surveillance
programs and emergency response systems to be adequate to detect and
control FMD outbreaks within the national boundaries of the region of
consideration in Argentina, Patagonia South.

Although consequences of an FMD outbreak are severe, the likelihood of
an outbreak occurring via exposure of the domestic livestock population
to ovine meat or products imported from the Patagonia South region of
Argentina is low.

[]{#__RefHeading___Toc111609755 .anchor}**Background**

Argentina has officially requested that USDA/APHIS conduct an evaluation
to recognize the Patagonia region of Argentina south of the 42° Parallel
(Patagonia South) as Free from Foot-and-mouth Disease. The last outbreak
in Patagonia South occurred in October 1976. No new outbreaks have been
reported since then. This is the first evaluation of the Patagonia South
region in Argentina by the United States for FMD freedom.

Documentation was submitted by animal health officials of SENASA to
support their request for FMD freedom. A site visit was also conducted
in December 2003 to verify and complement the information submitted by
Argentina. It focused on the legal framework and veterinary
infrastructure, border and movement controls, agricultural practices,
laboratory diagnostics and surveillance programs related to the animal
health program in Argentina.

[]{#__RefHeading___Toc111365950 .anchor}Figure 2: Map of the
epidemiological zones of Patagonia

[]{#__RefHeading___Toc111609756 .anchor}**Objectives**

This is an analysis of the risk of introducing FMD into the United
States in FMD-susceptible species and related unprocessed products from
Argentina, south of the 42° Parallel. The risk analysis is intended as a
decision-making tool for APHIS Managers that will allow development of
appropriate regulatory conditions with mitigations to address potential
risks of disease introduction following any initiation of trade. It also
constitutes an information source for APHIS stakeholders, providing
justification for the conditions in the rule. The assessment focuses on
the FMD status and control measures applicable to the Patagonia region
of Argentina, south of the 42° Parallel.

*Supporting data*

The analysis is based on documentation provided by the Servicio Nacional
de Sanidad y Calidad Agroalimentaria (SENASA) \[1-8\], observations made
by a joint Canadian Food Inspection Agency/APHIS site visit team
\[9-11\], and published information \[12-53\]. SENASA, the full title of
which translates into English as the National Health and Agrifood
Quality Service, is the government agency in Argentina responsible for
animal health activities.

[]{#__RefHeading___Toc111609757 .anchor}**Hazard identification**

The Animal and Plant Health Inspection Service (APHIS) has identified
several World Organization for Animal Health (OIE) listed diseases
\[13\] as the primary hazards associated with initiating trade in
animals and animal products from foreign regions. Listed foreign animal
diseases of primary concern are addressed specifically in APHIS
regulations (9 CFR Part 94). One of these diseases that are recognized
in APHIS regulations as such a hazard is Foot-and-mouth Disease. \[54\]
In this regard, before opening trade in FMD-susceptible species and
related products with a region or country that APHIS has not previously
evaluated for FMD status, APHIS is obligated to conduct an import risk
assessment to support rulemaking (9 CFR 92.2). \[55\]

The hazard identified is the Foot-and-mouth Disease virus.
Epidemiological characteristics of the disease agent relevant to the
import risk it may pose are described in Appendix 1.

[]{#__RefHeading___Toc111609758 .anchor}**Risk analysis**

This analysis is composed of four components, the release assessment,
the exposure assessment, the consequence assessment, and the risk
estimation. These components are defined in OIE guidelines and represent
the international recommended components for animal health import risk
analysis.

[]{#__RefHeading___Toc111609759 .anchor}**Release assessment**

For the purpose of this report, release assessment refers to the
evaluation of the likelihood that FMD exists in the Patagonia region of
Argentina south of the 42° Parallel and, if so, how likely would the
disease be introduced into the United States through imports of
FMD-susceptible animals or their products from Argentina. The report
includes an in-depth evaluation of the 11 factors \[55\] identified by
APHIS in *Title 9, Code of Federal Regulations*, Part 92.2 (9CFR 92.2)
as information to consider in assessing risk levels of free regions.
Those factors are the following:

1.  The authority, organization, and infrastructure of the veterinary
    services organization in the region,

2.  Disease status-i.e., is the restricted disease agent known to exist
    in the region?

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

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

5.  The vaccination status of the region,

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

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

8.  Livestock demographics and marketing practices in the region,

9.  The type and extent of disease surveillance in the region,

10. Diagnostic laboratory capacity,

11. 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.

[]{#__RefHeading___Toc111609760 .anchor}**Eleven factor analysis**

Livestock systems in Patagonia South are mainly extensive (animals are
grass-fed and range over vast areas of land with a minimum of labor or
expense). The climate and the environment of Patagonia South are major
factors which make the sheep industry the most prevailing livestock
activity. This area contains almost 60% of the entire sheep population
of Argentina. There were over 7 million sheep in 2003 and more than 72%
of Argentina's best wool was produced in this region. Livestock density
is less than one animal per hectare. Total sheep exports from the
Patagonia South region surpassed 90% of the total of sheep exports from
all of Argentina. Currently, Argentina is exporting 10,000 tons/year of
sheep meat to the European Union (EU). Sheep production is highest in
the province of Chubut, followed by Santa Cruz and then Tierra del
Fuego. \[1, 2\]

[]{#__RefHeading___Toc111609761 .anchor}**1. The authority,
organization, and infrastructure of the veterinary services organization
in the region**

*Central authority*

All regulations related to the control of FMD are based on the General
Animal Health Enforcement Law (Law No. 3959/1903). This law, along with
its accompanying regulations of 1906, grants authority to the Government
to restrict and regulate individual 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
resolutions. National Law No. 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 No. 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 Nos. 478/99, 779/99, 192/2001, 370/2001, 383/2001,
510/2001, and 37/2002 and SAGPyA Resolution No. 378/99 establish
measures in controlling FMD outbreaks including sanitary steps with
susceptible, ill and in-contact animals in the region of the outbreaks,
notification and operative procedures if FMD is detected on a farm,
prevention of spread of the disease, and implementation of the National
Sanitary Emergency System. There are also a large number of resolutions
that 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 Nos. 495/2001 and
115/2002 establish requirements for shipping FMD-susceptible livestock
to slaughter to the EU or from farms approved to export to the EU or
markets with equivalent requirements. \[1-3\]

SENASA is divided into several sections, four of which focus on animal
health issues: (1) the National Animal Health Office (DNSA), (2) the
National Agrifood Inspection Office (DNFA), (3) the Quarantine, Borders
and Certification Unit (CCFyC), and (4) the Laboratories and Technical
Control Office (DILACOT). These reflect organizational changes made in
2001 and 2002 \[1, 2, 11\] to address issues and problems identified
during the FMD outbreak in 2001.

Prior to this reorganization SENASA personnel in each province reported
to one of three regional directors, each of which administered huge
regions. Resources were not allocated to address the regional workload.
Specifically, regions with high levels of activity 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.

SENASA's reorganization was focused in three major areas: \[11\]

(1) Structure

(2) Financial resources

(3) Human resources

*Structure:*

The reorganization was defined by Decree 394/2001. \[2\] In the new
structure of SENASA, not only are the units no longer based on political
borders, but also the chain of command has been changed to address
issues that arose during the FMD outbreaks. The reorganization 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,
SENASA failed to report the FMD outbreak of 2000 for several months
after it had been detected. \[14\]

Issues addressed also included centralization of command and control of
the animal health programs. Apparently, 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, they had trouble
focusing on animal health. Regarding the transparency issue, many of the
reorganization elements addressed issues of internal monitoring,
accountability, and compliance with national policies. The
reorganization also addressed international standards, certification
requirements, and an increased emphasis on border controls. \[11\]

In the reorganization, boundaries of regional units were redefined in
order to assign personnel to them appropriate to the level of activity
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 more evenly. \[11\] Regions 21 and
22 on the map below make up Patagonia North A and B. Regions 23 and 24
make up Patagonia South. This is an evaluation of the FMD status of
Patagonia South.

[]{#__RefHeading___Toc111365951 .anchor}Figure 3. Map of SENASA Regional
and Local Units

![](media/image5.png){width="4.098611111111111in" height="7.0in"}

In addition, the reorganization involved the creation of several new
units, including ones with a primary focus on compliance and one focused
on auditing. In June 2003, the compliance unit contained 20 people. It
was designed to operate outside of SENASA rules, giving it an element of
independence.

In Animal Health, there are four main offices that report directly to
the President of SENASA. These offices are as follows: \[1\]

-   National Animal Health Office (DNSA)

-   National Agrifood Inspection Office (DNFA)

-   Quarantine, Borders and Certifications Unit (CCFyC)

-   Laboratories and Technical Control Office (DILACOT)

The DNSA organization and structure is defined in SENASA Resolution No.
274/2002. \[2\] The DNSA is specifically responsible for animal health
control and eradication programs, including the necessary preventive,
control and eradication actions to ensure compliance with current
statutes. The actions of this office are carried out by the 316 local
offices located throughout the country and supervised by 25 regional
supervisors. The local offices are staffed by 237 veterinary medical
personnel, 436 animal technicians, and 181 administrative employees. 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, and surveillance and assessment of the
vaccination programs. \[1\]

The General Field Coordination Unit, which reports to the DNSA,
implements its responsibilities through the local offices and regional
supervisors mentioned in the previous paragraph. Its duties include:
\[2\]

-   Coordination and management of the prevention, control and
    eradication actions of animal disease control programs.

-   Control of compliance of sanitary actions and enforcing the Law of
    Sanitary Police and pertinent regulations.

-   Supervision of livestock movement, premises approval and
    certification.

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.

-   Updating producers' document registries, establishments, livestock
    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 jurisdiction and epidemiological surveillance actions.

-   Supervision of compliance of legal regulations in force

-   Organization and operation of local offices.

-   Assessment of the field staff performance.

-   Official representation of SENASA in their zone.

The DNFA is 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 Inspection Service performs these controls at
slaughtering plants approved for export. \[1\] The staff is comprised of
345 veterinary inspectors and 905 support staff. \[2\]

The CCFyC oversees the Animal and Plant Quarantine Unit, the
International Movements Unit and the Borders and Sanitary Barriers Unit.
The Borders and Sanitary Barriers Unit operates the control posts at the
inland sanitary barriers and border crossings (fluvial and marine ports,
airports and border crossings). \[1\]

The DILACOT has two units -- the Laboratory for Animal Products and
Byproducts and the Laboratory for Plant Products and Byproducts. This
office operates the National 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.
The functions of the DILACOT are as follows: \[1\]

-   Establish the methods and test protocols that are used at the
    Central Laboratory and the laboratories that participate in the
    national network of laboratories.

-   Intervene in dispute resolution

-   Confirm positive test results issued by the laboratories involved 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.

-   Participate in reviewing regulations in its field of action and
    attend international meetings (e.g. Codex Alimentarius, MERCOSUR,
    OIE).

Additional support for the animal health system comes from a
participatory structure based on 349 local animal health offices that
were created in 1989 for the FMD Eradication Program, 10 of which are
located in the Patagonia region. These local offices represent various
local organizations and have 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 NESS in accordance with the responsibilities
and functions spelled out in the legal regulations in force. They work
at the local, provincial and national levels and comply with established
methodologies, procedures and operations. \[2\]

At the regional level, 23 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
strategies to carry out the zoosanitary policies defined by SENASA.
\[1\]

[]{#__RefHeading___Toc111365952 .anchor}Figure 4. Functional
Organization Chart of SENASA

![](media/image6.wmf){width="6.251388888888889in"
height="4.589583333333334in"}

*Financial resources:*

SENASA reported that its 2003 budget was 117 million pesos \[11\]
(approximately \$39 million US dollars). SENASA officials described the
system as self-sufficient because user fees are required for almost
every service SENASA provides, including slaughter surveillance,
issuances of certificates, and laboratory tests.

*Human resources*:

In June 2003, SENASA reported a total of 3479 employees, including
personnel who deal with plant issues. Of these 2558 are permanent staff
members, of which 572 are veterinarians. Rules are in place for
employees to address conflict of interest issues. For example, plant and
field inspectors are not allowed to own or sell beef.

SENASA can expand its staff, when necessary, by hiring contract
personnel, including veterinarians and animal health technicians. These
are individuals who are employed on the basis of a standardized profile
defined by SENASA for 4-month increments of time, and contracts are
renewable. Permanent and contract veterinarians have the same authority.

In 2003, SENASA reported a complement of 921 contractors, of which 219
were contract veterinarians. This staff was expanded significantly
during the time of the FMD outbreaks. Four thousand additional people
were employed by SENASA during this period. \[11\]

SENASA can also broaden the scope of its activities through agreements
with outside parties. For example, it has entered agreements with some
academic institutions to cooperate in activities 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 all along the border by land or water. Border police also
assist SENASA with enforcement of quarantines. They played a significant
role in security during the FMD outbreak. Security forces that work at
slaughter facilities also assist in the disease control program. \[11\]
SENASA can call upon many border police and other security forces to
help prevent entry of disease into Argentina.

The number of animal health officials and affiliates in the South
Patagonia region is listed below:

[]{#__RefHeading___Toc103570779 .anchor}Table 1. Animal Health Personnel
in the Patagonia South Region

  ---------------- -------------- -------------- -------------- --------------
                   Chubut         Santa Cruz     Tierra del     TOTAL
                                                 Fuego          

  SENASA local     6              3              2              11
  offices                                                       

  Commissions      26             4              \-             30

  SENASA           7              3              2              12
  veterinarians                                                 

  SENASA           12             6              2              20
  technicians                                                   

  SENASA           3              2              2              7
  administrative                                                
  personnel                                                     

  Provincial       6              11             2              19
  veterinarians                                                 

  Private          145            31             26             202
  veterinarians                                                 
  ---------------- -------------- -------------- -------------- --------------

The DNFA in the Patagonia South region is comprised of 20 veterinary
inspectors and 32 support staff. \[2\]

*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. They are
registered at the National or Provincial Professional Association of
Veterinary Physicians in the jurisdiction of employment; the respective
association issues the license. National and provincial licensure is
mandatory. \[2\]

The National Private Veterinary Physician Registry, created by SENASA
Resolution No. 470/95, registers private veterinarians who take part in
the NESS, notifying the local DNSA commission of any diseases that have
similar clinical signs to FMD. SENASA Resolutions Nos. 234/96 and 422/03
incorporate Veterinary Physician Professional Associations and Councils
into the NESS by use of the private registered veterinarians in their
corresponding jurisdictions to monitor and report suspect diseases.
Registration must be renewed annually and veterinary licensure must be
kept up-to-date. SENASA issues 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 comply with a continuous training program which includes procedures
and standards that are currently in force to control reportable
diseases. \[2\]

In 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 compliance with the scheduled training goals. This
resolution is in the implementation stage.

Private veterinarians also perform pre-inspection examinations on
bovines intended for export to the European Union. 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 SENASA veterinarian.

Official SENASA veterinarians 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 return to the health status of FMD-free with
vaccination in the region north of the 42° Parallel and to promote
measures to strengthen the national and continental structure of FMD
epidemiological surveillance. 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 agents is part of a central theme in the
development of national animal health programs. Training programs for
all the staff levels are developed within the Bureau of Human Resources
and Training of SENASA. Staff is responsible for the supervision of each
one of the activities of the Plan and their adequate performance is
vital to meet the established goals. The content of training courses
meets the technical guidelines established by the FMD National
Eradication Plan and the specific bibliography of the OIE/WHO/FAO.
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 health diseases
besides FMD. All programs are conducted by experts and teachers from
SENASA and other institutions through agreements with national
universities, research institutes such as INTA (National Institute for
Agricultural Technology) and others (FAO, etc.). A list of training
activities for SENASA staff from 2001 -- 2003 is listed in the November
2004 submission. \[2\]

Training for staff in the DNFA includes the following subjects:
legislation in force (Decree No. 4238/68 and others), approval of
establishments producing products intended for domestic consumption and
export, HACCP, GMP, SSOP (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. \[1\]

Provincial veterinarians are part of the organizations that are involved
in the campaign against FMD and 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 No. 445/95
-- Regional Patagonia Plan). \[2\]

*Field offices and premises identification*

SENASA has 25 regional offices representing 24 numbered regions and a
twenty-fifth region (City of Buenos Aires) that is not numbered.
Regional supervisors provide oversight for field offices. Field offices
deal with local prevention and control measures, eradication,
compliance, emergency actions, health actions (e.g., vaccination) and
premises identification and movement controls and record-keeping. Many
of these responsibilities are controlled through the registration of and
assignment of a unique premises identification number (called a RENSPA
number), which, in addition to other information on premises, is
maintained in a national database. The team that visited Argentina in
December 2003 visited regional and/or field offices in Viedma, Carmen de
Patagones, and Choele Choel in Patagonia North A and in Río Grande and
Río Gallegos in Patagonia South.

SENASA requires that all premises with agricultural animal production
register with SENASA and obtain a RENSPA (Registro Nacional Sanitario de
Productores Agropecuarios - National Sanitary Registry of Ag-producers)
number. This is an alphanumeric identifier that encodes information
about individual premises. The structure of the RENSPA number is such
that it identifies the province, the municipality, the premises, and
various aspects characterizing a particular premises, such as ownership,
rental status, or shared occupancy. For example, if an individual owns
more than one premises or if there are multiple producers using a single
premises, the number code identifies this. Also, the 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. \[1, 11\]

+-------------+-----------+----------+----------------+--------------+
| XX          | XXX       | X        | XXXXX          | XX           |
+-------------+-----------+----------+----------------+--------------+
| Province    | District  | Internal | Unique Farm \# | Possession   |
|             |           | Control  | (unique in     | Type Owner   |
|             |           | \#       | province)      | (00)         |
|             |           |          |                |              |
|             |           |          |                | Renter (01)  |
|             |           |          |                |              |
|             |           |          |                | Etc.         |
+-------------+-----------+----------+----------------+--------------+

The name of a responsible 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 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 veterinarian, the owner, or both depending on who fails to
notify SENASA.

In association with the RENSPA number, census information on all species
on the premises, permit information showing animal movements, as well as
other data are included in the database maintained by field officials.
The database also records the FMD test status of the premises, as
defined by the national surveillance program. Monthly statistical
reports are generated from this database.

Compliance with the requirement to register premises is controlled by at
least three mechanisms, and SENASA considers compliance with this
requirement to be good for these reasons. \[10, 11\]

First, all premises with bovines must vaccinate for FMD. The vaccines
are administered by personnel authorized, controlled, and audited by
SENASA, which are contracted by the FMD foundations. In these areas, the
premises must be registered in order for the cattle to be vaccinated.
The official vaccinator counts the animals and updates the census.
SENASA veterinarians visit premises for other purposes also. The
veterinarian is expected to update a census of all animal species on the
premises during his visit and report the information to the field
office. Since FMD vaccines are administered twice yearly, census
information on premises containing cattle can be updated twice yearly.
If premises do not have cattle or are located in the non-vaccination
zone, census information comes from a private veterinarian or through
other official herd health practices.

Administration of FMD vaccines to any susceptible species does not occur
in Patagonia South or Patagonia North B. Patagonia produces mainly sheep
wool; therefore, epidemiological surveillance is carried out while
performing wool industry-related tasks such as shearing, branding,
pre-birth exams, and other husbandry activities. Also, other inspections
related to FMD health verification such as serological sampling,
dispatch of livestock, etc. and ectoparasite control are carried out
throughout the year.

In Patagonia South, epidemiological surveillance is carried out jointly
with endemic disease control programs against scabies and melofagosis.
Resolution No. 445/94 "Patagonia Plan for the Control and Eradication of
Scabies and other Endemic Diseases" is in force and lays down an
executive structure (commissions, organizations, foundations, etc.) for
sanitary projects. Due to its self-management and financing
characteristics, the animal health work is adequately and more easily
carried out. With these different animal health programs in place, a
wide coverage of official inspections in sheep establishments over
several years has been carried out with an annual average of more than
2,000 inspected establishments and over 1,500,000 sheep examined in the
Province of Chubut alone. \[2\]

Second, premises must be registered in order to obtain a permit to move
animals for commerce. The RENSPA number must appear on the permit. The
Animal Transport Document (DTA) is required for all animal movements and
must accompany the shipment. \[1\] Owners must apply for a permit within
30 days of movement for either beef or lamb and pay user fees associated
with the movement.

Third, SENASA considers it likely that neighbors of unregistered
premises with animal health problems will report the unregistered
premises to the authorities.

The local office in Río Grande is one of 2 local offices in Tierra del
Fuego. The office mainly deals with animal movement control and
recordkeeping and inspections at the local airport. The emergency
response system was tested when an outbreak of sheep scabies occurred on
Tierra del Fuego in 1998. The disease was quickly contained and
eradicated. When a suspect animal is reported to SENASA, an investigator
must be sent out in 12 hours or less to investigate the case. A
notification document is sent to Buenos Aires and the regional
supervisor is informed only after the SENASA official confirms the
suspect case after examination. \[10\]

The Río Grande Farmers' Association is a local non-governmental
organization (NGO) that works with the provincial health commissions on
matters of agricultural importance. It has no legal power, but is an
industry group that works with the government on sanitary policy and
supports the objectives of the agriculture industry.

The local office in Río Gallegos is one of 3 local offices in Santa Cruz
province. The office basically has the same duties as the Río Grande
local office plus has some staff that inspects baggage on the
Argentina/Chile border at the Monte Aymond border post. Records of all
farms showing ownership, number and types of animals, farm name and
location, animal movements and RENSPA number are stored on a computer
database. This database was demonstrated to the site visit team by one
of the SENASA staff members. The software has the ability to search for
data by any of the previously mentioned parameters. When shipping
farm-to-farm, after animals are moved to the point of destination, the
DTA must be turned in to the local SENASA office in the destination
department within 15 days. That office notifies the local SENASA office
of origin that the shipment has arrived. If the circle is not closed, no
more DTAs for that RENSPA number can be issued.

The regional office of Viedma is located in Carmen de Patagones. The
region has 11 local offices and 17 delegations (sub-local offices).
There are 7 veterinarians working within this office. The local office
of Carmen de Patagones is in the same building. This office manages all
the data of the farms electronically and issues RENSPA numbers.

The local office in Choele Choel is under the jurisdiction of the
Patagones Regional Office. It covers the border area between Patagonia
North A and Patagonia North B along the Río Negro River. There are
cattle owners on both sides of the river and some vaccination occurs
south of the river along a water canal. The most common type of farm is
10-50 hectares and grows crops such as fruit, potatoes, and onions using
irrigation.

FUNBAPA (Fundacion Barrera Patagonica -- Patagonian Barrier Foundation)
is a contract foundation that coordinates with SENASA to guarantee the
health and quality of agriculture products in Patagonia. The Foundation
was set up by a SENASA resolution, but no money comes from the SENASA
budget. The annual budget is about \$3 million U.S. dollars, and the
money is acquired through the collection of fees (50% from spraying fees
and 50% from producers moving products). Contributions mainly come from
fruits and vegetables, about \$1 per ton of fruit or product that is
exported out of the region.

SENASA sets the health regulations and FUNBAPA enforces them. The Chair
of FUNBAPA is the President of SENASA. The advisory board consists of 11
members: 3 cattle/sheep farmers, 3 vegetable/fruit producers, 1 SENASA
official, and 4 from the provincial governments. Technical and
administrative audits are done for each of the programs by the SENASA
national office or the SENASA local supervisors. Budget audits occur
every year, and technical audits can occur every 6 months, depending on
the program. Some past findings have been inadequate roads or lack of
equipment, which are now being addressed.

Money and personnel are managed by FUNBAPA, rather than by the
government. This allows for more efficient decision-making concerning
budgetary matters and for better personnel management and movement (e.g.
people that work well are promoted, while those that don't can be
released more easily than if employed by the government). Potential
employees for FUNBAPA must fill out an application and be interviewed.
If they are hired, they will be trained in various technical duties
including recognition of FMD clinical signs, self-defense techniques,
use of fire extinguishers and application of first aid. The probationary
period is 6 months. Employees receive training once a year in a
refresher course that covers any new rules or regulations.

FUNBAPA is involved in a number of programs, most of which deal with
fruits and vegetables. One such program is the Programa Barrera
Zoofitosanitaria Patagonica (Patagonian Zoophytosanitary Barrier
Program). Since 1993, FUNBAPA has been in charge of the Río Colorado (14
posts) and Río Negro (4 posts) barrier areas. In 2001, it took over 4
posts from SENASA and the provincial government in the Río Negro
province on the border that separates the areas of vaccination from the
areas with no vaccination. Then, in 2003, it took over the 3 posts along
the 42^nd^ Parallel. Seven airports are also covered by FUNBAPA. There
are a total of 177 FUNBAPA employees, and the organization feels it is
adequately staffed. \[10\]

*Movement controls within Argentina*

A movement permit (DTA) is required when animals go to slaughter, go to
market in Patagonia, cross provincial lines or are exported
internationally and generally if an animal is moved from one farm to
another. These permits are required in order to establish that the farm
of origin is registered so that tracing can be conducted quickly. They
record the identification numbers of both the premises of origin and the
premises of destination. If a registered farm attempts to ship more
animals than the census would predict and the discrepancy is noted when
the permit application is being processed, then the shipment does not
get a movement permit. The number and species of animal is recorded on
the permit and then are subtracted from the RENSPA stock recorded for a
particular farm.

Movements to slaughter within each sanitary region (intraregion) are
carried out under the conditions established by SENASA Resolution No.
178/01. This resolution requires that these animals be accompanied by a
DTA and the pertinent livestock Guia, 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 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. \[1, 2\]

Movement of FMD-susceptible animals is limited in Patagonia South. The
local SENASA office issues a DTA to keep track of all animal movements
off a farm. Another movement permit, a provincial transit certificate
(Guia), is issued by the Provincial Authority to validate ownership and
identification of the animals. A SENASA official must inspect these
animals on the farm of origin before movement and must verify official
documents. When animals are shipped from farm-to-farm, the DTA must be
returned within 15 days to the local office of destination and that
office will contact the local office of origin of the shipment arrival.
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 inspection at the slaughter facility.
\[10\]

All vehicles carrying commercial shipments must also be registered with
and approved by SENASA and issued a number. Former SENASA Resolution No.
809/81 establishes the mandatory washing and disinfection of all
livestock vehicles, empty or with animals, that transport livestock
within the country. Typically, the number issued by SENASA is painted on
the trucks, and the driver must show proof of the authenticity and
validity of that number. 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. 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 where vaccination is not practiced. These points are approved by
SENASA and are located at certain risk borders. \[1, 2\]

Transport washers must be approved by SENASA. They are required to use
products specific for veterinary use and approved by SENASA. The washing
and disinfection tasks are performed by official staff or staff hired by
SENASA using motor-propulsion machinery or sprinkler equipment and
products approved for vehicular disinfection. \[2\]

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 or B).
There are automatic sprayers at all commercial entry points and handheld
sprayers at others. Apparently, there is no charge for the DTA either.
The Province charges for the Guia which includes a fee that is then used
for agricultural projects in the Province (e.g. herd improvement) and
funding for the Guia issuing offices. There is also a fee per kilo of
wool shipped that is collected by the Province and used the same way. It
is really 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 Province, except for the vaccination
program where the farmers must pay for the FMD vaccine and the
Brucellosis vaccine. \[10\]

*Swill feeding*

SENASA Resolution No. 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 does authorize
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 on condition of compliance of the following
requirements:

-   The swill is subjected to a cooking process guaranteeing destruction
    of pathogenic organisms.

-   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.

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. \[2\]

Compliance is monitored using regulations that deal with other
sanitary/hygiene issues. SENASA Resolution No. 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 No. 225/95. Also, work is presently being done on
a regulation combined with 350/98 to regulate pig activity and widen the
scope of the current regulations with the purpose of more effectively
controlling trichinellosis infestations. As a consequence, there will be
safeguards that spill over to grant additional sanitary protections
against FMD contamination of feed. \[2\]

*Conclusions*

Argentina has the veterinary and regulatory infrastructure to adequately
monitor and control any incursion of FMD into the country. There is
sufficient monitoring of animal premises and movements to permit
effective surveillance and detection programs that would result in
sufficient administration of eradication efforts, if needed.

APHIS recognizes that there were substantial delays (approximately 9
months) in reporting of the FMD outbreaks in Argentina in 2000/2001 that
raised questions in the international arena regarding SENASA\'s
transparency with regard to disease reports. However, the observations
made by APHIS during its 2004 visit to Patagonia and a 2005 site visit
to the region north of the 42° Parallel revealed that many changes had
been made in the veterinary infrastructure since that time. APHIS
expressed confidence, based on its questions to and interactions with
SENASA personnel, that reporting would not be delayed if an analogous
event were to occur today.

[]{#__RefHeading___Toc111609762 .anchor}**2. Disease status-i.e., is the
restricted disease agent known to exist in the region?**

The Patagonia South region of Argentina has not recorded an outbreak of
FMD since October 1976. This outbreak occurred in Chubut Province. The
disease had originated from one lot of animals that had come from north
of the 42° Parallel; the virus was type A. When the suspicion of FMD
became known, SENASA implemented legal quarantine procedures, closure of
streets and neighboring roads, installation of control and disinfection
posts, epidemiological tracing and staff reinforcement. Animal movement
restrictions and ring vaccination were carried out to stop the spread of
the disease. The species vaccinated included 4789 bovine, 8881 sheep,
and 391 pigs. This was the only case when a stamping-out policy was not
applied. \[1, 2\]

The last recorded outbreak in Santa Cruz Province occurred in Río
Gallegos in 1971 (type O1). Pigs were exposed to the FMD virus by
consuming infected beef with bone from the Province of Buenos Aires.
Bovine, sheep and pigs were affected. A suspicious disease outbreak was
reported to the authorities in Río Gallegos in some bovine animals on a
small dairy farm near the city. The farm had 15 cattle and some pigs.
The Local Commission began emergency response procedures which resulted
in restricted movement of susceptible animals in the farm area,
epidemiological tracing, installation of vehicle disinfection units,
staff reinforcements and the on-site presence of the Chief of the FMD
program. As a result of the epidemiological tracing, affected pigs in
the farms located near the primary outbreak were detected. More
preventative measures were taken including banning movement of
susceptible animals, skins and products and by-products of animal origin
and depopulation of farms in the area with susceptible species by
stamping out. The carcasses were later buried in a pit that was built on
the premises of the primary outbreak. In total, 2300 sheep, 48 cattle,
618 pigs, and 5 goats were slaughtered. \[2, 10\]

The last recorded outbreak in Tierra del Fuego occurred in December 1966
(type C). It was controlled using stamping out procedures and burial of
the carcasses in early 1967. From the clinical and laboratory test
results and epidemiological research, it was concluded that there was
only one outbreak in cattle in only one establishment near Río Grande.
Later studies showed that this virus was a new subtype C4 and was
serologically related to isolated samples in Uruguay. The Police, the
Navy and the YPF (Fiscal Oilfields) were all instrumental in preventing
the spread of the outbreak. At first, 611 animals were slaughtered and
then all pigs in a radius of 15 km of the outbreak were slaughtered.
Animals were shot and buried. There were no secondary outbreaks. \[1,
2\]

During 2002, SENASA received 3 reports of suspect FMD cases in the
Patagonia North A and B regions. FMD was ruled out in all cases. No such
cases were reported in Patagonia South. \[6\]

The first case occurred in the Department of Pichi Mahuida, Province of
Río Negro (Patagonia North A). Adult bovines had shown traumatic lesions
in the tongue. No lesions were found in calves. The lesions were
diagnosed as injuries caused by feeding on Pampas and salted grasses.
This case was registered as a "notification."

The second case took place in the Department of Bariloche, also in Río
Negro (Patagonia North B). Two dead sheep were found at an establishment
but with no clinical signs in the rest of the herd. A diagnosis of Maedi
Visna/ Adenomatosis was made after necropsy. The animals came from other
establishments with a history of the disease. This case was also
registered as a "notification."

The third case occurred in the Department of Patagones, Province of
Buenos Aires (Patagonia North A). In this case, it was necessary to
collect samples to confirm or rule out a vesicular disease since a
diagnosis could not be determined by clinical signs alone. This case was
registered as a "suspicion of vesicular disease." The original report
was filed by a private veterinarian that found oral lesions compatible
with FMD in 14 bovines, from a total of 217, during an inspection of a
herd before transporting to a livestock auction. The animals did not
show any other systemic signs. From that moment, the premises was placed
under legal quarantine. The official veterinarian in charge collected
epithelium and serum samples from the lot of affected cattle. Serology
tests were done using ELISA 3ABC and EITB. All samples were negative.
The epithelium samples were used to run virus isolation tests in BHK
cell culture and suckling mice. These samples were also used for ELISA
typing and PCR. All tests were negative. The diagnosis of FMD was ruled
out with the results of the laboratory tests and follow-up of the
diseases in the field. Infectious bovine rhinotracheitis (IBR) was
diagnosed later by serology.

No reports of suspect vesicular diseases were made in 2003 or 2004 in
the Patagonia regions.

Sheep are the predominant livestock in Patagonia South. Almost 60% of
the sheep in Argentina reside in Patagonia. The livestock density is
less than 1 animal per hectare. Due to the extensive husbandry practices
and low animal density, contact between sheep and other species is
negligible and between other sheep is low. Although every animal is not
closely monitored due to husbandry practices, the low animal density,
low number of animal movements off the farm, and the restrictive import
policies into Patagonia reduce the risk of introduction of the FMD virus
into the area and rapid spread of the disease before detection. In all
cases of FMD outbreaks in Patagonia South the international community
and trading partners of Argentina were immediately notified of the
outbreaks after detection. \[1, 2\]

No vaccination is carried out in Patagonia South, so any cattle or swine
in that region exposed to the FMD virus would act as good sentinels of
an outbreak.

Federal, provincial and municipal authorities, veterinarians in private
practice and citizens must report any signs of disease, the existence of
suspect cases of this disease, or the positive test results for this
disease to the local animal health authorities or to the National Animal
Health Office of SENASA (Law No. 3959/1903, Law No. 24.305/93, Decree
No. 643/96). \[1, 5, 6\] There will be no indemnification for destroyed
animals if the disease is not reported and the one who fails to report
the disease as stated above will be fined.

*Conclusions*

The last FMD outbreak in the Patagonia South region of Argentina
occurred in 1976. There is no evidence that there are any species
infected with the FMD virus in Patagonia South.

[]{#__RefHeading___Toc111609763 .anchor}**3. The status of adjacent
regions with respect to the agent**

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 is considered by APHIS, Veterinary Services, to be FMD-free.
\[56\]

Argentina recognizes FMD status for surrounding countries as classified
by OIE. Chile is recognized as FMD-free without vaccination. Uruguay and
Paraguay are considered FMD-free countries with vaccination. The states
of Río Grande do Sul and Santa Catarina in Brazil, bordering Argentina,
are recognized as FMD-free regions with vaccination. Bolivia is not
considered FMD-free. \[2, 4\]

Information on the epidemiological situation of the countries in the
region around Argentina is acquired through data systematically and
periodically submitted by the Pan American Foot-and-Mouth Disease Center
(PANAFTOSA), 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 FMD Eradication
(PHEFA). This program comprises of border work sub-projects,
reimplementation of vaccination against FMD, epidemiological
surveillance actions and improvement of the Continental System of
Information. 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 Surveillance Systems. \[2\]

The Hemispheric Plan for FMD Control and Eradication is coordinated by
PANAFTOSA. As a subprogram of the Hemispheric Plan, the Cuenca del Plata
Agreement for the Eradication of FMD coordinates common strategy between
Argentina, Brazil and Uruguay in the fight against FMD. The initial
agreement was 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 country. 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 includes five veterinarians
from each country and two permanent consultants, the Coordinator 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.

Argentina provides technical assistance to Bolivia by transferring
technology and aiding in technical matters in the fight against FMD. The
Bureau of Laboratories of SENASA has trained agents from Bolivia on
performance and standardization of FMD diagnostic serological tests
(VIAA and EITB).

Argentina has a bilateral agreement with Paraguay to make a joint effort
to establish an FMD vaccination, prevention and epidemiological
surveillance program in the border area between the two countries. The
aim of the program is to mitigate the risk of an FMD occurrence in the
area. Recently, SENASA signed a letter of intent with SENASCSA (Paraguay
sanitary service) and the White Helmet commission to "agree on a
participation and cooperation mechanism" of the latter on both sides of
the border, within the framework of the Regional Program for the
Eradication of FMD, and supported by the South Farming Council. The
White Helmets, a United Nations-sponsored group that deals with
emergency situations related to public health throughout the world, has
played a role in enhancing communications in the region.

Patagonia North B is a surveillance area which Argentina recognizes as
free of FMD where vaccination is not practiced. The last FMD outbreak in
this region occurred in 1994. There were six outbreaks in the region. A
stamping out policy was applied with a total of 565 cattle, 8286 sheep,
296 pigs, one goat and one camelid slaughtered (ill and contacts). \[1,
2\]

Patagonia North A is a buffer zone separated from Patagonia North B by
the Negro River and from the rest of Argentina by the Colorado River.
Vaccination is practiced in Patagonia North A. The last FMD outbreaks
occurred in 2001 with seven outbreaks reported. All the outbreaks were
confirmed to be caused by a Type A virus. The source was most likely
from the central zone where the epidemic developed. Five outbreaks were
registered in the Department of Patagones, Province of Buenos Aires.
They took place between May 11, 2001 and July 23, 2001. The exposed
population included 3268 cattle, 2690 sheep and 35 pigs. One hundred
ninety-nine young cattle, less than 2 years old, were the only
clinically ill animals. Initial attack rates varied from 0.3 to 12%. The
average interdiction time of the establishments was 67 days.

Two more isolated outbreaks occurred in the Province of Río Negro in
Patagonia North A as a consequence of entry of the virus from the
central zone where the epidemic developed. Between August 2, 2001 and
August 8, 2001, two suspicious cases were detected in the Department of
Pichi Mahuida, Province of Río Negro. Both were located on premises on
the south bank of the Colorado River. The second outbreak occurred near
the Department of Patagones like the earlier ones. A link between the
last case, which was the only confirmed (by laboratory diagnosis)
FMD-positive case among the later outbreaks, and the primary affected
area in Patagones was established. There was a familial relationship
between owners of the affected premises in the initial affected area and
the later outbreak in Patagones which probably resulted in transport of
the virus to the other premises. Control of the outbreaks included
animal quarantine and movement controls along with ring vaccination of
animals in the surrounding areas.

*Conclusions*

There is no evidence that FMD has been transported from surrounding
countries or regions of Argentina north of the 42° Parallel into
Patagonia South. All sides of Patagonia South are bordered by the ocean
or areas free of FMD without vaccination according to OIE standards.

[]{#__RefHeading___Toc111609764 .anchor}**4. The extent of an active
disease control program, if any, if the agent is known to exist in the
region**

There is no active disease control program since no FMD outbreaks have
occurred since 1976 in Patagonia South. \[1\] Some surveillance programs
do exist, but passive surveillance and strong border and animal movement
controls are the major defenses against an incursion of the disease into
this area.

Any Argentine citizen is responsible for reporting disease. Compensation
is provided only when disease is reported, a situation that should serve
to encourage reporting. Indemnities are paid at market value.

*Conclusions*

Argentina has a structured system of notification and official
involvement to investigate any suspect FMD cases. An active surveillance
program does exist, mainly in the buffer zones, to monitor viral
activity in various FMD-susceptible species.

[]{#__RefHeading___Toc111609765 .anchor}**5. The vaccination status of
the region**

Vaccination is not practiced in South Patagonia and has never been
systematically applied. Vaccination is also not performed in North
Patagonia B. Administration of serum against FMD infection is not
permitted in these regions. \[1\]

During the 1976 FMD outbreak in Chubut, cattle, sheep and pigs were
vaccinated in the surrounding areas around the zone where the outbreak
occurred. An initial dose was applied, and then the animals were
revaccinated. Vaccination was discontinued after that since the
emergency action plans had been set in place. \[2\]

*Conclusions*

No vaccination program is underway in Patagonia South or North B. In the
absence of vaccination, it is likely that clinical signs resulting from
an incursion of disease would be quickly identified.

[]{#__RefHeading___Toc111609766 .anchor}**6. The degree to which the
region is separated from adjacent regions of higher risk through
physical or other barriers**

The geographic description of the Argentine borders follows below: \[4\]

1.  Chile (West and South)

2.  Bolivia (North)

3.  Paraguay (Northeast)

4.  Brazil (Northeast and East)

5.  Uruguay (East)

CHILE

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
    East (Average of 3000 m in the West and 400 m in the East). The
    climate and topography also change from more mountainous in the West
    to flatter lowlands towards the East.

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 Paraguay 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 as the Pantalón System)

-   The inland border lies to the West. The flat topography of the
    Province of Formosa continues into Paraguay with no natural
    barriers.

-   The Pilcomayo River enters Argentina again to the East, 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 Misiones)

Inland border: 27 km (Bernardo de Irigoyen area)

-   To the North, the border with Brazil runs along the Iguazú River and
    continues to the South 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 North and
    continues along the De la Plata River.

The Patagonia South region is located in the southern region of the
country and is made up of the provinces of Chubut, Santa Cruz, and
Tierra del Fuego, islands of the South Atlantic and part of Antarctica.
The geographic description of the South Patagonian borders follows
below: (July 2003 and Nov 2004 submissions)

1.  Chile (West and South)

2.  Atlantic Ocean (South and East)

3.  Province of Río Negro, Argentina (North)

The northern border runs along the 42° Parallel from the Atlantic Ocean
to the Piltriquitrón Mountains. It then runs north along these mountains
to the Serrucho Mountains, then west along the Villegas and Manso Rivers
to the border of Chile.

The Cordillera of Los Andes forms a natural border between Patagonia
South and Chile. It runs about 1900 km.

The Patagonia North B region is comprised of the Province of Neuquén
(except for part of the Confluent department) and the area of the
province of Río Negro that is south of the Negro River.

The Patagonia North A region is comprised of the Province of Río Negro
north of the Negro River, part of the Confluent department of the
Province of Neuquén, and the Patagones Department in the Province of
Buenos Aires.

The Patagonia North A and B regions are bordered by constantly flowing
rivers that make crossing difficult.

The area that runs along the 42° Parallel is sparsely populated with a
population in the two main Departments along the Parallel having just
over 3000 inhabitants altogether. National Route N° 258 in the west and
National Route N° 3 in the east along the Atlantic Coast are the two
main highways that enter Patagonia South at the Parallel. These routes
are the principal roads used for extra-regional transit including
commercial and tourist traffic. Other routes have lost their commercial
importance because of the construction of Route N° 258 or are minor
roads with only local traffic and not in good condition.

The climate is dry and windy in the summer and cold, windy and snowy in
the winter. The land is not used for growing crops, but mainly for sheep
meat and wool production. The terrain and desolate nature of the area
act as an effective barrier to disease incursion through illegal
trafficking of prohibited products. Areas where there are no natural
barriers have control mechanisms which include mobile patrols and a
permanent coordination between national and provincial entities to
maintain a constant presence at the region route controls (National
Border Police, other police authorities).

SENASA Resolution No. 9/2001, as amended by SENASA Resolutions Nos.
25/01 and 58/01, implements a sanitary barrier by law at the 42°
Parallel in order to preserve the area south of the Parallel as a region
free from FMD without vaccination. \[2\]

*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. In those areas where natural
barriers do not exist, government control measures compensate. In fact,
Argentina has set up a sanitary barrier by law that applies to the
entire 42° Parallel to preserve the FMD-free status of the Patagonia
South region.

[]{#__RefHeading___Toc111609767 .anchor}**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 are administered by the SENASA\'s Quarantine, Borders
and Certifications Unit. \[4\] Importations of live animals, genetic
material, animal products and animal by-products are allowed only under
permit issued by SENASA. Animals and 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:

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)

-   Integración Austral Crossing (Province of Santa Cruz in Patagonia
    South)

BOLIVIA

-   Salvador Maza 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 (Province 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, Province 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 the National Aeronautical Police. (July 2003
submission) 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. \[7\] Cooperation with these groups occurs under the terms of
official agreements. \[7, 11\] Other groups assisting with border
inspections include the National Customs Bureau and Provincial and Local
institutions. SENASA considers agreements with the security forces to be
critical to the control program. Argentina port authorities check and
confiscate products prohibited for movement domestically (e.g., because
of potential FMD risk to Patagonia, which Argentina considers to be
FMD-free without vaccination) and internationally. Human resources
associated with control posts in Patagonia South and North A and B are
listed in Table 2.

[]{#__RefHeading___Toc103570780 .anchor}Table 2. Human Resources at
Strategic Control Posts in the Three Patagonia Sanitary Regions

+------------+---------+--------+-------+--------+--------+----------+
| Sanitary   | Human   |        |       |        |        |          |
| Regions    | Re      |        |       |        |        |          |
|            | sources |        |       |        |        |          |
+------------+---------+--------+-------+--------+--------+----------+
|            | Profe   | Prov   | Local | Supp   | Super  | Admini   |
|            | ssional | incial | Link  | orting | visor/ | strative |
|            | Barrier | Link   | S     | pr     | aux    |          |
|            | Coor    | SENASA | ENASA | ofessi | iliary |          |
|            | dinator |        |       | onals/ |        |          |
|            |         |        |       | Tech   |        |          |
|            |         |        |       | nician |        |          |
|            |         |        |       | Point  |        |          |
|            |         |        |       | Chief  |        |          |
+------------+---------+--------+-------+--------+--------+----------+
| *          | 2       | 1      | 1     | 3      | 72     | 17       |
| *Patagonia |         |        |       |        |        |          |
| North A**  |         |        |       |        |        |          |
|            |         |        |       |        |        |          |
| Colorado   |         |        |       |        |        |          |
| River      |         |        |       |        |        |          |
| barrier    |         |        |       |        |        |          |
+------------+---------+--------+-------+--------+--------+----------+
| *          | 1       | 2      | 3     | 4      | 82     | \--      |
| *Patagonia |         |        |       |        |        |          |
| North B**  |         |        |       |        |        |          |
|            |         |        |       |        |        |          |
| T          |         |        |       |        |        |          |
| errestrial |         |        |       |        |        |          |
| points -   |         |        |       |        |        |          |
| airports   |         |        |       |        |        |          |
+------------+---------+--------+-------+--------+--------+----------+
| *          | \--     | 3      | \--   | 5      | 42     | \--      |
| *Patagonia |         |        |       |        |        |          |
| South**    |         |        |       |        |        |          |
|            |         |        |       |        |        |          |
| T          |         |        |       |        |        |          |
| errestrial |         |        |       |        |        |          |
| points -   |         |        |       |        |        |          |
| airports   |         |        |       |        |        |          |
+------------+---------+--------+-------+--------+--------+----------+
| Totals     | 3       | 6      | 4     | 12     | 196    | 17       |
+------------+---------+--------+-------+--------+--------+----------+

*Commercial imports*

SENASA Resolution No. 9/2001, as amended by SENASA Resolutions Nos.
25/01 and 58/01, implements a sanitary barrier by law at the 42°
Parallel in order to preserve the area south of the Parallel as a region
free from FMD without vaccination. \[2\]

SENASA does not allow the movement of FMD-susceptible animals to
Patagonia South and North B regions from other regions of Argentina
(including Patagonia North A), not even for slaughter (Resolution N°
1051/2002). \[1, 2, 10\] Imports from Patagonia North B to Patagonia
South are allowed if import requirements are met. These requirements
include:

-   Two negative serological tests for FMD from FMD-susceptible species
    within an interval of 21 days, during which period the animals shall
    be isolated under quarantine from other animals or other species.

-   Two negative Probang tests from cattle and sheep with an interval of
    21 days between samples.

-   FMD-susceptible animals must have remained in the source facilities
    for at least 90 days prior to dispatch application.

-   Movement of animals to destination with official dispatch and
    previous notice.

-   Animals shall be kept isolated for 21 days at the destination, after
    which period premises shall be cleared of potential disease
    contamination after a clinical inspection of FMD-susceptible animals
    on the premises.

-   Animals shall be transported in sealed trucks and shall not move
    through zones where FMD vaccination is practiced.

Susceptible animals from FMD-free countries or zones where vaccination
is not practiced, as recognized by OIE, are permitted to enter Patagonia
South after approval. All sanitary requirements must be complied with by
the foreign veterinary service, and then the animals are quarantined in
Argentina before release.

Argentina requires a risk analysis for all imports of live animals to
determine the epidemiological status of the country or region of origin,
the existence of national or regional programs to control exotic
diseases, the specific capabilities of the laboratories or quarantine
facilities and their staff, and other factors that reduce the risk of
importing exotic or high risk diseases into the country. SENASA
Resolution N° 1354/94 defines the pre-importation procedures and
controls and the health certificate requirements for live animals and
their reproductive material.

Argentina follows OIE guidelines 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 than
Argentina into a FMD-free zone. Argentina requires risk assessment and
mitigation to minimize the potential risks associated with the
importation of these products. SENASA Resolutions that regulate and set
sanitary standards for importation of such products specifically to the
Patagonia region include N° 58/01 and 1051/02. Resolution N° 816/02
defines the general pre-importation procedures and controls for animal
products and byproducts. \[1, 2\]

The procedures and criteria applied by Argentine 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
must be approved by the SENASA Central Office.

The procedures to assess the risk and approve processing plants and
processing procedures in the country of origin are stated in Resolution
N° 816/02. Import permits may be issued after an analysis of: \[1\]

-   The type of product that will be imported

-   The health status of the exporting country

-   Approval of the slaughtering or processing plant in the country of
    origin

-   Type of shipment

-   Transit of the product through other countries

-   Border post at the point of entry into Argentina

-   Expected use of the product

Import procedures and requirements established by SENASA follow OIE
guidelines. All products and live animals that require approval from
SENASA must meet similar security requirements. Import requirements are
summarized as follows: \[1\]

1.  Pre-importation authorization.

2.  Verification of the health certificate issued by the country of
    origin.

3.  Physical inspection, document control and verification of the
    identity of the imported products.

4.  A Restricted Transit Permit for shipments of animal products to
    processing plants with official SENASA veterinary inspection. Live
    animals must be placed in quarantine at the Official Quarantine
    Facility.

5.  After inspection, the imported products are sampled for the purpose
    of the CREHA (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.

Imported animals are placed in SENASA's Quarantine 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, fish). The duration of the quarantine period varies to
allow sufficient time for completion of all required testing procedures,
depending on the species and the place of origin. The quarantine period
is between 15 and 60 days.

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 procedures in SENASA
Resolution No. 816/02. Two inspection modes are used at borders: \[2\]

-   Direct inspection -- questioning, observation manual inspection of
    luggage and vehicles (e.g., trunks, rooms, cabins, boxes)

-   Indirect inspection at the most relevant entry points -- Auxiliary
    methods used to detect organic products that could be potential
    carriers of pests or diseases (e.g., organic material scanner,
    Beagle 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 personnel, increasing vehicular
disinfection tasks and strengthening of patrol and control tasks.
Security forces (National Border Police, Argentine Navy, National
Airforce Police) that carry out sanitary supervision tasks at the border
will be alerted to be more vigilant.

Shipping of animal-origin products to Patagonia must only be done from
official establishments under SENASA control. They must be transported
in authorized vehicles that have been sealed at the official point of
origin and be accompanied by an official health certificate stating that
the products being carried comply with the sanitary requirements for
marketing in the Patagonia region. At the inspection posts, shipments
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.

Animals coming into Patagonia North A from the northern regions of
Argentina must go straight to slaughter. The slaughter establishments
must be approved by SENASA and previously assessed for biosecurity
conditions and compliance with SENASA Resolutions Nos. 58/01 and 178/01.
There are five slaughter facilities in this region. \[2, 10\]

*Non-commercial traffic*

The proportion of travelers, means of transportation and types of
luggage inspected varies according to the borders at risk and parameters
that make it possible to identify a risk profile according to the
recommendations of the Procedures Manual and regional characteristics of
each control post. The particular types of inspection activities that
occur depend on 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
(Aeroparque Jorge Newbery, Bariloche, Neuquén, Comodoro Rivadavia,
Ushuaia and, soon, El Calafate) 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 with trained staff present all day long which
interact with security forces, through cooperation agreements, to
enforce sanitary regulations. It is not possible to estimate the amount
and frequency of unauthorized crossings due to the condition of being
illegal transit, but the measures explained above aim at minimizing the
risk of introduction of animals or products of risk by informal methods.
\[2\]

*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) and in the Patagonia South, North A and
North B regions (2001-2003). \[1, 2\] Controls applied at the Patagonia
sanitary barriers follow federal transit standards by prohibiting entry
of forbidden and restricted animals and products as well as low risk
products such as cold meats or eviscerated chicken.

The Patagonia region was supplied by the central region, allowing fluid
trade and supply channels of all kinds of products of animal origin when
the country was considered one sanitary block in 1999/2000. With the new
restrictions and prohibitions at the critical points of entry into
Patagonia during and after the 2001 FMD outbreak, there was a large
initial economic impact resulting in a large number of confiscations,
especially in Patagonia North A and B. With the economic crisis in 2002,
confiscations decreased dramatically due to decrease in trade in the
buffer and surveillance areas and a decrease in tourist traffic
throughout the region.

Most offenders at border checkpoints are passengers that carry small
quantities of products of animal origin as a souvenir or for personal or
family use, or handcrafts which are forbidden.

Of the livestock transports that had infringements of laws or
regulations in 2003, 72% were empty livestock transports that did not
have a washing and disinfection certificate or had a certificate, but
with hygiene deficiencies noted during visual inspection. These
transports were not allowed to enter the Patagonia region until they
corrected the sanitary deficiency in an authorized washing station.

Another 13% of livestock transports with infringements had deficiencies
related to proper completion and filling out of the transport documents.
This resulted in rejection of the shipment or no authorization to pass
the checkpoint until the issuing official could be contacted.

Another 8% of these transports were stopped due to a lack of some
identification on some of the animals. The transport was rejected and
returned to the point of origin as condemned or an investigation was
started to clear up the problem.

A lack of seals on the doors or badly placed seals was recorded in 2% of
the cases. The contents were checked by border staff, and if no
deficiencies were found, the transport was sealed again and authorized
entry into the region. If a deficiency was found, the transport was
rejected.

The remaining 6% of the infringements was due to expiration of the
transport approval (approval is annual). In these cases, the
infringement is recorded and then entry into the region is authorized.

*Airports* \[10\]

The site team visited several airports which act as control points
mainly for tourist traffic. The Jorge Newberry Airport is in Buenos
Aires and handles a significant level of traffic to Patagonia. Eighty
percent of the flights are domestic and 20% are international (from
Uruguay). Two airlines handle the Uruguay traffic which numbers about
400-500 passengers/day. Four airlines fly to the south into Patagonia
carrying about 2500 passengers/day to Patagonia South and North A and B.
A number of safety measures (described below) are implemented to
prohibit the introduction of risky material to Patagonia. Other airports
visited in the Patagonia region included the Río Grande, Ushuaia, Río
Gallegos, and Neuquén airports.

The security measures implemented at the Jorge Newberry Airport are
quite thorough. SENASA is assisted in its activities by the aeronautical
police. All carry-on baggage is put through scanners that can
differentiate organic materials from other substances. Checked baggage
from domestic flights is usually not scanned unless it is going to
Patagonia. International flights from Uruguay had a separate line to
scan baggage. All checked baggage from international flights is
examined. About 90% of all luggage is scanned at the airport.

Passengers are provided with information on prohibited substances and
required to fill out a customs declaration form if flying in on an
international flight. Passengers carrying food products are given
information on prohibited material regardless of destination. Any
unauthorized cargo is confiscated. A new statement has been developed to
accompany packages stating certain products are not being shipped in the
packages or with a passenger. The proposed statement will be used for
all airplane and bus travelers. One side will have the declaration
statement and signature stating that no prohibited plant or animal
products are being carried by the passenger and the other side will list
the Resolutions involved and prohibited items. If undeclared prohibited
items are found on inspection, there will be a review by SENASA 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 Newberry is
subject to inspection by the Beagle patrol. A beagle dog is used to
sniff for prohibited substances in baggage on the carts outside. One dog
is brought over from Ezeiza airport for 10 days a month to inspect
cargo. If there is luggage that is suspect, it is identified and 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 material 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 witnessed a beagle working who, in the
process, detected a suspect package. The SENASA official labeled it so
officials at the point of destination would investigate the package. The
point of destination is the place to where the package is being shipped.
They do not open these packages at the airport where the dog detects
something suspicious. The package is flown to its destination and then
the owner is notified and SENASA opens the package with the owner
present.

The site visit team noticed that all carry-on luggage was examined by
inspectors when passengers entered the airport and checked baggage was
spot checked in the presence of the owner at the Río Grande airport.
Passengers walked over a carpet with disinfectant (usually Virkon S) as
they entered the terminal from the tarmac.

Checked baggage is usually scanned at the Ushuaia airport, but since the
scanner was not operational, all such baggage was examined manually
along with the carry-on baggage. A footbath with Virkon S was located in
the passenger exit ramp to disinfect shoes. Any baggage that was
identified in Buenos Aires as suspect by the beagle and tagged is
examined by the officials in this airport with the owner present. A
report of the investigation is sent back to Buenos Aires. Confiscated
material from passengers is denatured and disposed of as waste.

All baggage originating north of Parallel 42° is examined by SENASA
officials at the Río Gallegos airport. Baggage originating from within
Patagonia is randomly checked. Any prohibited material seized is kept in
the office, treated with methylene blue, picked up by a SENASA official
at the end of the day and destroyed in the digester at the slaughter
plant. Cargo is usually scanned. Suspicious packages go to the SENASA
main office. Perishables are refrigerated. The owner must go to the
office to retrieve the cargo and be present when SENASA opens it.

The Neuquén airport has a zoophytosanitary post operated to enforce
Resolution N° 58/01 which prohibits the entrance of products that could
potentially carry the FMD virus. It is a control point that examines
passenger carry-on and checked luggage and commercial cargo from
northern Argentina. This airport deals mainly with small cargo although
it is a commercial airport that could potentially receive larger cargo
shipments.

There are six domestic flights which come in from the north daily about
3 hours apart. Occasionally, charter flights fly in from Chile.

Three employees work at the airport for FUNBAPA. SENASA staff is not at
this airport. There is at least one person on duty at all times in case
an unscheduled flight arrives or any other sanitary questions arise.

All baggage is scanned (carry-on and check-in). A scanner capable of
detecting organic material is used. Very few animal products are found;
most are fruit. Most of the traffic is people from the area traveling to
Buenos Aires, so most people are aware of the sanitary situation and
know about the restrictions. There is very little tourism to this area.
All confiscated items and airplane garbage are incinerated daily on the
premises, and items confiscated are recorded. In 2002, about 148 kg of
products were seized for various reasons (e.g. hidden products, no
certificates, non-fumigated fruit, bone-in beef) at the Neuquén and
Viedma airports.

There are some small, private airports in the Patagonia North A and B
regions, but they aren't common. Long distances restrict travel as there
are not a lot of places to refuel. These airports are not
well-regulated, but if air control hears of something out of the
ordinary, it reports the incident to FUNBAPA.

The airports in the Patagonia region with sanitary inspection are listed
in Table 3.

[]{#__RefHeading___Toc103570781 .anchor}Table 3. Airports with Sanitary
Inspection in Patagonia South and North A and B.

  ----------------------------- -----------------------------------------
  SANITARY REGION               AIRPORTS

  North A                       3 (Viedma, G. Roca (closed), Neuquén)

  North B                       3 (R. Sauces, Bariloche, Capelco)

  South                         9 (Pto. Madryn, Rawson, C. Rivadavia,
                                Trelew, Esquel, Río Gallegos, Calafate,
                                Río Grande and Ushuaia)

  Total Airports                14
  ----------------------------- -----------------------------------------

*Land ports*

*General -- International borders*

Permanent SENASA personnel are stationed at each international border
port. However, SENASA is not the only group responsible for biosecurity
at borders. The number of personnel available for border control is
supplemented through agreements with security forces like the
gendarmeria. In this regard, 14,000 officials are stationed along 9,370
miles of border. \[11\] As previously mentioned, SENASA is assisted at
import centers by several designated security forces. SENASA officials
emphasized the importance of the national forces (i.e., the land, water
and border police) in identification of illegal imports. \[11\] If
needed, SENASA also has the authority to call upon local police to
assist.

SENASA checkpoint officials are notified approximately 15 days before
the shipment arrives. This minimizes potential problems with the customs
authority and helps facilitate and expedite the process. All exporters
and importers must be registered with SENASA. The shipment must be
accompanied by a 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
appears to be falsified. There are no fines for commercial shipments
that are rejected because the paperwork is incomplete; however, the
shipments are denied entry. Sometimes SENASA may confiscate and destroy
the product. In comparison, if SENASA detects deliberate falsification
of documents, a fine of 800 pesos is levied. This is equivalent to
one-month salary. \[11\]

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: As previously mentioned, Argentina is separated from
most of Chile by the Andes Mountains. In addition, Argentina is working
with Chile on joint surveillance and wants to implement a satellite
surveillance system of people movement across the border (i.e.
monitoring transport of prohibited materials/animals by people crossing
the border). The responsibility includes aspects of disease prevention
and animal movement. Much of the movement 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.

*Patagonia -- International border*

Patagonia South borders one country, Chile. The terrestrial border
stations along this border are: \[1\]

1.  Los Huemules in the Andes Mountains in Chubut Province

2.  Cohayque in the Andes Mountains in Chubut Province

3.  Intergración Austral (Monte Aymond) in the southern part of Santa
    Cruz Province

The site review team visited the border post at Monte Aymond. This post
is under the joint control of the Argentine and Chilean governments.
Argentina inspects Chilean shipments, and Chile checks Argentine
shipments. Joint inspection teams are made up of Border Patrol staff
which act as an International Trade Enforcement Authority. The plan is
to integrate the two border post facilities into one unit with
integrated staff from both countries.

Bus traffic between Santa Cruz and Tierra del Fuego Provinces must go
through a few posts for inspection. When leaving Argentina to go through
Chile, passengers must pass through Joint Argentine-Chilean Immigration
and Customs and repeat this step again when entering Tierra del Fuego
from Chile, where Customs checks passports and luggage. Customs then
passes passengers on to the Border Patrol. If someone is suspected of
carrying hazardous agricultural or food items they are passed on to a
SENASA inspector. If SENASA personnel are not present, the Border Patrol
staff carries out SENASA duties. When the joint border post is in
operation, SENASA staff will be present 24 hours a day.

Tri-language (English, Spanish, Portuguese) notices are posted at border
crossings and other ports of entry to inform visitors of biologically
hazardous materials and products. A scanner that can detect organic
materials is present at the Monte Aymond post, but wasn't in operation
at the time of the visit. Officials said that it would be in operation
in a month from the time of the site visit.

The animal health status of Chile and Patagonia South is equivalent.
Both areas are considered FMD and fruit fly free. Breeding stock is
traded between these two regions. Commercial meat shipments are also
allowed. However, passengers cannot bring meat over the borders.
Contraband agricultural and food products confiscated from January to
November 2003 amounted to 76 kg, 80% of which was fish products. Certain
fresh plant products are also prohibited into the area.

A standard certificate for export/import must be presented by shippers
at the border crossing. SENASA must have pre-notification so staff can
be present when the shipment arrives at the border, but staff from the
Border Patrol can also inspect shipments. The border posts are staffed
24 hours, 7 days a week by Border Patrol officials. They check seals and
documents, but do not open the seals to inspect cargo. The seals are
inspected to ensure that they haven't 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. A record of all seized products is made. These
products are put in a barrel and sprayed with methylene blue or povidine
to render them inedible. They are then burned in large holes and covered
with soil once the holes are filled.

Argentina and Chile conducted four exercises to coordinate border
crossing activities. The results were very positive. The Foreign
Services office organized these events. The countries share inspection
responsibilities and leverage their personnel usage. Similar exercises
have been conducted in northern Argentina with Uruguay and Brazil.

*Patagonia -- Internal borders* \[10\]

Border posts from Patagonia North B to Patagonia South are situated
along the 42° Parallel. They are the Arroyo Verde, Río Villegas, and El
Maitén posts. \[1\]

The Arroyo Verde post is located on National Route N° 3 which is the
main transportation route for commercial, tourist, and resident traffic
along the Atlantic Coast. It is an obligatory route to the main cities
of provincial political power, population centers, and tourism and
commercial activities. These are areas with the highest population
density and large commercial and economic interests.

The site review team visited the Arroyo Verde control post which has
been in place since 1994. It deals mainly with zoosanitary traffic, but
staff will also confiscate any discovered prohibited plant materials.
Eight employees live at the post. There are no towns in the area. All
vehicles going north to south are checked, except non-agricultural cargo
trucks that have already been checked at a previous post and are sealed.
The cabin of the truck is still checked in case the driver purchased
something en route. All animal cargo trucks are checked, even if sealed.
The seals are broken, the cargo checked and the vehicle is re-sealed.
The old seal number and the new seal number are recorded on a stamp that
is placed on the back of the health documents. Most animal products are
bovine, chicken and fish. The seal must be broken by an official of
either SENASA or the Food Safety Service. Unloading of cargo is
monitored and the vehicle is re-sealed. Each destination must have its
own PTR (restricted transit permit), so one truck may have multiple PTRs
to drop shipments off at different locations.

For traffic going south to north, passenger cars are not inspected but
buses are.

Land control posts between Patagonia North B and the northern part of
Argentina run along the Barrancas River. They are located near bridges
at Barrancas, Desfidero, Mora and El Porton. There are 10 control posts
around the city of Neuquén in the Confluent Department between Patagonia
North B and North A. The rest of the land control posts between North A
and B run along the Negro River. They are located near bridges at Paso
Cordova, Valle Azul, Pomona, and San Antonio Oeste. The site visit
review team visited the control post at San Antonio Oeste.

San Antonio Oeste is a small post near the sea port of the same name. It
is located in a trailer at present, but a small building is being built.
It is only a zoosanitary post. There are six employees, with an
additional three as needed, which staff the post 24 hours a day. They
stop all traffic going into Patagonia North B and only cargo vehicles
going north into Patagonia North A to check paperwork. Around 500
vehicles pass through this point daily. The previous month, November
2003, the post confiscated 5 kg of meat in a box being shipped to
Patagonia North B on a passenger bus. Inspectors also have stopped wool
being shipped without the correct documentation. There is a documented
case in which a sealed truck could not be adequately inspected, so the
staff re-sealed it and notified SENASA at the destination point so that
officials could inspect the truck during unloading.

Due to a lot of smuggling of bone-in meat to Neuquén, authorities wanted
to protect the animals in the surrounding area with the FMD vaccine. A
circular area around the city of Neuquén with 10 control posts was
established and included as part of Patagonia North A. Roads in the area
are in the shape of a triangle with the border posts on the roads
leaving the Confluent Department. This zoning was done in consultation
with OIE. More than 18,000 vehicles cross the bridge daily between the
cities of Neuquén and Cipolleti.

The area between the control posts separating Patagonia North A from
North B is very inhospitable in the western region. It is mainly an
oil-producing area with no electricity or water. FUNBAPA has mobile
units to patrol the area and check vehicles. Vehicles passing through
this area will eventually have to pass through a town. The police will
stop anyone that seems to be trying to bypass a control post.

Land control points between Patagonia North A and the northern part of
Argentina run along the Colorado River. They are located near bridges
at:

-   25 de Mayo

-   Dique Catnel

-   Medanitos

-   Casa de Piedra

-   La Japonesa

-   Pichimahuida

-   Río Colorado

-   Adela

-   Pedro Luro

-   Km 714

All control posts along the border are for zoosanitary inspection. Only
some of them are for phytosanitary inspection. The site visit review
team visited the control posts at Km 714 and Pedro Luro.

The control post at Km 714 is located north of the barrier between
Patagonia North A and the northern part of Argentina. It is located
north of the Colorado River at the point just before the main road
splits in two. Most of the traffic heads west toward Neuquén; a small
amount goes south to Pedro Luro. Seventy percent of the traffic going
into Patagonia goes through this control point. It is strategically
situated for fruit fly control (outside of the production area). There
are at least two signs on each side of the highway warning travelers to
stop for agricultural inspection as they approach the control post. All
trucks and cars are sprayed and disinfected for fruit flies; however not
all vehicles are sprayed for FMD virus disinfection. Only in an
emergency situation, such as an active outbreak of FMD, do truck and
cars get disinfected for FMD. The site review team witnessed a truck
going through the disinfection process which consisted of sprayers in
the road that spray the vehicles from the sides and from below.

The post has an adequate infrastructure (e.g. employees, space,
electricity, equipment). There are three 8-hour shifts with a total of
48 people staffing the post. Agricultural inspectors number 10-11 during
the day and 8 at night (less traffic). Officials can dispatch police for
violations of trucks and autos. In some instances, confiscated products
from this control post can be donated since the post is not within a
controlled area yet; however, only the large confiscated shipments can
be donated. Substances seized from personal vehicles are destroyed in
front of the people so that the public knows the products are not just
being stolen. Data are entered into a computer about what animals/animal
products and fruits are transported and for what purpose. All
confiscated materials are recorded on paper records.

The Pedro Luro Control Post is a smaller post (the office is in a small
trailer) through which a small minority of the main traffic through Km
714 passes. Generally, more traffic heads out of the area than goes in
on that road. This post distributes about 30,000 leaflets per year to
let people know what they can and cannot bring into the region.
Generally, people do know what is prohibited and are cooperative.

The post is staffed by 5 people. There is also a police car at all times
just outside of the office with at least two policemen. The same
standard procedures are followed in this post as in Km 714 and other
posts visited. The staff appeared to be adequately trained and
knowledgeable of their duties and responsibilities.

The control post inspectors confiscate about 10 kg of meat products per
day. Meat in-bone is returned to the place of origin, unless it had been
hidden, in which case it is destroyed. Examples of other interdictions
include sausage, ovine meat, bees, dirty empty trucks, trucks without
proper paperwork, and dirty trucks carrying passengers. Most of the
confiscated items (e.g. prohibited foodstuffs and animal products) are
burned immediately after seizure and buried in a hole in the ground on
the side of the road by the post.

The post keeps paper records of all confiscated materials and other
data. There is no computer or phone at this post, only a CB radio. Data
are entered into a SENASA computer on a monthly basis.

*Training of personnel*

SENASA personnel conduct training of security and other forces working
on border security. There is a manual of procedures that is applicable
at a national level for all types of border crossings \[4\]. The manual
includes:

-   The legal framework

-   The national and international zoosanitary status

-   A glossary of terms

-   The list of officials that are authorized to sign the international
    certificates and a list of authorized border control posts
    throughout the country

-   An epidemiological characterization of the Border Posts (in the
    process of implementation)

-   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 standardized approach for border personnel.

FUNBAPA employees are trained after they are hired in various technical
duties including recognition of FMD clinical signs, self-defense
techniques, use of fire extinguishers and application of first aid. The
probationary period is 6 months. Employees receive training once a year
in a refresher course that covers any new rules or regulations.

*Conclusions*

APHIS considers Argentina, in the region under review (Patagonia South),
to have 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 adequate
staffing to monitor the influx of animals and products via foot or
passenger traffic from adjacent areas of higher risk.

[]{#__RefHeading___Toc111609768 .anchor}**8. Livestock demographics and
marketing practices in the region**

Livestock production systems in Patagonia South are mainly extensive on
large farms carrying large numbers of sheep. The climate and the
environment of Patagonia South are major factors that make the sheep
industry the prevailing livestock activity. This area contains almost
60% of the entire sheep population of Argentina. There were over 7
million sheep in 2003 and more than 72% of Argentina's best wool was
produced in this region. Prevailing breeds in the region are Merino and
Corriedale. Average livestock density is 14 sheep per km^2^ with Santa
Cruz province having the lowest density at 9.5 sheep per km^2^. Total
sheep exports from the Patagonia South region surpassed 90% of the total
of sheep exports from all of Argentina. Currently, Argentina is
exporting 10,000 tons/year of sheep meat to the EU. Argentina estimates
that it will export 6,000 tons/year of sheep meat to the United States,
with a maximum of 9,000 tons/year and a minimum of 4,000 tons/year.
Sheep production is highest in the province of Chubut, followed by Santa
Cruz and then Tierra del Fuego. \[1, 2, 57\]

Bovine production is secondary. Beef produced in Patagonia South is
consumed locally. Matured and de-boned beef must be imported from
outside to meet the consumption demands of the population in this
region. Pigs are raised only for local consumption. Fresh pork meat
(chilled and frozen) and pork sausages are not allowed into Patagonia
South from other parts of Argentina. Livestock statistics are listed in
Tables 4 and 5 below.

[]{#__RefHeading___Toc103570782 .anchor}Table 4. Total number of
livestock producers and establishments and number of bovine and sheep
livestock and establishments in Patagonia South in 2003.

  ---------- ---------------- ----------- ---------------- --------- ---------------- -----------
  PROVINCE   Total No. of     Total No.   Establishments   Total No. Establishments   Total No.
             Establishments   of          with Bovines     of        with Sheep       of Sheep
                              Producers                    Bovines                    

  Chubut     4,095            4,323       1,733            188,347   3,116            4,633,518

  Santa Cruz 1,567            1,567       119              46,798    771              2,333,526

  Tierra del 87               78          75               30,815    50               520,403
  Fuego                                                                               

  TOTAL      5,749            5,968       1,927            265,960   3,937            7,487,447
  ---------- ---------------- ----------- ---------------- --------- ---------------- -----------

[]{#__RefHeading___Toc103570783 .anchor}Table 5. Number of pig and goat
livestock and establishments in Patagonia South in 2003.

  ----------- ---------------- -------------- ---------------- --------------
  PROVINCE    Establishments   Total No. of   Establishments   Total No. of
              with Pigs        Pigs           with Goats       Goats

  Chubut      331              10,818         894              140,364

  Santa Cruz  11               1,481          4                1,250

  Tierra del  14               432            0                0
  Fuego                                                        

  TOTAL       356              12,731         898              141,614
  ----------- ---------------- -------------- ---------------- --------------

Each province has standards (provincial rural codes) for animal
identification referent to the Registries of Marks and Signals. In
addition, at a national level, Resolution No. 178/01 requires the
identification of origin of animals to be moved to any destination. A
clear, legible and identifiable mark or signal, in concordance with the
design described in the DTA, shall be submitted.

For bovine species exported to the EU, there is a mandatory system
called "Identification System for Bovine Cattle intended for Export,"
created by SENASA Resolution No. 15/2003. 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 intended 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.

Movements of livestock within the Patagonia region are limited. There
are no fairs or livestock concentration markets in Patagonia South.
Annual exhibitions/fairs for selling breeding rams occur once a year in
Santa Cruz (Río Gallegos) and Chubut (Comodoro Rivadavia, Trelew and
Esquel). Each auction sells about 400 rams. Also, large farms carry out
their annual breeder auctions on their own premises so breeding
livestock transport is limited mainly from farm to farm.

Due to the type of production and marketing systems in Patagonia South,
there are no livestock concentration markets for fattening and
slaughter. Trade is carried out directly from the farm to the
slaughterhouse with direct selling of cull animals and lambs to
coldstore plants. Lambs are usually destined for export.

Animals are transported in special vehicles used for this purpose only.
The vehicles must comply with SENASA Resolution No. 97/99 which requires
approval of the vehicle by SENASA and SENASA Resolution No. 809/82 which
prescribes hygiene and sanitation requirements.

To market or move animals, the farms must be registered and have a
RENSPA number. Shipment of animals to any destination requires a DTA and
a Guia 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 basis to the statistics unit of DNSA, the
Technical Management Unit and the CCFyC.

There are 19 slaughter plants approved by SENASA in the Patagonia region
that comply with the regulations in force established by SENASA. All
plants approved by SENASA are federally inspected. There are 3 plants
approved for export of sheep meat to the European Union. Two are located
in the city of Río Gallegos in the Province of Santa Cruz and one is in
the city of Puerto Madryn in the Province of Chubut. No slaughter
facilities are approved for export to the United States.

The procedures to approve plants for export are regulated by SAGPyA
Resolution No. 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
assessment of the compliance of building, operative and documentary
requirements, in accordance with a Procedures Initiative. Also, it must
be verified that the requirements of the country of destination and
those of the National Bureau of Agricultural 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 assessment:

-   Capacity of pens at the export area.

-   Daily slaughter numbers intended for export

-   Slaughter capacity (animal/hour)

-   Capacity of the maturations chambers, if pertinent

-   Capacity of carcasses that can be introduced into chambers intended
    for "maturation," complying with the following items in accordance
    with Decree No. 4238/68:

    -   Prohibition of commingling of carcasses coming from areas of
        different sanitary conditions.

    -   Presence of viable technical methods to register environmental
        temperature in the maturation chambers.

The slaughter establishments must be approved for the activity
appropriate to the requested destination and a pre-determined volume of
production. The establishment has to have documented procedures to
identify and trace the products to be exported and provide the Service
of Veterinary 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 compliance 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 in all the slaughter facilities approved by SENASA
are the following:

-   Pens: animals are kept within pens and cannot go out of the
    slaughtering plant once they enter the premises.

-   Effluent treatment: all effluents from the coldstore (pens,
    slaughter yard, and water used in all the processes) are treated by
    separating solids, fats, liquids and 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
    slaughtered at the emergency yard and their meat and products not
    used for export. Dead animals, including their skin, are treated at
    the necropsy digester after diagnosis.

-   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 with thermal treatment to make non-edible by-products.

-   Slaughter pathology wastes: Wastes are processed in digesters with
    pressurized steam or in melters to obtain by-products.

A slaughter facility in Río Gallegos buys animals (sheep) from regional
farms and markets the meat. It is approved for export to the EU, Israel
and Islamic countries and has about 70 employees. They must change into
clothes that can only be worn in the main part of the facility and then
shower and change back into their street clothes before going home.
\[10\]

When a shipment arrives, the transport vehicles are washed and
sanitized. The shipper must produce documents, such as the DTA and Guia,
which have to be signed by the local official veterinarians or else the
shipment is not unloaded. The local SENASA office that issued the DTA is
contacted when the animals arrive.

A SENASA official inspects the flocks 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 card
which is kept in the office. A post-mortem on any animals that die is
performed in a nearby necropsy room.

After animals are killed, an inspector examines the carcass and organs.
There are SENASA inspectors plus 4 plant staff that examine the organs.
No one is specifically assigned to inspect feet post-mortem. The
inspectors look for parasites and inspect the head lymph nodes and other
sites. All the feet and any condemned tongues and heads go directly into
the digester. Condemned whole carcasses go through a different line and
are put into the digester. There are no rendering plants in Patagonia
South.

Carcasses are stamped with the flock number and animal number. The
barcode label includes weight, animal number and flock number. Carcasses
for market are stored at about -22°C.

*Conclusions*

Large extensive sheep operations and export-approved slaughter
facilities are likely to be the source of sheep meat and products
exported to the United States from the Patagonia South region of
Argentina. The livestock industry in Patagonia South appears to be
well-organized, committed to the production of quality products and
aware of necessary biosecurity precautions. APHIS concludes that the
biosecurity measures and controls at major production facilities are
effective in the prevention of FMD outbreaks. There appears to be high
awareness and compliance with these measures. Processing facilities are
under adequate official control and inspection. APHIS did not identify
significant risk pathways to consider commercial sheep operations as a
likely source for introducing FMD into the United States.

[]{#__RefHeading___Toc111609769 .anchor}**9. The type and extent of
disease surveillance in the region**

Patagonia South (i.e., the area of interest under consideration in this
risk assessment south of the 42° Parallel) does not conduct its own
sampling surveillance designed specifically for Patagonia. Surveillance
activities in the Patagonia Region[^1] are conducted only under the
national surveillance design and include both passive and active
surveillance. Serological sampling in Patagonia is carried out mostly in
Patagonia North A and Patagonia North B under Argentina's two-stage
national serological sampling design put forth in 2001 to assess the
foot-and-mouth situation in the national territory after the July 2000
epidemic.

While valid statistical inferences can be made about the presence or
absence of disease in Patagonia from data collected under the national
surveillance plan, the statistical confidence associated with such
inferences may not be the same as that of the entire country. Confidence
levels about Patagonia may be less than the confidence level under the
national plan. In order to compensate for any possible loss in
statistical confidence associated with inferential statements made
specifically about Patagonia, additional sampling was conducted in
Patagonia South in 2002-2003 to identify and measure viral activity in
specific targeted areas of Patagonia. Additional sampling conducted in
Patagonia included samplings of pigs, sheep, goats, farm deer and wild
biungulates, and should compensate for any statistical confidence lost.
In addition, the historical absence of disease, and the fact that in the
absence of vaccination in Patagonia, clinical signs can be detected
quickly, should give further evidence for the continued absence of viral
activities in Patagonia South.

Overall, over 30% of all serological samplings in Argentina in 2002-2003
were conducted in the Patagonia Region. No animals sampled in Patagonia
South ever tested positive and no viral activities were found in this
area. Accordingly, the only two issues associated with conclusions based
on serological sampling are the validity of the sampling procedures and
the adequacy of the sampling coverage. APHIS believes that the sampling
design under which sampling is conducted is both valid and efficient and
the sampling coverage is adequate.

*Serological Sampling in Argentina as a Whole*

In July 2000, just after Argentina was recognized by the OIE in May 2000
as an FMD-free country without vaccination, a foot-and-mouth disease
outbreak occurred and spread to 15 of the 18 provinces located to the
north of the Río Negro and the Province of Neuquén (see Figure 5). The
region south of these borders, including Patagonia South, remained free
from FMD. Shortly after the outbreak, Argentina began a nationwide
serological sampling in conjunction with a strong passive surveillance
aimed at monitoring the disease and assessing its status throughout the
national territory.

Since the July 2000 epidemic, serological sampling in Argentina has been
conducted on a yearly basis starting in 2001 with a frequency of at
least once a year. Their sampling approach is a standard two-stage
stratified random sampling whereby the country is first divided into
strata and where herds are selected at the first stage and animals
within herds are selected at the second stage of sampling. This sampling
design, explained in more detail below, allows for standard operating
procedures of random sampling to be followed. In addition, more targeted
sampling is conducted to target high risk areas, populations and herds
such as those that had introduced animals from the northern regions of
the country during the period when sanitary barriers had been lifted
(Page 29 of the November 2004 submission entitled "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"). Serological sampling has been an integral part of the
country's FMD Eradication Plan aimed at removing the FMD virus from its
national territory. SENASA maintains that after the July 2000 epidemic
the primary reason for all of its epidemiological surveillance, both
passive and active, has always been to search for the disease. SENASA's
main goal in conducting repeated countrywide serological samplings was
to monitor the disease over time and to measure the progress of its
FMD-Eradication Plan.

In general, serological sampling in the national territory of Argentina
is conducted for the following main reasons:

i.  To estimate the prevalence of FMD in the areas where there had been
    disease outbreaks.

ii. To detect the presence of infection in the areas where there had
    been no registries of clinical cases of FMD or where its occurrence
    was sporadic.

iii. To detect viral activity (or infection), and

iv. To estimate levels of population immunity given by vaccination
    against FMD where vaccination was practiced.

> *Two-stage sampling design*

The Republic of Argentina has a surface of 2,780,199 km^2^, 270,000
establishments with a population of 52.5 million bovines and 13.8
million sheep. For the purpose of sampling, the country is divided into
zones and sub-zones with different geographical, productive and
epidemiological characteristics with respect to the disease historical
behavior and to the vaccination implementation (see Figure 4 below).

All serological samplings in Argentina have been conducted according to
a two-stage statistical sampling plan that APHIS considers to be both
valid and efficient[^2]. This sampling design (e.g., sample size and
sampling regions and sub-regions, etc.) allows the estimation of the
prevalence in the areas where there had been disease outbreaks at the
desired level of statistical confidence (typically 95%) and the
detection of the presence of infection in the areas where there had been
no outbreaks. The design is flexible enough to permit necessary changes
and adjustments to target high-risk areas based on epidemiological and
other relevant considerations at the time of sampling and the goals that
are set. For example, in 2003, with more than a year without clinical
cases, sampling was redirected to detect the presence of infection in
all the regions of the country and to estimate the immunity level of
those areas where vaccination is practiced.

![](media/image7.jpeg){width="5.816666666666666in"
height="8.248611111111112in"}

[]{#__RefHeading___Toc111365953 .anchor}Figure 5. Epidemiological zoning
of Argentina for the purpose of serological sampling

![](media/image8.jpeg){width="7.632638888888889in"
height="5.790277777777778in"}

[]{#__RefHeading___Toc111365954 .anchor}Figure 6. Areas with and without
vaccination

> *Determining sampling sizes*

As mentioned above, serological sampling in Argentina is conducted in
two stages. The country is divided into zones and sub-zones according to
several factors such as livestock production system and movement of
animals, geographic characteristics and weather and climate conditions.
In the first stage of sampling in each zone or sub-zone, herds
(establishments) are selected at random from a list of herds according
to the following standard statistical formula (See, for example, Cannon
2000): \[53\]

![](media/image9.png){width="3.0625in" height="0.4895833333333333in"}

Where

*n~h~* Number of herds to be selected for sampling.

γ*~h~* Level of confidence for the detection of at least one positive
herd.

*D~h~* Number of infected herds in the population.

*Nh* Total number of herds in the population

The second stage of sampling consists of sampling of animals from within
a selected herd according to the following standard formula \[53\]

![](media/image10.png){width="3.1666666666666665in"
height="0.4791666666666667in"}

Where

*n~w-h~* Number of animals to be sampled from each of the *n~h~*
selected herds.

γ*~w-h~* Level of confidence for the detection of at least one positive
animal within the selected herd.

*D~w-h~* Number of infected animals within the selected herd.

*Nw-h* Average number of animals within a herd, i.e., average herd size.

The list of herds, as well as all livestock census data in Argentina,
are compiled and updated by the Sanitary National Registry of
Agricultural and Livestock Producers (RENSPA). Tables 6 and 7 list some
of the demographic information and livestock figures used to construct
sampling lists in Patagonia and elsewhere.

[]{#__RefHeading___Toc103570784 .anchor}Table 6. Livestock figures used
to construct sampling lists.

  ------------------ ------------------ ----------------- ------------------ ---------------- -----------------
  **Province**       **Flocks/Herds**   **Total Bovine**  **Total Sheep**    **Total Swine**  **Total Goats**

  01 - BUENOS AIRES  61742              21050731          1194435            532465           9620

  03 - CORDOBA       29444              6508375           98619              444343           45089

  07 - ENTRE RIOS    39572              4697308           358300             42155            3277

  10 - LA PAMPA      9351               3342981           128724             95093            25377

  20 - SANTA FE      30252              6968040           55738              695451           47635

  02 - CATAMARCA     3690               154575            11388              3159             54695

  09 - JUJUY         4032               88918             473463             6518             106126

  11 - LA RIOJA      3092               278874            8209               26658            142781

  16 - SALTA         3037               447933            46725              34830            70899

  21 - SANTIAGO DEL  9394               1179385           99813              134939           278428
  ESTERO                                                                                      

  23 -TUCUMAN        6013               125361            7009               14102            7609

  04 - CORRIENTES    10047              4480962           1540590            18956            5314

  05 - CHACO         10911              1640889           284351             59811            129262

  08 - FORMOSA       8945               1565381           60619              83805            155562

  13 - MISIONES      26252              315442            6792               68619            2646

  12 - MENDOZA       894                137378            8680               4529             192020

  17 - SAN JUAN      733                30727             0                  2811             30639

  18 - SAN LUIS      5747               1523289           43225              21327            38940

  [14 -              [3757]{.mark}      [133758]{.mark}   [194007]{.mark}    [6039]{.mark}    [568500]{.mark}
  NEUQUEN]{.mark}                                                                             

  [15 - RIO          [5306]{.mark}      [697501]{.mark}   [1728045]{.mark}   [7668]{.mark}    [176353]{.mark}
  NEGRO]{.mark}                                                                               

  [06 -              [4095]{.mark}      [188347]{.mark}   [4633518]{.mark}   [10818]{.mark}   [140364]{.mark}
  CHUBUT]{.mark}                                                                              

  [19 - SANTA        [1567]{.mark}      [46798]{.mark}    [2333526]{.mark}   [1481]{.mark}    [1250]{.mark}
  CRUZ]{.mark}                                                                                

  [22 - TIERRA DEL   [87]{.mark}        [30815]{.mark}    [520403]{.mark}    [432]{.mark}     [0]{.mark}
  FUEGO]{.mark}                                                                               

  **Total**          **276306**         **55556155**      **10982250**       **2314096**      **2231136**
  ------------------ ------------------ ----------------- ------------------ ---------------- -----------------

[]{#__RefHeading___Toc103570785 .anchor}Table 7. Livestock figures used
to construct sampling lists by province in Patagonia South.

  -------------------- ----------- ----------- --------------- ------------
                       Chubut      Santa Cruz  Tierra Del      Total
                                               Fuego           

  Total N^o^ of        4,095       1,567       87              5,749
  Establishments                                               

  Total N^o^ of        4,323       1,567       78              5,968
  Producers                                                    

  Establishments with  1,733       119         75              1,927
  Bovines                                                      

  Total N^o^ of        188,347     46,798      30,815          265,960
  Bovines                                                      

  Establishments with  3,116       771         50              3,937
  Sheep                                                        

  Total N^o^ of Sheep  4,633,518   2,333,526   520,403         7,487,447

  Establishments with  331         11          14              356
  Pigs                                                         

  Total N^o^ of Pigs   10,818      1,481       432             12,731

  Establishments with  894         4           0               898
  Goats                                                        

  Total N^o^ of Goats  140,364     1,250       0               141,614
  -------------------- ----------- ----------- --------------- ------------

*Serological Sampling Activities in Patagonia*

Serological sampling activities have been conducted in the entire
Patagonia Region since the July 2000 FMD outbreak. The primary focus of
this evaluation is serological sampling in Patagonia South However,
because Patagonia does not have its own independent serological sampling
design, any discussion of serological sampling in Patagonia must
necessarily be given in the context of serological sampling at the
national level.

> *Serological Sampling in 2001 in Patagonia*

After the reintroduction of FMD in the country in 2000, two serological
surveys were carried out in 2001 in the Patagonia Region to verify the
FMD free status of the region. The first survey was a population
sampling approach conducted in accordance with the national two-stage
statistical design; the second was a sampling targeting the
establishments that had introduced animals from the northern regions of
the country during the period when sanitary barriers had been lifted
when the country was recognized free from FMD without vaccination by the
OIE in May 2000. \[6\]

The species sampled in these two surveys were bovines and sheep. In the
case of bovines, the test used was ELISA 3ABC-EITB, and for sheep
VIAA-IDGA and ELISA in liquid phase[^3]. An establishment was considered
to be positive if at least one animal of any species was positive.

The tables 8 and 9 below show the collected samples and the results of
these two serological studies. \[2\] Table 9 has information specific to
Patagonia South.

> []{#__RefHeading___Toc103570786 .anchor}Table 8. Sampled
> establishments, collected samples and results of the population
> sampling of Patagonia in 2001.

+-----------------+-------------+----------+-------------+-----------+
| **Region**      | **Sampled   | *        | **Est       | **Serop   |
|                 | Esta        | *Sampled | ablishments | ositive** |
|                 | blishment** | A        | with        |           |
|                 |             | nimals** | Positive    | **        |
|                 |             |          | Serology**  | Animals** |
+-----------------+-------------+----------+-------------+-----------+
| Patagonia North | 251         | 5019     | 1           | 2         |
| B               |             |          |             |           |
+-----------------+-------------+----------+-------------+-----------+
| Patagonia South | 256         | 6177     | 0           | 0         |
+-----------------+-------------+----------+-------------+-----------+
| TOTAL           | 507         | 11196    | 1           | 2         |
+-----------------+-------------+----------+-------------+-----------+

> []{#__RefHeading___Toc103570787 .anchor}Table 9. Sampled
> establishments, collected samples and results of the targeted sampling
> of Patagonia in 2001.

  ----------------- ------------------ ----------- ------------------ ----------------
  **Province**      **Number of        **Number of **Establishments   **Seropositive
                    Establishments**   Sampled     with Positive      Animals**
                                       Animals**   Serology**         

  Chubut            26                 1171        0                  0

  Neuquén           32                 1014        7                  11

  Río Negro         5                  559         0                  0

  Santa Cruz        6                  471         0                  0

  Tierra Del Fuego  1                  87          0                  0

  TOTAL             70                 3302        7                  11
  ----------------- ------------------ ----------- ------------------ ----------------

Additional studies were carried out in the establishments where animals
reacting to the tests have been found. These studies included new
samplings of susceptible animals, with EPF (esophagus-pharyngeal fluid)
sample collection for isolation and PCR of positives. In all the cases
the tests were negative, discarding the presence of infection.
Additional samples, corresponding to a joint study with the Livestock
and Farming Service of Chile (SAG), were collected from bovines and pigs
in the Province of Tierra del Fuego. \[8\]

In addition, 30 pigs were sampled in Patagonia South in a serological
survey carried out jointly with the Livestock and Agricultural Service
(SAG) of Chile in Tierra del Fuego but independently from the country's
national serological sampling plan.

*Serological Sampling in 2002 in Patagonia*

A series of four sero-epidemiological studies were carried out
nationwide in 2002, the first of which was implemented at a national
level while the others were more targeted. These studies were not
specific for Patagonia South but were conducted as part of the active
surveillance tasks performed in Argentina as a whole after the
reappearance of the disease. We briefly discuss three of the four
studies below and their results that are relevant to the two areas of
interest, namely, Patagonia South and Patagonia North B where
vaccination was not practiced. The four studies are: \[2\]

> Study 1. Bovine, ovine and goat sampling - Autumn 2002 (March-May)
>
> Study 2. Farm deer sampling - June and October 2002
>
> Study 3. Wild biungulates sampling in Patagonia- May-July 2002
>
> Study 4. Goat sampling in Mendoza - September, October 2002

The first one was implemented at a national level, while the others
responded to more targeted areas in Patagonia. The first three are
discussed in more detail below.

*[2002 Study 1]{.underline}. Viral Activity - Bovine, ovine and goat
sampling*

This study was conducted at the national level in March through May of
2002 according to the two-stage national sampling plan. In this study,
the country was divided into three zones: A, B and C (see Figure 6).
These were distinguished by differences in epidemiological
characteristics relating to occurrence of clinical cases of the disease
and the implementation of vaccination against the FMD virus.

![](media/image11.jpeg){width="2.40625in" height="2.78125in"}

[]{#__RefHeading___Toc111365955 .anchor}Figure 7. 2002 zoning map for
serological sampling

The three zones were further divided into smaller sub-zones[^4] in order
to define areas that were as homogenous as possible in terms of the
production, geography and management practices. Homogeneity was assessed
according to the following parameters: (1) animal density, (2)
composition of the bovine population (relationship heifer/cow), (3)
animal movement (inflow and outflow), (4) geographical and
political-administrative characteristics, and (5) vaccination campaigns
operational capacity (in A and B zones only). The five sub-zones are
(see Figure 7):

1.  Sub-zone C1: Province of Neuquén.

2.  Sub-zone C2: Province of Río Negro (except for the vaccination area)

3.  Sub-zone C3: Province of Chubut.

4.  Sub-zone C4: Province of Santa Cruz.

5.  Sub-zone C5: Province of Tierra del Fuego.

![](media/image12.jpeg){width="1.917361111111111in"
height="2.8743055555555554in"}

[]{#__RefHeading___Toc111365956 .anchor}Figure 8. 2002 further
sub-zoning of Zone C in Map 2 above

We shall confine our discussion of serological samplings in 2002 below
to those conducted in Zone C only since this zone contains the area of
interest in this risk analysis, namely, Patagonia South.

The purpose for serological sampling in this zone was to ascertain the
absence of antibodies to non-structural protein (NSP) of the FMD virus
in sheep and bovines in the Patagonia Region. Recall that Zone C has
300,000 bovines and 9,000,000 sheep, representing 1% and 65% of the
total bovine and sheep populations, respectively, in the country. The
disease was not detected in this zone during the 2000-2001 epidemics,
and vaccination against FMD virus is not practiced.

The species sampled in this study were bovines, sheep and goats. Bovines
were classified into two categories according to their age - Category 1:
from 6 to 12 months of age; and Category 2: from 12 to 24 months of age.
Sheep and goats, not vaccinated, of any age were sampled.

The sample size was determined in accordance with the two-stage national
sampling design assuming a herd prevalence of 2% in Zone C; within-herd
prevalence of 10%; and a level of statistical confidence of 95%.
However, due to the different livestock characteristics in different
sub-zones with respect to the proportion of susceptible species in Zone
C, the design was slightly modified in each sub-zone. For example, in
sub-zones C3, C4 and C5 (Provinces of Chubut, Santa Cruz and Tierra del
Fuego), only ovine were sampled[^5]; 152 premises were required to be
sampled and 28 sheep from each premise, with a total of 4,256 samples by
sub-zone.

In Neuquén and Río Negro Provinces (sub-zones C1 and C2), bovine species
represent 33% and ovine species represent 67% of the entire livestock
population in Zone C. Both species were sampled with 152 premises by
sub-zone, with 28 bovine samples and 28 ovine samples taken from each
premises. A total of 4,256 samples were taken for each species. A total
of 21,280 samples were requested by the sampling design for all of Zone
C.

Table 10 reports the total number of establishments and animals required
by the serological design to be sampled in this study. The number in
parentheses represents the proportion of sampling in Zone C out of all
sampling conducted nationwide in 2002.

[]{#__RefHeading___Toc103570788 .anchor}Table 10. Number of samples
required by the two-stage sampling design in 2002.

**(Numbers in parentheses represent the proportions of sampling in Zone
C out of sampling conducted nationwide in 2002.)**

  -------- ---------------- ---------------- ---------------- ---------------
  Zone     Establishments   Bovines          Sheep/Goats      TOTAL

  A        2800             25200            14000            39200

  B        984              19680            0                19680

  C        760 (or 16.73%)  8512 (or 15.94%) 21280 (or 60.3%) 29792 (or
                                                              33.6%)

  TOTAL    4543             53392            35280            88672
  -------- ---------------- ---------------- ---------------- ---------------

Only 78% or (69,017/88,672) of the samples required by the design was
analyzed. There were various reasons for this, including sample
collection difficulties in the field and laboratory samples that could
not be processed because of identification and/or preservation problems.
Table 11 gives the total number of actually analyzed samples, i.e., the
effective sample size, by zone in Zone C. Here too, the number in
parentheses represents the proportion of analyzed samples in Zone C out
of all sampling nationwide conducted in 2002.

[]{#__RefHeading___Toc103570789 .anchor}Table 11. Number of samples
actually analyzed in each zone in 2002.

(Numbers in parentheses represent the proportions of analyzed samples in
Zone C out of all sampling nationwide in 2002)

  --------- --------------------- ------------------- --------------------
  Zone      Bovines               Sheep/Goats         Total

  A         21671                 9171                30842

  B         14893                 0                   14893

  C         5292 (or 12.64%)      17990 (or 66.24%)   23282 (or 33.73%)

  TOTAL     41856                 27161               69017
  --------- --------------------- ------------------- --------------------

Table 12 shows the results of serological sampling in Zone C in 2002 for
each sub-zone.

[]{#__RefHeading___Toc103570790 .anchor}Table 12. Number of
establishments with at least one positive animal of any species in Zone
C .

+--------------------------+---------------+--------------+-----------+
| Sub-zone                 | Po            | Prevalence % | IC 95%    |
|                          | sitives/total |              |           |
+--------------------------+---------------+--------------+-----------+
| Province of Neuquén      | 4/118         | 3.4          | 0.1-6.7   |
+--------------------------+---------------+--------------+-----------+
| Province of Río Negro    | 5/259         | 1.9          | 0.2-3.6   |
|                          |               |              |           |
| (except for the          |               |              |           |
| vaccination area)        |               |              |           |
+--------------------------+---------------+--------------+-----------+
| Province of Chubut       | 0/151         | 0.0          |           |
+--------------------------+---------------+--------------+-----------+
| Province of Santa Cruz   | 0/151         | 0.0          |           |
+--------------------------+---------------+--------------+-----------+
| Province of Tierra del   | 0/30          | 0.0          |           |
| Fuego                    |               |              |           |
+--------------------------+---------------+--------------+-----------+
| TOTAL                    | 9/709         | 1.3          | 0.5-2.1   |
+--------------------------+---------------+--------------+-----------+

Establishments with positive results were sampled further to determine
if there was viral circulation. It has to be underlined that animals in
this zone are not vaccinated; therefore, bovines are highly susceptible
to the disease. Nevertheless, no clinical cases were detected during the
2000/2001 epidemic. In addition, no viral activity was detected in sheep
in this zone. \[2\]

Table 13 reports the results of testing demonstrating that there was no
viral activity in sheep/goats tested in this study in Zone C.

[]{#__RefHeading___Toc103570791 .anchor}Table 13. Results of viral
activity in sheep/goats for each sub-zone in Zone C.

+--------------------------------+-----------------+------------------+
| Sub-zone                       | Positives/total | Prevalence %     |
+--------------------------------+-----------------+------------------+
| Province of Neuquén            | 0/1138          | 0                |
+--------------------------------+-----------------+------------------+
| Province of Río Negro          | 0/3971          | 0                |
|                                |                 |                  |
| (except for the vaccination    |                 |                  |
| area)                          |                 |                  |
+--------------------------------+-----------------+------------------+
| Province of Chubut             | 0/4271          | 0                |
+--------------------------------+-----------------+------------------+
| Province of Santa Cruz         | 0/4349          | 0                |
+--------------------------------+-----------------+------------------+
| Province of Tierra del Fuego   | 0/4261          | 0                |
+--------------------------------+-----------------+------------------+

*[2002 Study 2.]{.underline} Serological Sampling of Farm Deer*

A serological sampling of commercial deer farms was carried out during
the months of June and October 2002 in order to ascertain the absence of
FMD virus in commercial deer farms in Argentina. Four provinces were
randomly chosen; a total of 15 farm deer establishments were randomly
selected from them; and a total of 478 deer serum samples were collected
as shown in Table 14.

[]{#__RefHeading___Toc103570792 .anchor}Table 14. Number of deer
establishments and deer sampled in 2002.

  --------------------- ------------------------- ------------------------
  Province              N° of establishments      N° of samples

  Buenos Aires          5                         180

  La Pampa              4                         124

  Neuquén               5                         145

  Río Negro             1                         29

  Total                 15                        478
  --------------------- ------------------------- ------------------------

These deer establishments were considered to be separate populations of
deer since they were managed independently of one another and from other
types of production. The sampling of at least 29 samples from each
establishment allows a 95% statistical level of confidence to detect at
least one positive case if the prevalence of infected animals were 10%
or higher[^6].

All of the samples tested negative for antibodies to structural (ELISA
in liquid phase) and nonstructural proteins (VIAA-IDGA) of the FMD
virus.

*[2002 Study 3.]{.underline} Monitoring of wild biungulates in areas
without vaccination*

In 2002, a serological survey in wild biungulates in areas without
vaccination was carried out with the aim of verifying the role of these
species in the FMD epidemiological behavior in these areas and to
ascertain the absence of FMD virus in wild susceptible species of the
areas without vaccination. It was performed in game reserves in
Patagonia.

The big game reserves in Patagonia are located in the Provinces of
Neuquén and Chubut. There are no hunting areas approved in the other
Patagonian regions. A total of 32 hunter-kill serum samples were
obtained for the study. These consisted of 27 red deer captured in 9 big
game reserves in the Province of Neuquén and 5 guanacos in an
establishment in the Province of Chubut[^7].

As the animals are not vaccinated, a positive result to any of the tests
would indicate that an animal has been in contact with the FMD virus.
Here too, all the analyzed samples were negative to both tests.

*Serological Sampling in 2003 in Patagonia*

Serological sampling in 2003 was implemented countrywide in a similar
manner to the way it was conducted in 2002. Here too, the country was
divided into zones according to the following parameters: (1) animal
density, (2) composition of the bovine population (relationship
heifer/cow), (3) geographical and politic-administrative
characteristics, (4) operating capacity of the vaccination campaigns,
(5) risk areas (zones bordering with countries with FMD), and (6)
surveillance zones (of free areas). That resulted in six zones as
follows: \[2\]

Zone 1: Central-Mesopotamia\
Zone 2: Fattening\
Zone 3: NOA-Cuyo\
Zone 4: North A Patagonia\
Zone 5: South and North B Patagonia\
Zone 6: Border

Only ovine were sampled in Patagonia South and North B. However, bovines
were sampled in Patagonia North A.

Slightly different sampling approaches were used in each zone. For
example, in determining the minimum sample size required for sampling in
Patagonia North A, a 1% herd prevalence, a 15% within-herd prevalence
and a 95% statistical confidence were assumed. Bovines were categorized
in three age categories: 6 to 12 months (Category 1), 12 to 24 months
(Category 2), and more than 24 months (Category 3) in Patagonia North A.

In Patagonia South and North B, a 1% herd prevalence, a 10% within-herd
prevalence and a 95% statistical confidence were assumed. Also, only
sheep were sampled in these regions since sheep is the predominant
species in these two areas. Accordingly, it was estimated that 459
premises should be selected and 10 sheep of any age from each one should
be sampled, for a total of 4,590 samples.

Serological tests measured antibodies to non-structural proteins of the
FMD virus in bovines and structural proteins in sheep. In bovines, the
ELISA 3ABC-EITB test was used. The ELISA in liquid phase (ELISA lph)
test was used to detect antibodies to structural proteins of FMD virus
for O1 Campos and A 2001 types in sheep. The sampling approach by region
is described in Table 15.

[]{#__RefHeading___Toc103570793 .anchor}Table 15. Sampling 2003. Number
of premises sampled and collected and processed samples to determine
viral activity by region.

  --------------------- --------------- ----------- ------------ ------------
  **Zone**              **Number of     **Number of **Number of  **Number of
                        Establishment   Bovine      Ovine        Animals
                        Sampled**       Samples**   Samples**    Samples**

  Central-Mesopotamia   417             4,140       0            4,140

  Fattening             309             2,847       0            2,847

  Border                419             4,287       0            4,287

  NOA-Cuyo              348             3,371       0            3,371

  Patagonia North A     321             3,161       0            3,161

  Patagonia South and   486             0           4,951        4,951
  North B                                                        

  TOTAL                 2,300           17,806      4951         22,757
  --------------------- --------------- ----------- ------------ ------------

Table 16 shows the ovine samples collected and their results for the
Patagonia South and North B regions, per province.

[]{#__RefHeading___Toc103570794 .anchor}Table 16. Number of ovine
premises sampled and processed samples to determine viral activity in
the Patagonia South and North B regions per province and their results.

  ----------------- ------------------ ------------------- ------------ ------------
  **Zone**          **Province**       **Establishment**   **Serums**   **Positive
                                                                        Serums**

  **Patagonia North Neuquen            18                  180          0
  B**                                                                   

                    Rio Negro          86                  840          0

                    Chubut             214                 2235         0

  **Patagonia       Santa Cruz         140                 1390         0
  South**                                                               

                    Tierra Del Fuego   28                  276          0

  TOTAL                                486                 4921         0
  ----------------- ------------------ ------------------- ------------ ------------

If an establishment was found to have at least one positive animal,
additional serological sampling was conducted in collecting up to 60
animals per establishment. If an animal resulted positive to this
additional sampling, collection of Esophagus Pharyngeal liquid 1 was
performed in two opportunities. For all of Argentina, out of the 2,300
premises that were sampled, 92 had at least one positive animal and were
investigated further[^8]. However, no positives were found in Patagonia
South or Patagonia North B. That is, all 4,921 samples from 486
establishments were negative to the ELISA test in liquid phase. Similar
results were obtained in 2002 when 17,990 sheep sampled collected in the
same region tested negative (Table 6 above).

*Conclusions*

APHIS believes that the sampling design under which serological sampling
is conducted in Patagonia is both valid and efficient and the sampling
coverage is adequate. APHIS also believes that the serological sampling
that has been conducted in Patagonia both under the national serological
sampling plan, which will continue in the future, and the additional
targeted sampling of pigs, sheep, goats, farm deer and wild biungulates
since the July 2000 outbreak is adequate to detect disease and/or
identify and measure viral activity in the area. Furthermore, the
historical absence of disease in the region, quick detection of clinical
signs should disease be introduced in the absence of vaccination, and
the fact that 30% of all serological samplings in Argentina in 2002-2003
were conducted in the Patagonia Region resulting in no animals sampled
in Patagonia South ever testing positive and no viral activity ever
found, would support further evidence of the absence of disease in
Patagonia.

[]{#__RefHeading___Toc111609770 .anchor}**10. Diagnostic laboratory
capacity**

In Argentina, SENASA has one diagnostic laboratory in Buenos Aires with
a biosafety level NBS3 Ag (equivalent to BL3) that was approved in 1997.
This laboratory is authorized to manipulate FMD virus and other
microorganisms that must be handled in BL3 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 No. 219/95
does allow accreditation of private laboratories by SENASA to produce
FMD vaccines. \[1, 2\]

In 2000, the laboratory was audited by foreign 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.
The findings were satisfactory.

Security measures in place at the central laboratory include:

-   Restricted and controlled access

-   Airtight compartments and mandatory showering

-   Negative air flow with two HEPA filters

-   Heat treatment of liquid effluents (100°C during 1 hour)

-   Border autoclave

-   Airlock with formaldehyde spraying

-   Category II biosafety booths

-   Electric energy generator

The Argentinian biosafety requirements to manipulate the FMD virus are
stated in former SENASA Resolution No. 219/95.

The staff of the 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 also provides support to SENASA with the
best technical and human resources in the country. It was established in
1992, and its members include professionals from the INTA and the Animal
Virology Center (CEVAN) of the National Council for Technical and
Scientific Research (CONICET).

The APHIS team visited with the director of the 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. \[10\]

I. Laboratory structure and organization

The DILOCOT (Figure 9) is comprised of the General Department of Animal
Laboratory, and the General Department of Plant Laboratory and
Laboratory Networks. 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, Seroepidemiology, and Vaccine Control and
Experimental Farm. The advisory board for Virology includes SENASA, INTA
and CEVAN laboratories. The Virology Laboratory is staffed with 26
veterinarians, 13 technicians and 3 administrative personnel. BL3
laboratory space is about 150 square meters and it accommodates four
people at a time. The laboratory can process 40 epithelial samples a
day.

The laboratory uses a laboratory 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 for 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 desired data. The staff was very capable in managing the
system.

A new laboratory building is under construction for poultry, equine and
small animal diagnostics with BL3 facility for FMD PCR.

[]{#__RefHeading___Toc111365957 .anchor}Figure 9. Functional
Organization Chart of SENASA Laboratory

![](media/image13.wmf){width="6.251388888888889in" height="4.3125in"}

II\. National reference laboratory missions

The main functions of the national reference laboratory are to establish
protocols and validate reference assays for disease control as dictated
by SENASA, perform quality control testing on FMD vaccines produced by
the manufacturers, serve as a reference laboratory in confirming
positive cases, apply biosafety standards as set by SENASA and set forth
the sampling strategy for disease control and surveillance.

The laboratory is working towards accreditation by the Argentine
Accreditation Organization (Organismo Argentino de Acreditación -- OAA)
under international standards ISO 17025. The first audit occurred in
November 2004. The food safety department (residues and food control) is
now accredited and SENASA is looking into accrediting the biological
departments (analytical methods) for the different diseases during 2005.

III\. Diagnostic samples

Epithelial tissue samples are preserved and transported in Vallee medium
composed of phosphate glycerin (pH 7.2) with phenol red. Received
diagnostic 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 from the technical
staff as part of the laboratory quality control standards. Submission
for biocontainment is labeled on the package and opened in the BL3 lab.

Epithelial tissues for FMD virus isolation are homogenized and frozen
immediately upon arrival. Homogenates are thawed out and screened for
FMD virus by the antigen ELISA. If ELISA results are negative, the
homogenate is inoculated on to baby hamster kidney (BHK) cells for 48
hrs 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 hr and tested for FMD by ELISA. If the ELISA results
are negative on the second passage the sample is considered negative.
The laboratory receives between 1-2 investigation(s) a year for suspect
vesicular disease. The primary target of these investigations is FMD.

For detection 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 same animals tested positive by serology.
Probang samples are tested for the presence of FMD virus by carrying out
virus isolation on BHK cell lines.

It is important to note that the serology for FMD is done at the BL2
facility since space is limited in the BL3 facility. Serum from FMD
infected animals may contain the virus up to 5 days post infection, so a
BL3 facility might be preferable. To minimize the risk of handling a
potential live virus outside of containment, the laboratory staff
chooses to heat inactivate the sera before running the ELISA. Heat
treatment of the FMD virus at 56°C for 30 min has been shown not to be
completely effective in inactivating FMD virus. SENASA might consider
running samples from suspect cases in biocontainment to minimize the
risk of contaminating the BL2 facility.

VIAA is the only test approved by PANAFTOSA to screen sheep for FMD
antibody. In the past, SENASA had a regional laboratory network to run
VIAA for FMD antibody test, but it is only run at the central laboratory
now.

The SENASA laboratory does not have the proper facility to run PCR for
FMD. Consequently, samples submitted for PCR testing are partially
processed in the BL3 where live FMD virus is being handled. Test samples
are place in trizol or the RNA is extracted and sent without being
safety tested to the non-accredited BL3 INTA laboratory to run the PCR
assay. SENASA is planning to have a separate BL3 facility for PCR
assays.

[]{#__RefHeading___Toc103570795 .anchor}Table 17. Number of diagnostic
tests for FMD and VS serology 2003.

+-----------------------------------------------------------------------+
|                                                                       |
|  ---------------------- ---------------------- ---------------------- |
|   Test                   First semester         Second semester       |
|                                                                       |
|   VIAA                   29,690                 6,004                 |
|                                                                       |
|   3ABC ELISA             32,436                 14,620                |
|                                                                       |
|   EITB                   3,123                  5,750                 |
|                                                                       |
|   Structural ELISA       29,690                 5,990                 |
|                                                                       |
|   Typing ELISA           80                     41                    |
|                                                                       |
|   VS ELISA               398                    524                   |
|                                                                       |
|   Total                  91,686                 32,929                |
|                                                                       |
|  ---------------------- ---------------------- ---------------------- |
+-----------------------------------------------------------------------+

IV\. Diagnostic tests capability

Technology for following tests is currently available at the SENASA,
INTA and CEVAN laboratories:

1.  FMD

    a.  Serology: 3ABC ELISA, EITB, VIAA and monoclonal-based liquid
        phase ELISA are used for serotyping. The virus neutralization
        test has been used in the past and, at the time the laboratory
        was reviewed, it was currently encountering problems growing the
        virus in the cell culture. Definition of conditions for
        re-optimizing the test was in progress.

    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 INTA laboratory after processing the
        samples in the SENASA laboratory.

2.  Vesicular Stomatitis

    a.  Serology: Reagents for the IgG ELISA are purchased from the
        PANAFTOSA laboratory. The live virus is not handled in the
        laboratory because of the limited BL3 laboratory space.
        Therefore virus neutralization test is not currently available.

    b.  Agent detection: Ag ELISA is used in the central laboratory. PCR
        and genomic sequencing are conducted in the INTA and CEVAN
        laboratories.

3.  Swine Vesicular Disease\
    No test is available. Reagents for the antibody ELISA will be
    purchased from the OIE reference laboratory in Pirbright to start
    screening the swine population.

*Conclusions*

Argentina has the diagnostic capabilities to adequately test samples for
the presence of the FMD virus. In this regard, quality 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.

[]{#__RefHeading___Toc111609771 .anchor}**11. Policies and
infrastructure for animal disease control in the region**

Elements of the FMD disease control program are provided in the *Foot
and Mouth Disease: Manual of Procedures for Focus Attention* (the
Manual). \[2\]

Law No. 24.305 requires immediate and mandatory reporting of FMD in
Argentina. SENASA has legal authority to apply severe penalties to any
individual or company that fails to report an FMD case. The Animal
Health Law Enforcement Act (No. 3959/1903) requires all veterinarians in
private practice that work in rural areas must report epizootic
diseases. This law, with its amendments, specifies the penalties that a
person could incur in different 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, too, are subject to severe
penalties for failure to comply with statutory requirements. \[1, 2\]

Identification of outbreaks or suspicious signs of FMD is mainly carried
out through passive surveillance in Patagonia. Observations by the
producers, animal caretakers, transporters and other people 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. In spite of the large size of the farms in Patagonia, animals
are periodically inspected by the staff in charge of them. Also, the
INTA has a network of Experimental and Extension facilities in rural
areas that work with the farmers and receive updated information on the
health conditions of the herds.

Veterinarians also take part in passive surveillance. Routine
examinations of livestock occur during wool industry-related tasks and
official surveillance programs, plus 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 and support the national
eradication programs.

In the event of an outbreak of exotic or endemic diseases that present
as a health hazard to the national livestock herd, and if SENASA
determines to follow a stamping-out policy, SENASA's actions and level
of involvement are defined in Resolutions Nos. 1410/2000 and 488/2002.
The actions are listed in Resolution No. 779/1999 through which the
National Animal Health Emergency System (SINAESA) was created as
authorized by Law No. 24.305, Act No. 3959/1903 and Decree Nos.
1585/1996 and 643/1996. By Decree No. 394/2001 that updated Decree No.
1585/1996, 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 SINAESA defines the responsibilities and functions to control FMD in
emergency situations. It operates at three levels: Central, Regional and
Local.

At the central level, there is a Central Animal Health Emergency
Committee that is responsible for describing the emergency scenario,
defining the control measures, 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 and able to respond
immediately in cases of emergency. An alternate is available for each
person in case a member is unable to respond.

At the local level, the staff of the Local SENASA Office in the affected
area collaborates with the field technicians to provide support. The
responsibilities of the Local Office 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 Local Animal Health Emergency
    Committee.

-   Carry out the actions defined 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, including a geographic description.

-   Keep updated information on local suppliers and service suppliers
    such as: mobile telephone companies, equipment suppliers,
    transportation and rental companies of said equipment, trucks, etc.

-   Keep updated information on the livestock population, inventory of
    other products, shippers of animal products and byproducts, cattle
    dealers, other professionals related to the farming sector
    (veterinarians, agronomists, cattle buyers, dairy farm inspectors,
    etc.).

-   Keep updated records of the local authorities such as: municipal
    officials, law enforcement authorities, fire brigade, veterinarians
    in private practice and others in the area).

-   Oversee the surveillance and repopulation of farming operations.

The main control measure in the case of a confirmed FMD outbreak in the
FMD-free area without vaccination is the stamping out policy of all the
affected animals and contacts. Other additional measures such as
vaccination will depend on each situation (e.g. a primary outbreak or
not, the number and location of the affected premises, the number and
species of involved animals).

Due to the regulations in force and the established Epidemiological
Surveillance System, the time to detect a case of FMD in susceptible
species in Patagonia should be no more than 48 hours. At that time,
there is immediate notification of the outbreak or suspicion of FMD to
the OIE within 24 hours of detecting the case. Argentina also notifies
the EU, due to trade commitments, and bordering countries, if the
outbreak occurs in a border area.

At the international level, Argentina rapidly and regularly gives
notification of the 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 OIE, 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 immediate notification of any reportable disease detected in the
country that could represent a sanitary potential risk for a neighboring
country. One such bilateral agreement is the Cuenca del Plata Agreement
between Argentina, Brazil, Uruguay, Paraguay, Bolivia and Chile.

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 Animal Health, by virtue of the
complexity of personnel, two professionals work as consultants who will
lead the 22 training delegates of the provinces who shall coordinate,
audit and guide the process of teaching the official veterinarians. This
program is under implementation. The training legal framework includes
SAGPyA Resolutions Nos. 51/2003 and 02/2002 and SENASA Resolution No.
166/2003.

*Conclusions*

Argentina has the infrastructure and legal authority to declare an
emergency and take appropriate action in case of an END outbreak. They
have a disease control program that is in written form 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. There are also systems for
notification and training that ensure emergency preparedness and
response with a legal framework to authorize needed actions.

[]{#__RefHeading___Toc111609772 .anchor}**Release Assessment -- Summary
of risk factors and mitigations considered**

APHIS identified risk factors that might be associated with importing
sheep to the US from the export region. 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.S.

[]{#__RefHeading___Toc111609773 .anchor}**Likelihood of FMD introduction
into the Argentina Patagonia South region**

***Risk Factor***

1.  FMD is endemic in most countries in South America. Consequently,
    there is an ongoing risk of reintroduction of FMDV from adjacent
    affected areas into the export region. Therefore, there is a risk
    that FMD-susceptible species or products from such species destined
    to the U.S. could originate from or be commingled with animals or
    animal products from affected neighboring areas.

> Discussion: Argentine authorities do not allow live animals to enter
> the Patagonia South region except from Patagonia North B and FMD-free
> countries without vaccination for breeding purposes and after
> extensive testing. Lamb meat is the major product that would
> potentially be exported to the U.S. Cull animals that are slaughtered
> are used only for local consumption.
>
> Matured, deboned fresh beef is imported into Patagonia South from
> areas in Argentina north of the 42° Parallel for local consumption
> only since beef is not produced in sufficient quantities for local
> demand. This meat has a low risk of introducing the FMD virus into the
> export region since it must go through a maturation process that kills
> the FMD virus, swill which may contain meat scraps must be properly
> treated before being fed to pigs, and the sheep do not come into
> contact with the meat since they go directly from the range to the
> slaughter facilities.
>
> Conclusion: Any sheep or sheep products exported to the U.S. will
> originate only from Patagonia South. Other products from
> FMD-susceptible animals are not expected to be exported to the U.S.
>
> Mitigations: If beef exports from Patagonia South to the U.S. are ever
> expected, certification by a full-time salaried veterinary officer of
> the Government of Argentina will be required to state that the beef
> did not originate or was not commingled with other meat from outside
> the Patagonia South region.

[]{#__RefHeading___Toc111609774 .anchor}**Likelihood of detection of FMD
if reintroduced into the Argentina Patagonia South region**

***Risk Factor***

1.  Sheep in the Patagonia South region of Argentina are primarily
    grass-fed on extensive establishments, 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
    may not be in human contact for significant periods of time.
    Therefore, close observation of animals might be infrequent, and
    clinical signs might be missed.

> Discussion: In spite of the large size of the farms in Patagonia,
> staff periodically inspects the animals. Producers, animal caretakers,
> transporters and other industry staff are well aware of FMD or other
> vesicular disease symptoms, reporting requirements and available
> resources to avoid the disease. Routine examinations of livestock
> occur during wool industry-related tasks and official surveillance
> programs, plus animals are also inspected at fairs and before and
> after slaughter.
>
> Conclusion: Husbandry and surveillance practices in Patagonia South
> serve to mitigate the lack of close animal supervision on extensive
> farms. The risk of missing FMD clinical signs in export herds is
> minimal.

[]{#__RefHeading___Toc111609775 .anchor}**Release Assessment --
Conclusion**

Based on evaluation of the 11 factors and observations from the site
visits, APHIS considers that Argentina possesses the legal framework,
animal health infrastructure, detection capabilities, reporting systems,
and emergency response systems that are necessary for maintaining the
Patagonia South region as free of FMD.

[]{#__RefHeading___Toc111609776 .anchor}**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. \[13\]

APHIS considers that the most likely pathway of exposure of domestic
livestock to FMDV in beef is through feeding of contaminated food waste
to swine. \[15\] 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. \[16\] The analysis included two
pathways for exposure of swine to contaminated waste; namely, exposure
associated with illegal household imports, and exposure associated with
legal imports. With 95% confidence, VS estimated that 0.023% or less of
plate and manufacturing waste would be inadequately processed prior to
feeding to swine. \[16\] Based on this fraction, less than 1 part in
4,300 of imported beef is likely to be fed to swine as inadequately
cooked waste.

VS conducted a survey in 2001 of the U.S. swine waste-feeding sector to
update a similar study done in 1994. \[17\] Based on this survey, VS
estimated that the proportion of plate and manufacturing waste fed to
swine diminished by about 50% 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 feeding food wastes to swine,

-   The continental U.S. saw a 40.5% decrease in the number of
    waste-feeding premises, Hawaii a 37.5% decrease and Puerto Rico a
    52.3% decrease, and

-   Institutions and restaurants provide nearly 90% of all plate waste
    fed to swine.

APHIS considers that prohibiting the feeding of unprocessed plate waste
to swine has further contributed to the reduction of waste feeding to
swine. In that regard, waste-feeder operations must be licensed and
inspected regularly by USDA inspectors (9 CFR 166). \[12\] 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 processed 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 to 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 importing inadequately cooked
infected beef from the export region to be low.

[]{#__RefHeading___Toc111609777 .anchor}**Consequence Assessment**

A consequence assessment describes the biologic and economic
consequences of FMD introduction into the U.S. This consequence
assessment addresses both direct and indirect consequences as
recommended by the OIE. \[13\]

The magnitude of the biologic and economic consequences following an
introduction of FMD would depend on the location of the introduction,
the FMDV serotype introduced, the rate of spread of FMD virus and
whether other environmental conditions at the introduction site that
might facilitate this spread, ability to detect the disease rapidly,
livestock demographics and movement patterns, and ease of employing
eradication procedures. \[18\] 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 consequences*

Direct consequences include effects of the disease on animal health and
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]{.underline}

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.
\[19\] In pigs, Dunn and Donaldson (1997) \[20\] estimated a general
mortality rate of 40% for two outbreaks in Taiwan in 1997. Geering
(1967) \[21\] cites mortality rates of 40, 45 and 94% of lambs in
several outbreaks. Mortality in older animals occurs less frequently but
may be significant with certain virus strains.

FMD causes significant losses in the production capacity of affected
animals. Productivity losses of 10 to 20 percent are reported in
FMD-infected livestock \[18\] if the disease is allowed to run its
course. For example, the drop in milk yield of dairy cattle averages
approximately 25% per year. \[22\] In addition, FMD can cause reduction
in the growth rate of animals raised for meat. According to Doel (2003)
\[23\], estimates vary considerably but one study has indicated that
cattle would require approximately 10-20% longer to reach maturity. The
comparatively greater severity of FMD in pigs would imply at least
similar losses to those described for cattle. \[23\]

[Control and eradication costs]{.underline}

The overall cost of control and eradication depends on the mitigation 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 payments, vaccination costs,
surveillance and laboratory testing, etc.

For disease-free countries like the U.S. that have a substantial export
market for livestock and livestock products, the preferred option for
control and eradication has traditionally been to stamp-out infected
herds without the use of vaccine. In fact, the U.S. policy for FMD
emergencies is to follow strict quarantine measures and stamping-out of
infected and contact herds with ongoing assessment for the need for and
implementation of strategic vaccination.

Published studies indicate that where 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, vaccination might be
beneficial in protecting high-producing livestock. \[24\] A recent 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. \[25\]

Available data do not allow 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 (2003) \[26\] 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 5 sale yards located in 3 counties of California. The
study found that mean herd indemnity payments were \$2.6 million and
\$110,359 for dairy and non-dairy 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) \[18\] conducted a
comprehensive study to assess the potential economic impact of FMD in
the whole of the U.S. The study estimated the direct costs (control and
eradication program costs) and increased costs borne by consumers of FMD
introduction over a 15-year period (1976-1990). The study examined
several control and eradication options. Relevant to this assessment are
strategies employed to eradicate the disease by stamping out or area
vaccination. In the extreme event of endemic FMD in the U.S., the impact
of compulsory or voluntary control programs was also considered. A
summary of the findings are shown in table 15. The results were updated
using the difference in the Consumer Price Index (CPI) in 2001. \[27\]

[]{#__RefHeading___Toc103570796 .anchor}Table 18. Economic impacts of
FMD adjusted from 1976 dollars to March 2001 dollars by Consumer Price
Index^1^.

+--------------------------+------+-----+-----+------+-------+-------+
| McCauley estimates       | Cons |     | P   |      | T     |       |
|                          | umer |     | rog |      | otals |       |
|                          | Imp  |     | ram |      |       |       |
|                          | acts |     | Co  |      |       |       |
|                          |      |     | sts |      |       |       |
+--------------------------+------+-----+-----+------+-------+-------+
|                          | \-\  |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-- |     |     |      |       |       |
|                          | mill |     |     |      |       |       |
|                          | ions |     |     |      |       |       |
|                          | of   |     |     |      |       |       |
|                          | dol  |     |     |      |       |       |
|                          | lars |     |     |      |       |       |
|                          | \-\  |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-\ |     |     |      |       |       |
|                          | -\-- |     |     |      |       |       |
+--------------------------+------+-----+-----+------+-------+-------+
|                          | *197 | *2  | *1  | *    | *1976 | *2001 |
|                          | 6\$* | 001 | 976 | 2001 | \$*   | \$*   |
|                          |      | \$* | \$* | \$*  |       |       |
+--------------------------+------+-----+-----+------+-------+-------+
| Endemic FMD w/ voluntary | \$11 | \$  | na  | na   | \$1   | \$    |
| control                  | ,600 | 35, |     |      | 1,600 | 3     |
|                          |      | 844 |     |      |       | 5,844 |
+--------------------------+------+-----+-----+------+-------+-------+
| Eradication by strict    | \$10 | \$  | \$  | \$1  | \$1   | \$    |
| slaughter & quarantine   | ,600 | 32, | 539 | ,666 | 1,139 | 3     |
|                          |      | 754 |     |      |       | 4,420 |
+--------------------------+------+-----+-----+------+-------+-------+
| Eradication by area      | \$11 | \$  | \$  | \$2  | \$1   | \$    |
| vaccination              | ,600 | 35, | 690 | ,132 | 2,290 | 3     |
|                          |      | 844 |     |      |       | 7,976 |
+--------------------------+------+-----+-----+------+-------+-------+
| Compulsory vaccination   | \$8  | \$  | \   | \$12 | \$1   | \$    |
| program w/               | ,900 | 27, | $4, | ,978 | 3,100 | 4     |
|                          |      | 501 | 200 |      |       | 0,479 |
| endemic FMD              |      |     |     |      |       |       |
+--------------------------+------+-----+-----+------+-------+-------+

1\. Increase by difference in CPI = 3.09, Bureau of Labor Statistics, US
Department of Labor.

*Source: Adapted, McDowell 2001, personal communication.*

[Effect on the Environment]{.underline}

Environmental effects of the proposed action have been considered under
applicable U.S. environmental review laws. The proposed action involves
routine monitoring and adjustment of the disease status of the region in
Argentina relative to the regulation of specific animals and animal
products and poses negligible impact. Therefore, this action is
categorically excluded from further review under the APHIS NEPA
implementing procedures definition for categorical exclusions under 7
CFR 372.5(c)(1). This action also will have no effect on federally
listed or proposed endangered or threatened species or critical habitat
(16 U.S.C. 1531 et seq.). \[28\]

[Effect on public health]{.underline}

Although public health consequences are not issues under APHIS'
regulatory authority, we address the issue in this assessment. FMD may
rarely affect humans. 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 has been isolated and typed in only
40 patients during the last century. Symptoms in humans are mostly mild
and mainly include fever, and blisters on the hands, feet, mouth, and
tongue. Patients usually recover within a week after the last blister
formation. \[29\]

Perhaps more importantly, a 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 movement
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, revealed high rates of
depression, alcohol consumption and mortality among farmers during the
crisis (Lancaster University, Unpublished report). \[58\]

*Indirect consequences*

In addition 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 billions of US
dollars. The value of U.S. exports of beef products alone, which would
be immediately lost, was over US\$3 billion in 2001. 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. \[30\] conducted a study to estimate the
potential revenue impact of an FMD outbreak in the U.S. similar to the
one that occurred in the United Kingdom. The study suggested that
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%), beef (20%),
milk (16%), swine (34%), pork (24%), sheep and lambs (14%), and sheep
and lamb meat (10%). Thompson et al (2002) \[39\] estimated the loss of
about 20% of the estimated total income from farming in 2001 because of
the FMD outbreak in the United Kingdom.

Japan, Korea and Mexico constitute the three major U.S. export markets
for ruminant products. The value of lost exports to these three ruminant
markets would total \$3 billion annually if trade restrictions were
enforced against the U.S.: Japan (\$1.2 billion); Mexico (\$1.12
billion); and South Korea (\$712 million). Indirect economic losses to
U.S. firms that support ruminant exports to these three markets would
equal an additional \$2.5 billion annually. The magnitude of these
values reflects both animal and product exports. \[31\]

More than 33 thousand full-time U.S. jobs, accounting for almost \$1
billion in wages annually, could be jeopardized by loss of these three
markets. In the longer term, if trade restrictions persisted and
alternative export markets did not develop, the U.S. ruminant production
sector could contract, allowing other supplying countries to establish
trade relationships in the absence of U.S. supply. \[31\]

Other losses due to restrictions on live swine, pork, and pork products
are likely to be significant as well. The U.S. exports of pork and pork
products are estimated at \$1.3 billion dollars in 2003. \[32\] Since
the U.S. exports only small amounts of lamb and mutton, economic losses
associated with these commodities are not likely to be significant
compared to cattle and swine.

[]{#__RefHeading___Toc111609778 .anchor}**Risk Estimation**

Risk estimation consists of integrating the results from the release
assessment, exposure assessment, and consequence assessment to produce
overall measures of risk associated with the hazards identified at the
outset. Thus, risk estimation takes into account the whole risk pathway
from hazard identified to the unwanted event. \[13\]

APHIS concludes from the assessment that the surveillance, prevention,
and control measures implemented by Argentina are sufficient to minimize
the likelihood of introducing FMD into the U.S. via imports of
FMD-susceptible species or products from such species from the Argentina
Patagonia South region. Although consequences of a FMD outbreak are
potentially substantial, the likelihood of an outbreak occurring via
exposure of the domestic livestock population to animal products
imported from the Argentina Patagonia South region is low.

The consequences of a FMD outbreak in the U.S. 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\$44 billion,
in 2001 dollars depending on the magnitude of the outbreak and
eradication strategy. Although such consequences are significant, it is
important 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 a FMD outbreak in the U.S.
would be very high, given the findings of the release and exposure
assessments, APHIS considers the risk of FMD-infected animals or
products entering the U.S. from the export region and exposing the U.S.
livestock through feeding of infected materials to susceptible animals,
to be low.

[]{#__RefHeading___Toc111609779 .anchor}**References**

[]{#__RefHeading___Toc111609780 .anchor}**Appendix 1: Epidemiologic
characteristics of foot-and-mouth disease (FMD)**

*Etiologic Agent*

Family *Picornavirida*e, Genus *Aphthovirus*, types O, A, C, SAT 1, SAT
2, SAT 3 and Asia 1.

*Status in the U.S.*

FMD virus was eradicated from the U.S. in 1929.

*Epidemiology*

FMD is a highly communicable disease of cloven-hoofed animals caused by
an *Aphthovirus* of the family *Picornaviridae*. FMD has seven
immunologically distinct serotypes (O, A, C, SAT1, SAT2, SAT3 and Asia
1). The O, A, and C serotypes have historically been found in South
America. \[33\] Research indicates that one serotype does not confer
protective immunity against the other six, thus a disease outbreak can
be caused by one serotype or a combination of serotypes. \[34\]

FMD virus can be transmitted by direct or indirect contact or aerosol.
Fomites such as feed, drinking water, tools, animal products, as well as
human clothing, transportation vehicles, rodents, stray dogs, wild
animals and birds can transmit FMD over long distances. The five main
elements that influence the extent of FMD spread are: (1) the quantity
of virus released, (2) the means by which the virus enters the
environment, (3) the ability of the agent to survive outside the animal
body, (4) the quantities of virus required to initiate infection at
primary infection sites, and (5) the period of time the virus remains
undetected. \[35, 36\]

The incubation period of the FMD virus is 2-14 days in cattle depending
on the viral strain and dose and the level of susceptibility of the
animal. \[37\] Morbidity in unvaccinated herds can be high but mortality
usually does not exceed 5 percent. If it occurs during the calving
season, calf mortality can be considerable. \[38\] Young calves may even
die before the development of clinical signs usually because the virus
attacks the heart muscles. \[37\]

The respiratory tract is the usual route of infection in species other
than pigs. Infection can also occur through abrasions of the skin or
mucous membranes. In cattle and sheep, the earliest sites of virus
infection and possibly replication appear to be in the mucosa and the
lymphoid tissues of the pharynx. Following initial replication in the
pharynx, the virus then enters the bloodstream. Viremia in cattle lasts
for 3 to 5 days, and, as a result, the virus spreads throughout the body
and establishes sites of secondary infections. \[39\]

FMD virus localizes in various organs, tissues, body fluids, bone
marrow, lymph nodes. \[40, 41\] Viral replication may reach peak levels
as early as 2 to 3 days after exposure. \[42, 43\] Virus titers differ
in different organs or tissues. Some tissues, such as the tongue
epithelium, have particularly high titers. Recent data indicate that the
most viral amplification occurs in the stratified, cornified squamous
epithelia of the skin and mouth (including the tongue). Although some
viral replication also occurs in the epithelia of the pharynx, the
amount of virus produced there is apparently much less than the amount
produced in the skin and mouth during the acute phase of the disease. By
comparison, the amount of virus (if any) produced in other organs like
salivary glands, kidneys, liver and lymph nodes, is negligible. \[42,
43\]

Immunity to FMD is primarily mediated by circulating antibodies. \[44\]
The host reaction, including antibody production, occurs from 3 to 4
days after exposure and usually clears the virus, except in carriers. In
infected pigs, the virus is cleared in less than 3 to 4 weeks. In
contrast, around 50% or more of cattle will develop a low-level
persistent infection, localized to the pharynx. \[45-47\] According to
Alexandersen (2002)\[44\], a model for progression of infection can be
described as follows: first, virus exposure and accumulation of virus in
the pharyngeal area is followed by initial spread through regional lymph
nodes and via blood stream to epithelial cells. This is followed by
several cycles of viral amplification and spread. \[44\]

Clinical signs in cattle during acute infection include fever, profuse
salivation, and mucopurulent nasal discharge. The disease is
characterized by development of vesicles on the tongue, hard palate,
dental pad, lips, muzzle, gum, coronary band and interdigital spaces.
Vesicles may develop on the teats. Affected animals loose condition
rapidly and there is a dramatic loss of milk production. \[37\] The
animal usually recovers by 14 days post infection provided no secondary
infections occur. \[39\]

Diagnosis of the disease relies heavily on recognizing clinical signs.
In unvaccinated cattle and pigs the clinical signs are obvious. However,
in small ruminants the disease is often subclinical or is easily
confused with other conditions. In addition, in endemic regions,
clinical signs in partially immune cattle may be less obvious and could
pass unnoticed. \[37\] Virus isolation and serotype identification are
necessary for confirmatory diagnosis. The clinical signs of FMD are
similar to those seen in other vesicular diseases. Differential
diagnosis of vesicular diseases includes vesicular stomatitis, mucosal
disease of cattle, bluetongue, rinderpest, and FMD. Serological
diagnostic tests include the complement fixation test (CFT), virus
neutralization test (VNT), and an ELISA test. Other diagnostic tests
include one‑ or two‑dimensional electrophoresis of the viral DNA,
isoelectric focusing of the viral structural proteins, or nucleotide
sequencing of the viral RNA. \[36\]

The FMD virus is relatively resilient. It can survive up to 15 weeks in
feed, 4 weeks 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. For example, in muscular tissues the acidity of
rigor mortis, which occurs naturally, inactivates the virus. The
production of lactic acid in these tissues during maturation is
considered to be the primary factor for inactivation. \[48\] An acid
environment where the pH is less than 6.0 will destroy the virus
quickly. \[48, 49\] Several studies showed that in tissues where no
acidification occurs (e.g., lymph nodes, bone marrow, fat, and blood),
the virus may survive for extended times in cured and uncured and frozen
meat. \[41, 48-51\] Heating at 50°C \[31\] and up to 155°F \[52\] will
inactivate the virus.

[^1]: The Patagonia Region consists of three areas: Patagonia South,
    Patagonia North B and Patagonia North A.

[^2]: The design of all serological samplings and the analysis of their
    results in Argentina are carried out by the Epidemiology Advising
    Commission and the Virology Advising Council, of the National Bureau
    of Animal Health of the Bureau of Epidemiology.

[^3]: According to the supplier of the diagnosis kits, it was reported
    that the characteristics of the serological tests are the following:

    ELISA 3ABC (PANAFTOSA): Sensitivity: between 99.8 and 100% (infected
    animals without/with vaccination, respectively.) Specificity:
    between 95.2 and 99.05 % (according to whether it has been
    vaccinated or not, and the number of vaccines received)

    ELISA 3 ABC (CEVAN): Sensitivity: 100 %; Specificity: 99.5%

    EITB (PANAFTOSA): Sensitivity: 99.8 to 100% (animals without/with
    vaccination, respectively); Specificity: 99.68 to 100% (according to
    whether it has been vaccinated or not, and the number of vaccines
    received)

    VIAA-IDGA: Sensitivity: 70 %; Specificity: 99 %

[^4]: A sub-zone may comprise a whole province, a group of provinces or
    an area formed by parts of different provinces.

[^5]: In these provinces the bovine species represents 3% of the entire
    susceptible livestock (sheep and bovines) in Zone C. Therefore, it
    was not considered as significant for the purposes of the sampling
    and only ovine samples were requested.

[^6]: Considering that the population of sampled is not vaccinated and
    the high contact rate among individuals within a deer establishment
    and the behavior of the FMD in general in non immunized populations,
    the 10% design prevalence is conservative.

[^7]: Red deer, wild boar and the guanaco are among the wild species of
    varying susceptibility to the FMD virus which are hunted in the
    different Patagonia game reserves.

[^8]: Here too, additional studies were carried out in the
    establishments where animals reacting to the tests have been found.
    These studies included new samplings of susceptible animals, with
    EPF (esophagus-pharyngeal fluid) sample collection for isolation and
    PCR of positives. In all the cases the tests were negative,
    discarding the presence of infection. \[8\]