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# Recognition of Patagonia Region in Argentina as Free of
Foot-and-Mouth
Disease

Environmental Assessment, January 2014

# Recognition of Patagonia Region in Argentina as Free of
Foot-and-Mouth Disease

Environmental Assessment, January 2014

Agency Contact: Dr. Silvia Kreindel, Senior Staff Veterinarian Regionalization Evaluation Services Staff National Center for Import and Export Veterinary Services Animal Plant Health Inspection Service U.S. Department of Agriculture

4700 River Rd. Unit 38 Riverdale, MD 20737

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## Table of Contents

I. Need for the Action

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

A. Introduction

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

B. Need

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

II. Alternatives

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

A. No Action

............................................................................................................................... ........... 6

B. Preferred Alternative

........................................................................................................................ 6

III. Environmental Consequences

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

A. No Action

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

B. Preferred Alternative

...................................................................................................................... 10

1. FMDV and Vaccinations

.............................................................................................................. 11

2. FMD and Processing

.................................................................................................................... 14

3. Regulatory Control of FMD

......................................................................................................... 14

4. Interspecies Transmission of FMD

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

5. Environmental Fate of FMD

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

6. Public Health

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

IV. Other Environmental Issues............................................................................................................... 23

A. Environmental Justice and the Preferred Alternative

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

B. Protection of Children and the Preferred Alternative

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

C. Threatened and Endangered Species and the Preferred Alternative

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

D. Potential Cumulative Impacts

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

V. Listing of Agencies Consulted

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

VI. References

............................................................................................................................... ........... 274 

## I. Need for the Action

A. Introduction

Generally, the importation of livestock is prohibited except under certain circumstances from specific areas, as stated in Title 9 Code of Federal Regulations (CFR) § 94. These restric tions are designed to prevent the

introduction of a number of animal diseases includi ng foot-and-mouth disease (FMD). In 1997, the U.S. De partment of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), established rules for recognizing regions, rather than only countries, for the purpose of importation of animals and animal pr oducts into the Un ited States (9 CFR 92.2). This action was design ed to facilitate trade while minimizing the risk of the introductio n of animal disease to the United

States.

Argentina submitted an official reques t to APHIS to attain recognition of a region of Patagonia, which consists of Patagonia South (the region of Argentina south of the 42 nd parallel) plus the adjacent region immediately north of the 42 nd parallel known as Patagonia North B (hereafter referred to as Patagonia Region), as free from FMD. The World Organization for Animal Hea lth (OIE) consid ers the Patagonia Region to be free of FMD. The la st outbreak of FMD in the Patagonia Region occurred in 1994. Consistent with U.S. regulations, APHIS conducted a risk analysis to evalua te the likelihood of FMD introduction into the United States through the importation of animals and animal products from the Patagoni a region in Argentina. The findings of that document are summarized and incorpor ated by reference into this environmental assessment (EA).

FMD is an acute, highly contagious viral disease that primarily affects cloven-hoofed animals. FMD may affect humans; however, that occurrence is rare (USDA-APHIS, 2013). All cloven-hoofed animals including cattle, sheep, goats, deer, buffalo, and swine are susceptible to

FMD. The death rate from this dise ase is usually low; however, clinical signs during the acute phase of the inf ection can result in costly losses in meat and milk production. The diseas e is characterized by vesicles that develop in the hooves and mouth areas. FMD is transmitted to susceptible animals through exposure to the active virus. Transmission may occur through inhalation of ai rborne droplets (primarily from animals in close contact) through di rect contact (such as ingestion, sexual transmission, mucous membrane discharge from the eyes, nose, or mouth, skin or mucous membrane abrasions), or through indirect exposure (feed, drinking water, eq uipment, animal products, human clothing, transportation vehicles). Ex clusion of this disease from the5 United States is particularly important in that the virus responsible for this disease is highly contagious a nd can survive in the environment for extended periods of time. Previous outbreaks of FMD in the United States have been very costly to cont ain and eradicate. The United States reported the last FMD outbreak in 1929.

APHIS conducted site visits to Arge ntina in 2003, 2005 , 2006, 2009, and 2013. Based upon the find ings of those site visits and the risk assessment, APHIS concludes that the Patagonia Region is free of FMD and the

likelihood of introduction of FMD vi rus (FMDV) into th e United States via susceptible species or their prod ucts imported from the Patagonia Region is very low. The combination of Argentina’s legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs, an d emergency response capacity provides a comprehensive system wi th redundant safeguards that are sufficient to detect, prev ent, control, and eradic ate FMD outbreaks within

the boundaries of th e Patagonia Region.



### B. Need

In response to an official request from Argentina and in accordance

with relevant U.S. statutes and regulations and agreements, APHIS has reviewed the issues related to importation of species and products susceptible to FMD from the Patag onia Region of Ar gentina. The preparation of this EA complies with the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321-4327, its implementing regulations, and Executive Orde r 12114, “Environmental Effects Abroad of Major Federal Actions ”. The issue of potential

environmental risks of an outbreak of FMD in the United States resulting from imported animals a nd animal products is of great

concern to APHIS. Characterization of the disease ri sk potential and adequate mitigation measures are critical to excluding this disease

from the United States.



## II. Alternatives

This EA analyzes potential envir onmental consequen ces of recognizing the Patagonia Region of Argentina as free of FMD. This recognition would allow the importation of FMD-susceptible animals or products originating in the Patagonia Region of Argentina under certain conditions. The two possible alternatives considered in this EA are (1) the current recognition of the Patago nia Region of Arge ntina as an FMDaffected region similar to the rest of the country (no action), and (2) recognition of the Patagonia Regi on as free of FMD (preferred alternative). The issues of potential environmental impacts associated6 with the disease risks of each alte rnative are discussed in section 3, Environmental Consequences of the Alternatives.



### A. No Action

The No Action Alternative is define d as continuation of the current sanitary regulation of importation of animals a nd animal products from all of Argentina. This alternativ e would involve con tinuation of the prohibition of the importation of FMD-susceptible animals and products from Argentina. The lack of any ch anges in conditions for the entry of commercial shipments of live rumi nants, beef, pork, lamb, and other livestock products from Argentina ma intains overall dis ease risks at the
status quo.



### B. Preferred Alternative

Recognition of the Patagonia Region as FMD-free

Argentina has requested that AP HIS recognize the Patagonia Region

as free of FMD. The Preferre d Alternative would recognize the Patagonia Region of Argentina as FMD-free and would allow the importation of FMD-susceptible animals and products from the Patagonia Region, under certain cond itions. After conducting a risk assessment in connection with the request, APHIS has determined that ruminant and ruminant products can be safely imported from the Patagonia Region within Argentina pr ovided that certain requirements are met. In addition, because rinde rpest has never be come established in South America, APHIS would recognize the Patagonia Region of Argentina as free of rinderpest. Th e Preferred Alternative is designed to maintain sanitary security in the United States while facilitating trade with Argentina.

The conclusions of the risk asse ssment for the Patagonia Region, as presented in the disease risk analysis (USDA–APHIS, 2013) are summarized for each regionalization factor below. 1 Argentina’s consistent and ongoing fulfillment of these factors is part of the requirement for recognition of disease-free status –

1 The 11 factors (defined by APHIS as necessary to regionalization as described in 9 CFR § 92.2(b)) are met by the Patagonia Region of Argentina. In 2012, APHIS consolidated the 11 factors into 8 factors. However, since the evaluation of the Patagonia Region started before 2012, and the topics addressed by the 11 factors are contained within the 8 factors, this report

follows the 11 factor format.7 (1) Argentina has made significant improvements to its veterinary

infrastructure since FMD outbr eaks in Argentina in 2000-2001. Based upon site visits and doc umentation reviews, APHIS considers Argentina’s Servicio Nacional de Sa nidad y Calidad Agroalimentaria (SENASA) to have sufficient legal authority to carry out official disease cont rol, eradication, and quarantine activities. In addition, APHIS is confident that in the unlikely event of another outbreak, re porting would be prompt and
transparent.

(2) The last FMD outbreak in th e Patagonia Region occurred in 1994. There is no evidence to suggest that any species have been infected with FMDV in this region since 1994.

(3) Argentina is bordered by Paragu ay to the north, Bolivia to the northwest, Uruguay and Br azil to the northeas t, and Chile to the west. APHIS only considers Ch ile to be FMD-free; however, there is no evidence that FMD has been transported from surrounding countries a nd/or other regions of Argentina into the Patagonia Region in 20 years. All sides of this region are bordered by either the ocean or areas that are either free of

FMD with or without vaccina tion following OIE standards.

(4) There is not an active diseas e control program in the Patagonia Region since an FMD outbreak has not occurred since 1994. There are measures in place, however, including strict animal movement controls, border inspections, and cl inical surveillance for prevention and early detection if the disease were introduced.

(5) FMD vaccination is prohibited in the Patagonia Region. In the absence of vaccination, it is likely that clinical signs compatible with FMD resulting from an incursion of disease would be

identified.

(6) Most of the Argentine border is protected by natural barriers that help reduce the unrestricted flow of animals and animal products from areas of higher risk. Government movement control measures compensate in areas where natural barriers do

not exist.

(7) The Patagonia Region has adequate controls at ports of entry for legal commercial and nonco mmercial importation of FMDsusceptible species and livestock pr oducts. Site visits to border control posts demonstrate adequate staffing levels, knowledge of requirements and procedures, professionalism, and efficiency.

(8) Argentina has a system designed to capture farm inventory,8 animal movement information, sanitary information, identification numbers, and cont rol movements. The National Identification System is comprehensive and enables the Patagonia Region to comply w ith the U.S. certification requirements.

(9) Argentina has a surveillance system designed to estimate herd immunity of the vaccinated cattle population and to

demonstrate the absence of FMDV circulation. In 2011, serological sampling was cond ucted to demonstrate the absence of disease in the Patagon ia Region; no reactors were found. In 2013, a serol ogical survey of Patagonia North A was designed to supplement inform ation needed to apply for recognition of this area as an FMD-free zone without

vaccination. No reac tors were identified in any of the samples

collected.

(10) Argentina has one diagnostic laboratory for FMD in Buenos Aires. The laboratory was determined by APHIS to have sufficient capacity to accurately diagnose FMD.

(11) Emergency res ponse capab ilities in Argentina are adequate. Local veterinary officials are well-trained in procedures to

control and contain FMD outbr eaks. A plan developed by

SENASA in 2007 also addre sses procedures for rapid

containment of disease in case of an outbreak.

Under the Preferred Alternative, onc e a country is listed as FMD-free following APHIS’ evaluation, other requirements must be met to import ruminants into the United States from the Patagonia Region. These requirements ensure that FM D-susceptible animals and products can be safely imported from the Patagonia Region:

 The ruminants must be accompanied by a health certificate issued by a full-time salaried vete rinary officer of the national government of the region of origin (9 CFR 93.405.a);

 The ruminants must have been kept in the FMD-free region during the last 60 days immedi ately preceding the date of shipment to the United States (9 CFR 93.405.a.1) during which time they may not have been exposed to communicable disease, or have been under any quaranti ne (9 CFR 93.405.a.2) or other movement restrictions due to animal health concerns. If any restrictions have occurred, they must be communicated to APHIS in advance of an import permit being issued;

 The animals must have been isol ated without contact with any

other ruminants or animals that could transmit diseases or9 ruminants for a period of 60 days prior to export, during which time they must be tested for communicable diseases as specified by APHIS;

 The ruminants may not have been vaccinated for FMD;

 All ruminants imported into the United States (except from Canada, Mexico, Central America, and West Indies) must be quarantined in a USDA facility (or a privately-owned, APHISapproved quarantine facility) for not less than 30 days starting from the date of arrival at the port of entry (9 CFR 93.411.a).

These requirements mitigate the risk of exposure by increasing the probability of disease detection prio r to export and during quarantine

in the United States.

The requirements in 9 CFR 94.11 mitig ate the risks associated with importing meat and other animal pr oducts from regions with less restrictive practices by (1) restri cting the sourcing of meat of

ruminants and swine to the FM D-free region, (2) prohibiting commingling of live animals, meat, or meat products for export with such commodities from regions not considered free of FMD, and (3) requiring exporting slaughter establ ishments to be approved by the USDA’s Food Safety and Inspection Se rvice. In addition, an official veterinarian of the exporting c ountry must certify that these

conditions have been met.



## III. Environmental Consequences

A. No Action

The No Action Alternative would le ave the current recognition of FMD status in the Patagonia Region unchanged. Under this alternative, the Patagonia Region w ould continue not to be allowed to export FMD-susceptible ruminant s and ruminant products to the

United States.

The biological history and disease potential of FMD suggest that

the continuation of the current regulations of FMD-susceptible animals and products (no entry) from the Patagonia Region of Argentina would maintain the status quo with respect to impact on

the human environment. As w ith most commodities, there is always some risk of smuggling; however, the frequency is low due to the high punitive costs from noncompliance. Due to the high potential risks from disease associated with noncompliance, APHIS’ policy is to provide a stro ng deterrent. Therefore, APHIS10 keeps importers and shippers info rmed of its import regulations and of the penalties fo r inadequate compliance. The importer or shipper could be subject to civil penalties, criminal fines, jail sentences, and loss of revenue due to APHIS’ rejection of commodities, permit applications, and/or compliance agreements. A major tool for APHIS is the opt ion to refuse entry, require treatment, or require destruction of infected or potentially infected cargo. All of these options are costly to the shipping line and exporter who must assume all costs for the delays and any

treatments.

All of these measures provide strong incentive for full compliance with import regulations. Monitoring the rates of compliance with a phytosanitary rule, promulgated in 1998, found that proper compliance with those import requirements was achieved approximately 98 percent of the time (USDA–APHIS, 2003). Co mparable compliance is expected for any present or revised sanitary regulations related to the importation of FMD-susceptible animals and produ cts from the Pata gonia Region.



### B. Preferred Alternative

The environmental consequences fr om recognition of the Patagonia Region of Argentina as FMD-free ar e largely contingent upon the effectiveness of various mitigations and procedures to preclude exposure of the Patagonia Region to FMDV and to preclude importation from the Patagonia Regi on to the United States of any ruminants or ruminant products that could potentially be infected with FMDV. The risk analysis (US DA–APHIS, 2013) of importing FMD in susceptible species and pr oducts from the Patagonia Region

evaluates the risk of the diseas e in the region. While permitting exports from the Patagonia Region is assumed to pose some theoretical risk of exposure beyond the No Action Alternative, APHIS has determined that such risk is very low and that FMD-susceptible animals and products can be safely imported from the Patagonia Region within Argentina provided that certain requir ements are met. Findings of the risk analysis are summarized within this document and are incorporated by reference herein.

Compliance with NEPA requires AP HIS to consider all potential

effects to the human en vironment from this ru le. In addition to

consideration of disease issues re lated to livestock, this document analyzes characterization of the potential effects to humans, wildlife, and environmental quality. The info rmation is presented by topics related to program requirements an d mitigative actions that affect potential disease risks associat ed with the importation of FMD-11 ruminant susceptible species and as sociated unprocessed products from the Patagonia Region in Argentina. This includes sections with issues related to the vaccinations, surv eillance, the disease transmission

mechanism as related to wildlife, and the pers istence of FMDV under

various environmental conditions on or in environmental media such as in soil, in water, on plan ts, and on abiotic surfaces.

FMDV is the virus that causes FM D. FMDVs are members of the Picornaviridae family a nd viruses of the genus Aphthovirus . FMDV is a small virus that is very infectious, multiplying in and causing damage to cells throughout the body of suscepti ble animals. The virus can survive

in the environment for extended periods of time. FMD is an acute, highly contagious viral disease, main ly of cloven-footed animals. The

risk to humans from FMDV is mini mal. Confirmed cases of FMD in humans are rare. Symptoms in hum ans are mostly mild and primarily

include fever and blisters in the mout h. Patients usually recover within a

week after the last blister fo rmation (USDA–APHIS, 2013).

The major host species for FMDV is wi dely recognized to be domestic

cattle. FMD in cattle is characterize d by the formation of lesions on the feet and mouth, damage to th e mucous membrane lining the gastrointestinal system, and high fe ver. Damage from FMDV also may occur to the heart muscle cells (parti cularly in young animals), the milksecreting cells of the udder, and hormone-producing cells. All clovenhoofed animals including cattle, sheep, goats, de er, buffalo, and swine are susceptible to FMD. The death rate from this disease is usually low; however, clinical signs during the acute phase of the infection can result in costly losses in meat a nd milk production. The disease is characterized by vesicles that develop in the hooves and mouth areas.

FMD is transmitted to susceptible animals through exposure to the active virus. Transmission may occur throug h inhalation of airborne droplets (primarily from animals in close cont act), through direct contact (such as ingestion, sexual transmission, mucous membrane discha rges from the eyes, nose or mouth, skin or muc ous membrane abrasions), or through indirect exposure (feed, drinking water, equipment, animal products, human clothing, transportation vehicles). Exclusion of this disease from the United States is particularly impo rtant in that the virus responsible for this disease is highly contagious and can survive in the environment for extended periods of ti me. Previous outbreaks of FMD in the United States have been very costly to cont ain and eradicate. The United States reported the last FMD outbreak in 1929.

For FMD to remain in a population, each infected animal must infect at least one other animal. The prim ary methods in which FMDV moves

out of an infected animal are in ai rborne droplets from the lungs and the 1. FMDV and
Vaccinations12 fluid-filled vesicles; in the saliva, urine, feces, semen, and milk; secretions from the eyes, nose, pr epuce, and vagina (WIN, 2001). Infected meat, hides, and bones also carry the FMDV.

It is possible for animals to carry FMDV without appearing clinically ill under conditions such as recovery fr om clinical dis ease and undetected subclinical disease; nevertheless, re ports of carrier animals infecting susceptible animals are extremely ra re (WIN, 2001). Different strains 2

of FMD have different ca pacities to establish pe rsistent infection, and the proportion of animals that become carriers following exposure to virus varies depending on the severi ty of the challenge, but does not appear to be influenced by the age or sex of the host (WIN, 2001). The

establishment of carriers is reduced in endemic areas if routine

vaccination is used. Vaccination does not cause animals to become FMDV carriers; properly inactivated vaccine, when injected into animals, does not give rise to the carrier state (WIN, 2001).

Three general conditions must be present for a virus to pe rsist over a long term in a host. First, the viru s must be able to infect host cells without being lethal to the cell. Second, there mu st be mechanisms for long-term maintenance of the viral genome 3 in host cells. Third, the

virus has to avoid detection and elimination by the host’s immune system (Fields et al., 1996). Viruses have devised various strategies to accomplish these goals. The normal response of the immune system is to detect antigens 4 and establish an immune re sponse to those antigens. A virus will modify specific antigens or proteins so as to evade the host’s immune system, thereby establis hing persistent infection in the host. In the case of FMD, the m odification of specific antigens or proteins gives rise to a substrain of virus.

Given that viruses tend to modi fy their antigenic and protein characteristics for persistent survival within the host, it is likely that

FMDV will switch strains. Vaccination against a certain FMD strain does not result in protection against other strains. Argentine animal health authorities may respond to the presence of outbreaks in the Patagonia Region by following a stamping out that involves the killing of susceptible animals that were likely to have been exposed to the index case. Regardless of the strain that may cause an outbreak, SENASA will

2 A strain is a taxonomic subdivision of a micro-organism based on characteristic antigens or proteins.

3 A genome represents all of the genetic information or hereditary material possessed by an organism or micro-organism.

4 An antigen is a substance that can trigger an immune response, usually a foreign protein, which is not found naturally in the body.13 manage FMD outbreaks following their contingency plan, and a sanitary state of emergency will be declar ed with the accompanying quarantine and movement restrictions and sanitary measures (USDA–APHIS, 2013).

a. FMD Situation in the Patagonia Region

The epidemiological office of the National Animal Health Office in Argentina is responsible fo r the regulatory aspects a nd the assessments of the recorded information. The general field office, the regional supervisors, and

the local SENASA veterinarians are responsible for the operations.

In May 2002, the OIE recognized th e area south of the 42nd parallel (Patagonia South) as FMD free wit hout vaccination. In May 2007, the OIE recognized Patagonia North B as FM D free without vaccination. The northern border of the Patagonia Region borders an area of Argentina which is considered by the OIE to be free of FMD with vaccination (Northern Argentina). Vaccination is not prac ticed in the Patagon ia Region and has never been systematically applied. V accination also is not performed in Patagonia North B. Administration of serum against FMD infection is not permitted in these regions.

b. FMD Surveillance

FMD has not been diagnosed in South America for two years (last outbreak reported in Paraguay in 2012) (USDA-APHIS, 2013). Effective FMD surveillance programs in the South America region are essential in the prevention and co ntainment of disease outbreaks.

APHIS has evaluated the movement an d detection controls in place for the Patagonia Region of Argentina a nd has determined that they are adequate to maintain an overall very low level of risk of introducing FMDV to the United States via the pathway of live ruminants and ruminant products exported from the Patagonia Region (USDA–APHIS, 2013).

The FMD surveillance performed in the Patagonia Region can be broadly characterized as having two phases: (1 ) demonstrating freedom from disease in a zone, and (2) monitoring of the zone. Argentina employs “active” and “passive” systems of surveillance. Passive surveillance—watching for any suspicion of FMD—in Argentina is bolstered by effective community education and involvement, while the bul k of active surveillance consists of the annual serological sampling of ra ndomly selected animals and regular survey of higher-risk areas (USDA–AP HIS, 2013). APHIS considers the14 Patagonia Region to have implemente d effective disease surveillance strategies.

Animal processing can lead to exposure and spread of FMD. Only livestock from production areas complying with the APHIS certification requirements

under the Preferred Alternative w ould be accepted for slaughter, and processing would occur only at approved facilities in the Patagonia Region of Argentina.

Federal, State, and local veterinary aut horities enforce the animal health laws in Argentina. SENASA establishes and en forces animal health regulations at the national level in Argentina to pr event the introduction and spread of animal pests and diseases. Argen tina has instituted the National Identification System. Domestic m ovement controls over animals are stringent. Through these FMD regulat ions, the Government controls the

movement of cattle from one location to another. SENASA, Federal and State veterinary facilities, and accredit ed veterinarians all play a role in ensuring the health of li vestock in Argentina.

The severity of an FMD outbreak may be influenced by government’s decisions such as reporting and notifi cation delays. As noted in the risk analysis, Argentina’s cu rrent reporting and notif ication systems meet

U.S. and international standards.

The establishment of effective survei llance and monitoring of susceptible livestock also is important in preventing and limiting FMD outbreaks. Argentina requires that all premises with agricultural animal production register with SENASA and obtain unique identification numbers that encode information about individual premises, and link to data on the health, test status, and movement of their animals. Animals are tracked from field to slaughter; slaughterhouses must be able to identify every supplier and trace all products intended for export, show ing compliance with the requirements

of SENASA and those of the destinati on country. The SENASA individual animal and premises identification sy stem (SENASA Resolution 754/2006) is mandatory for all bovine and ovine des tined to the European Union (USDAAPHIS, 2013).

Chile is the only South American count ry considered by APHIS to be FMDfree (USDA–APHIS, 2013). To avoid disease introduction and spread into Argentina, Argentina operates domestic checkpoints; its international borders are monitored in a regional disease- control effort. Even so, disease transmission into Northern Argentina fr om adjacent countries has occurred.

In areas where natural barriers do not exis t, and at sea, air, and land ports of entry, Argentina has enhanced governmental protocols to protect their animal populations against FMD. Border su rveillance and extensive biosecurity measures are in place to control the movement of people, animals, and goods as they enter the country. Imports of FMD-susceptible livestock from 2. FMD and Processing

3. Regulatory
Control of

FMD15 approved countries are quarantined a nd tested. Imports of live FMDsusceptible animals into the Pata gonia Region are only allowed from countries recognized by the OIE a nd SENASA as free of FMD (without vaccination). Argentina participates with other South American governments in the Cuenca del Plata Agreement— a harmonized regional subprogram of the PANAFTOSA Hemispheric Plan for the Eradication of FMD—in reporting and responding to disease ri sks in neighboring countries.

APHIS conducted site visits to Argentina in 2003, 2005, 2006, 2009, and

2013. APHIS also evaluated documentati on provided by SENASA, scientific literature, and site observations in Ar gentina reported by the Canadian Food Inspection Agency. APHIS concludes that the risk of introducing FMD into the United States through the importation of ruminants and ru minant products originating in the Patagonia Region is very low (USDA–APHIS, 2013). APHIS considers that Argentina’ s SENASA possesses sufficient legal authority to carry out official preventi on, control, and quarantine activities for animal health programs, and that it has demonstrated an infrastructure adequate for rapid detection of FMD and for carrying out surveillance and eradication programs (USDA–APHIS, 2013).

The climate in the Patagonia Region is mostly 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 a nd wool production. The terrain and

desolate nature of the area act as an effective barrier to disease incursion through illegal trafficking of prohibite d products. Areas where there are no

natural barriers have control mechanis ms that 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 and other police au thorities).

FMD is one of the most contagious animal diseases known (AVIS/OIE, 2000); although rare, human cases have occurred. However, FMD is not considered zoonotic under natural conditions (Enserink, 2001; AVMA, 2007). Natural infection with FMDV has been reported worldwide in animal families, including the Bovidai, Cervidai, Suidae, Tayasuidae, Camelidae, Giraffidae, Erinaceidae, Muridae, Elephantidae, Tapiridae, and Ursidae (Mouchantant et al., 2005). Transmissi on between susceptible cloven-hoofed wild and domesticated animals is possi ble and known to have occurred once in the United States in 1924 (Rhyan et al., 2006). The virus also may be transmitted mechanically by humans and nonsusceptible animals (carrier animals), such as rodents and birds. 4. Interspecies
Transmission of

FMD16 FMD can cause blisters and flu-like symptoms in humans, and lasting debilitation or rarely death in clove n-hoofed animals. There is no known treatment for FMD (AVMA, 2007). Severity of the disease and expression of symptoms can vary greatly, even with in a species. Sheep are generally considered to be “carriers,” while sw ine are “amplifiers” and cattle are “indicators” (CIDRAP, 2007). Alth ough occasionally FMD can be very destructive to wildlife popul ations (for example, the South African impala in the late 19th century, or mountain ga zelles in Israel more recently (Shimshony et al., 1986; Thomson et al., 2003)), generally FMD in wildlife “results in a relatively mild disease from which the affected animals recover in a week or two. The significance of the disease for wildlife lies largely in the potential that cloven-hoofed wild animals have for transmitting the

disease to domestic livestock . . .” (Thomson et al., 2003).

Experts generally consider the transfer of FMD from wildlife to domestic animals to be unlikely. In most cases, it does not appear that FMD can long survive independently of domes ticated animals. FMD in wildlife appears to be an extension of the di sease in livestock, with the exception of the sub-Saharan Africa. Therefore, if FMD is eradicated from livestock in a region, it generally di sappears from wildlife in the region (Thomson et al., 2003). There are seve ral ways that the virus may be

transferred between wildlife and su sceptible livestock (USGS, 2001; WDNR, 2003)—

• exposure to infected saliva, fece s, urine, milk, semen, meat, and meat byproducts of infected animals;

• exposure to viral particles ca rried via wind, an imals, or on virtually any object (farm equi pment, hay, shoes, etc.);

• drinking from a common source of contaminated water; and

• exposure to raw or improper ly cooked infected garbage.

In order to conduct a thorough analysis of the effect that implementing the

Preferred Alternative could have on the human environment in the United States, APHIS examined the consequences of the movement of

FMDV between wild animals and domes tic livestock within the Patagonia Region of Argentina and surrounding re gions, as well as within the United

States.

APHIS considers that the livestock sampling conducted in the Patagonia Region under the national serological samp ling plan is adequate to detect disease and identify and measure vira l activity in the export region (USDAAPHIS, 2013). In 2013, a wildli fe surveillance study was conducted involving wild boar in the Patagonia North A area. No reactors were identified in the samples (USDA-APHIS, 2013). This could indicate that the virus does not survive or is not present in local species of wildlife capable of carrying or being in fected with FMDV.17 If FMDV enters the United States, sus ceptible livestock and wildlife may be potentially at risk of c ontracting and spreading the disease. North American wildlife (including white-tai led deer and other deer sp ecies, feral pigs, bison, moose, antelope, peccaries, musk ox , caribou, sheep, and elk) are known to be susceptible to FMD and would likely be targeted for eradication in the vicinity of FMD outbreaks (USGS, 2007a; USGS, 2007b). Loss of livestock, rare species, and habitat due to the culling process, the pollution of the environment from mass carcass disposal s, and increased danger to humans and animals from widespread disinfectant or other chemical uses are all likely

in the event of an FM D outbreak (Pinto, 2004).

“All cloven-hoofed animals and Came lidae . . . are susceptible to

infection with FMD viruses but the fa cility with which different species and even breeds of animals develop cl inical disease varies . . . This variation is largely quantified in th e case of domestic animals but for most species of wildlife their relative susceptibilit y is unknown . . . With a few exceptions, excretion and transm ission of FMD by wildlife has not been studied in any detail. For that reason much of what is currently accepted in that regard has been ex trapolated from what is known to occur in domestic species” (Thomson et al., 2003). It is difficult to diagnose FMD in wildlife because symptoms can vary greatly. The disease tends to be subclinically expr essed, and physical examinations of wild populations are difficult to carry out (Thomson et al., 2003). However, despite the fact that seve ral South American wildlife species are susceptible to FMD, their role in the epidemiology of FMD is considered to be insignificant. Research into FMD in South America has determined that wildlife populations, including feral swine, do not play a significant role in the main tenance and transmission of FMD. During outbreak situations, wildlif e may become affected by FMD; however, the likelihood that they will become carriers under field conditions is rare. As a consequen ce, they would not be capable of sustaining the epizootic once the disease has been cleared from

domesticated cattle. Domesticated bovines are considered the primary

reservoir for the FMD virus within South America.

a. The Export Region and Surrounding Countries

While FMDV can be transmitted over l ong distances and remain viable for up to 15 weeks under certain co nditions (USDA–APHIS, 2013), the potential for transmission between wildli fe and domestic livestock in the Patagonia Region of Argentina is offs et by strict national surveillance programs and animal movement controls (USDA–APHIS, 2013).

APHIS considers the feeding of contam inated waste to swine (which may

then transmit the virus to other lives tock populations) to be the primary18pathway for FMDV introduction. Because of the risk presented by FMDcontaminated waste, Argentina prohib its feeding untreated swill to animals and has disposal requirements for conf iscated products and for organic waste from ships and airplanes, which lessens the possibility for viral exposure to wild or feral animals (USDA–APHIS, 2013).

Certain wild and domestic species may become infected and shed the virus without showing clinical signs, thus acting as carriers of FMD (USGS, 2001; Kitching and Hughes , 2002; Thomson et al., 2003). FMDV can survive up to 91 hours on the feathers of live birds and can pass unaltered through their dige stive system (WDNR, 2003). The pathway does not need to be a live infected or carrier animal. Infectious

levels of virus can survive in cleaned, salted, and dried intestine destined for sausage casing or in the clothing or nasal passages of human travelers (Haas and Kramer, 2000; Schoenian, 2005).

b. United States

The United States has retained an FMD-free status since 1929 (AVMA, 2007). Prohibition of impor tation of live ruminant s and swine and their products from FMD-affected countri es, and the avoida nce of contact with livestock, zoo animals, and wildlife by returning travelers

continues to be considered esse ntial for preventing FMD outbreaks (AVMA, 2007). However, there is the potential for interspecies

movement of FMD in the United St ates should infected meat be imported into the country.

For instance, in the event that FMD-contaminated meat was imported and disposed of in U.S. landfills, susc eptible wildlife populations could become infected. For example, th e rapidly growing white-tailed deer and feral pig populations in the United States are lead ing to increased foraging, scavenging, predation, and contact with these animals by domestic livestock popula tions; thus, infected sp ecies could be entirely wiped out or provide a further source of infection (USGS, 2001; LDWF, 2007; ODA, 2007). Nonsusceptible animals and humans consuming or contacting the contaminated meat coul d transfer the virus mechanically, as previously discussed.

The United States has already battle d FMD in wildlife populations. In 1924, in a section of St anislaus National Fo rest, California, FMD

became established in deer (CDA, 1926). At the time of the outbreak it was impossible to gather the wild deer to determine the extent of infection. The eradication effort, wher e all deer were either poisoned or shot within a 1,000-square mile area of the national forest, took 2 years.

Available literature does not indicate th at the wild deer ever reinfected19 cattle herds. The eradication process was expensive, it restricted human and livestock access to the area, and it angered people who were

concerned with the well-b eing of the wild deer population. This is the only known occurrence of wildlife FMD infection in the United States, and, in 1929, the last outbr eak of FMD in the United States occurred in

cattle.

APHIS cooperates with other Fede ral and State authorities in the detection and management of notifia ble disease outbreaks in the United States. If susceptible wild species are exposed to FMD, Morgan et al. (2003) suggested analyzing and possibly implementing the following measures in order to pr event the transmission of the disease to domestic

livestock—

• lethal collection of wild animals for diagnostic testing,

• provisions for surveillance zone,

• the possibility of reducing the density of susceptible wildlife populations within an infected zone,

• long-term observation, and

• additional prevention and control me asures, such as the closure of hunting seasons and restriction of access to public lands by humans (because humans can sp read the virus via physical contact).

In the United States, APHIS has a robust national emergency program in place for exotic/invasive pest detection and Fede ral response.

Should an outbreak of FMD occur in the United States, APHIS will conduct further environmental analyses specific to the ch aracteristics of the location and the scale of the emergency.

c. Ongoing Wildlife Research

In the event of an FMD outbreak, the risk to wildlife will depend on the distribution, density and biology of species in the affected location, the level of exposure to infected animals, and existing environmental conditions (Corn and Fischer, 2001) . In order to develop more effective control of FMD, more needs to be understood about the epidemiology of the disease and the role of possible wildlife reservoirs.

USDA–Agricultural Research Service, in association with the Department of Homeland Security and a Maryland biopharmaceutical company has developed a new FMD vaccine that is not only considered affordable, but can be manufactured in the United States without using

infectious FMD materials. The curr ent formulation is for use on cattle, and may prove effective in protec ting domestic and wild animal populations. The vaccine will a llow for improved diagnosis and20 response, and may lead to a change in trade restrictions as the new formula makes it possible to dete rmine whether the FMD antibodies possessed by an animal were acquired from vaccination or from infection (FASS, 2007).

APHIS interacts with the U.S. Depart ment of the Interior–U.S. Geological Survey–National Wildlife Health Center to coordinate research and monitor outbreaks of FMD in South America. This Federal team is developing prevention and contingency plans for informing U.S. land management and conservation agencies about the risk FMD may pose to wildlife (USGS, 2007a). In addition to helping the Un ited States control FMD in wildlife populations, these efforts also may assist Argentina and other countries in the future when dealing with the potentia l interspecies movement of FMD.

FMDV may persist in the external en vironment for extended periods of time whenever susceptible animals in close contact are exposed to the virus. For a virus to become freely ci rculating, it must be able to persist

in the environment either inside or outside of the host long enough to infect a susceptible host. The Cottr al study (1969) reports the survival

time of FMDV on or within various contaminated objects at ambient temperatures, as shown in table 1.

Table 1. Survival Time of FMD Virus on Various Contaminated Objects At Ambient Temperatures.

Contaminated Objects Weeks of Survival

Soil, S–W 5 1–21

Barn dirt; Barn sand 1–10

Road sand; garden soil 1.5–4

Manure, S–W 1–24

Sewage, S–W 3–15

Barns (brick, adobe, wood), S–W 2–11

Walls, brick and plaster 2–4

Soil, water, lichens 4

Pasture plants, S–W 1–7

Haystack, S–W 4–29

Feed sacks; bran 20

5 S–W, 1–21: summer 1 week, winter 21 weeks. 5. Environmental
Fate of FMD21 Meal 7

Vegetables 1

Water 3–14

Houseflies 10

Ticks 15–20

Wool, sheep 2

Hair, cattle 4–6

Glass surface 2

Clothing and footwear, S–W 6 3–9, 14

Meat cloth (at 4 o C) 6

In addition to the objects listed in table 1, many other contaminated items have been suspected as the source of FMD outbreaks, including various domestic or wild animals and birds, humans, truck tires, and even postal

materials. The survival time of FMDV is shorter for virus in the environment than for virus in animals. Sunlight , temperature, pH changes, relative humidity, and the dilution effect of rain and melting snow all affect virus survival; however, sunlight and ultraviole t radiation have little effect on virus persistence (Pharo, 2002). Longer su rvival times for FMDV on objects would be expected at the low temperatur es associated with high altitudes, or the arctic regions, than at sea leve l or in the tropical regions. Although temperatures above 50 °C destroy most infectivity, it is lik ely that a small proportion of the virus particles are relati vely resistant to the effects of heat and pH in most populations (Pharo, 2002).

The effect of temperature and pH on tim e for 90 percent virus inactivation is shown in table 2 and table 3, respec tively, based on findings from the Bachrach et al. (1975) st udy. There is also the potential for FMDV to be

disseminated over considerable distan ces by aerosols (Cottral, 1969). In aerosols, FMDV survives best when th e relative humidity exceeds 70 percent and there is a critical humidity le vel of 55 to 60 percent, below which survival is poor (Pharo, 2002). Base d on available scientific data, the survival of residual FMDV in the external environment following eradication of an outbreak of FMD in susceptible animals would be expected to persist no longer than 8 months.

6 Cotton garments, leather shoes, rubber boots.22 Table 2. Effect of Temperature (at pH 7.5) On Time for 90 Percent FMDV
Inactivation.

Temperature Inactivation Time (90 percent)

61 o C 30 seconds

55 o C 2 minutes

49 o C 1 hour

43 o C 7 hours

37 o C 21 hours

20 o C 11 days

4 o C 18 weeks

Table 3. Effect of pH (at 4 o C) On Time for 90 Percent FMDV Inactivation.

ph Inactivation Time (90 percent)

10.0 14 hours

9.0 1 week

8.0 3 weeks

7.0–7.5 >5 weeks

6.5 14 hours

6.0 1 minute

5.0 1 second

FMD may affect humans; however, its oc currence is quite rare. The number of cases reported worldwide is so small when compared with the number of persons exposed to FMD that it is ge nerally not considered a threat to

humans. FMDV has been isolated a nd 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 blis ter formation (USDA–APHIS, 2013).

Perhaps more importantly, an FMD outbreak of the magnitude observed in the United Kingdom can result in severe psychosocial effects on farmers and farming communities. Farmers and their families can suffer from grief over losing animals (in some cases blood lines kept over many generations), as

well as loss of control over their liv es due to movement restrictions, disruptions in community life, and s hort- and long-term stress over their financial future. Researchers from Lancaster University in the United Kingdom conducted a new study on the soci al consequences of FMD in the Cumbria community. The study revealed high rates of depression, alcohol consumption, and mortality among farmer s during the crisis (USDA–APHIS, 2013). 6. Public Health23 

## IV. Other Environmental Issues

A. Environmental Justice a nd the Preferred Alternative

Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations,” requires each Federal agency to make achieving environmental justice part of its mission by identifying and addressing, as appr opriate, dispropor tionately high and

adverse human health or environmental effects of its programs, policies, and activities on minority populat ions and low-income populations in the United

States and its territorie s and possessions. Importation of ruminants and ruminant products from the Patagonia Region of Argentina, under the Preferred Alternative, is not expected to substantially affect the condition of minority livestock producers in the Un ited States. Most of the modest impact-generating compliance actions under the Preferred Alternative will

occur outside of the United States (in Argentina), and none has any disproportionate adverse effects on mi nority or low-income populations in the United States. Although one c ould design scenarios involving the introduction of FMD to the United States, these are primarily remote and hypothetical. Even if such scenarios c ould occur, their impact to minority and low-income populations would be expected to be negligible.



### B. Protection of Children and the Preferred Alternative

Executive Order 13045, “Protection of Ch ildren from Environmental Health Risks and Safety Risks,” requires each Federal agency to address disproportionate environmental health ri sks or safety risks to children that arise in the course of ag ency policies, programs, ac tivities, and standards. Implementation of the Preferred Altern ative does not pose greater risks to children than to other parts of the aff ected populations. C ontrol of the risks associated with ruminant and ruminant product importation depends primarily upon adherence to sanitary requirements. Proper adherence will remove the potential for adverse effects to humans and make other commodity introduction-rela ted risks remote and of very low concern in regard to the protection of children.



### C. Threatened and Endangered Species and the

Preferred Alternative

Section 7 of the Endangered Species Act and its implementing regulations require Federal agencies to ensure that their actions are not likely to jeopardize the continued existence of th reatened or endangered species or

result in the destruction or adverse m odification of critical habitat. APHIS24 considered the potential effects of th e Preferred Alternative on threatened and endangered species and designated cri tical habitat. There are six listed ungulate species that are potentially su sceptible to FMD (table 4); however, based on the supposition of required m itigation measures for the importation of FMD-susceptible products, the risk fo r these species to be exposed to and, thus, be affected by this action is ve ry low. Therefore, APHIS expects changing the recognition status of the Patagonia Region to FMD-free will have no effect on threatened or endangere d species or their critical habitat in

the United States.

APHIS determined that the risk of FMD-infected ruminants and ruminant products entering the United States from the Patagonia Region of Argentina, and the potential to expose U.S. livesto ck to FMD, to be very low (USDA– APHIS, 2013). This risk would be further mitigated by requiring implementation of the measures outlined in 9 CFR § 94.11. Based upon the effectiveness of the mitigation measures included in 9 CFR § 94.11 and the very low likelihood that FM D would establish in U.S. livestock, changing the status of the Patagonia Region to FMD-fr ee is expected to have no effect on federally listed endangered species or designated critical habitat.

Table 4. Endangered Species in the United States Susceptible to Foot-andMouth Disease.

Common Name Scientific Name Critical
Habitat Listing Status

Woodland caribou Rangifer tarandus caribou No Endangered

Columbian white-tailed deer Odocoileus virginianus

leuceurus No Endangered

Key deer Odocoileus virginianus clavium No Endangered

Sonoran pronghorn Antilocapra americana
sonoriensis No Endangered

Bighorn sheep Ovis Canadensis Yes Endangered

Sierra Nevada bighorn sheep Ovis canadensis californiana No Endangered



### D. Potential Cumulative Impacts

The potential impacts from the change in status of the Patagonia Region

in combination with similar actions are referred to as cumulative impacts. These impacts are not expect ed to pose any substantial risks based upon the findings of the risk assessment (USDA–APHIS, 2013). It is difficult to precisely quantify the potential cumulative impacts that are dependent upon disease conditio ns in the Patagonia Region of25 Argentina, as well as compliance with importation conditions in the region and other regulated countries . However, APHIS considers the Patagonia Region to be free of FMD, making introduction of the disease extremely unlikely. In addi tion, the nature of disease mitigation is of principal concern for this issu e, and the constraints provided by the anticipated mitigations are considered to provide adequate protection.26 

## V. Listing of Agencies Consulted

Environmental and Risk Analysis Services Policy and Program Development Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 149 Riverdale, MD 20737–1237

Regionalization Evaluation Services National Import Export Services Veterinary Services Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 38 Riverdale, MD 20737–1231

Regulatory Analysis and Development Policy and Program Development Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 118 Riverdale, MD 2073727 

## VI. References

APHIS—See U.S. Department of Agri culture, Animal and Plant Health Inspection Service

AVIS—See Advanced Veterinary Information System

AVIS/OIE—See Advanced Veterinary Information System/ International Office of Epizootics

Advanced Veterinary Informatio n System, 2002. Foot and mouth disease (2002 suite). AVIS/FMD/Control: Species of wildlife susceptible to FMD. [Online.] Available: http://www.aleffgroup.com/AVISFMD/

Advanced Veterinary Information System/ International Office of Epizootics, 2000. International Of fice of Epizootics: Animal

Disease Cards. Foot and M outh Disease (FMD). Office International des Epizooties: Augu st 30, 2000. [Online.] Available: http://www.aleffgroup.com/avi sfmd/cards/A010-fmd-00.HTM [2007, August 21].

AVMA—See American Veterinary Medical Association

American Veterinary Medical Asso ciation, 2007. Foot and Mouth Disease Backgrounder. February 14, 2007. [Online.] Available: http://www.avma.org/reference/backgrounders/fmd_bgnd.pdf [2007, November 7].

Bachrach, H.L., Breese, S.S., Callis, J.J., Hess, W.R., and Patty, R.E.,

1975. Inactivation of foot-and-mout h disease virus by pH and temperature changes and by formaldehyde. Proceedings of the Society for Experimental Biology and Medicine , 95, 147-52.

CDA—See Californi a Department of Agriculture

California Department of Agricultu re, 1926. The epizootic of footand- mouth disease in California. February 17, 1924 to June 10, 1926. Charles Keane, D.V.S. Sp ecial Publication No. 65, 110 pp. Sacramento, CA.

CIDRAP—See Center for Infectious Disease Research and Policy

Center for Infectious Disease Resear ch and Policy, 2007. University of Minnesota, Academic Health Cent er. Foot-and-mouth disease.28 [Online.] Available: http://www.cidrap.umn.edu/cidrap/conte nt/biosecurity/ag- biosec/animdisease/foot-mouth.html [2007, Sept. 13].

Corn, J., and Fischer, J., 2001. Wh at if FMD hits? Southeastern cooperative wildlif e disease study (SCWDS) Briefs, April 2001, 17.1 [Online.] Available: http://www.uga.edu/scwds/topi c_index/2001/WhatifFMDHits.pdf [2007, Nov. 7].

DEFRA—See Department for Environment, Food, and Rural Affairs

Cottral, G.E., 1969. Persistence of foot-and-mouth disease virus in animals,
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Department for Environment, F ood, and Rural Affairs, 2007. H5N1 Highly pathogenic avian influenza outbreak/Holton, Suffolk/February 2007: Lessons to be learned repor t. August 3, 2007. [Online.]

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FASS—See Federation of Animal Science Societies

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Fields, B.N., Knipe, D.M., and Howley, P.M., 1996. Fundemental Virology, 3 rd Edition.

Haas, B., Kramer, M., 2000. Appe ndix 11: Possible introduction of FMDV with sheep intestines from FMD countries. FAO/AGA/The European Commission for the control of foot-andmouth disease. [Online.] Available: http://www.fao.org/ag/AGA/AGAH/ EUFMD/reports/rg2000bv/app11.pdf [2007, Nov. 6].

Kitching, R.P., and Hughes, G.J., 20 02. Clinical variation in foot and mouth disease: sheep and goats. OIE: Rev. sci. tech. Off. int. Epiz., 2002, 21 (3), 505–512. [Online.] Available:29 http://www.oie.int/eng/publicat /rt/2103/1.8%20Kitchingsheep.pdf [2007, Nov. 6].

LDWF—See Louisiana Department of Wildlife and Fisheries

Louisiana Department of Wildlife and Fisheries, 2007. Surveillance plan to help control wild hog popul ation adopted. Re leased: 11/13/07. [Online.] Available: http://www. wlf.state.la.us/news [2007, Nov. 14].

Morgan, J.T., Fischer, J., Hoste tler, M.E., 2003. If foot-and-mouth disease came to Florida: potential impact on white-tailed deer in Florida. University of Florida, Marc h 2003. [Online.] Available: http://edis.ifas.ufl.edu/BODY_UW183 [2004, Oct. 20].

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ODA—See Oregon Department of Agriculture

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WIN—See Wildlife Information Network

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