Proposed Rule for the 

Status of Santa Catarina, 

Brazil, Regarding Footand-Mouth Disease, 

Classical Swine Fever, 

Swine Vesicular Disease, 

African Swine Fever, and 

Rinderpest

Environmental Assessment,

January 2010

United States

Department of 

Agriculture

Marketing and 

Regulatory

Programs

Animal and 

Plant Health 

Inspection 

Service
Proposed Rule for the Status 

of Santa Catarina, Brazil,

Regarding Foot-and-Mouth 

Disease, Classical Swine 

Fever, Swine Vesicular 

Disease, African Swine Fever, 

and Rinderpest

Environmental Assessment,

January 2010

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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__________________________________________________________

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to report factually on available data and to provide specific information.
Table of Contents

I. Need for the Proposed Rule................................................... 1

A. Introduction.......................................................................... 1

B. Need.................................................................................... 3

II. Alternatives.............................................................................. 3

A. No Action ............................................................................. 3

B. Preferred Alternative ............................................................ 4

III. Environmental Consequences............................................... 5

A. No Action ............................................................................. 5

B. Preferred Alternative............................................................ 7

1. Foot-and-Mouth Disease Virus........................................ 7

2. Classical Swine Fever Virus.......................................... 10

3. Swine Vesicular Disease Virus...................................... 12

4. African Swine Fever Virus............................................. 13

5. Rinderpest Virus............................................................ 16

6. Regulatory Control ........................................................ 18

7. Interspecies Transmission............................................. 19

8. Public Health................................................................. 21

IV. Other Environmental Issues ............................................... 22

A. Environmental Justice and the Preferred Alternative......... 22

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

VI. References ............................................................................ 26
1

I. Need for the Proposed Rule 

A. Introduction

Sanitary import regulations are designed to prevent the introduction and 

dissemination of injurious animal pests and diseases that are new or not 

widely distributed in the United States. Currently, importation into the 

United States of live ruminants, ruminant products (including ruminant 

meat and semen), live swine, and swine products (including swine meat 

and semen) from the Brazilian State of Santa Catarina is prohibited 

because the U.S. Department of Agriculture (USDA), Animal and Plant 

Health Inspection Service (APHIS) considers all of Brazil to be a country

affected with foot-and-mouth-disease (FMD), classical swine fever (CSF), 

swine vesicular disease (SVD), and African swine fever (ASF). USDA–

APHIS established policy and rules in 1997 for recognizing regions, rather 

than only countries, for the purpose of importation of animals and animal 

products into the United States (62 Federal Register (FR) 55999, 62 FR 

56027). This regionalization action was designed to facilitate trade while 

maintaining a low risk of animal disease introduction to the United States.

An official request was submitted by Brazil to USDA–APHIS to review 

the disease status of Santa Catarina, Brazil, in order to initiate trade in 

fresh pork from that State. In order to make an informed decision,

USDA–APHIS–Veterinary Services (VS) conducted a risk analysis as a 

decision-making tool that would allow the development of appropriate 

regulatory conditions with mitigations to address potential risks of disease 

introduction following any initiation of trade with the State of Santa 

Catarina, Brazil (USDA–APHIS, 2009). The risk analysis associated with 

this proposed rulemaking, entitled “APHIS Evaluation of the Status of the 

Brazilian State of Santa Catarina Regarding Foot-and-Mouth Disease, 

Classical Swine Fever, Swine Vesicular Disease, and African Swine 

Fever,” is summarized and incorporated by reference in this environmental 

assessment (EA). Rinderpest, another dangerous and destructive disease 

affecting swine and ruminants and of potential concern to the United 

States when importing susceptible foreign animals and related products, 

was not included as a risk factor in this evaluation because it is not 

endemic to the Americas and has never become established in Brazil 

(USDA–APHIS, 2009). The hazard of the disease to the United States is 

considered to be offset by the absence of potential exposure from Santa 

Catarina exports, resulting in a corresponding absence of risk. 

APHIS’ risk analysis was based on the information gathered from the 

document submitted by the Brazilian Ministry of Agriculture, Livestock 

and Food Supply (MAPA), the Companhia Integrada de Desenvolvimento 
2

Agricola de Santa Catarina (CIDASC),

1

and from site visits to Santa 

Catarina (2008) and other Brazilian States (2002, 2003, and 2006). While 

the site visits focused on the veterinary and legal infrastructure, border 

control procedures, laboratory and diagnostic capabilities, biosecurity

procedures on swine farms, animal health recordkeeping systems, 

movement controls, and disease surveillance systems, the following 

factors were considered relevant in determining the disease status of 

Santa Catarina—

 the State of Santa Catarina has not vaccinated against FMD since 

May 2000;

 no FMD outbreaks have occurred in Santa Catarina since 1993;

 no outbreaks of CSF have occurred in Santa Catarina since 1990;

 no outbreaks of ASF have occurred in Santa Catarina since 1981;

and

 SVD has never occurred in the Brazilian territory.

It was shown that surveillance programs in cattle and swine populations

have not detected any presence of FMD, CSF, SVD, or ASF virus in the 

Brazilian State of Santa Catarina, nor was there any evidence of viral 

activity for FMD in cattle during or since the outbreaks in other areas of 

the country in 2000–01 and 2005–06. APHIS–VS also found the legal 

framework, animal health infrastructure, movement and border controls, 

diagnostic capabilities, surveillance programs, and emergency response 

systems within the boundaries of the Brazilian State of Santa Catarina to 

be adequate to detect and control FMD, CSF, SVD, and ASF outbreaks. 

Although the consequences of these disease outbreaks are severe, APHIS 

considers the likelihood of outbreaks occurring in the United States by

means of exposure of the domestic livestock population to swine or other 

susceptible species or their related unprocessed products imported from 

the Brazilian State of Santa Catarina to be very low (USDA–APHIS, 

2009). 

Rinderpest is very close to being completely eradicated in the few regions

of the world where it still occurs. In addition, rinderpest has never been

established in North America, Central America, the Caribbean Islands, or 

South America (USDA–APHIS, 2009). Because rinderpest is not a 

disease of concern with specific regard to potential risks and 

environmental impacts from promulgation of this rule, the scope of this 

EA will be restricted to FMD, CSF, SVD, and ASF.

 

1

The coordinating agency directly responsible for administration of field activities is an integrated 

public company referred to as Companhia Integrada de Desenvolvimento Agricola de Santa Catarina 

(CIDASC).
3

B. Need

In response to an official request from the government of Brazil, and in 

accordance with sanitary and phytosanitary (SPS) agreements to facilitate 

the importation of live ruminants, ruminant products, live swine, and 

swine products, APHIS has reviewed the issues related to this importation 

and would like to amend the sanitary regulations (9 Code of Federal 

Regulations (CFR) part 94).

The preparation of this EA was prompted by the anticipated public 

concern about the potential disease risk from the importation of live 

ruminants, ruminant products, live swine, and swine products, and the 

need to address environmental issues related to FMD, CSF, SVD, and 

ASF risks. The issue of potential environmental risks of FMD, CSF, 

SVD, and ASF outbreaks in the United States resulting from the 

importation of live ruminants, ruminant products, live swine, and swine 

products is of great concern to USDA–APHIS. Characterization of 

disease risk potential and adequate mitigation measures are critical for

excluding these diseases from the United States.

This EA is designed to satisfy the provisions of the National 

Environmental Policy Act of 1969 (NEPA), 42 United States Code 

(U.S.C.) 4321–4327, its implementing regulations, and Executive Order 

12114, “Environmental Effects Abroad of Major Federal Actions.”

II. Alternatives

This EA evaluates two alternatives of a proposal to add the Brazilian State 

of Santa Catarina to the list of regions declared free of FMD, CSF, SVD,

and ASF: (1) the no action alternative, under which the Brazilian State of 

Santa Catarina would continue not to be included on the list of regions 

declared free of FMD, CSF, SVD, ASF, and rinderpest, and (2) the 

preferred alternative, which would amend the regulations to add the State 

of Santa Catarina, Brazil, to the list of regions declared free of FMD, CSF, 

SVD, and rinderpest. Santa Catarina will also be excluded from the list of 

regions in 9 CFR part 94 where ASF is known to or reasonably believed to 

exist. This amendment would relieve restrictions on the importation of 

live ruminants, ruminant products, live swine, and swine products from

Santa Catarina. 

A. No Action

Under the no action alternative, the Brazilian State of Santa Catarina

would not be declared free of FMD, CSF, SVD, ASF, and rinderpest and,

therefore, would not be allowed to export live ruminants, ruminant 

products, live swine, and swine products to the United States. The no 
4

action alternative maintains overall low levels of disease risk. However, 

selection of this alternative may not satisfy international trade regulations 

requiring justification of more rigorous requirements of maintaining 

current regulations over less restrictive alternative approaches. In 

compliance with SPS measures stipulated by the World Trade 

Organization, APHIS is obligated to consider less restrictive sanitary

measures that provide comparable protection against disease risks. (The 

issues of potential environmental impacts associated with the disease risks 

of each alternative are discussed in chapter 3, Environmental 

Consequences of the Alternatives.)

B. Preferred Alternative

The preferred alternative would amend regulations under 9 CFR part 94 to 

add the Brazilian State of Santa Catarina to the list of regions declared free 

of FMD, CSF, SVD, ASF, and rinderpest. This amendment would allow

the importation of live ruminants, ruminant products, live swine, and 

swine products from the Brazilian State of Santa Catarina under specific 

conditions of entry. Under the preferred alternative, each shipment of live 

ruminants, ruminant products, live swine, and swine products would be 

required to have an approved permit from APHIS, a sanitary certificate 

indicating that the live ruminants, ruminant products, live swine, and 

swine products were handled in accordance with the importation 

requirements, and a statement of origin and disease-free status of the 

shipment based upon inspection. The preferred alternative has been 

designed to provide sufficient mitigation to maintain sanitary security

while facilitating trade. 

Assessing the likelihood of introducing, FMD, CSF, SVD, and ASF into 

the United States requires an evaluation of relevant characteristics of the 

exporting regions in relation to the epidemiology of the diseases. In that 

regard, APHIS described 11 factors in its regionalization rule (9 CFR 

92.2) that provide a context for evaluating the risk of exporting a foreign 

animal disease from a defined region into the United States. 

APHIS conducted an in-depth evaluation of Santa Catarina’s disease 

status using the 11 factors identified in 9 CFR part 92.2 as necessary to 

consider in assessing risk levels of free regions. Those factors are:

1. the authority, organization, and infrastructure of the veterinary

services organization in the region;

2. disease status;

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

4. the extent of an active disease control program, if any, if the agent 

is known to exist in the region;

5. the vaccination status of the region;
5

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; and

11. policies and infrastructure for animal disease control in the region, 

that is, emergency response capacity.

APHIS officials reviewed information concerning these 11 factors and 

undertook site visits to Brazil in 2002, 2003, 2006, and 2008. APHIS has

concluded that Santa Catarina consistently achieves the level of disease 

freedom and veterinary infrastructure necessary to regionalization as 

described in 9 CFR part 92.2 (USDA–APHIS, 2009). Santa Catarina’s 

adequate legal framework, animal health infrastructure, movement and 

border controls, diagnostic capabilities, surveillance programs, and 

emergency response systems are assumed to continue and form an integral

part of the preferred alternative risk mitigation.

III. Environmental Consequences

Compliance with NEPA requires APHIS to consider all potential effects to 

the human environment from a proposed action. Environmental 

consequences to the United States that may stem from introduction and 

spread of FMD, CSF, SVD, and ASF may range widely from marginal to 

broad, and mild to severe. Animal or human sickness; loss of threatened 

and endangered species; pollution and infrastructure issues arising from 

transportation and carcass disposal; economic hardship for consumers, 

producers, and associated industries; and risk from chemical exposure are 

some of the potential adverse impacts to the human environment which

could occur from an outbreak of these diseases of concern. The nature of 

each disease and its causal agent, and its potential impacts on the physical 

environment as well as the health of U.S. human, livestock, and wildlife 

populations are discussed in the following sections of this chapter.

A. No Action 

The biological histories and disease potentials of the five diseases of 

concern suggest that continuation of the current regulations prohibiting 

imports of live ruminants, ruminant products, live swine, and swine 

products into the United States from any region of Brazil, regardless of 

Santa Catarina’s disease-free status, would not result in an increased pest 

risk and, therefore, would not adversely impact the human environment. 

The proposed rule (preferred alternative) would provide a means of export 
6

of live ruminants, ruminant products, live swine, and swine products from 

the State of Santa Catarina, Brazil. Although the required mitigations of 

the preferred alternative have been shown to be effective against all 

known strains2of the viruses causing these five diseases, there remains 

some potential risk that does not exist under the no action alternative. 

The prohibition of importation of live ruminants, ruminant products, live 

swine, and swine products from Brazil, under 9 CFR 94, has maintained 

low disease risks to U.S. human and animal populations, and has caused 

negligible environmental effects in the United States. As with most 

commodities, there is always some risk of illegal entry, whether deliberate 

or accidental; however, the frequency has been low and is believed to be 

due to the impending high punitive cost to the perpetrators. The potential 

of high risks from disease associated with noncompliance makes it 

APHIS’ policy to provide a strong deterrent. Therefore, APHIS strives to 

keep travelers, importers, and shippers informed of import regulations and 

of the penalties for inadequate compliance. An importer or shipper could 

be subjected to civil penalties, criminal fines, jail sentences, and loss of 

revenue due to APHIS’ rejection of commodities, permit applications, 

and/or compliance agreements. APHIS has the option to refuse entry, 

require treatment, or require destruction of infected or potentially infected 

cargo. 

All of these options are costly to the targeted shipping line and exporter 

who must assume all costs for resultant delays and treatments. This offers 

strong incentive for their full compliance with import regulations. 

Monitoring of 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, 2003a). Comparable compliance could be expected for any 

current or revised sanitary regulations related to importation. 

The ecological, physiological, psychological, and economic costs of an 

uncontrolled outbreak of FMD, CSF, SVD, ASF, or rinderpest could be 

extremely high if such an outbreak were to occur in the United States. 

Animal illness and mortality from outbreaks of these diseases elsewhere 

have devastated susceptible wild and domestic populations, polluted the 

environment, and indirectly impacted humans and other animals 

depending upon them as a resource. 

The no action alternative would leave the current importation regulations 

unchanged. Under this alternative, the entire country of Brazil would 

continue to be prohibited from importing commodities, under 9 CFR 94,

into the United States. The current import regulations, however, do not

 

2

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

proteins.
7

reflect Santa Catarina, Brazil, as being free of the five diseases of concern

(FMD, CSF, SVD, ASF, and rinderpest). Under international trade 

agreements, the continuation of unsupported trade restrictions is contrary

to U.S. obligations; this makes the no action alternative unacceptable. 

B. Preferred Alternative

Compliance with NEPA requires APHIS to consider all potential effects to 

the human environment from a proposed action. In addition to the 

consideration of disease issues related to livestock, this document analyzes 

potential effects to humans, wildlife, and environmental quality. This 

section of the EA considers issues pertaining to the regulatory control 

process, the disease transmission mechanism as related to wildlife, and the 

persistence of disease causal agents under various environmental 

conditions on or in environmental media, such as soil, water, plants and 

plant material, and abiotic surfaces. The environmental consequences 

from implementation of the preferred alternative are largely contingent 

upon the ability of various mitigation measures and program treatment 

procedures to (1) preclude exposure of Santa Catarina, Brazil’s animal 

population to the five diseases of concern, and (2) exclude the importation 

to the United States of any animals or animal products from Santa 

Catarina that are potentially infected with any of the causal viruses. 

APHIS’ evaluation of the disease status of Santa Catarina, Brazil (USDA–

APHIS, 2009) examined the sanitary issues associated with fulfilling the 

change-in-status request from Santa Catarina, Brazil. The risk analysis 

assessed the likelihood of exposure to and infection from FMD, CSF, 

SVD, and ASF for susceptible livestock in the United States following 

implementation of the rule. 

The absence of the five diseases of concern in the Santa Catarina region, 

coupled with the probability of quick detection of clinical signs (should 

disease be introduced in the absence of vaccination) are supporting 

evidence of continued freedom from these diseases in the State of Santa 

Catarina. No adverse environmental consequences are expected to occur 

in Brazil or the United States as a result of implementation of the preferred 

alternative, as the risk of introduction of any of these diseases to the 

United States through implementation of the proposed rule is low, and

both countries have effective systems in place to prevent and contain 

outbreaks of the five diseases of concern.

Foot-and-mouth disease virus (FMDV) is the micro-organism that causes 

FMD. FMDVs are members of the Picornaviridae family, and viruses of 

the genus Aphthovirus. FMDV is a small virus which is very infectious, 

multiplying in and causing damage to cells throughout the body of 

susceptible animals, and it can survive in the environment for extended 

periods of time. FMD is an acute, highly contagious viral disease, mainly, 

but not exclusively, of cloven-footed animals. The risk to humans from 

1. Foot-andMouth 

Disease Virus 
8

FMDV is very slight. Confirmed cases of FMD in humans are rare. 

Symptoms in humans are mostly mild, and primarily include fever and 

blisters on the hands, feet, mouth, and tongue. 

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. Mortality in 

older animals occurs less frequently but may be significant with certain 

virus strains (USDA–APHIS, 2009).

FMD also causes significant losses in the production capacity of affected 

animals. Productivity losses of 10 to 20 percent are reported in FMDinfected livestock if the disease is allowed to run its course. In addition, 

FMD can cause a reduction in the growth rate of animals raised for meat. 

The comparatively greater severity of FMD in pigs would imply at least 

similar losses to those described for cattle (USDA–APHIS, 2009).

FMD is characterized by the formation of lesions on the feet and mouth, 

damage to the mucous membrane lining the gastrointestinal system, and 

high fever. Damage from FMDV may also occur to the heart muscle cells 

(particularly in young animals), the milk-secreting cells of the udder, and 

hormone-producing cells. For FMD to remain in a population, each 

infected animal must infect at least one other animal. The primary 

methods in which FMDV moves out of an infected animal are in air-borne 

droplets from the lungs and the fluid-filled vesicles; in the saliva, urine,

feces, semen, and milk; secretions from the eyes, nose, prepuce, and 

vagina; and through direct contact with skin or pieces of infected skin that 

may drop off the animal (WIN, 2001). 

It is also possible to transmit FMDV in infected carcasses, meat, hides, 

and bones (WIN, 2001). FMDV is commonly spread by the movement of 

infected animals; however, the virus may also move independently outside 

of the animal. Humans, birds, rodents, dogs, and cats may carry and 

spread the virus if they contact any of the above-mentioned body

substances and, particularly with humans and probably other vertebrates, 

for a short time after they have breathed in the infected airborne droplets. 

The wind may move the airborne droplets containing the virus up to 

250 kilometers (km) over water, and shorter distances over land (WIN, 

2001). The virus must reenter a susceptible animal in which it can 

multiply; this can be through inhalation, ingestion, sexual transmission, 

conjunctival membranes, inoculation, and damaged skin. 

It is possible for animals to carry FMDV without appearing clinically ill 

under certain conditions, such as recovery from clinical disease and 

undetected subclinical disease. However, development of a permanent 

carrier status for animals infecting susceptible animals is now less likely. 

Vaccination does not make animals into FMDV carriers. Properly 
9

inactivated vaccine, when injected into animals, does not give rise to the 

carrier state (WIN, 2001). 

Three general conditions must be fulfilled for a virus to persist over a long 

term in a host. First, the virus must be able to infect host cells without 

being lethal to the cell. Second, there must be mechanisms for long-term 

maintenance of the viral genome3in 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 antigens4

and establish an immune response to those antigens. A virus will modify

specific antigens or proteins so as to evade the host’s immune system, 

thereby establishing persistent infection in the host. The modification of 

specific antigens or proteins gives rise to substrains of the virus. 

Documenting surveillance systems sufficient to ensure early detection of 

the diseases under consideration has been integral in assessing the level of 

risk from implementation of the preferred alternative. The next section 

explains the characteristics of FMD and its associated safeguards (e.g., 

surveillance programs) in the State of Santa Catarina. 

FMD Safeguards

The last outbreak of FMD in the State of Santa Catarina, Brazil, occurred 

in 1993; since 2007, the World Organization of Animal Health (OIE)

recognized Santa Catarina as an FMD-free zone where vaccination is not 

practiced (USDA–APHIS, 2009). The country of Brazil employs both 

passive and active surveillance strategies designed to demonstrate freedom 

from FMD, with differing emphases depending on the phase of the 

eradication process within a given State or zone. Active surveillance is 

used to demonstrate freedom from disease within a specific area. Passive 

surveillance is the primary type of surveillance used once freedom from 

infection has been established and the area is recognized as free of FMD 

by the OIE, either with or without vaccination (in the case of Santa 

Catarina it is recognized as free without vaccination). Active surveillance 

complements passive surveillance primarily by targeting specific “highrisk” areas within the area for serological sampling and more in-depth 

investigations. 

Brazil has shifted from active surveillance for FMD in Santa Catarina to 

focus on passive surveillance using a strategy designed to prevent the

reintroduction of the disease, to maintain good sanitary conditions, and to 

provide technical grounds to demonstrate the continual absence of disease 

 

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.
10

and viral activity in the State. APHIS considers the risk of introduction of 

FMD to the United States through the importation of infected animals and 

animal products from Santa Catarina to be low (USDA–APHIS, 2009). 

Therefore, APHIS does not expect that such importation will have a 

consequential impact on the human environment.

Acute and chronic cases of CSF have been described in scientific 

literature. The severity of the disease depends largely on the age of the 

animal and virulence of the viral strain, with young animals usually more 

severely affected than older animals. In older breeding pigs, the course of 

infection is often mild, or even subclinical, whereas mortality rates may

reach 90 percent in young pigs. Low virulence strains may manifest 

primarily as poor reproductive performance and birth of piglets with 

neurologic defects (USDA–APHIS, 2009). 

Clinical signs of CSF may include viremia (presence of virus in the blood) 

characterized by persistent fever, skin discoloration, conjunctivitis

(inflammation of the eye), abortion, and/or diarrhea that is unresponsive to 

antibiotics. Leucopenia (decrease in the number of white blood cells in 

the blood) is a consistent clinical laboratory finding. Severity of CSF is 

variable. Three common forms are acute, chronic, and late onset—

 Acute—illness in weaned pigs under 12 weeks of age that is 

unresponsive to antibiotics and characterized by fever, skin 

discoloration, conjunctivitis, hind-limb weakness, and/or diarrhea. 

 Chronic—characterized by subdued acute infection, followed by 

brief recovery before relapse of fever, anorexia leading to wasting and

death 1 to 3 months after onset. 

 Late onset—pigs born to sows infected after day 50–70 of gestation 

may be persistently infected and appear normal for several months 

before dying, or born with congenital tremors. (Sows infected prior to 

day 50–70 of gestation may abort or give birth to stillbirths, mummies, 

or pigs with congenital defects.) (USDA–APHIS, 2007a). 

APHIS considers that a case of CSF is confirmed when it meets the 

clinical case definition and is laboratory-confirmed via virus isolation with 

sequence confirmation (USDA–APHIS, 2007a). 

CSF Safeguards

Passive surveillance for CSF is carried out within Brazil, particularly at 

the border between the CSF-free zone and the infected region. This work 

is facilitated by the fact that the border of the CSF-free zone corresponds 

to that of the FMD-free zone for FMD in Brazil; therefore, the staff and 

structures of the sanitary defense in place at this line for the control of the 

2. Classical 

Swine Fever 

 Virus
11

entry of susceptible animals and products is utilized for both diseases at 

the same time (USDA–APHIS, 2009). 

In order to delineate and maintain the free zone, serologic surveys are

carried out under the coordination of MAPA in accordance with the 

statistical parameters set by OIE. The target population includes the entire 

population of hogs and wild boars within the free area, except for those in 

swine breeding farms that have been officially and individually certified as 

free from diseases (i.e., Farms of Certified Swine Breeders (GRSC)

(USDA–APHIS, 2009)). 

Screening and diagnostic tests are conducted at official public service 

laboratories. Screening tests are performed using an enzyme-linked 

immunosorbent assay (ELISA) for the detection of antibodies of the CSF 

virus. Any reactive or suspicious samples are submitted for differential 

diagnosis using virus-neutralization tests in cell cultures (USDA–APHIS, 

2009). 

As with FMD and other vesicular diseases, every Brazilian citizen is 

obligated to report the suspicion of CSF to the nearest local veterinary

unit. If the owner of the animal(s) fails to report the suspicion of disease, 

he or she will lose a claim to indemnity in the event that the herd must be 

destroyed for disease control purposes. In addition, veterinarians and 

other field professionals may be subject to legal action before their 

respective trade guilds (USDA–APHIS, 2009). 

In the event that a sanitary emergency or documented disease event 

occurs, samples are collected from all susceptible animals present on the 

farm. All suspicious cases of CSF or other diseases with similar clinical 

signs must be investigated promptly by the official veterinarian. If 

indicated, a quarantine and additional sampling will be initiated. 

Additional procedures performed by the official veterinarian include

(USDA–APHIS, 2009)—

 filling out the initial disease investigation form,

 collecting information on the establishment under suspicion,

 prohibiting the movement of hogs and their products and 

byproducts from the property,

 cleaning and disinfecting the equipment and materials utilized in 

exams and collection of specimens,

 incinerating expendable work clothes, and,

 prohibiting the admittance of outsiders to the facilities.

In Santa Catarina over the last 4 years, there were three notifications of 

CSF. Follow-up tests were negative for CSF, and the implicated farms 

received follow-up evaluations by the official veterinary service (USDA–

APHIS, 2009). 
12

SVD is an acute, contagious, viral disease of swine caused by an

enterovirus. It is characterized by fever and vesicles with subsequent 

ulcers in the mouth and on the snout, feet, and teats. The pathogen is 

relatively resistant to heat and can persist for a long time in salted, dried, 

and smoked meat products. People coming into contact with the swine 

vesicular disease virus (SVDV) should exercise caution as human

infection has been reported in laboratory staff working with the virus

(USDA–APHIS, 2003b). 

This disease can be introduced into a herd by feeding it garbage containing 

infected meat scraps, by bringing in infected animals, or by direct contact 

with infected feces (e.g., in an improperly cleaned truck). After the initial 

infection, the disease spreads through the contact of susceptible pigs with 

infected pigs and infected feces (USDA–APHIS, 2003b).

Clinical signs are very similar to those of FMD and other vesicular

diseases (USDA–APHIS, 2003b) and include:

 fever;

 vesicles in the mouth, and on the snout and feet;

 lameness and an unsteady gait, shivering and jerking–type leg 

movements; and/or

 ruptured vesicles which can cause ulcers on limbs and feet, and 

foot pads may be loosened.

SVD is typically a transient vesicular disease of pigs. Young animals are 

more severely affected; however, essentially, the virus causes no 

mortality. Infected pigs generally recover within 1 week but recovery can 

take up to 3 weeks. Some strains produce only mild clinical symptoms or 

are asymptomatic. Morbidity rates may be low throughout a whole herd 

but high in certain pens (USDA–APHIS, 2009).

SVD Safeguards

There is no routine testing for SVD as it is exotic to Brazil. However, 

passive surveillance for this disease is carried out similarly to other 

vesicular diseases, such as FMD, as detailed above. If FMD is ruled out 

as a diagnosis in clinically affected pigs, evaluation for SVD is included as 

part of the follow-up testing. It is important to note that, in suspicious 

cases, movement of animals from the involved farms and the region will 

be restricted until a definitive diagnosis is reached.

There is no vaccine for SVD. Prevention measures are similar to those for 

FMD—controlling animals imported from infected areas, sanitary disposal

of garbage from international aircraft and ships, and prohibitions on 

feeding garbage to animals. Suspect animals will be placed in strict 

quarantine while an investigation is carried out. Eradication measures for 

the disease include quarantining infected areas, depopulation and disposal 

3. Swine 

Vesicular 

Disease 

Virus 
13

of infected and contact pigs, and cleaning and disinfecting contaminated 

premises (USDA–APHIS, 2003).

ASF is a serious viral disease of pigs that can spread very rapidly in pig 

populations by direct contact with infected animals or indirect contact with 

fomites (any inanimate object or substance capable of carrying infectious 

organisms) and tick vectors. Humans are not susceptible to the African 

swine fever virus (ASFV). ASF affects members of the pig family

(Suidae) and can have 100 percent mortality in native herds. Species that 

can be infected include domesticated swine, European wild boars, 

warthogs (Phacochoerus africanus), bush pigs (Potamochoerus porcus), 

giant forest hogs (Hylochoerus spp.), and peccaries (Tayassu spp.). 

Symptomatic infections occur in domesticated pigs, feral pigs, and 

European wild boars. ASFV infections are generally asymptomatic in 

warthogs, bush pigs, and giant forest hogs; these species are thought to be 

the reservoirs for the virus in Africa. Other species that may be able to 

carry the virus asymptomatically include the collared peccary (Tayassu 

tajacu) and the white-lipped peccary (Tayassu albirostris), both found in 

the Americas (CFSPH, 2006). 

ASFV, formerly classified as a member of the family Iridoviridae, is 

currently the sole member of the new genus Asfivirus in the family

Asfarviridae. ASFV is the only DNA virus transmitted by arthropods. 

This virus can persist for long periods in pig products and the 

environment. It can also become endemic in feral or wild Suidae, and in 

Ornithodoros ticks. ASFV isolates vary in virulence from highly 

pathogenic strains (that cause near 100 percent mortality) to low-virulence 

isolates that can be difficult to diagnose. There is no vaccine or treatment

for ASF (CFSPH, 2006). 

Disease outbreaks have occurred in Africa, Europe, South America, and 

the Caribbean; the cost of eradication has been significant. During 

outbreaks in Malta and the Dominican Republic, the swine herds of these 

countries were completely depopulated. In Spain and Portugal, ASFV 

became endemic in the 1960s; complete eradication took more than 

30 years. Outside Africa, ASFV is currently endemic only in feral pigs in 

Sardinia, Italy; however, changes in production practices and increased 

globalization have increased the risk of ASF being introduced into North

America (CFSPH, 2006). Severe epidemics of ASF occurred in Brazil 

from 1978 to 1981 (OIE, 2009a).

ASF is a highly contagious hemorrhagic disease. All age groups of pigs 

are equally susceptible. With highly virulent forms of the virus, ASF is 

characterized by high fever, loss of appetite, hemorrhages in the skin and 

internal organs, and death in 2 to 10 days, on average. Mortality rates may 

be as high as 100 percent (OIE, 2009a).

4. African Swine 

Fever Virus 
14

Transmission during direct contact is usually by mouth or nose. Aerosol 

transmission is thought to be unimportant, and only seems to occur over 

short distances when pigs are in close contact. ASFV can be found in all 

tissues and body fluids, but particularly high levels are found in the blood. 

Massive environmental contamination may result if blood is shed during 

necropsies or pig fights, or if a pig develops bloody diarrhea. The virus 

can also spread on fomites, including vehicles, feed, and equipment. 

There is evidence that some pigs may become carriers.

ASF often spreads to new areas when pigs are fed uncooked scraps that 

contain ASFV-infected pork. In one outbreak, pigs became infected after 

being fed the intestines of guinea fowl that had eaten infected ticks. 

Individual ticks can apparently remain infected for life, and infected soft 

tick colonies can maintain this virus for years. Other bloodsucking 

insects, such as mosquitoes and biting flies, may also be able to transmit 

the virus mechanically. Stable flies (Stomoxys calcitrans) can carry high 

levels of the virus for 2 days. Under experimental conditions, these flies 

could transmit ASFV 24 hours after feeding on infected pigs (CFSPH, 

2006).

ASFV is highly resistant to environmental conditions. It can survive for a 

year and a half in blood stored at 4 oC (39 oF), 11 days in feces at room 

temperature, and at least a month in contaminated pig pens. The virus will 

also remain infectious for 150 days in boned meat stored at 3.9 oC (39 oF), 

140 days in salted dried hams, and several years in frozen carcasses

(CFSPH, 2006).

ASF can be a peracute, acute, subacute, or chronic disease. Less virulent 

strains of ASFV produce milder symptoms that are easily confused with 

other diseases, and can take several weeks to spread through the herd. 

Animals infected with isolates of low virulence may be able to destroy the 

virus via an immune response without symptoms, abort, or develop 

chronic ASF (CFSPH, 2006).

Highly virulent strains produce peracute or acute disease, and may affect 

the entire herd within a few days. Sudden deaths with few lesions are 

characteristic of the peracute form, and may be the first sign of an 

infection in a herd (CFSPH, 2006). 

Acute disease is characterized by a high fever, moderate anorexia, 

lethargy, weakness, recumbency (the state of leaning, resting, or 

reclining), and erythema (abnormal redness of the skin) that is most 

apparent in white pigs. Some pigs develop cyanotic skin (bluish or 

purplish discoloration of skin), blotching on the ears, tail, lower legs, or 

hams. Pigs may also have abdominal pain, constipation, or diarrhea; the 

diarrhea is initially mucoid, and later may become bloody. Generalized 

hemorrhages can occur in the skin or internal organs. Difficulty breathing, 
15

vomiting, nasal and eye discharges, and neurologic signs have also been 

reported. Pregnant animals frequently abort; in some cases, abortions may

be the first signs of an outbreak. Leukopenia can be seen in laboratory

tests. In acute ASF, death often occurs within 7 to 10 days (CFSPH, 

2006). 

Subacute ASF, which is caused by moderately virulent isolates, is similar 

to acute ASF but less severe. In this form of the disease, the death rate is 

generally lower in adult swine, but may still be very high in very young 

animals. In subacute disease, fever, thrombocytopenia, and leukopenia 

may be transient; affected pigs usually die or recover within 3 to 4 weeks

(CFSPH, 2006). 

The symptoms of chronic disease include an intermittent low fever, 

appetite loss, and depression. Pigs may become emaciated and develop 

respiratory problems and swollen joints. Coughing is common, and 

diarrhea and occasional vomiting have been reported. Ulcers, reddened or 

raised tissue, or death of tissue in localized areas may appear over body 

protrusions and other areas subject to trauma. In some cases, the only 

symptoms may be emaciation and stunting. Chronic ASF can be fatal

(CFSPH, 2006). 

ASF Safeguards

For ASF, which is an exotic disease to Brazil, no specific surveillance is 

conducted. Instead, if CSF is ruled out in a susceptible pig population, 

ASF is considered as a possibility and investigated as such. As with SVD 

and other notifiable diseases, any implicated farms, as well as those they

are associated with, undergo movement restrictions until the investigation 

has been completed and a final diagnosis achieved (USDA–APHIS, 2009). 

ASF can be diagnosed by virus isolation in blood and tissue samples 

collected from suspect pigs. Nucleic acids can be detected with a 

polymerase chain reaction (PCR) assay, or by the hybridization of nucleic 

acid probes to tissue sections. PCR is particularly useful in putrefied 

samples that cannot be used for virus isolation and antigen detection. A 

rapid, real time PCR technique using tonsil scraping samples has recently 

been published. This test can detect the virus a few days before the onset 

of symptoms (CFSPH, 2006). 

Serology is also useful for diagnosis, particularly in endemic regions. 

ELISA is prescribed for diagnosis of animals or materials destined for 

international trade. Animal inoculation, performed in pigs, was used in 

the past to distinguish ASF from CSF. This test is no longer 

recommended by OIE due to humane considerations and the complexity of 

the test (CFSPH, 2006). 
16

To prevent introduction of ASFV into areas free of the disease, 

international standards are consistent in saying that all garbage fed to pigs 

should be cooked. Although Brazilian law allows some feeding with 

inactivation of waste, this practice is forbidden by State law in Santa 

Catarina (USDA–APHIS, 2009). 

Unprocessed meat must be heated to at least 70 oC (158 oF) for 30 minutes 

to inactivate the virus; 30 minutes at 60 oC (140 oF) is sufficient for serum 

and bodily fluids. Eradication is by slaughter of infected and in-contact 

animals, and disposal of carcasses, often by burying, rendering, or 

burning. Rapid diagnosis and the prevention of disease spread to feral or 

wild pigs are very important. Strict quarantines must be imposed. Many

common disinfectants are ineffective—care should be taken to use a 

disinfectant specifically approved for ASF. Sodium hypochlorite and 

some iodine and quaternary ammonium compounds are effective. 

Potential tick vectors should be controlled with acaricides (pesticides that 

kill mites and ticks). During an outbreak, a detailed entomological 

investigation should be conducted to investigate the possible role of local 

soft tick vectors and their potential for becoming long-term carriers. So 

far, however, Ornithodoros ticks have not become chronically infected 

during outbreaks in South America. Nonetheless, ticks and other biting 

insects which may be able to transmit the virus mechanically should be 

controlled. No treatment or vaccine exists for this disease (CFSPH, 2006).

The proposed rule will amend 9 CFR 94 to recognize the region of Santa 

Catarina, Brazil, as free from rinderpest. Rinderpest has never become 

established in the Americas and will not be considered a threat to the 

human environment as a result of implementing the preferred alternative. 

Passive surveillance by Brazil for rinderpest is carried out similarly to 

other vesicular diseases. Differential diagnosis5of vesicular diseases in 

clinically affected animals includes FMD, mucosal disease of cattle, 

bluetongue, vesicular stomatitis, and irnderpest (USDA–APHIS, 2009). It

is important to note that, in suspicious cases, movement of animals from

the involved farms and from the export region will be restricted until a 

definitive diagnosis is reached (Kreindel, pers. com. 2009).

 

OIE recognizes Brazil as a rinderpest-free country (OIE, 2008a). 

Rinderpest-free countries are included on the OIE list only after submitted 

evidence of no rinderpest vaccinations, adequate ongoing surveillance, and 

outbreak reporting has been accepted by OIE. Retention on the list 

requires that the information be resubmitted annually, and changes in the 

epidemiological situation or other significant events be reported according 

to OIE requirements (OIE, 2008b). 

 

5

Differential diagnosis is the distinguishing of a disease or condition from others presenting with 

similar signs and symptoms.

5. Rinderpest 

Virus 
17

In addition, OIE considers rinderpest close to being eradicated worldwide 

(OIE, 2009b); however, because surveillance is difficult in countries with 

civil strife or other calamities, disease-free countries (such as Brazil and 

the United States) may continue to restrict the movement of susceptible 

animals and uncooked meat products from areas where rinderpest might 

still be found (CFSPH, 2008). The Global Rinderpest Programme 

(GREP), introduced by the Food and Agriculture Organization (FAO) of 

the United Nations, is considered to be a primary instrument for 

successfully eradicating this disease (CFSPH, 2008). GREP is working to 

eliminate the last reservoir of infection, which is suspected to be persisting 

in Africa in the border area between Kenya and Somalia. GREP has set 

the year 2010 as the time by which all countries need to be accredited by

OIE as free from rinderpest. There is no known technical reason global 

eradication should not be achieved (FAO, 2009).

Rinderpest is a fatal viral disease of cattle, domesticated buffalo, and some 

species of wildlife (OIE, 2008a). It also affects sheep, goats, and some 

breeds of pigs (Asian pigs seem more susceptible than African and 

European pigs). Rinderpest can infect a large variety of wildlife species, 

including African buffaloes, eland, kudu, wildebeest, various antelopes, 

bushpigs, warthogs, and giraffes; however, it is rare among camelids 

(USDA–APHIS, 2009), and it has not been reported to infect humans 

(CFSPH, 2008).

Rinderpest virus (RPV) is the micro-organism that causes rinderpest. 

RPV is a single-stranded RNA virus in the family Paramyxoviridae, genus 

Morbillivirus. Rinderpest is an OIE-listed disease (OIE, 2008a). Three 

lineages of RPV have been found in different geographic areas, and some 

recent strains have caused mild disease in livestock but severe losses in 

wildlife. Each strain has the potential to undergo changes in virulence 

(CFSPH, 2008).

Transmission of rinderpest can occur through direct or close indirect 

contacts. The usual route of infection is via the respiratory tract, with an 

incubation period of generally 4 to 5 days following natural exposure, but 

it may range from 3 to 15 days. Viral shedding begins 1 to 2 days before 

pyrexia (fever) through tears, nasal secretions, saliva, urine, and feces, and

this typically continues for 8 to 9 days after the onset of clinical signs. 

Blood and all tissues are infectious before the appearance of clinical signs 

(USDA–APHIS, 2009). 

Rinderpest can take several clinical presentations—classic, peracute, 

subacute, and atypical. There is no carrier state following infection. The 

classic form is characterized by a 2- to 3-day period of symptoms, 

including high fever, depression, anorexia, increased respiratory and 

cardiac rate, congested mucus membranes, and excessive salivation. 

When the fever drops, gastrointestinal signs appear with profuse 
18

hemorrhagic diarrhea. Dehydration, abdominal pain, abdominal 

respiration, weakness, and death generally occur within 8 to 12 days. In 

rare cases, clinical signs regress by day 10, and recovery occurs by day

20 to 25 (USDA–APHIS, 2009). 

The peracute form of rinderpest has no preceding signs and is 

characterized by high fever (>40 to 42 °C) and death. The peracute form 

occurs in highly susceptible young and newborn animals. The subacute 

form has a low mortality rate and a clinical presentation similar to the 

classic form. The atypical form is characterized by irregular pyrexia with 

mild or no diarrhea (USDA–APHIS, 2009). RPV is relatively resistant 

and is stable between pH 4.0 and 10.0, but is susceptible to most common 

disinfectants, including lipid solvents. The virus remains viable for long 

periods in chilled or frozen tissues. Small amounts of RPV may survive 

relatively high temperatures, for example, 56 °C (133 oF) for 60 minutes 

or 60 °C (140 oF) for 30 minutes (USDA–APHIS, 2009). 

a. Santa Catarina, Brazil

In order to ensure compliance with the appropriate controls for FMD, 

APHIS will propose in its rule that MAPA certify the origin of FMDsusceptible animals and products, and certify that they were not 

commingled with animals or products from areas APHIS considers to be 

FMD-affected. Specifically, APHIS will require the following 

certifications for beef or pork products exported to the United States from 

the State of Santa Catarina: 

 The beef or pork comes from animals that have been born, raised, and 

slaughtered in the State of Santa Catarina; and

 The beef or pork comes from animals that originated on premises 

where FMD has not been present during the lifetime of any of the 

animals that are slaughtered for export of meat to the United States.

There is a potential risk from illegal introduction of affected animals or 

animal products from affected regions. Santa Catarina contains several 

posts located in internal and external border areas. Even where there are 

barriers or checkpoints, there is the potential that people, cars, and animal 

products could cross both domestic and international borders illegally. 

The potential for viruses under evaluation to transit the border during 

these times is increased, particularly via passenger car. Despite this 

possibility, Santa Catarina’s controls, biosecurity procedures, and 

quarantine procedures have been successful in mitigating this risk. APHIS 

evaluated Santa Catarina’s controls for the movement of animals into the 

State and concluded that risk from illegal importations from affected 

regions to be sufficiently mitigated (USDA–APHIS, 2009). 

6. Regulatory

Control
19

Were FMD or the swine diseases under evaluation to be reintroduced into 

the State of Santa Catarina, disease might be spread through animals 

scavenging unmonitored garbage dumps. Brazilian laws prohibit the 

feeding of untreated garbage to animals, while Santa Catarina goes even 

farther and prohibits garbage feeding outright, regardless of treatment. 

These laws are enforced effectively with the result that feeding of garbage 

to animals is unlikely to occur in Santa Catarina. 

b. The United States

In the United States, APHIS provides Federal regulation, assistance, and 

information concerning animal diseases, and operates an ongoing system 

of emergency response and disease controls. The export requirements of 

the proposed rule reflect norms and procedures which allow for the safe 

export of uncooked meat and meat products. Recent outbreaks of FMD in 

the United Kingdom and an suspected case of the disease in a domestic 

herd of swine in Minnesota provided opportunities to test the FMD 

programs in place in the United States (USDA–APHIS, 2007b; DJIN, 

2007). A similar response scenario is likely should a disease epidemic be 

caused by imports from Santa Catarina. For example, should an inspector, 

farmer, or other individual report a suspicious case, Federal agriculture 

and national security personnel would be deployed, followed by

involvement, as necessary, of the Departments of State, Transportation, 

and Health and Human Services. A quarantine area would be established, 

tissue samples would be analyzed, and laboratory determinations would be 

published. Depending on jurisdiction, Federal or State authorities regulate 

the methods and materials used for animal movement, vaccination, culling 

and carcass disposal, cleaning and disinfection, and surveillance. 

Based on evaluation of the 11 regionalization factors and observations 

from the site visits, APHIS considers the State of Santa Catarina to 

possess the detection capabilities, reporting systems, and emergency

response systems that are necessary for combating FMD, CSF, SVD, and 

ASF. APHIS considers the likelihood of introduction and establishment 

of the FMD, CSF, SVD, or ASF viruses into the United States via 

susceptible species or animal products from Santa Catarina, Brazil, to be 

low. Implementation of the preferred alternative and adherence to its 

stipulated risk mitigations is not expected to result in any consequential 

impact on the human environment.

There are several ways that the FMD, CSF, SVD, ASF and rinderpest

viruses may be transferred between wildlife and susceptible livestock 

(USGS, 2001; WDNR, 2003)—

 exposure to infected saliva, feces, urine, milk, semen, meat, and meat 

byproducts of infected animals;

7. Interspecies 

Transmission
20

 exposure to viral particles carried via wind, animals, or on virtually

any object (farm equipment, hay, shoes, etc.);

 drinking from a common source of contaminated water; and

 exposure to raw or improperly cooked infected garbage. 

The likelihood of exposure of susceptible species to infected live animals 

to the viruses of concern under this rulemaking was evaluated by briefly 

reviewing virus persistence and shedding in live swine and ruminants, as 

well as standard import requirements for these species. The risk analysis 

(USDA–APHIS, 2009) focuses on breeding animals because

transportation costs are prohibitive for export of other live animals (e.g. 

feeder pigs or cattle) to the United States from Brazil. APHIS considers 

exposure of susceptible U.S. animals to illegally imported infected live 

animals from Santa Catarina to be highly unlikely (USDA–APHIS, 2009).

The survival period of the CSF virus within live swine ranges from 1 week 

to greater than 6 months, depending on various host-pathogen factors. 

Similarly, up to 50 percent of ruminant animals may become carriers of

the FMD virus (USDA–APHIS, 2009). The maximum reported duration 

of the carrier state is 3.5 years in cattle, 9 months in sheep, and 4 months 

in goats. Carrier virus is fully infectious and, consequently, the carrier 

state is associated with at least a theoretical risk of introducing FMD into a 

susceptible population. ASF may also exhibit a chronic carrier state.

While the SVD virus is not known to cause persistent infection, a large 

percentage of infections are subclinical and, therefore, may remain 

undetected without diagnostic testing prior to export (USDA–APHIS, 

2009).

Consequently, APHIS considers this potential pathway for disease 

introduction to have high risk without mitigation. However, current U.S. 

regulations require certification that ruminants and swine have been kept 

in a region entirely free of FMD, CSF, SVD, and ASF for 60 days prior to 

export (9 CFR 93.405 and 93.505). The regulations also require a 

minimum quarantine of 30 days for most imported ruminants (9 CFR 

93.411), and 15 days for all imported swine (9 CFR 93.510). These 

requirements serve to partially mitigate the risk of exposure by increasing 

the likelihood of disease detection (USDA–APHIS, 2009).

Based on the results of the release assessment, APHIS considers the 

likelihood of entry of animals infected with the FMD, CSF, SVD, or ASF 

viruses into the United States via live animals from Santa Catarina, Brazil,

to be low; therefore, the resultant likelihood of susceptible exposure to the 

FMD, CSF, SVD, and ASF viruses via this pathway is similarly low

(USDA–APHIS, 2009). 
21

Genetic Material

Genetic material (e.g., swine semen) has been implicated in the 

introduction of foreign animal disease into susceptible populations, as well 

as the spread of established disease epidemics over considerable distances. 

For example, two semen collection centers became infected during the 

course of the 1997–98 CSF epidemic in the Netherlands (USDA–APHIS, 

2009). Potentially contaminated semen was distributed to 1,680 swine 

herds over the course of 5 weeks, during which the disease remained 

undetected in the donor boars. Although investigators concluded that only 

36 farms had been infected through artificial insemination, all suspect 

farms were subjected to quarantine and testing, resulting in a tremendous 

expenditure of resources.

Survival of the CSF virus in semen has been estimated in experimental 

studies to be 12 to 72 hours at 20 oC but ranges from 1 month to several 

years at 4 oC or below (USDA–APHIS, 2009). Survival in embryos and 

ova is unknown (USDA–APHIS, 2009). The FMD virus may be present 

in semen up to 4 days before clinical signs become apparent (USDA–

APHIS, 2009). Survival of both the SVD and ASF viruses in genetic 

material is possible but is not considered to be a primary mode of 

transmission (USDA–APHIS, 2009). The likelihood of release of the CSF 

or FMD viruses via infected semen from Santa Catarina, Brazil, is 

considered to be low; therefore, the likelihood of exposure of domestic 

livestock would be similarly low (USDA–APHIS, 2009).

Direct public health consequences are insubstantial because the occurrence 

of the FMD, CSF, SVD, or ASF virus in humans is quite rare. In fact, the 

number of cases reported is so small when compared with the number of 

persons exposed to these viruses that the World Health Organization 

generally does not consider FMD, CSF, SVD, or ASF to be a threat to 

humans (USDA–APHIS, 2009). FMD may affect humans; however, its 

occurrence is quite rare. 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. CSF, ASF, and rinderpest are not known to cause infection in 

humans (CIDRAP, 2009; CFSPH, 2004a; and CFSPH, 2004b). SVD has 

been accidentally transmitted to laboratory workers. Clinical signs of 

SVD include mild influenza-like symptoms, generalized abdominal and 

muscle pain, and meningitis (occurred in one case) (CFSPH, 2004c).

Perhaps more importantly, a substantial foreign animal disease outbreak 

can result in severe psychosocial effects on farmers and farming 

communities. Farmers and their families can suffer from grief over losing 

animals and 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. 

8. Public Health
22

For example, a study of the social consequences of the 2001 FMD 

outbreak in the Cumbria community of the United Kingdom revealed high 

rates of depression, alcohol consumption, and mortality among farmers 

during the crisis (USDA–APHIS, 2009).

IV. Other Environmental Issues 

A. Environmental Justice and 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 appropriate, disproportionately 

high and adverse human health or environmental effects of its programs, 

policies, and activities on minority populations and low-income 

populations in the United States and its territories and possessions. 

The proposed rule allows for the importation of live ruminants, ruminant 

products, live swine, and swine products to the United States. FMD, CSF, 

SVD, ASF, and rinderpest outbreaks in the United States have the 

potential to cause severe adverse consequences for domestic livestock and 

wildlife populations, and to disrupt the flow of animals and related 

commodities to consumers. As mentioned at the beginning of this 

document, rinderpest is not considered to be a disease of concern. The 

risk analysis concluded that the proposed mitigations for FMD, CSF, 

SVD, and ASF in the State of Santa Catarina, Brazil, are sufficient to 

prevent the introduction of these diseases into the United States and are 

adequate to initiate trade with Santa Catarina in susceptible animals and 

products. The risk analysis also concluded that the volume of animals and 

animal products likely to be imported into the United States from the State 

of Santa Catarina would be very small relative to overall U.S. supply of 

those commodities (production and imports from all foreign sources). 

Most of the modest impact-generating compliance actions under the 

proposed rule occur outside of the United States (in Brazil), and none have 

any disproportionate adverse effects on minority or low-income 

populations. Although one could design scenarios involving the 

introduction of FMD, CSF, SVD, ASF, or rinderpest to the United States, 

these are primarily remote and hypothetical. 
23

B. Protection of Children and the Preferred

Alternative

Executive Order 13045, “Protection of Children from Environmental 

Health Risks and Safety Factors,” requires each Federal agency to address 

disproportionate environmental health risks or safety risks to children 

from implementation of proposed policies, programs, activities, and

standards. The proposed rule changes do not pose greater risks to children 

than to other parts of the affected populations. The risks from importation 

depend primarily upon adherence to the sanitary requirements for entry of 

live ruminants, ruminant products, live swine, and swine products and this 

adherence precludes potential for adverse effects to humans, and makes 

other introduction-related risks remote and of negligible 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 endangered or threatened species or 

result in the destruction or adverse modification of critical habitat. APHIS 

has considered the potential effects of implementation of the preferred 

alternative on threatened and endangered species and designated critical 

habitat. 

CSF, SVD, and ASF are host specific, and there are no known federally

listed or proposed endangered or threatened species in the United States 

that would be affected by CSF, SVD, or ASF. Rinderpest has never been 

established in Brazil. However, FMD has been present in Santa Catarina,

and six endangered ruminant species in the United States are susceptible 

to that disease (see table 1). 

APHIS conducted a risk assessment and determined that Santa Catarina is 

free of FMD, CSF, SVD, and ASF, and has the infrastructure to prevent, 

rapidly detect, and effectively eradicate the diseases if they were to be 

introduced (USDA–APHIS, 2009). In that risk assessment, APHIS also 

determined that the likelihood of outbreaks occurring in the United States 

via exposure of the domestic livestock population to swine or other 

susceptible species or their related unprocessed products imported from 

the State of Santa Catarina, Brazil, to be very low (USDA–APHIS, 2009). 

Therefore, the proposed rulemaking is expected to have no effect on 

endangered ruminants or their designated critical habitats. 
24

Table 1. Endangered Species in the United States Susceptible to 

Foot-and-Mouth 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

Sierra Nevada bighorn sheep Ovis canadensis 

californiana

Yes Endangered

Peninsular bighorn sheep Ovis canadensis nelsonii Yes Endangered

D. Potential Cumulative Impacts 

The potential impacts from the proposed rule in combination with similar 

actions are referred to as cumulative impacts. Based upon the findings of 

the risk analysis, these impacts are not expected to pose any substantial

risks (USDA–APHIS, 2009). Although importation of live ruminants, 

ruminant products, live swine, and swine products does increase the 

potential for introduction of FMD, CSF, SVD, ASF, and rinderpest to the

United States, the mitigations required of Santa Catarina, Brazil, make 

introduction of the diseases of concern extremely unlikely, even when 

considering the current and future importations of the same animals and 

their products from other regions. It is difficult to precisely quantify the 

potential cumulative impacts which are dependent upon disease conditions 

and compliance with importation conditions in Santa Catarina, Brazil, and 

other regulated countries. The nature of disease mitigation is of principal 

concern for this issue, and the constraints provided by program mitigations 

are considered to provide adequate protection.
25

V. Agencies and Persons 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

Regionalization Evaluation Services

National Center for Import & Export

Veterinary Services

Animal and Plant Health Inspection Service

U.S. Department of Agriculture

4700 River Road, Unit 38

Riverdale, MD 20737

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 20737
26

VI. References

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Minnesota, Academic Health Center, Center for Infectious Disease 

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http://www.cidrap.umn.edu/cidrap/content/biosecurity/ag-biosec/animdisease/rpest.html [2009, Feb. 18].

CFSPH—The OIE Collaborating Centre on Diagnosis of Animal Diseases 

and Vaccine Evaluation in the Americas. See Iowa State University, 

College of Veterinary Medicine, Center for Food Security and Public 

Health.

DJIN—See Dow Jones International News

Dow Jones International News, 2007. Associated Press. White House got 

secret summer briefings on foot-mouth concern. Source: APHIS 

NewsAlert. October 15, 2007.

FAO—See Food and Agriculture Organization of the United Nations, 

Agriculture Department, Animal Production and Health Division. 

Fields, B.N., Knipe, D.M., and Howley, P.M., 1996. Fundamental 

virology, 3rd Edition.

Food and Agriculture Organization of the United Nations, Agriculture 

Department, Animal Production and Health Division, 2009. Global 

rinderpest eradication program: questions and answers. [Online.] 

Available: 

http://www.fao.org/Ag/againfo/programmes/en/grep/qa_rinder.html

[2009, May 6].

Iowa State University, College of Veterinary Medicine, Center for Food 

Security and Public Health, 2004a Classical Swine Fever. [Online.] 

Available:

www.cfsph.iastate.edu/diseaseinfo/ppt/ClassicalSwineFever.ppt [2009, 

May 26].

Iowa State University, College of Veterinary Medicine, Center for Food 

Security and Public Health, 2004b African Swine Fever. [Online.] 

Available: 

www.cfsph.iastate.edu/DiseaseInfo/ppt/AfricanSwineFever.ppt [2009, 

May 26].
27

Iowa State University, College of Veterinary Medicine, Center for Food 

Security and Public Health, 2004c. Swine Vesicular Disease. [Online.] 

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[2009, May 4].

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Kreindel, S. Telephone conversation with author, 30 April 2009.

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USDA–APHIS—See U.S. Department of Agriculture, Animal and Plant 

Health Inspection Service

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U.S. Department of Agriculture, Animal and Plant Health Inspection 

Service, 2007a. Procedure Manual for Classical Swine Fever (CSF) 

Surveillance. Appendix A: Classical Swine Fever (CSF) Case Definition. 

Version 2.0 - April 1, 2007. Accessed 5/4/09 at 

http://www.aphis.usda.gov/vs/nahss/swine/csf/CSF_PM_2007_AppendA_

CaseDef.pdf [2009, May 4].

U.S. Department of Agriculture, Animal and Plant Health Inspection 

Service, 2007b. APHIS Veterinary Services, Centers for Epidemiology

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disease, United Kingdom. 
28

U.S. Department of Agriculture, Animal and Plant Health Inspection 

Service, 2009. Risk analysis: APHIS Evaluation of the Status of the 

Brazilian State of Santa Catarina Regarding Foot-and-Mouth Disease, 

Classical Swine Fever, Swine Vesicular Disease, and African Swine 

Fever. 

USGS—See U.S. Geological Survey

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wildlife health alert for foot-and-mouth disease. Released April 18, 2001. 

[Online.] Available: http://www.usgs.gov/newsroom/article.asp?ID=480. 

[2009, Feb. 23].

WIN—See Wildlife Information Network

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disease virus. Online database. [Online] Available:

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ecies/picornaviridae/Picornaviridae_FMDVirus.htm [2009, May 11].

WDNR—See Wisconsin Department of Natural Resources

Wisconsin Department of Natural Resources, 2003. Foot-and-mouth 

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[2004, Sept. 15].

World Organization of Animal Health, 2008a. Official Animal Health 

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