United States 

Department of 

Agriculture

Marketing and 

Regulatory 

Programs

Animal and 

Plant Health 

Inspection 

Service

Proposed Rule for

Importation of Fresh

Beef from a Region in

Brazil

Environmental Assessment, 

December 2013
Proposed Rule for Importation 

of Fresh Beef from a Region in 

Brazil

Environmental Assessment, 

December 2013

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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any product mentioned. Product names are mentioned solely 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.................................................................................... 2

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

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

B. Proposed Rule ..................................................................... 3

III. Environmental Consequences............................................... 7

A. No Action ............................................................................. 7

B. Proposed Rule.................................................................... 9

1. FMDV and Vaccinations................................................ 9

2. FMD and Beef Processing ............................................ 14

3. Regulatory Control of FMD............................................ 15

4. Interspecies Transmission of FMD................................ 17

5. Environmental Fate of FMD .......................................... 23

6. Public Health................................................................. 25

IV. Other Environmental Issues ............................................... 26

A. Environmental Justice and the Proposed Action ............... 26

B. Protection of Children and the Proposed Action................ 26

C. Threatened and Endangered Species and the

Proposed Action ............................................................... 26

D. Potential Cumulative Impacts............................................ 27

V. Listing of Agencies Consulted............................................. 29

VI. References ............................................................................ 30
1

I. Need for the Proposed Rule

A. Introduction

The sanitary import regulations contained in 19 United States Code 

(U.S.C.) § 1306 prohibit or regulate the importation of beef and beef 

products into the United States. These regulations are designed to prevent 

the introduction and dissemination of injurious animal pests and diseases 

that are new to or not widely distributed in the country. Generally, the 

importation of beef is prohibited except under certain circumstances from 

specific areas, as stated in Title 9 Code of Federal Regulations (CFR)

§ 94. These restrictions are designed to prevent the introduction of a 

number of animal diseases including foot-and-mouth disease (FMD). In

1997, the U.S. Department of Agriculture (USDA), Animal and Plant 

Health Inspection Service (APHIS), established policy and rules 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 action was 

designed to facilitate trade while maintaining a low risk for the 

introduction of animal disease to the United States.

An official request was submitted to APHIS to export fresh (chilled or 

frozen), maturated, and deboned beef from a region (14 States) of Brazil to 

the United States. The exporting region of Brazil consists of the States of 

Bahia, Distrito Federal, Espirito Santo, Goias, Mato Grosso, Mato Grosso 

do Sul, Minas Gerais, Paraná, Rio Grande do Sul, Rio de Janeiro, 

Rondonia, Sao Paulo, Sergipe, and Tocantins. The most recent outbreaks 

of FMD within the export region of Brazil occurred in Mato Grosso do Sul 

and Paraná in 2006. Thus, given the history of the disease in Brazil and the

fact that Brazil vaccinates its cattle population against FMD in most States,

APHIS conducted a disease risk analysis to evaluate the likelihood of FMD 

introduction through the importation of beef from Brazil. The findings of

that document are summarized and incorporated 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). Cattle, sheep, goats, deer, 

buffalo, and swine are all adversely affected by FMD, but the effects on 

cattle herds tend to be particularly devastating. The death rate from this 

disease is low; however, both temporary and permanent physical damage 

to the body of infected animals results in costly losses in meat and milk 

production. Although lesions to the feet and mouth areas are the most 

prominent symptoms, the systemic damage to the gastrointestinal tract and 

circulatory system from this disease causes greater damage to the animal’s 

health and productivity. FMD is transmitted to healthy animals through
2

exposure to the active virus. Exposure may occur through inhalation of 

air-borne droplets (primarily from animals in close contact), ingestion, 

sexual transmission, conjunctival membranes (e.g., eyes, nose), contact 

with damaged/diseased skin, inoculation, and exposure from ticks or other 

animals that can carry the FMD virus (FMDV). Exclusion of this disease 

from the United States is particularly important in that the virus 

responsible for this disease is highly contagious and can survive in the 

environment for extended periods of time. Previous outbreaks of FMD in 

the United States have been very costly to contain and eradicate.

In response to the request from Brazil, and based upon the findings of site 

visits and the animal disease risk analyses, APHIS–Veterinary Services 

(VS) is proposing to allow importation of fresh beef from a region in 

Brazil to the United States under specific conditions of entry. The animal 

disease risk analyses determined that the likelihood of beef from the 

export region of Brazil introducing and establishing FMD in the United 

States is low. The analysis concluded that the proposed mitigations and 

conditions for entry are sufficient to initiate trade in fresh (chilled or 

frozen), maturated, and deboned beef from the specified export region in 

Brazil.

B. Need

In response to an official request from Brazil and in accordance with 

sanitary and phytosanitary (SPS) agreements to facilitate importation of 

beef to the United States, APHIS has reviewed the issues related to this 

importation and is proposing to amend the sanitary regulations (9 CFR

§ 94) by allowing importation of beef from these regions under specific 

conditions. The preparation of this EA was prompted by the anticipated 

public concern regarding the potential disease risk from the importation of 

beef, and the need to address environmental issues related to this disease 

risk. The issue of potential environmental risks of an outbreak of FMD in 

the United States resulting from imported beef is of great concern to 

APHIS. Characterization of the disease risk potential and adequate 

mitigation measures are critical to excluding this disease from the

United States.

This EA analyzes the potential environmental impacts resulting from 

approval of this proposed rule and from its change in the current 

regulations. There are tariff rate quotas set by the U.S. International Trade 

Commission on the quantity of beef that can be imported from different 

parts of the world without tariffs. The aggregate annual quantity of beef 

permitted import to the United States from Brazil is 64,805 metric tons, 

(Brazilian Embassy, 2006). Some of the cattle would remain in Brazil to 

maintain the national herd beef, and some cattle eligible for export would 

most likely be destined for other countries. These potential importations 

from Brazil would largely compete with existing domestic stocks and
3

displace imports of fresh beef from other countries. APHIS expects the 

net increase in imports from Brazil to equal about 0.1 percent of the U.S. 

beef supply, which is not expected to have a significant economic impact 

on entities potentially affected by this rule.

This EA is designed to satisfy the provisions of the National 

Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321–4327, its 

implementing regulations, and Executive Order 12114, “Environmental 

Effects Abroad of Major Federal Actions.”

II. Alternatives

This EA analyzes potential environmental consequences of the proposal to 

amend the regulations governing importation of beef into the United States 

(9 CFR § 94). The amendment would allow the importation of fresh beef 

from cattle raised in approved regions in Brazil under certain conditions. 

The two possible alternatives considered in this EA are (1) the current 

prohibition of importation of fresh beef from Brazil (no action), and (2) 

regulation under the proposed rule (preferred alternative).

A. No Action

The no action alternative is defined as continuation of the current sanitary 

regulation of importation of beef from Brazil. This alternative would 

involve continuation of the prohibition of the importation of fresh beef 

from Brazil. The lack of any changes in conditions for the entry of 

commercial shipments of beef from Brazil maintains overall disease risks 

at the present low levels, which are acceptable. Selection of this 

alternative may not, however, satisfy international trade regulations 

requiring justification of the more rigorous sanitary requirements of 

maintaining current regulations over less restrictive alternate approaches. 

In compliance with the SPS measures stipulated by the World Trade 

Organization, APHIS is obligated to consider less restrictive sanitary 

measures that provide comparable protection against disease risks. In 

addition, consistent regulation of comparable risks is important to APHIS. 

Countries such as Uruguay meeting APHIS’ regionalization requirements 

for an FMD-free status (based upon similar risk issues) have already been 

approved for importation of fresh beef to the United States in compliance 

with specific conditions of entry. 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. Proposed Rule

The preferred alternative will amend 9 CFR § 94.22 to allow the 

importation of fresh beef from Brazil, under certain conditions. 

Requirements similar to those of the preferred alternative have been

used effectively for establishing conditions of importation of fresh beef
4

from Uruguay, a neighboring country which has comparable disease

risks. The preferred alternative is designed to maintain sanitary security

in the United States while facilitating trade with Brazil. Implementation 

of this alternative would result in promulgation of amended sanitary

regulations for the importation of fresh beef from a region of Brazil 

under specific conditions of entry. The exporting region of Brazil 

would consist of the States of Bahia, Distrito Federal, Espirito Santo, 

Goias, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Paraná, Rio 

Grande do Sul, Rio de Janeiro, Rondonia, Sao Paulo, Sergipe, and 

Tocantins.

Under the preferred alternative, fresh (chilled or frozen) beef from Brazil 

would be exported to the United States under the following conditions—

• The meat is beef from bovines that have been born, raised, and 

slaughtered inside the exporting region.

• FMD has not been diagnosed in the export region within 12 

months prior to exportation of the beef.

• The beef came from bovines that originated on premises where 

FMD has not been present during the lifetime of any bovines 

slaughtered for the export of beef to the United States.

• The beef came from bovines that were moved directly from the 

premises of origin to the slaughtering establishment without any 

contact with other animals.

• The beef came from bovines that received ante-mortem and postmortem veterinary inspections (paying particular attention to the 

head and feet) at the slaughtering establishment, with no evidence 

found of vesicular disease.

• The beef consists only of bovine parts that are, by standard 

practice, part of the animal's carcass that is placed in a chiller for 

maturation after slaughter. Bovine parts that may not be imported 

include all parts of bovine heads, feet, hump, hooves, and internal 

organs.

• All bone and visually identifiable blood clots and lymphoid tissue 

have been removed from the beef.

• The beef has not been in contact with meat from regions other than 

those considered as FMD-free by APHIS and listed in § 94.1(a)(2).

• The beef comes from carcasses that were allowed to maturate at 

40 to 50 °F (4 to 10 °C) for a minimum of 24 hours after slaughter 

and that reached a pH of less than 6.0 in the loin muscle at the end 

of the maturation period. Measurements for pH must be taken at 

the middle of both longissimus dorsi muscles. Any carcass in 

which the pH does not reach less than 6.0 may be allowed to 

maturate an additional 24 hours and be retested, and, if the carcass 

still has not reached a pH of less than 6.0 after 48 hours, the meat 

from the carcass may not be exported to the United States.

• An authorized veterinary official of the government of the 

exporting region certifies on the foreign meat inspection certificate 
5

that the above conditions have been met.

• The establishment in which the bovines are slaughtered allows 

periodic on-site evaluation and subsequent inspection of its 

facilities, records, and operations by an APHIS representative.

In addition to the above mitigations, there are several other aspects of the 

program that affect potential FMD risks; some relate to the extent to which

the 11 factors (defined by APHIS as necessary to regionalization as 

described in 9 CFR § 92.2) are met by the exporting region of Brazil. In 

2012, APHIS consolidated the 11 factors into 8 factors. However, since 

the evaluation of this region of Brazil started before 2012, and the topics 

addressed by the 11 factors are contained within the 8 factors, this report 

follows the 11 factor format. The description of Brazil’s consistent and 

ongoing fulfillment of these factors is assumed to continue as part of the

proposed program requirements. The conclusions of the review of this 

region of Brazil, as presented in the disease risk analysis (USDA–APHIS, 

2013) are summarized for each regionalization factor as follows—

(1) Based upon site visits and documentation reviews, APHIS 

considers Brazil’s MAPA to have sufficient legal authority, 

organization, and infrastructure to carry out official control, 

eradication, and quarantine activities. The census information, 

coverage of premises in the export region, record-keeping, control 

of vaccination, documentation of animal movement, funding 

available for indemnity, and sight recognition of FMD clinical 

signs at local veterinary units (LVUs) support their disease control 

mission.

(2) APHIS did not detect any evidence to suggest that active outbreaks 

of FMD exist in the export region. Despite occasional outbreaks 

of FMD in Brazil and in neighboring countries of South America, 

APHIS considers the disease to be under control in the export 

region. In addition, APHIS concluded that MAPA could detect 

disease quickly, limit its spread, and would report promptly. This 

was evident in the FMD outbreaks in 2005 and 2006—the cases 

were quickly identified, disease was contained, and international 

authorities were notified in a timely manner.

(3) APHIS does not consider countries of South America to be FMDfree, with the exception of Chile. Outbreaks have occurred 

recently in Argentina, Uruguay, and Paraguay,

1

all countries that 

had been classified by the World Organization for Animal Health 

(formerly Office International des Epizooties (OIE)) as “free 

without vaccination” or “free with vaccination” prior to the 

outbreaks. FMD has not been eradicated from Colombia, Bolivia, 

 

1

For the purposes of APHIS’ evaluation of Brazil, the neighboring countries of Brazil are Paraguay, Uruguay, Bolivia, 

and Argentina.
6

Ecuador, Venezuela, Northern Argentina, or Peru. The recent 

history of introductions (2000 to 2006) from adjacent countries 

relates to illegal movement of animals and mechanical 

transmission of the virus. In 2000 and 2001, Brazil became 

vulnerable to the introduction of the disease due to the lack of 

reporting the disease by Argentina. In 2002, Brazil successfully 

instituted emergency measures when an outbreak occurred in 

Paraguay, near its border with Brazil. Similar successful

emergency actions in 2003 and 2006 resulted in preventing the

introduction of the disease from Argentina and Paraguay.

(4) The disease control program and national response plan to FMD 

emergencies, through quarantine and testing, have been determined to 

be sufficient to respond quickly. The active surveillance plan, 

serological monitoring, and community participation in notification of

disease outbreaks help to prevent and detect outbreaks early.

(5) Vaccination of cattle and buffalo occurs twice annually with an 

inactivated, trivalent,

2

oil-based vaccine which is mandatory in the 

export region. The vaccine is formulated with FMD viral strains 

A24, Cruzeiro, O1 Campos, and C3 Indaial. The system of controls 

for compliance with timing, movement permits, census data, field 

inspections, and fines for noncompliance meets international 

standards for vaccination programs.

(6) Many natural barriers, such as rivers and forest areas, exist along 

the borders of the region. Although movement of FMDsusceptible species or products could occur due to the lack of 

sufficient physical barriers, most borders are actively monitored 

for cattle, and collaborative efforts on animal health issues at 

borders have been established to ensure immediate notification.

(7) Brazil has a system of permits in place to control animal 

movements which is tied to vaccination records. Land border 

checkpoints exist at both international and domestic borders and 

are considered adequate for legal movement based on site visits by 

APHIS. Airports and seaports indicate a high level of biosecurity.

(8) Marketing practices in Brazil are designed to eliminate most 

disease risks through the livestock circuits, animal identification 

system, slaughter facilities, and the larger commercial operations. 

Cattle in Brazil are primarily grass-fed and may not be subject to 

routine supervision under certain pasture rotation plans, 

particularly some larger operations.

(9) Brazil has a two-phase surveillance system designed to include 

both active and passive surveillance techniques. The LVUs are 

 

2

A trivalent vaccine contains three antibodies capable of counteracting a specific antigen.
7

trained to provide consistent implementation and execution of the 

surveillance program.

(10) Brazil has diagnostic laboratories for FMD at Belem and Recife.

The facilities were determined by APHIS to have sufficient 

capacity to process the sampling load and testing procedures that 

are in accord with OIE guidelines.

(11) Emergency response in Brazil is contingent upon community 

notification of FMD outbreaks. There is considerable autonomy

at the State level to deal with such emergencies. The rapid and 

effective responses to the FMD outbreaks in Rio Grande do Sul 

in 2001 and 2005, as well as to the outbreaks in Mato Grosso do 

Sul and Paraná in 2006, indicate that their Federal contingency

plan for FMD in the export region is sufficient.

Proposed Amendment to Regulations

APHIS considers Brazil to be an FMD-affected country that practices 

vaccination against the disease. It has not experienced an FMD outbreak 

for more than a year. Brazil has requested to be allowed to export fresh 

beef into the United States. After conducting a risk assessment in 

connection with the request, it has been determined that fresh (chilled or 

frozen) beef can be safely imported from certain States within Brazil 

provided that certain requirements are met. These States are Bahia,

Distrito Federal, Espirito Santo, Goias, Mato Grosso do Sul, Minas Gerais, 

Paraná, Rio de Janeiro, Rondonia, Sao Paulo, and Tocantins. (Imports will 

be allowed from a region of Brazil that excludes a buffer area located along

the border of Bolivia, Paraguay, and Argentina.) APHIS would amend 9 

CFR § 94 to reflect this determination and include a list of the specific

requirements for export under § 94.22. In addition, because rinderpest has

never become established in Brazil and is not endemic to the Americas, 

APHIS would recognize the entire country of Brazil as free of rinderpest.

III. Environmental Consequences

A. No Action

The biological history and disease potential of FMD suggest that the 

continuation of the current regulations of beef (no entry) from Brazil 

would result in no potential for increased pest risk and, therefore, no 

change in potential impact on the human environment. Although the

required mitigations under the proposed rule provide a means of export for

Brazilian producers that have been shown to be effective against all known 

strains of FMDV, there remains some potential risk that does not exist under the

no action alternative.
8

The lack of importation of fresh beef from Brazil has maintained low 

disease risks and negligible environmental effects. As with most 

commodities, there is always some risk of smuggling; however, the 

frequency is low due to the high punitive costs from noncompliance. The 

high potential risks from disease associated with noncompliance make it 

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

importers and shippers informed of their import regulations and of the 

penalties for 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 option 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.

This offers 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). 

Comparable compliance could be expected for any present or revised 

sanitary regulations related to the importation of fresh beef from Brazil.

The issue of potential environmental risks of an outbreak of FMD in the 

United States is of great concern to APHIS as the consequences of an 

FMD outbreak in the United States would be extremely high. The major 

economic consequence of importing FMD would be export trade losses. 

In Brazil, the sum of the consumer impacts, direct costs, and trade losses

over a 15-year period would be between $37 and 44 billion, depending on 

the magnitude of the outbreak and the eradication strategy (USDA–

APHIS, 2013). Although such consequences are substantial, it is 

important to note that the results of the risk analysis for release and 

exposure assessment indicated low likelihood of introduction and 

establishment of FMD when the proposed program mitigations are 

followed.

The no action alternative would leave the current importation regulations 

unchanged. Under this alternative, Brazil would continue not to be 

allowed to export beef to the United States. The status in Brazil as low 

risk for FMD is not reflected in the current import regulations. The 

continuance of such unsupported trade restrictions would be contrary to 

U.S. obligations under international trade agreements.
9

B. Proposed Rule

The environmental consequences from promulgation of the proposed rule 

are largely contingent upon the ability of various mitigations and

program treatment procedures to preclude exposure of the Brazilian cattle

herds to FMD, and to exclude the importation to the United States of any

Brazilian beef that could potentially be infected with FMDV. The 

disease risk analysis (USDA–APHIS, 2013) of fresh beef from a 

designated region in Brazil examined the sanitary concerns related to 

fulfilling the request from the Brazilian MAPA. The analysis assesses 

the likelihood of introduction and outbreak of FMD to livestock in the 

United States from implementation of the rule. Findings of the risk 

assessments are summarized within this document and are incorporated 

by reference herein.

Compliance with NEPA requires APHIS to consider all potential effects to 

the human environment from this rule. In addition to consideration of 

disease issues related to livestock, this document analyzes characterization 

of the potential effects to humans, wildlife, and environmental quality.

The information is presented by topics related to program requirements 

and associated mitigative actions that affect potential disease risks 

associated with this proposed beef importation rule. This includes

sections with issues related to the vaccination process, the meat maturation 

process, the regulatory control process, the disease transmission

mechanism as related to wildlife, and the persistence of FMDV under 

various environmental conditions on or in environmental media such as in 

soil, in water, on plants, and on abiotic surfaces.

1. FMDV and

Vaccinations

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 which 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 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. 

Patients usually recover within a week after the last blister formation 

(USDA–APHIS, 2013). The major host species for FMDV is widely 

recognized to be domestic cattle. 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
10

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 on 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, ticks, 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 air-borne 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 conditions such as recovery from clinical disease and undetected 

subclinical disease; nevertheless, reports of carrier animals infecting 

susceptible animals are extremely rare (WIN, 2001). Different strains

3

of 

FMD have different capacities to establish persistent infection, and the 

proportion of animals that become carriers following exposure to virus 

varies depending on the severity 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 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 genome

4

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

5

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

 

3

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

4

A genome represents all of the genetic information or hereditary material possessed by an

organism or micro-organism.

5

An antigen is a substance that can trigger an immune response, usually a foreign protein, which is

not found naturally in the body.
11

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

thereby establishing persistent infection in the host. In the case of FMD, 

the modification of specific antigens or proteins gives rise to a substrain of 

virus.

Given that viruses tend to modify their antigenic and protein characteristics 

for persistent survival within the host, it is likely that FMDV will switch

strains. Because vaccination against a certain FMD strain does not result 

in protection against other strains, if an FMDV strain against which cattle

in Brazil are not vaccinated causes an outbreak, the animals would be more

likely to show clinical signs and the disease would be detected more

quickly. Brazilian animal health authorities may respond to such an 

occurrence by following a stamping out course of action which involves 

the killing of susceptible animals, the vaccination of animals for the new 

strain, or a combination of both with other emergency procedures. No 

matter what strain may cause an outbreak, MAPA will manage any

outbreak in the same manner, and a sanitary state of emergency will be 

declared with the accompanying quarantine and movement restrictions and

sanitary measures (USDA–APHIS, 2013).

Adequate preparation for upcoming strains of the FMDV involves research 

to predict future strains and the preparation and storage of vaccines for

potential future outbreaks. Different strains of virus and vaccine vary in 

their ability to stimulate immune responses. Vaccination with more than 

one strain at a time neither enhances nor competitively inhibits response to 

the different strains. Problems in developing effective vaccination regimes 

for an area may arise related to the existence of seven different 

immunotypes and the large number of strains associated with FMDV; 

therefore, polyvalent

6

vaccines may be necessary. Vaccine efficacy is 

dependent on a number of factors including—

• the percentage of the susceptible animal population vaccinated,

• similarity between the field strain and the vaccine strain used,

• immune response of the individual animal,

• time between vaccination and challenge and the level of challenge, and

• the mixing of stock.

a. Vaccination Practices and Safeguards

Currently, Brazil requires that all cattle and buffalo are vaccinated every

6 months. Vaccination of cattle and buffalo is mandatory in the export 

region. Animals are vaccinated twice a year on a schedule appropriate

for each area. In some areas, animals less than 2 years of age are

 

6

A polyvalent vaccine contains several antibodies (proteins produced by the body as part of its defense), each 

capable of counteracting a specific antigen.
12

vaccinated two or more times per year, and some adult animals are

vaccinated only once. Animals must participate in four vaccination 

rounds before they can be vaccinated only once a year. 

The vaccine used is an inactivated, trivalent, oil-based vaccine. Brazilian 

laws allow only the production of vaccine formulated with FMD viral 

strains A24, Cruzeiro, O1 Campos, and C3 Indaial. Production capacity

for FMD vaccines in Brazil is around 300 million doses per year

(USDA–APHIS, 2013).

All FMD vaccines produced or used in Brazil are tested for quality and 

safety. Quality control tests of each batch of the vaccine are conducted in 

the laboratories in Recife and Porto Alegre and strictly follow 

international standards as set by OIE. A vaccine batch will pass the 

quality control tests when the expected percentage of protection is greater 

than or equal to 75 percent. There is no evidence to suggest that 

unacceptable biological products or vaccines are being used in Brazil. 

MAPA maintains adequate control of vaccine supplies and conducts 

mandatory registration and testing of vaccines for safety and quality 

(USDA–APHIS, 2013).

In certain cases where the need appears (such as in areas inhabited by rural 

landless and Indian tribes, or areas densely populated with backyard and 

street cattle), vaccination is supervised by and sometimes conducted by

the personnel of the LVU. In some areas with relatively large numbers of 

small and poor farmers, a State employee will vaccinate the cattle at one 

specific location. In other cases, large establishments will share vaccine 

with their smaller neighbors. This helps the small farmer as the vaccine is 

sold by the bottle and not by individual animal doses. Otherwise, farmers 

may vaccinate their own animals or hire trained professionals. Some State 

offices have emergency funds available to assist with the cost of 

vaccination on Indian reservations.

Vaccination records may be verified by field inspectors visiting individual 

premises. Field inspectors may request copies of the vaccination sales 

receipt and the vaccination-use records. LVU personnel monitor 

vaccination through vaccine sales. Vaccines can be obtained only from 

designated commercial establishments. Once a vaccine is sold, the record 

of that sale is filed with the LVU. After a herd is vaccinated, the owner 

must provide the LVU with a statement/affidavit documenting the amount 

of vaccine used. The statement must be provided within 10 days of 

vaccination, and vaccination must be completed within a specified period 

of time after purchase. LVU personnel match the information on the 

owner’s affidavit to the sales records to determine whether the information 

is consistent. The information is also used to update the census record for 

the premises. In addition, vaccination records are compared to movement 

permits on a farm-by-farm basis for auditing and quality control. The 

requirement for vaccination and vaccination records provide a vehicle for 

control of animal movement and for the generation of census data at the 
13

local level. Registration of herds with the LVU is mandatory. Each

owner has a registration number for identification. LVUs maintain a list of

individual properties, number of animals, and vaccination records for those

animals. The census data and information on vaccination compliance

collected by LVU personnel is passed on to Federal officials.

The risk analysis associated with this proposed rulemaking concludes that 

Brazil conducts its FMD vaccine program appropriately and in accordance 

with international standards (USDA–APHIS, 2013). Further, based on the 

proposed mitigations and current mitigations already in place in Brazil, no 

significant environmental impacts are anticipated as a result of allowing

the importation of fresh beef from Brazil (north of the 42oparallel) into 

the United States.

b. Vaccination Compliance

Brazilian officials believe the overall compliance level for vaccination 

approaches 100 percent (USDA–APHIS, 2013). The best compliance 

tends to be provided by neighboring ranchers because they want to protect 

their animals. The high compliance rate is significant because animal 

identification is accomplished through contacts made during the 

vaccination process (USDA–APHIS, 2013).

Noncompliance with vaccination can be detected by late filing or not 

returning vaccination forms, by apprehension of illegal movement, or by 

anonymous callers to an established hotline. The official service prohibits 

all animal movement from noncompliant farms until the owner produces 

sufficient evidence that the animals were vaccinated. LVU personnel 

follow up with noncompliant farmers by hand-delivering a warning letter 

and a visit to the premises. If the situation warrants, action may be taken, 

including levying a fine; if this occurs, a State veterinarian vaccinates the 

animals at the owner’s expense. Failure to vaccinate may result in 

penalties or fines (USDA–APHIS, 2013).

Brazil is collaborating with neighboring countries in order to make 

decisions regarding vaccination programs, as well as the development of 

criteria for discontinuation of vaccination. As a result of the 2006 

introduction of the disease into the export region, the need for 

international cooperation and transparency has become very evident 

during recent years (USDA–APHIS, 2013).

c. FMD Surveillance

FMD is considered endemic to most countries in South America, and 

outbreaks of the disease are likely to continue to occur in the exporting 

regions (USDA–APHIS, 2013). It is possible that FMD-affected animals, 

animal products, people, and vehicles may cross domestic or international 

boundaries illegally. Effective FMD surveillance programs are essential
14

in the prevention and containment of disease outbreaks. APHIS has 

evaluated the movement and detection controls in place for Brazil, and has 

determined that they are adequate to maintain an overall low level of risk 

of introducing FMDV to the United States via the pathway of beef 

exported from the designated regions (USDA–APHIS, 2013).

The FMD surveillance performed in Brazil can be broadly characterized as 

having two phases: (1) demonstrating freedom from disease in a zone,

and (2) monitoring of that zone. APHIS considers Brazil to have 

implemented effective disease surveillance strategies for the proposed 

export regions, and is not requiring additional measures for this mitigation 

(USDA–APHIS, 2013).

2. FMDV and 

Beef 

Processing

Brazil employs dual “active” and “passive” systems of surveillance which 

are designed to detect the presence of disease. The dual systems also 

provide a basis for demonstrating freedom from FMD over certain areas or 

periods of time. Generally speaking, the passive surveillance gathers 

qualitative information about FMD, and the active surveillance gathers 

quantitative data. Passive surveillance in both countries is bolstered by 

effective community education and involvement, while the bulk of active 

surveillance consists of the annual serological sampling of randomly 

selected animals and regular survey of higher-risk areas (USDA–APHIS,

2013).

Animal processing can lead to exposure and spread of FMD. Only cattle 

from production areas certified under the requirements of the proposed 

rule would be accepted for slaughter, and processing would occur only at 

approved facilities in the export regions of Brazil. Mitigations during 

processing will be required to allow for the detection and removal of 

animals showing clinical signs of disease, removal of animal parts which 

can carry FMDV, and maturation of the beef in order to inactivate any 

FMDV which may be present and undetected. Incorrectly processed beef 

may harbour FMDV and devastate exposed domestic and wild animal 

populations, polluting the environment with massive carcass disposals, as 

well as adversely affecting the human economy and food supply.

A critical mitigation measure affecting the introduction potential of many 

exotic virus diseases is the drop in the pH of meat which accompanies 

rigor mortis (muscular stiffening following death). FMDV is sensitive to 

pH and cannot survive in skeletal muscle after rigor mortis has developed; 

the resulting accumulation of lactic acid sufficiently decreases the pH. 

Virus survival is optimal between pH 7.2 and 7.6; at pH values above 9 or 

below 6, the virus is rapidly destroyed. As long as meat is maturated to a 

pH below 6, FMDV is inactivated, if present (AVIS, 2002).

It is generally accepted that FMDV in animal tissue is totally inactivated at 

pH 6 or below after 48 hours at a temperature of 4 oC. OIE recommends a 

minimum maturation time of 24 hours, and a pH value less than 6 for beef
15

where vaccination is practiced. Currently, processing facilities in the 

Brazilian export regions follow the European Union (EU) standards of a 

minimum of 24 hours of maturation at 2 to 10 oC, and rejection of 

maturated carcasses with a pH greater than 5.9.

APHIS is requiring all bovine carcasses from the export regions be 

allowed to maturate at 40 to 50 oF (4 to 10 oC) for a minimum of 36 hours 

after slaughter and, at the end of the maturation process, a pH of 5.8 or

less is reached (USDA–APHIS, 2013). The disease risk analysis mentions 

that a longer maturation time of 36 hours might not be expected to result

in a higher rejection rate than the one currently observed in Brazil. 

Increasing the maturation time from 24 to 36 hours, however, is believed 

to ensure that the proportion of carcasses rejected will not be significantly 

more than has been observed previously in Brazil. A longer maturation 

period is supported by scientific evidence that there is a gradual trend 

towards lower pH with time and that the pH averages 5.6 to 5.8 after 48 

hours of aging, although the pH does tend to rise slightly after 72 to 96 

hours of maturation (Cottral et al., 1960).

The slaughter protocols, which will be required under the proposed rule 

for allowing beef from Brazil to be exported to the United States, are 

designed to mitigate the risk of FMD in cattle sent to be slaughtered and 

processed for export. The proposed mitigations will utilize existing 

technology and government infrastructure in Brazil, and are designed to 

reduce the risk of FMD outbreaks in the United States by mitigating risk 

of the disease in the export regions. There are no adverse environmental 

consequences expected in Brazil or the United States due to 

implementation of the beef processing requirements in the designated 

regions under the proposed rule.

The current Brazilian risk mitigation processes evaluated by APHIS are 

considered adequate and will be incorporated as part of the requirements 

for the preferred alternative (USDA–APHIS, 2013).

3. Regulatory 

Control of 

FMD

Federal, State, and local veterinary authorities enforce the animal health 

laws in Brazil. MAPA establishes and enforces animal health regulations 

at the national level in Brazil to prevent the introduction and spread of 

animal pests and diseases. Brazil has instituted national animal 

identification systems. Domestic movement controls over animals are 

stringent and are linked to FMD-vaccination coverage. Through these 

FMD regulations, the government controls the movement of cattle from 

one location to another. MAPA, Federal and State veterinary facilities, 

and accredited veterinarians all play a role in ensuring the health of 

livestock in Brazil.

The establishment of effective surveillance and monitoring of susceptible 

livestock are also important in preventing and limiting FMD outbreaks.
16

Brazil is in the final stage of implementing the national identification 

system (SISBOV) for cattle and buffalo. The goal of SISBOV is to 

individually identify and monitor all cattle and buffaloes born or imported 

into Brazil. The system is designed to trace animals from birth to death, 

and participation has been mandatory for all beef producers since the end 

of 2007 (USDA–APHIS, 2013).

To avoid disease introduction and spread, Brazil operates domestic 

checkpoints, and their international borders are monitored in a regional 

disease-control effort. Even so, disease transmission into and from 

adjacent countries has occurred. In areas where natural barriers do not 

exist, and at sea, air, and land ports of entry, Brazil has enhanced 

governmental protocols to protect their animal populations against FMD. 

Border surveillance 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 approved countries 

are quarantined and tested. Imports of live FMD-susceptible animals are 

prohibited from FMD-affected countries as such animals are considered 

potential sources of FMDV. Brazil 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 risks in 

neighboring countries. Since 2006, Brazil has joined Argentina, Uruguay, 

Paraguay, and Bolivia in creating buffer zones with intensive mutual 

surveillance along their national boundaries. The buffer area for Brazil is 

approximately 15 km to either side of the border it shares with these 

countries.

APHIS conducted site visits to Brazil in 2002, 2003, 2006, 2008, and 2013. 

The last reported outbreak of FMD in Brazil occurred in 2006. APHIS 

evaluated documentation provided by MAPA and scientific literature. The 

conclusion reached by APHIS’ disease-pathway analysts is that the risk is 

low for FMD-contaminated beef entering the United States from the 

proposed export regions in Brazil and, thus, low for presenting a threat to 

U.S. livestock via feeding or contact with susceptible animals (USDA–

APHIS, 2013). Today, APHIS considers that Brazil’s MAPA possesses 

sufficient legal authority to carry out official control, eradication, and 

quarantine activities for animal health programs, and that the country has 

demonstrated an infrastructure adequate for rapid detection of FMD and

for carrying out surveillance and eradication programs (USDA–APHIS,

2013). Carcasses and cuts of meat, when produced under adequate 

regulation, present a lower health risk and are simpler to track the point of 

origin than other animal products (Barcos, 2001). Thus, to mitigate the 

potential risk associated with importing FMD-contaminated beef and beef 

products, the proposed rule incorporates a systems approach similar to that 

for the importation of Uruguayan beef into the United States.
17

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

information concerning FMD, and operates an ongoing system of 

emergency response and disease controls (USDA–APHIS, 2002). The 

export requirements of the proposed rule reflect norms and procedures that 

have been shown to allow safe export of uncooked meat and meat

products from FMD-affected South American regions

(PANAFTOSA/Tuskegee, 1995). Recent outbreaks of FMD in the

United Kingdom and a 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, 2007; DJIN, 2007). A similar 

response scenario is likely should an FMD epidemic be caused by the 

importation of beef from Brazil. 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 lab determinations 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.

Geographic characteristics (such as rivers, mountains, semi-arid, and 

forested areas) along the borders of the FMD-free export regions proposed 

for Brazil can provide natural barriers against the spread of diseases, such 

as FMD. Brazil, however, has numerous internal and external 

jurisdictional boundaries with few or no natural barriers (USDA–APHIS,

2013). In areas where natural barriers do not exist, Brazil has established 

buffer zones, checkpoints, and more intensive governmental controls. 

Although in Brazil the potential remains for introduction of FMDV by 

anthropogenic means, there is no evidence available to substantiate 

wildlife populations as a possible risk factor for spreading FMD to 

domestic species in either export region (USDA–APHIS, 2013). This is 

discussed further in the next section.

4. Interspecies 

Transmission 

of FMD

FMD is one of the most contagious animal diseases known (AVIS/OIE,

2000). Although rare, human cases have occurred; 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). Transmission between susceptible clovenhoofed wild and domesticated animals is possible, and is known to have 

occurred once in the United States in 1924 (Rhyan et al., 2006). The virus 

may also be transmitted mechanically by humans and nonsusceptible 

animals, such as rodents and birds.
18

FMD can cause blisters and flu-like symptoms in humans, and lasting 

debilitation or death in cloven-hoofed animals. There is no known 

treatment for FMD (AVMA, 2007). Severity of the disease and 

expression of symptoms can vary greatly, even within a species. Sheep

are generally considered to be “carriers,” while swine are “amplifiers” and 

cattle are “indicators” (CIDRAP, 2007). Although occasionally FMD can 

be very destructive to wildlife populations (for example, the South African 

impala in the late 19th century or mountain gazelles in Israel more

recently (Shimshony et al., 1986; Thomson et al., 2003)), generally FMD 

“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 domesticated animals. After FMD has been 

eradicated from livestock in Africa, for example, “it has also generally 

disappeared from wildlife in those regions . . . Wildlife appear to have

been an extension of the disease in livestock” (Thomson et al., 2003). 

There are several ways that the virus 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;

• 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.

In order to conduct a thorough analysis of the effect that the proposed rule 

could have on the human environment in the United States, APHIS 

examined the consequences of the movement of FMDV between wild 

animals and domestic livestock within Brazil and surrounding regions, as 

well as within the United States. Successive serological surveys have

been conducted since the last FMD outbreaks in Brazil, including areas in 

the proposed export regions where wild animals may be in contact with 

domestic species; survey results have not revealed evidence of viral 

activity in domestic ruminants likely to have contact with wildlife

(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 

infected with FMDV.

The possibility remains that wildlife in the export regions and neighboring 

areas might become infected with or transport FMDV and, by their natural 

movement, infect FMD-free livestock being considered for export, 

ultimately resulting in contaminated meat being imported into the
19

United States. FMDV can survive for long periods in meat (EUFMD,

2007). Once virus-infected meat enters the United States, susceptible 

livestock and wildlife may be at risk of contracting and spreading the 

disease. North American wildlife (including white-tailed deer and other 

deer species, 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 

disposals, and increased danger to humans and animals from widespread 

disinfectant or other chemical uses are all likely in the event of an FMD 

outbreak (Pinto, 2004).

Although unlikely, there is the potential for wildlife to spread FMD into 

the proposed export region. The APHIS disease risk analysis for the 

proposed rule indicates that there is no evidence to suggest that FMD may 

exist in wildlife in Brazil. MAPA officials believe that Brazil’s wildlife 

does not constitute a risk factor for spreading FMD to domestic animals. 

These officials indicated to APHIS that over the course of many years of 

combating the disease, no consistent relationship between outbreaks of the 

disease in domestic animals and coexistence of susceptible wild animals 

has ever been confirmed (USDA–APHIS, 2013).

Nonetheless, scientific studies in the United States have not determined 

that a relationship does not exist. Much is still unknown about the risk of 

wildlife becoming infected with FMD or how likely wildlife are to infect 

livestock. “All cloven-hoofed animals and Camelidae . . . are susceptible 

to infection with FMD viruses but the facility with which different species 

and even breeds of animals develop clinical disease varies . . . This 

variation is largely quantified in the case of domestic animals but for most 

species of wildlife their relative susceptibility is unknown . . . With a few 

exceptions, excretion and transmission 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 extrapolated 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 expressed, and physical examinations of wild populations are 

difficult to carry out (Thomson et al., 2003).

a. The Export Region and Surrounding Countries

While FMDV can be transmitted over long distances and remain viable for 

up to 15 weeks under certain conditions (USDA–APHIS, 2013), the 

potential for transmission between wildlife and domestic livestock in

Brazil is offset by strict national surveillance programs and animal 

movement controls (USDA–APHIS, 2013). Successive serological 

surveys of cattle and/or sheep have been conducted by official veterinary
20

services in the designated export regions of both countries, including 

locations where wild animals may come into contact with domestic 

livestock; the survey results have revealed no evidence of viral activity 

(USDA–APHIS, 2013).

Generally, viral transfer of FMD is possible when wildlife and livestock 

exist within close proximity to one another. The APHIS risk analysis for 

fresh beef from Brazil consider geographic barriers and international 

borders in terms of the legal and illegal movement of domestic livestock 

and processed meat (USDA–APHIS, 2013). These areas could also be 

considered temporary reservoirs for FMDV if wildlife becomes infected. 

Wildlife may move across traversable national boundaries and infect 

other wildlife and livestock by means such as sharing contaminated 

water, exposure to infected saliva, feces, or urine, or mechanical transfer 

of the virus.

The interspecies transfer of FMD is possible if wildlife and livestock exist 

within close proximity to each other. Portions of the designated export 

region in Brazil are within the Amazon River Basin where more than one

third of all identified wildlife species in the world may be found (WWF, 

2007). Certain locations within Brazil export regions border dense

woods, indigenous reservations, and open land where resident animals 

may transport or be infected with FMDV (USDA–APHIS, 2013; Cané et 

al., 2004). While the APHIS risk analyses consider such areas effective 

barriers relative to the transfer of livestock, these areas could be 

considered reservoirs for the virus if wildlife there became infected. It is 

in such natural areas where wildlife has the potential to become infected 

or come into physical contact with the FMD-infected livestock. Wildlife 

could then travel and come into contact with FMD-free livestock, thereby 

infecting susceptible animals by contaminating shared water resources,

by the release of contaminated saliva, feces, or urine, or by mechanical 

transfer of the virus.

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 digestive system (WDNR, 2003). Neither does the pathway 

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).

In Brazil and surrounding countries, there is the potential for wildlife to 

consume or come into contact with virus-contaminated garbage present in 

livestock feed or landfill sites. APHIS considers the feeding of 

contaminated waste to swine (which may then transmit the virus to other
21

livestock populations) to be the primary pathway for FMDV introduction 

(USDA–APHIS, 2013). Because of the risk presented by FMDcontaminated waste, Brazil prohibits feeding untreated swill to animals, 

and incinerates waste and other confiscated products from their 

international airports and seaports, both of which lessen the possibility for 

viral exposure to wild or feral animals (USDA–APHIS, 2013).

b. The United States

The United States has retained an FMD-free status since 1929 (AVMA,

2007). Prohibition of importation of live ruminants and swine and their 

products from FMD-affected countries, and the avoidance of contact with 

livestock, zoo animals, and wildlife by returning travelers continues to be 

considered essential for preventing FMD outbreaks (AVMA, 2007). 

However, there is the potential for interspecies movement of FMD in the 

United States should infected meat be imported into the country.

If FMD-contaminated meat were imported and disposed of in U.S. 

landfills or became an ingredient of livestock feed, susceptible wildlife 

populations could become infected. For example, the rapidly growing 

white-tailed deer and feral pig populations in the United States are leading 

to increased foraging, scavenging, predation, and contact with these 

animals by domestic livestock populations; thus, infected species 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 could transfer the virus 

mechanically, as previously discussed.

The United States has already battled FMD in wildlife populations. In

1924, for example, in a section of Stanislaus National Forest, 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, where 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 that the wild deer ever reinfected 

cattle herds. The eradication process was expensive, restricted human and 

livestock access to the area, and angered people who were concerned with 

the well-being of the wild deer population. This is the only known 

occurrence of wildlife being infected in the United States, and, in 1929,

the last outbreak of FMD in the United States occurred in cattle.

APHIS cooperates with other Federal and State authorities in the detection 

and management of notifiable disease outbreaks in the United States. If 

susceptible, wild species should be exposed to FMD, Morgan et al. (2003) 

suggested analyzing and possibly implementing the following measures in 

order to prevent the transmission of the disease to domestic livestock—
22

• 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 measures, such as the closure of 

hunting seasons and restriction of access to public lands by humans 

(because humans can spread the virus via physical contact).

After a devastating FMD outbreak in 2001, the government of the

United Kingdom recognized that “robust contingency plans needed to be 

developed to manage such an outbreak, should it ever occur again, and 

that these plans needed to be supported by comprehensive operational 

arrangements providing a capability to respond to outbreaks of any size 

and scale” (DEFRA, 2007). Such planning reduces potential adverse 

effects to the human environment when a country is dealing with FMD’s 

pollution and disease control issues involving mass transportation,

emergency facility construction, large-scale disinfection, herd destruction, 

and disposal of carcasses and waste products. In the United States, APHIS 

has a national emergency program in place for exotic/invasive pest 

detection and Federal response. Should an outbreak of FMD occur in the 

United States, APHIS will conduct further environmental analyses specific 

to the characteristics 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 which is not only considered affordable, 

but can be manufactured in the United States without using infectious 

FMD materials. The current formulation is for use on cattle, and may 

prove effective in protecting domestic and wild animal populations. The 

vaccine will allow for improved diagnosis and response, and may lead to a 

change in trade restrictions as the new formula makes it possible to 

determine whether the FMD antibodies possessed by an animal were 

acquired from vaccination or from infection (FASS, 2007).

Currently, APHIS interacts with the U.S. Department 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
23

developing prevention and contingency plans for informing U.S. land 

management and conservation agencies regarding the risk FMD poses to 

wildlife (USGS, 2007a). In addition to helping the United States control 

FMD in wildlife populations, these efforts may also assist Brazil and other 

countries in the future when dealing with the potential interspecies 

movement of FMD.

5. Environmental Fate 

of FMD

FMDV may persist in the external environment for extended periods of 

time whenever susceptible animals in close contact are exposed to the 

virus. For a virus to become freely circulating, it must be able to persist in 

the environment either inside or outside of the host long enough to infect a 

susceptible host. The Cottral study (1969) reports the survival time of 

FMDV on or within various contaminated objects at ambient

temperatures, as shown in table 1.

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 ultraviolet radiation have little 

effect on virus persistence (Pharo, 2002). Longer survival times for 

FMDV on objects would be expected at the low temperatures associated 

with high altitudes or the arctic regions than at sea level or in the tropical 

regions. Although temperatures above 50 oC destroy most infectivity,

it is likely that a small proportion of the virus particles are relatively 

resistant to the effects of heat and pH in most populations (Pharo, 2002).

The effect of temperature and pH on time for 90 percent virus inactivation 

is shown in table 2 and table 3, respectively, based on findings from the 

Bachrach et al. (1975) study. There is also the potential for FMDV to be 

disseminated over considerable distances by aerosols (Cottral, 1969). In 

aerosols, FMDV survives best when the relative humidity exceeds

70 percent and there is a critical humidity level of 55 to 60 percent, below 

which survival is poor (Pharo, 2002). Based 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.
24

Table 1. Survival Time of FMD Virus on Various Contaminated Objects at

Ambient Temperatures.

Contaminated Objects Weeks of Survival

Soil, S–W

7

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

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

8

3–9, 14

Meat cloth (at 4

oC) 6

 

7

S–W, 1–21: summer 1 week, winter 21 weeks.

8

Cotton garments, leather shoes, rubber boots.
25

Table 2. Effect of Temperature (at pH 7.5) On Time for 90 Percent FMDV 

Inactivation.

Temperature Inactivation time (90 percent)

61

oC 30 seconds

55

oC 2 minutes

49

oC 1 hour

43

oC 7 hours

37

oC 21 hours

20

oC 11 days

4

oC 18 weeks

Table 3. Effect of pH (at 4

oC) 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

6. Public

Health

FMD may affect humans; however, its occurrence is quite rare. The 

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

persons exposed to FMD that it is generally not considered a threat to 

humans. FMDV has been isolated and typed in only 40 patients during the 

last century. Symptoms in humans are mostly mild and mainly include 

fever and blisters on the hands, feet, mouth, and tongue. Patients usually 

recover within a week after the last blister formation (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 lives due to movement 

restrictions, disruptions in community life, and short- and long-term stress 

over their financial future. Researchers from Lancaster University in the 

United Kingdom conducted a new study on the social consequences of 

FMD in the Cumbria community. The study revealed high rates of 

depression, alcohol consumption, and mortality among farmers during the 

crisis (USDA–APHIS, 2013).
26

IV. Other Environmental Issues

A. Environmental Justice and the Proposed Action

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 fresh beef to the United States 

from a region of Brazil. Importation of fresh beef from Brazil, under 

implementation of the preferred alternative, is not expected to

substantially affect profits of beef producers in the United States. 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 to 

the United States, these are primarily remote and hypothetical. Even if 

such scenarios could occur, their impact to minority and low-income 

populations would be expected to be negligible.

B. Protection of Children and the Proposed Action

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 

beef, 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

Proposed Action

Section 7 of the Endangered Species Act and its implementing regulations 

require Federal agencies to ensure their actions are not likely to jeopardize 

the continued existence of threatened or endangered species or result in

the destruction or adverse modification of critical habitat. APHIS 

considered the potential effects of the proposed action on threatened and 

endangered species and designated critical habitat. There are six listed 

ungulate species that are potentially susceptible to FMD (table 4);
27

however, based on the supposition of required mitigation measures for the 

importation of bovine products, there is no likelihood for these species to 

be exposed to and, thus, affected by this action. Therefore, APHIS

expects the proposed rule will have no effect on threatened or endangered 

species or their critical habitat in the United States.

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

Sierra Nevada bighorn sheep Ovis canadensis sierrae Yes Endangered

Peninsular bighorn sheep Ovis canadensis nelsonii Yes Endangered

APHIS conducted risk analyses and determined that the risk of infected 

bovine products entering the United States from Brazil and anticipates the 

potential to expose U.S. livestock to FMD to be low (USDA–APHIS,

2013). This risk would be further mitigated by requiring implementation 

of the measures outlined in 9 CFR § 94.11 that place restrictions on the 

importation of ruminants from regions free of FMD but share a common 

land border with regions designated as infected with FMD.

Based upon the effectiveness of the mitigation measures included in

9 CFR § 94.11, and the low likelihood that FMD would establish in U.S. 

livestock, implementation of the proposed rulemaking is expected to have 

no effect on federally listed endangered species or designated critical 

habitat.

D. Potential Cumulative Impacts

The potential impacts from the proposed rule in combination with similar 

actions are referred to as cumulative impacts. These impacts are not 

expected to pose any substantial risks based upon the findings of the risk 

analysis (USDA–APHIS, 2013). Uruguay is currently importing beef to 

the United States. As a result of current mitigations associated with 

regulations allowing Uruguayan beef imports, the combination of the 

Uruguayan beef imports with beef imports from Brazil are expected to 

result in no adverse environmental impacts.
28

Although importation of fresh beef does increase the potential for 

introduction of FMD to the United States, the required mitigations make 

introduction of the disease extremely unlikely, even when considering 

other importations or future importations of fresh beef from countries with 

comparable risks. It is difficult to precisely quantify the potential 

cumulative impacts that are dependent upon disease conditions in Brazil, 

as well as compliance with importation conditions in 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.
29

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 Center for Import & Export 

Veterinary Services

Animal and Plant Health Inspection Service

U.S. Department of Agriculture

4700 River Road, Unit 38

Riverdale, MD 20737–1231
30

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