# Proposed Rule for the

Status of Santa Catarina, Brazil , Regarding Foot and - M outh Disease , Classical Swine Fever, Swine Vesicular Disease, African Swine Fever , and Rinderpest Environmental Assessment, January 20 10 United States Department of Agriculture Mar keting and Regulatory Programs Animal and Plant Health Inspection Service

# Proposed Rule for the Status

of Santa Catarina, Brazil , Regarding Foot - and - M outh Disease , Classical Swine Fever, Swine Vesicular Disease, African Swine Fever , and Rinderpest Env ironmental As sessment, January 20 10

Ag encyContact: Dr. Silvia Kreindel , Senior Staff Veterinarian Regi onalization 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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–

W, W hitten Building, 1400 Independence Avenue, SW, Wa shington, DC 20250

– 9410 or call (202) 720

– 5964 (voice and TDD). USDA is an equal opportunity provider and employer.

________________________________ __________________________ Mention of companies or commerci al products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of 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

................................ ................................ .................... 3 II. A lternatives
................................ ................................ .............. 3 A. No Action

................................ ................................ ............. 3 B. Preferred Alternative

................................ ............................ 4 III. Environmental Consequences
................................ ............... 5 A. No Action

................................ ................................ ............. 5 B. Preferred Alternative

................................ ............................ 7 1. Foot
- and
- M outh 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 . Int erspecies T ransmission

................................ ............. 19 8 . Publi c Health

................................ ................................ . 21 IV. Other Environmental Issues
................................ ............... 22 A. Environmental Ju stice and the Preferred Alternative

......... 22 B. Protection of Ch ildren and the Preferred Alternative

......... 23 C. Threatened and Endangered Species and the Preferred A lternative

................................ ......................... 23 D. Potential Cumulative Imp acts

................................ ............ 24 V. Listing of A gencies Consulted
................................ ............. 25 VI. References
................................ ................................ ............ 261 

## I. Need for the Proposed Rule A. Introduction S anitary import regulations are designed to prevent the introduction and dissemination of injuri ous 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 sw ine 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

– APHI S established policy and rules in 1997 for recognizing regions, rather than only countries, for the purpose of importation of animals and animal pro ducts 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 b y Brazil to USDA

–APHI S to review the disease status of Santa Catarina, Brazil , in order to initiate trade in fresh pork from that State. In order to make a n informed decision, USDA

–APHI S

–Veterinary Services (VS) conducted a risk analy sis as a decision

- mak ing 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

–APHI S, 2009)

. The risk anal ys is associated with this proposed rulemaking, entitled “APHI S Evaluation of the Status of the Brazilian State of Santa Catarina Regarding Foot

- and

- M outh Disease, Classical Swine Fever, Swine Vesicular Disease, and African Swine Fever , ” is summarized and i ncorporated b y reference in this e nvironmental a ssessment (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 produc ts, 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 p otential exposure from Santa Catarina exports, resulting in a corresponding absence of risk. APHI S’ risk anal ys is 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 Desenvolvimento2 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, b order control procedures, laboratory and diagnostic capabilities, biosecurity procedures on swine farms, animal health recordkeeping s ys tems, movement controls, and disease surveillance s ys tems , 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;
 n o FMD outbreaks have occurred in Santa Catarina since 1993;
 n o outbreaks of CSF have occurred in Santa Catarina since 1990;
 n o 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 population s have not detected an y presence of FMD , CSF, SVD, or ASF virus in the Brazilian S tate 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. APHI S

–VS also found the legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs , and emergency response sy stems 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 importe d from the Brazilian State of Santa Catarina to be very low (USDA

–APHIS, 2009)

. Rinderpest is very

close to being completel y eradicated in the few regions of the world where it still occurs . In addition, rinderpest has never been established in North Am erica, Central America, the Caribbea n I slands, or South America ( USDA

–APHI S, 2009)

. Because r inderpest 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 s anitary

and p hy tosanitary (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 b y 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 risk s . The issue of potent ial environmental risks of FMD, CSF, SVD, and ASF outbreak s in the United States resulting from the import ation of live ruminants, ruminant products, live swine, and swine products is of great concern to USDA

–APHIS. Characterization of disease risk potent ial and adequate mitigation measures are critical for excluding th ese disease s 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
. Al ternati ve s 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 . Sant a Catarina will also be excluded from the list of regions in 9 CFR part 94 wher e 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 Ac tion 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 ex port live ruminants, ruminant products, live swine, and swine products to the United State s. The no4 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 ove r less restrictive alternative approaches. In compliance with SPS measures stipulated b y the World Trade Organization, APHI S 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 A lternative T h e preferred alternative would amend r egulations 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 am endment 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 , e ach shipment of live ruminants, ruminant products, live swine, and swine products would be required to have an approved permit from A PHIS, 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 in spection. 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 disease s . In that regard, APHI S 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. APHI S 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. d isease 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 phy sical or other barriers ; 7. the extent to which movement of animals and animal pro ducts is controlled from regions of higher risk, and the level of biosecurity regarding such movements ; 8. l ivestock demographics and marketing practices in the region ; 9. the ty pe and extent of disease surveillance in the region ; 10. d iagnostic laboratory capacity ; and 11. p olicies and infrastructure for animal disease control in the region , that is, emergency

response capacity

. APHI S officials reviewed information concerning these 11 factors and undertook site visits to Brazil in 2002, 2003, 2006, and 2008

. APHI S has concluded that Santa Catarina consistentl y 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 infra structure, movement and border controls, diagnostic capabilities, surveillance programs, and emergency

response s ys tems are assumed to continue and form an integral part of the preferred alternative risk mitigation. 

## II I
. Env ironmental Consequences Comp liance 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 m arginal 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 ind ustries; and risk from chemical exposure are some of the potential adverse impacts to the human environment which could occur from an outbreak of the se diseases of conc ern . The nature of each disease and its causal agent, and its potential impacts on the phy sical 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 Ac tion 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 an y region of Brazil, regardless of Santa Catarina’s disease

- free status, would not result in an increased pest risk and, therefore, would not adversel y impact the human environment. The proposed rule (preferred alternative) would provide a means of export6 of live ruminants, ruminant products, live swine, and swine products from the State of Sant a Catarina, Brazil. Although the required mitigations of the preferred alternative have been shown to be effective against all known strains 2 of the viruses causing these five diseases, there remains some potential risk that does not exist under the no ac tion alternative. The prohibition of importation of live ruminants, ruminant products, live swine, and swine products from Brazil , under 9 CFR 9 4 , has maintained low disease risks to U.S. human and animal populations, and has caused negligible environme ntal effects in the United States. As with most commodities, there is alway s 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 perpetrator s. The potential of high risks from disease associated with noncompliance makes it APHI S’ policy

to provide a strong deterrent. Therefore, APHIS strives to keep travelers, importers , and shippers informed of import regulations and of the penalties for in adequate compliance. An importer or shipper could be subject ed to civil penalties, criminal fines, jail sentences, and loss of revenue due to APHIS’ rejection of commodities, permit applications, and/or compliance agreements. APHI S ha s the option to refu se 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 result ant delay s and treatments. This offers strong incentive for their full compliance with import regulations. Monitoring of the rates of compliance with a ph yt osanitary rule promulgated in 1998 found that proper compliance with those import requirements was achieved approximately 98 percent of the time ( USDA

– APHI S, 2003a)

. Comparable compliance could be expected for an y current or revised sanitary regulations related to importation. The ecological, phy siological, psy chological , and economic cost s of an uncontrolled outbreak of FMD, CSF, SVD, ASF , or rinderpest co uld 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 devastate d susceptible wild and domestic populations , pollute d the environment, and ind irectly impact ed humans and other animals depending upon them as a re source. 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 9 4 , 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 p roteins.7 reflect Santa Catarina, Brazil, as being free of the five diseases of c oncern (FMD, CSF, SVD, ASF, and rinderpest)

. Un der international trade a greements, the continuation of unsupported trade restrictions is contrary to U.S. obligations ; this make s the no action alternative unacceptable. 

### B. Preferred A lternative 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 t o 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 an y of the causal viruses. APHI S’ evaluation of the disease status of Santa Catarina, Brazil (USDA

– APHI S, 2009 ) examined the sanitary issues associated with fulfilling the change

- in

- status request from Santa Catarina, Brazil. The risk analy sis assessed the likelihood of exposure to and in fection from FMD, CSF, SV D , and ASF for susceptible livestock in the United States following implementation of the rule. The absence of the five diseases of co ncern in the Santa Catarina region, coupled with the probability of quick detection of clinical signs ( should disease b e 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 sy stems in place to prevent and contain outbreaks of the fi ve 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, highl y contagious viral disease, mainl y, but not exclusively , of cloven

- footed animals. The risk to humans from 1 . Foot - and Mouth Disease Virus8 FMDV is very

slight. Confirmed cases of FMD in humans are rare. Sy mptoms 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 , re gardless of the size and sophistication of their livestock unit. Very high mortality

rates in yo ung animals can occur, particularl y among pigs and sheep. Mortality in older animals occurs less frequentl y but may be significant with certain virus strains ( USDA

–APHI S, 2009 )

. FMD also causes significant losses in the production capacity of affected animals. Productivity

losses of 10 to 20 percent are reported in FMD

infected livestock if the disea se is allowed to run its course. In addition, FMD can cause a reduction in the growth rate of animals raised for meat. The comparativel y greater severit y of FMD in pigs would imply at least similar losses to those described for cattle ( USDA

–APHI S, 2009 )

. FMD is characterized by

the formation of lesions on the fe et and mouth, damage to the mucous membrane lining the gastrointestinal sy stem, and high fever. Damage from FMDV may also occur to the heart muscle cells (particularl y 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 ey es, nose, prepuce, and vagina; and through direct contact with skin or pieces of infected skin that may drop off the animal (WI

N, 2001). It is also possible to transmit FMDV in infected carcasses, meat, hid es, and bones (WIN, 2001). FMDV is commonly spread by

the movement of infected animals; however, the virus may also move independentl y 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 clinicall y ill under certain conditions , such as recovery from clinical disease and undetected subclinical disease. However , development of a permanent carrier status for animals infecting susceptib le animals is now less likely

. Vaccination does not make animals into FMDV carriers. Properl y9 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 genome 3 in host cells. Third, the virus has to avoid dete ction and elimination by the host’s immune sy stem (Fields et al., 1996). Viruses have devised various strategies to accomplish these goals. The normal response of the immune system is to detect antigens 4 and establish an immune response to those antigens . A virus will modify specific antigens or proteins so as to evade the host’s immune sy stem, thereb y establishing persistent infection in the host. The modification of specific antigens or proteins gives rise to substrains of the virus

. Documenting sur

veillance sy stems 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 asso ciated safeguards (e.g. , surveillance programs ) in the State of Santa Catarina. FMD Safeguards The last outbreak of FMD in the S tate of Santa Catarina, Brazil , occurred in 1993; since 2007 , the World Organization of Animal Health ( OI E ) recognized Santa Catarina as an FMD

- free zone where vaccination is not practiced (USDA

–APHIS, 2009). The country of Brazil employ s both passive and active surveillance strategies designed to demonstrate freedom from FMD, with differing emphases depen ding 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 ty pe of surveillance used once freedom from infection h as 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 primaril y b y targeting specific “high

risk” 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 activit y in the S tate . APHI S 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

–APHI S, 2009)

. Therefore, APHI S does not expect that such importation will have a consequential impact on the human environment. Acute and chronic c as es of CSF have been described in scientific literature . The severit y of the disease depends largel y on the age of the animal and virulence of the viral strain, with young animals usuall y more severel y affected than older animals. In older breeding pigs , the c ourse of infection is often mild , or even subclinical, whereas mortality rates may reach 90 percent in y oung pigs. Low virulence strains may manifest primarily as poor reproductive performance and birth of piglets with neurologic defects (USDA

–APHI S, 2009 )

. Clinical signs of CSF may include viremia (presence of virus in the blood) characterized b y persistent fever, skin discoloration, conjunctivitis (inflammation of the ey e) , abortion , and/or diarrhea that is unresponsive to antibiotics. Leu copenia (de crease 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

—

 Ac ute

— illness in weaned pigs under 12 weeks of age that is unrespon sive to antibiotics and characterized by fever, skin discoloration, conjunctivitis, hind

- limb weakness , and/or diarrhea.

 Chronic

— characterized by subdued acute infection , followed b y 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 persistentl y infected and appear normal for several months before d yi ng , or born with congenital tremors. (Sows infected prior to day 50

– 70 of ge station may

abort or give birth to stillbirths, mummies, or pigs with congenital defects.) (USDA

–APHIS, 2007 a )

. APHI S 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

–APHI S, 2007 a ). CSF Safeguards Passive surveillance for CSF is carried out within Brazil, particularl y at the border between the CSF

- free zone and the infected region

. This work is facilitated b y 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 Virus11 entry of susceptible animals and products is utilized for both diseases at the same time (USDA

–APHI S, 2009)

. In order to delineate and maintain the free zone , serologic survey s are carried out under the coordination of MAPA in accordance with the statistical parameters set by OI E. The target popul ation include s the entire population of hogs and wild boars within the free area, except for those in swine breeding farms that have been officiall y and individually certified as free from diseases (i.e., Farms of Certified Swine Breed ers ( GRSC ) (USDA

–APHI S, 2009 ) )

. Screening and d iagnostic tests are conducted at o fficial p ublic s ervice l aboratories. Screening tests are performed using an enzy me - linked immunosorbent assay

( ELISA ) for the detection of ant ibodies o f the CSF virus . Any

reactive or suspici ous samples are submitted for differential diagnosis using virus

- neutralization tests in cell cultures (USDA

–APHIS, 2009)

. A s with FMD and other vesicular diseases, every Brazilian citizen is oblig at ed to report the suspicion of CSF to the nearest local veterinary unit . I f the owner of the animal ( s ) fail s to report the suspicion of disease, he or she will lose a claim to indemnity in the event that the herd must be destroy ed for disease control purposes. In addition, veterinarians and other field profe ssionals may be subject to legal action before their respective trade guilds (USDA

–APHI S, 2009)

. In the event that a sanitary emergency or document ed disease event occurs, samples are collected from all susceptible animals present on the farm. All sus picious 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 b y the official veterinarian include (USDA

–APHIS, 2009)

—  filling out the i nitial d isease i nvestigation f orm ,  collecting information on the establishment under suspicion ,  prohibiting the movement of hogs and their products and by products from the property ,  cleaning and disinfec ting 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 ye ars, 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

– APHI S, 2009)

.12 SVD is an acute, contagious , viral disease of swine cause d by an enterovirus. It is charac terized by fever and vesicles with subsequent ulcers in the mouth and on the snout, feet, and teats. The pathogen is relativel y 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, 2003 b )

. Th is disease can be introduced into a herd b y feeding it garbage containing infected m eat scraps, b y bringing in infected animals, or by direct contact with infected feces ( e.g., in an improperl y cleaned truck). After the initial infection, the disease spreads through the contact of susceptible pigs with infected pigs and infected feces (U SDA

–APHIS, 2003 b )

. Clinical signs are very

similar to those of FMD and other vesicular d iseases (USDA

–APHI S, 2003 b ) and include :  f ever ;  v esicles in the mouth , and on the snout and feet ;  l ameness and an unsteady gait, shivering and jerking

–ty pe leg moveme nts ; and/or
 r uptured vesicles which can cause ulcers on limbs and feet , and foot pads may

be loosened

. SVD is ty picall y a transie nt vesicular disease of pigs. Young animals are more severel y affected; however, essentially , the virus causes no mortality

. Infected pigs generall y recover within 1 week but recovery can take up to 3 weeks. Some strains produce only mild clinical sy

mptoms or are as ymptomatic. Morbidity rates may

be low throughout a whole herd but high in certain pens (USDA

–APHI S, 2009)

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

. H owever, passive surveillance for this disease is carried out similar ly 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 d iagnosis 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 t o 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 Virus13 of infected and contact pigs, and cleaning and disin fecting 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 (an y inanimate object or substance capable o f carrying infectious organisms) and tick vectors

. Humans are not susceptible to the African swine fever virus (ASFV)

. A SF affects members of the pig family (Suidae) and can have 100 percent mortality in nat i ve herds

. Species that can be infected includ e domesticated swine, European wild boars, warthogs (

Phacochoe rus africanus ), bush pigs ( Potamochoerus porcus ), giant forest hogs (

Hylochoerus spp.), and peccaries ( Tayassu spp.). Sy mptomatic infections occur in domesticated pigs, feral pigs, and European wild boars. ASFV i nfections are generally as ympto matic 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 as ymptomatically include the collared peccary ( Tayassu tajacu ) and the white

- lipped peccary ( Tayassu albirostris ), both found in the Americas (CFSPH, 2006)

. ASFV , for

merl y classified as a member of the family Iridoviridae, is currentl y 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 highl y 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 Re public, 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 ye ars. Outside Africa, ASFV is currently endemic only

in feral pigs in Sardinia, Italy ; h owever, c hanges in production practices and increased globalization have in creased the risk of ASF being introduced into North America (CFSPH, 2006). Severe epidemics of ASF occurred in Brazil from 1978 to 1981 (OIE, 2009 a )

. ASF is a highl y contagious hemorrhagic disease. All age groups of pigs are equally

susceptible. With high ly virulent forms of the virus, ASF is character ized by

high fever, loss of appetite, hemorrhages in the skin and internal organs, and death in 2 to 10 day s , on average. Mortalit y rates may be as high as 100 percent (OIE, 2009a )

. 4 . A frican Swine Fever Virus14 Transmission during direct contact is usuall y b y 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 particularl y high levels are found in the blood. Massiv e 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. Ind ividual ticks can apparently re main infected for life, and infected soft tick colonies can maintain this virus for y ears. Other bloodsucking insects, such as mosquitoes and biting flies, may also be abl e to transmit the virus mechani cally

. Stable flies ( Stomoxys calcitrans ) can carry high lev els of the virus for 2 day s. Under experimental condi tions, these flies could tr ansmit ASFV 24 hours after feed ing on infected pigs (CFSPH, 2006)

. ASFV is highl y resistant to environmental conditions. Itcan survive for a ye ar and a half in bl ood stored at 4 oC (39 o F) , 11 day s in feces at room temperature , and at least a month in contaminated pig pens. The virus will also remain infectious for 150 day s in boned meat stored at 3.9 oC (39 o F) , 140 day s in salted dried hams, and several y ears in frozen carcasses (CFSPH, 2006)

. ASF can be a peracute, acute, subacute , or chronic disease. Less virulent strains of ASFV produce milder sy mptoms that are easily

confused with other diseases, and can take several weeks to spread through the herd. Anima ls infected with isolates of low virulence may be able to destroy the virus via an immune response without sy mptoms, abort, or develop chronic ASF (CFSPH, 2006)

. Highl y virulent strains produce peracute or acute disease, and may affect the entire herd within a few day s. Sudden deaths with few lesions are characteristic of the peracute form, and ma y be the first sign of an infec tion in a herd (CFSPH, 2006)

. Acute disease is characterized by a high fever, moderate anor exia, lethargy , weakness, recumbency (the state of leaning, resting, or reclining) , and ery

thema (abnormal redness of the skin) that is most apparent in white pigs. Some pigs develop cy anotic 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 hem orrhages can occur in th e skin or internal organs. Difficult y breathing ,15 vomiting, nasal and ey e discharges, and n eurologic signs have also been reported. Pregnant animals frequentl y abort; in some cases, abortions may be the first signs of an outbreak. Leukopenia can be seen in laboratory tests. Inacute ASF , death often occurs within 7 to 10 day s (CFSPH, 2006)

. Subacute ASF , which is caused b y moderatel y virulent isolates, is similar to acute ASF but less severe. In this form of the disease, the death rate is generall y lower in adult swine, but may still be very high in very young animals. In subacute disease, fever, thrombocy topenia, and leuk openia may be transient ; af

fected pigs usuall y die or recover within 3 to 4 weeks (CFSPH, 2006)

. The sy mptoms of chronic disease include an intermittent l ow fever, appetite loss, and de pression. Pigs may beco me emaciate d and develop respi ratory

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 bod y protrusions and other areas subject to trauma. In some cases, the onl y sy mptoms may

be emaciation and stunting. Chronic ASF can be fatal (CFSPH, 2006)

. AS F Safeguards For ASF, which is an exotic disease to Brazil , no specific surveillance is conducted . In stead, 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, an y implicated farms , as well as those they are associated with , undergo movement restricti ons until the investigation has been completed and a final diagnosis achieved (USDA

–APHIS, 2009)

. ASF can be diagnosed b y virus isolation in b lood and tissue samples collected from suspect pigs . Nucleic acids can be de tected with a poly merase chain rea ction (PCR) assay , or by the hy bridization of nu cleic acid probes to tissue sec tions. 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 recentl y been published. This test can detect the virus a few day s before the onset of sy mptoms (CFSPH, 2006)

. Serology is also useful for diagnosis, particularl y i n endemic regions. ELISA is prescribed for diagnosis of animals or materials d estined for international trade. Animal inoculation, performed in pigs, was used in the past to distinguish ASF from CSF

. This test is no longer recommended b y OI E 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 b y State l aw in Santa Catarina (USDA

–APHI S, 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 b y 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 hy pochlorite and some iodine and quaternary ammonium compounds are effective. Potential tick vectors should be controlled with acari cides (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 chronicall y infected during outbreaks in South America. Nonetheless, ticks and other biting insects which may

be abl e to transmit the virus mechanic all y should be controlled. No treatment or vaccine exists for this disease (CFSPH, 2006). The pr oposed 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 th e preferred alternative. Passive surveillance by

Brazil for rinderpest is carried out similarly to other vesic ular diseases

. Differential diagnosis 5 of vesicular diseases in clinically affected animals includes FMD, mucosal disease of cattle, bluetongue, vesicular stomatitis, and irnderpest (USDA

–APHI S, 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)

. OI E recognizes Brazil as a rinderpest

- free country ( OI E, 2008a ). Rinderpest

- free countries are included o n the OIE list only after submitted evidence of no rinderpest vaccination s , adequate ongoing survei llance , and outbreak reporting has been accepted b y O IE. 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 OI E requirements (OIE, 2008b ).

5 Differential diagnosis is the distinguishing of a disease or condition from others presenting with similar signs and symptoms

. 5. Rinderpest Virus17 In addition, OI E consider s 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 b e a primary instrument for successfull y 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 Keny a and Somalia. GREP has set the y ear 2010 as the time by which all countries need to be accredited by OI E 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 ( OI E, 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, e land, 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 rinde rpest. 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 res piratory tract, with an incubation period of generall y 4 to 5 days following natural exposure, but it may range from 3 to 15 day s. Viral shedding begins 1 to 2 day s before py rexia (fever) through tears, nasal secretions, saliva, urine, and feces, and this ty pically continues for 8 to 9 day s 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 aty

pical. There is no carrier state following infection. The classic form is characterized by a 2

- to 3

- day

period of sy

mptoms, including high fever, depression, anorexia, increased respiratory and cardiac rate, congested mucus membranes, and excessive salivation. When the fever drops, gastrointestinal signs appear with profuse18 hemorrhagic diarrhea. Dehy dration, abdominal pain, abdominal respiration, weakness, and death generall y occur within 8 to 12 day s. In rare cases, clinical signs regress b y day 10, and recovery occurs by

day 20 to 25 ( USDA

–APHI S, 200 9). The peracute form of rinderpest has no preceding signs and is characterized b y high fever (>40 to 42 °C) and death . The peracute form occurs in highly

susceptible y oung and newborn animals. T he subacute form has a low mortalit y rate and a clinical presentation similar to the classic form. The at ypical form is characterized by irregular p yr exia with mild or no diarrhea (USDA

–APHI S, 2009). RPV is relativel y 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 relativel y high temperatures, for example, 56 °C (133 o F) for 60 minutes or 60 °C (140 o F) for 30 minutes (USDA

–APHI S, 2009).
a. Santa Catarina, Brazil In order to ensure compliance with the appropriate controls for FMD, APHI S will propose in its rule that MAPA certify the origin of FMD

susceptible animals and products , and certify that they were not commingled with animals or products from areas APHI S considers to be FMD

- affected. Specifically , APHIS will require the following certifications for beef or pork products exported to the United S tates 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 lifetim e of an y 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 inter

nal 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 illegall y. The potential for viruses under evaluation to transi t the border during these times is increased, particularl y via passenger car. Despite this possibility , Santa Catarina’s controls, biosecurity procedures, and quarantine procedures have been successful in mitigating this risk. APHI S evaluated Santa Catarina’s controls for the movement of animals into the S tate and concluded that risk from illegal importations from affected regions to be sufficientl y mitigated (USDA

–APHIS, 2009)

. 6
. Regulatory Control19 Were FMD or the swine diseases under evaluation to be reintroduced into th e 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, re gardless of treatment. These laws are enforced effectivel y with the result that feeding of garbage to animals is unlikely

to occur in Santa Catarina. b. The United States In the United States, APHI S provides Federal regulation, assistance, and inform ation concerning animal diseases, and operates an ongoing s ys tem 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. Rec ent 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

–APHI S, 2007b; DJ IN , 2007). A similar response scen ario is likely should a disease epidemic be caused b y 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 deploy ed, followed by i nvolvement, as necessary, of the Departments of State, Transportation, and Health and Human Services. A quarantine area would be established, tissue samples would be anal yz ed, and lab oratory determinations would be published. Depending on jurisdiction, F ederal 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 s ys tems, and emergency response s ys tems that are necessary for combating FMD, CSF, SVD, and ASF. APHI S considers the likelihood of introduction and establishment of the FMD, CSF , SVD, or ASF virus es into the United S tates 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 way s that the FMD, CSF, SVD, ASF and rinderpest viruses may

be transferred between wildlife and susceptible livestock (USGS, 2001; WDNR , 2003)

—

 e xposure to infected saliva, feces, urine, milk, semen, meat, and meat by products of infected animals ; 7
. Interspecies Transmission20  e xposure 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

 e xposure to raw or improperly cooked infected garbage. The likelihood of exposure of susceptible species to infected live animals to the viruses of co ncern under this rulemaking was evaluated b y briefl y reviewing virus persistence and shedding in live swine and ruminants, as well as standard import requirements for these species. The risk anal ys is (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. APHI S considers exposure of susceptible U.S. animals to illegally imported infected live animals from Santa Catarina to be highl y unlikel y (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

–APHI S, 2009) . The maximum reported duration of the carrier state is 3.5 y ears 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 m ay 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 entirel y free of FMD, CSF, SVD, and ASF for 60 day s prior to export (9 CFR 93.405 and 93.505) . The regulations also require a minimum quarantine of 30 day s for most imported ruminants (9 CFR 93.411) , and 15 day s for all imported swine (9 CFR 93.510). These requirements serve to partia lly mitigate the risk of exposure by increasing the likelihood of disease detection (USDA

–APHIS, 2009)

. Based on the results of the release assessment, APHI S considers the likelihood of entry

of animals infected with the FMD, CSF, SVD, or ASF virus es into the United S tates 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 similarl y low (USDA

–APHIS, 2009)

.21 Genetic M aterial Genetic material (e.g., swine semen) ha s 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 bec ame 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 onl y 36 farms had been infected through artificial insemination, all suspect farms were subject ed 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 o C but ranges from 1 month to several ye ars at 4 o C or below (USDA

–APHI S, 2009) . Survival in embry os and ova is unknown (USDA

–APHI S, 2009)

. The FMD virus may be present in semen up to 4 day s before clinical signs become apparent (USDA

– APHI S, 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

–APHI S, 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 generall y 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. FMD V has been isolated and ty ped in only 40 patients during the last century

. Sy mptoms in humans are mostly mild , and mainly

inc lude 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, 2004 b ). SVD has been accidentall y transmitted to laboratory workers. Clinical signs of SVD include mild influenza

- like sy mptoms, generalized abdominal and muscle pain, and meningitis (occurred in one case ) (CFSPH, 2004 c ). Perhaps more importantly , a substantial foreign animal disease outbreak can result in severe ps yc hosocial effects on farmers and farming communities. Farmers and their families can suffer from grief over losing animals and blood lines kept over man y 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 Health22 For example, a stud y 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

–APHI S, 2009 ). 

## IV
. Other Env ironmental Issues A. Environmental Justice and the P referred A lternative Executive Order 12898, “Feder al Actions to Address Environmental Justice in Minority

Populations and L ow - Income Populations,” requires each Federal agency

to make achieving environmental justice part of its mission by

identifying and addressing, as appropriate, disproportionatel y 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 liv e 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. T he risk anal ys is concluded that the proposed mitigations fo r 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 conclu ded 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). Mo st 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 inv olving the introduction of FMD , CSF, SVD, ASF, or rinderpest to the United States, these are primaril y remote and h ypothetical.23 

### B. Protection of Children and the P referred A lternative Executive Order 13045, “Protection of Children f rom Environmental Health Risks and Safet y 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 primaril y upon adherence to the sanitary requirements for entry of live ruminants, ruminant pro ducts, 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. Thr eatened and Endangered Species and the P referred A lternative Section 7 of the Endangered Species Act and its implementing regulatio ns require Federal agencies to e nsure that their actions are not likel y 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 b y CSF, SVD, or ASF

. Rinderpest has never been established in Brazil. However, FMD h as been present in Santa Catarina , and s ix endangered ruminant species in the United States are susceptible to that disease (see table 1). APHI S conducted a risk assessment and determined that Santa Catarina is free of FMD, CSF, SVD, and ASF, and has th e infrastructure to prevent, rapidly detect, and ef

fectively eradicate the diseases if they were to be introduced (USDA

–APHIS, 2009)

. In that risk assessment, APHI S also determined that the likelihood of outbreak s 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

–APHI S, 2009)

. Therefore, the proposed rulemaking is expected to hav e no effect on endangered ruminants or their designated critical habitats

.24 Table 1. Endangered S pecies in the United States S usceptible to

F oot - and - M outh D isease. Common Name Scientific Name Critical Habitat Listing Status Wo odland caribou Rangif er 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 s heep 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. B ased upon the findings of the risk anal ys is , these impacts are not expected to pose an y substantial risks (USDA

–APHIS, 200 9 ). Although importation of live ruminants , ruminant products , live sw ine, 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 disease s of concern extremel y unlikely , e ven when co nsidering the current and future importations of the same animals and their products from other regions

. It is difficult to precisel y quantify the potential cumulative impacts which are dependent upon disease conditions and compliance with importation c onditions 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. Ag encies and Persons Consulted
Environmental and Risk Analy sis Services Policy and Program Development Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 149 Riverdale, MD 20 737 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

Anal ys is and Development Po licy and Program Development Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 118 Riverdale, MD 2073726 

## VI. References
CIDRAP

— See Center for Infectious Disease Res earch and Policy Center for Infectious Disease Research and Policy, 2009. University of Minnesota, Academic Health Center, Center for Infectious Disease Research and Policy

. Foot

- and

- mouth disease. [ Online. ] Available: http://www.cidrap.umn.edu/cidrap/content/biosecurity /ag

- biosec/anim

disease/rpest.html [ 2009, Feb

. 18]

. CFSPH

— The OIE Collaborating Centre on Diagnosis of Animal Diseases and Vaccine Ev aluation in the Americas. See Iowa State Universit y, 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 g ot s ecret s ummer b riefings on f oot
- m outh c oncern. Source: APHI S 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 , 3 rd Edition. Food and Agriculture Organization of the United Nations, Agriculture Department, Animal Production and Health Division, 2009. Global r inderpest e radication p rogram: questions and answers. [Online

. ] Available: http://www.fao.org/Ag/againfo/programmes/en/grep/qa_rinder.html [ 2009, May

6]. Io wa 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 ]

. Io wa State University , College of Vet erinary 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 Io wa State University , College of Veterinary Medicine, Center for Food Security and Public Health, 2004c

. Swine Vesicular Disease. [Online.] Available: www.cfsph.iastate.edu/Disease Info/ppt/ SwineVesicularDisease .ppt [ 2009, May

26 ]

. Io wa State University , College of Veterinary Medicine, Center for Food Security and Public Health, 2006. African Swine Fever. ASF_A2008. Last updated December 19, 2006. 4 pp. [Online] Available: http://www.cfsph.iastate.edu/Factsheets/pdfs/african_swine_fever.pdf [ 2009, May

4 ]. Io wa State University , College of Veterinary Medicine, Center for Food Security and Public Health, 2008. Rinderpest. RIND_A2008. Last updated on August 8, 2008. 5 pp. [Online] Available: http://www.cfsph.iastate.edu/Factsheets/pdfs /rinderpest.pdf [ 2009, May 4 ]. Kreindel, S. Telephone conversation with author, 30 April 2009. OI E

— See World Organization of Animal Health USDA

–APHI S

— See U.S. Department of Agriculture, Animal and Plant Health Inspection Service U.S. Department of A griculture, Animal and Plant Health Inspection Service, 2003a. Importation of Solid Wood Packing Material. Final Environmental Impact Statement

— August 2003. Riverdale, MD. U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 200 3 b . Veterinary Services Factsheet: Swine Vesicular Disease. June 2003. [Online} Available: http://www.aphis.usda.gov/publications/animal_hea lth/content/printable_v ersion/fs_ahswinevd.pdf [2009, May 4]. 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) Cas e 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. D epartment of Agriculture, Animal and Plant Health Inspection Service, 2007b. APHIS Veterinary Services, Centers for Epidemiology and Animal Health info sheet: CEIimpact worksheet foot

- and

- mouth disease, United Kingdom.28 U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 2009. Risk analy sis: APHI S Evaluation of the Status of the Brazilian State of Santa Catarina Regarding Foot

- and

- Mouth Disease, Classical Swine Fever, Swine Vesicular D isease, and African Swine Fever. USGS

— See U.S. Geological Survey U.S. Geological Survey , 2001. Office of Communication. USGS issues 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]

. WI N

— See Wildlife Information Network Wildlife Information Network, 2001. Picornaviridae: foot

- and

- mouth disease virus. Online database. [Online] Available: http://www.wildlifeinformation.org/Subdirectories_for_Search2/SampleSp ecies/picornaviridae/Picornaviridae_FMDVirus.htm [2009, May 11]. WDNR

— See Wisconsin Department of Natural Resources Wisconsin Department of Natural Resources, 2003. Foot

- and

- mouth disease: issues for Wisconsin wildlife. L ast modified: April 17, 2003. Online. Available: http://www.dnr.state.wi.us/org/land/wildlife/whealth/issues/fmd.htm [ 2004, Sept

. 15]

. World Organization of Animal Health, 2008a. Official Animal Health Status: rinderpest. [Online] Available: http://www.oie.int/Eng/info/en_peste.htm [2009, Apr

. 29]. World Organization of Animal Health, 2008b. Terrestrial Animal Health Code. Chapter 8.13. Rinderpest. [Online

. ] Available: http ://www.oie.int/eng/normes/mcode/en_chapitre_1.8.13.htm#rubrique_p este_bovine_surveillance [2009, May 11]. World Organization of Animal Health, 2009 a . Media Resources. Animal Disease Information Summaries: African Swine Fever. Last updated March 16, 2 009. 3 pp. [Online

. ] Available: http://www.oie.int/eng/ressources/ASF

- EN.pdf [2009, May 8]. World Organization of Animal Health, 2009 b . Media Resources. Animal Disease Information Summar ies: Rinderpest. Last updated March 16, 2009. 3 pp. [Online

. ] Available: http://www.oie.int/eng/ressources/RDP_EN_DC.pdf [2009, May 11].