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<p><img src="embedded:image2.jpg" alt="image2.jpg"><b>Proposed Rule for the Status of Santa Catarina, Brazil, Regarding Foot-and-Mouth Disease, Classical Swine Fever, Swine Vesicular Disease, African Swine Fever, and Rinderpest</b></p>
<p><b>Environmental Assessment,
</b></p>
<p><b>January 2010</b></p>
<p><b>Proposed Rule for the Status of Santa Catarina, Brazil, Regarding Foot-and-Mouth Disease, Classical Swine Fever, Swine Vesicular Disease, African Swine Fever, and Rinderpest</b></p>
<p><b>Environmental Assessment,
</b></p>
<p><b>January 2010</b></p>
<p><b>Agency Contact:
</b></p>
<p>Dr. Silvia Kreindel, Senior Staff Veterinarian
</p>
<p>Regionalization Evaluation Services Staff
</p>
<p>National Center for Import and Export
</p>
<p>Veterinary Services
</p>
<p>Animal Plant Health Inspection Service
</p>
<p>U.S. Department of Agriculture
</p>
<p>4700 River Rd. Unit 38
</p>
<p>Riverdale, MD  20737
</p>
<p>The U.S. Department of Agriculture (USDA) prohibits discrimination in all </p>
<p>its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status.  (Not all prohibited bases apply to all programs.)  Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA’s TARGET Center at (202) 720–2600 (voice and TDD).
</p>
<p>To file a complaint of discrimination, write USDA, Director, Office of Civil </p>
<p>Rights, Room 326–W, Whitten Building, 1400 Independence Avenue, SW, Washington, DC  20250–9410 or call (202) 720–5964 (voice and TDD).  </p>
<p>USDA is an equal opportunity provider and employer.
</p>
<p>Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture </p>
<p>over others not mentioned.  USDA neither guarantees nor warrants the standard of any product mentioned.  Product names are mentioned solely </p>
<p>to report factually on available data and to provide specific information.
</p>
<p><b>Table of Contents
</b></p>
<p> <b> I.  Need for the Proposed Rule
1</b></p>
<p>A.  Introduction
1</p>
<p>B.  Need
3</p>
<p><b> II.  Alternatives
3</b></p>
<p>A.  No Action
3</p>
<p>B.  Preferred Alternative
4</p>
<p><b>III.  Environmental Consequences
5</b></p>
<p>
A.  No Action
5</p>
<p>B.  Preferred Alternative
7</p>
<p>1.  Foot-and-Mouth Disease Virus
7</p>
<p>2.  Classical Swine Fever Virus
10</p>
<p>3.  Swine Vesicular Disease Virus
12</p>
<p>4.  African Swine Fever Virus
13</p>
<p>5.  Rinderpest Virus
16</p>
<p>6.  Regulatory Control
18</p>
<p>7.  Interspecies Transmission
19</p>
<p>8.  Public Health
21</p>
<p><b>IV.  Other Environmental Issues 
22</b></p>
<p>A.  Environmental Justice and the Preferred Alternative
22</p>
<p>B.  Protection of Children and the Preferred Alternative
23</p>
<p>C.  Threatened and Endangered Species and the 
</p>
<p>      Preferred Alternative
23</p>
<p>D.  Potential Cumulative Impacts
24</p>
<p><b> V. 
Listing of Agencies Consulted
25</b></p>
<p><b>VI.  References
26
</b></p>
<p><b>I.  Need for the Proposed Rule </b></p>
<h2>A.  Introduction</h2>
<p>Sanitary import regulations are designed to prevent the introduction and dissemination of injurious animal pests and diseases that are new or not widely distributed in the United States.  Currently, importation into the United States of live ruminants, ruminant products (including ruminant meat and semen), live swine, and swine products (including swine meat and semen) from the Brazilian State of Santa Catarina is prohibited because the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) considers all of Brazil to be a country affected with foot-and-mouth-disease (FMD), classical swine fever (CSF), swine vesicular disease (SVD), and African swine fever (ASF).  USDA–APHIS established policy and rules in 1997 for recognizing regions, rather than only countries, for the purpose of importation of animals and animal products into the United States (62 <i>Federal Register</i> (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.
</p>
<p>An official request was submitted by Brazil to USDA–APHIS to review the disease status of Santa Catarina, Brazil, in order to initiate trade in fresh pork from that State.  In order to make an informed decision, USDA–APHIS–Veterinary Services (VS) conducted a risk analysis as a decision-making tool that would allow the development of appropriate regulatory conditions with mitigations to address potential risks of disease introduction following any initiation of trade with the State of Santa Catarina, Brazil (USDA–APHIS, 2009).  The risk analysis associated with this proposed rulemaking, entitled “APHIS Evaluation of the Status of the Brazilian State of Santa Catarina Regarding Foot-and-Mouth Disease, Classical Swine Fever, Swine Vesicular Disease, and African Swine Fever,” is summarized and incorporated by reference in this environmental assessment (EA).  Rinderpest, another dangerous and destructive disease affecting swine and ruminants and of potential concern to the United States when importing susceptible foreign animals and related products, was not included as a risk factor in this evaluation because it is not endemic to the Americas and has never become established in Brazil (USDA–APHIS, 2009).  The hazard of the disease to the United States is considered to be offset by the absence of potential exposure from Santa Catarina exports, resulting in a corresponding absence of risk. </p>
<p>APHIS’ risk analysis was based on the information gathered from the document submitted by the Brazilian Ministry of Agriculture, Livestock and Food Supply (MAPA), the Companhia Integrada de Desenvolvimento Agricola de Santa Catarina (CIDASC),
 and from site visits to Santa Catarina (2008) and other Brazilian States (2002, 2003, and 2006).  While the site visits focused on the veterinary and legal infrastructure, border control procedures, laboratory and diagnostic capabilities, biosecurity procedures on swine farms, animal health recordkeeping systems, movement controls, and disease surveillance systems, the following factors were considered relevant in determining the disease status of </p>
<p>Santa Catarina—</p>
<p>· the State of Santa Catarina has not vaccinated against FMD since May 2000;
</p>
<p>· no FMD outbreaks have occurred in Santa Catarina since 1993;
</p>
<p>· no outbreaks of CSF have occurred in Santa Catarina since 1990;
</p>
<p>· no outbreaks of ASF have occurred in Santa Catarina since 1981; and</p>
<p>· SVD has never occurred in the Brazilian territory.</p>
<p>It was shown that surveillance programs in cattle and swine populations have not detected any presence of FMD, CSF, SVD, or ASF virus in the Brazilian State of Santa Catarina, nor was there any evidence of viral activity for FMD in cattle during or since the outbreaks in other areas of the country in 2000–01 and 2005–06.  APHIS–VS also found the legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs, and emergency response systems within the boundaries of the Brazilian State of Santa Catarina to be adequate to detect and control FMD, CSF, SVD, and ASF outbreaks.  Although the consequences of these disease outbreaks are severe, APHIS considers the likelihood of outbreaks occurring in the United States by means of exposure of the domestic livestock population to swine or other susceptible species or their related unprocessed products imported from the Brazilian State of Santa Catarina to be very low (USDA–APHIS, 2009). </p>
<p>Rinderpest is very close to being completely eradicated in the few regions of the world where it still occurs.  In addition, rinderpest has never been established in North America, Central America, the Caribbean Islands, or South America (USDA–APHIS, 2009).  Because rinderpest is not a disease of concern with specific regard to potential risks and environmental impacts from promulgation of this rule, the scope of this EA will be restricted to FMD, CSF, SVD, and ASF.
</p>
<p><b>B.  Need</b></p>
<p> SEQ CHAPTER \h \r 1In response to an official request from the government of Brazil, and in accordance with sanitary and phytosanitary (SPS) agreements to facilitate the importation of live ruminants, ruminant products, live swine, and swine products, APHIS has reviewed the issues related to this importation and would like to amend the sanitary regulations (9 Code of Federal Regulations (CFR) part 94). </p>
<p>The preparation of this EA was prompted by the anticipated public concern about the potential disease risk from the importation of live ruminants, ruminant products, live swine, and swine products, and the need to address environmental issues related to FMD, CSF, SVD, and ASF risks.  The issue of potential environmental risks of FMD, CSF, SVD, and ASF outbreaks in the United States resulting from the importation of live ruminants, ruminant products, live swine, and swine products is of great concern to USDA–APHIS.  Characterization of disease risk potential and adequate mitigation measures are critical for excluding these diseases from the United States.
</p>
<p> SEQ CHAPTER \h \r 1This 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.”
</p>
<h2>II.  Alternatives </h2>
<p>This EA evaluates two alternatives of a proposal to add the Brazilian State of Santa Catarina to the list of regions declared free of FMD, CSF, SVD, and ASF:  (1) the no action alternative, under which the Brazilian State of Santa Catarina would continue not to be included on the list of regions declared free of FMD, CSF, SVD, ASF, and rinderpest, and (2) the preferred alternative, which would amend the regulations to add the State of Santa Catarina, Brazil, to the list of regions declared free of FMD, CSF, SVD, and rinderpest.  Santa Catarina will also be excluded from the list of regions in 9 CFR part 94 where ASF is known to or reasonably believed to exist.  This amendment would relieve restrictions on the importation of live ruminants, ruminant products, live swine, and swine products from Santa Catarina.  
</p>
<h2>A.  No Action</h2>
<p><img src="embedded:image3.png" alt="image3.png"> SEQ CHAPTER \h \r 1Under the no action alternative, the Brazilian State of Santa Catarina would not be declared free of FMD, CSF, SVD, ASF, and rinderpest and, therefore, would not be allowed to export live ruminants, ruminant products, live swine, and swine products to the United States.  The no action alternative maintains overall low levels of disease risk.  However, selection of this alternative may not satisfy international trade regulations requiring justification of more rigorous requirements of maintaining current regulations over less restrictive alternative approaches.  In compliance with SPS measures stipulated by the World Trade Organization, APHIS is obligated to consider less restrictive sanitary measures that provide comparable protection against disease risks.  (The issues of potential environmental impacts associated with the disease risks of each alternative are discussed in chapter 3, Environmental Consequences of the Alternatives.)
</p>
<p><b>B.  Preferred Alternative</b></p>
<p>T SEQ CHAPTER \h \r 1he preferred alternative would amend regulations under 9 CFR part 94 to add the Brazilian State of Santa Catarina to the list of regions declared free of FMD, CSF, SVD, ASF, and rinderpest.  This amendment would allow the importation of live ruminants, ruminant products, live swine, and swine products from the Brazilian State of Santa Catarina under specific conditions of entry.  Under the preferred alternative, each shipment of live ruminants, ruminant products, live swine, and swine products would be required to have an approved permit from APHIS, a sanitary certificate indicating that the live ruminants, ruminant products, live swine, and swine products were handled in accordance with the importation requirements, and a statement of origin and disease-free status of the shipment based upon inspection.  The preferred alternative has been designed to provide sufficient mitigation to maintain sanitary security while facilitating trade.  </p>
<p>Assessing the likelihood of introducing, FMD, CSF, SVD, and ASF into the United States requires an evaluation of relevant characteristics of the exporting regions in relation to the epidemiology of the diseases.  In that regard, APHIS described 11 factors in its regionalization rule (9 CFR 92.2) that provide a context for evaluating the risk of exporting a foreign animal disease from a defined region into the United States.  </p>
<p>APHIS conducted an in-depth evaluation of Santa Catarina’s disease status using the 11 factors identified in 9 CFR part 92.2 as necessary to consider in assessing risk levels of free regions.  Those factors are:
</p>
<p>1. the authority, organization, and infrastructure of the veterinary services organization in the region;</p>
<p>2. disease status;</p>
<p>3. the status of adjacent regions with respect to the agent;</p>
<p>4. the extent of an active disease control program, if any, if the agent is known to exist in the region;</p>
<p>5. the vaccination status of the region;</p>
<p>6. the degree to which the region is separated from adjacent regions of higher risk through physical or other barriers;</p>
<p>7. the extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regarding such movements;</p>
<p>8. livestock demographics and marketing practices in the region;</p>
<p>9. the type and extent of disease surveillance in the region;</p>
<p>10. diagnostic laboratory capacity; and</p>
<p>11. policies and infrastructure for animal disease control in the region, that is, emergency response capacity.
</p>
<p class="bullets">APHIS officials reviewed information concerning these 11 factors and undertook site visits to Brazil in 2002, 2003, 2006, and 2008.  APHIS has concluded that Santa Catarina consistently achieves the level of disease freedom and veterinary infrastructure necessary to regionalization as described in 9 CFR part 92.2 (USDA–APHIS, 2009).  Santa Catarina’s adequate legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs, and emergency response systems are assumed to continue and form an integral part of the preferred alternative risk mitigation. </p>
<p><b>III.  Environmental Consequences</b></p>
<p>Compliance with NEPA requires APHIS to consider all potential effects to the human environment from a proposed action.  Environmental consequences to the United States that may stem from introduction and spread of FMD, CSF, SVD, and ASF may range widely from marginal to broad, and mild to severe.  Animal or human sickness; loss of threatened and endangered species; pollution and infrastructure issues arising from transportation and carcass disposal; economic hardship for consumers, producers, and associated industries; and risk from chemical exposure are some of the potential adverse impacts to the human environment which could occur from an outbreak of these diseases of concern.  The nature of each disease and its causal agent, and its potential impacts on the physical environment as well as the health of U.S. human, livestock, and wildlife populations are discussed in the following sections of this chapter.</p>
<p><b>A.  No Action</b>  </p>
<p>The biological histories and disease potentials of the five diseases of concern suggest that continuation of the current regulations prohibiting imports of live ruminants, ruminant products, live swine, and swine products into the United States from any region of Brazil, regardless of Santa Catarina’s disease-free status, would not result in an increased pest risk and, therefore, would not adversely impact the human environment.  The proposed rule (preferred alternative) would provide a means of export of live ruminants, ruminant products, live swine, and swine products from the State of Santa Catarina, Brazil.  Although the required mitigations of the preferred alternative have been shown to be effective against all known strains
 of the viruses causing these five diseases, there remains some potential risk that does not exist under the no action alternative.  
</p>
<p>The prohibition of importation of live ruminants, ruminant products, live swine, and swine products from Brazil, under 9 CFR 94, has maintained low disease risks to U.S. human and animal populations, and has caused negligible environmental effects in the United States.  As with most commodities, there is always some risk of illegal entry, whether deliberate or accidental; however, the frequency has been low and is believed to be due to the impending high punitive cost to the perpetrators.  The potential of high risks from disease associated with noncompliance makes it APHIS’ policy to provide a strong deterrent.  Therefore, APHIS strives to keep travelers, importers, and shippers informed of import regulations and of the penalties for inadequate compliance.  An importer or shipper could be subjected to civil penalties, criminal fines, jail sentences, and loss of revenue due to APHIS’ rejection of commodities, permit applications, and/or compliance agreements.  APHIS has the option to refuse entry, require treatment, or require destruction of infected or potentially infected cargo.  
</p>
<p>All of these options are costly to the targeted shipping line and exporter who must assume all costs for resultant delays and treatments.  This offers strong incentive for their full compliance with import regulations.  Monitoring of the rates of compliance with a phytosanitary rule promulgated in 1998 found that proper compliance with those import requirements was achieved approximately 98 percent of the time (USDA–APHIS, 2003a).  Comparable compliance could be expected for any current or revised sanitary regulations related to importation.  
</p>
<p>The ecological, physiological, psychological, and economic costs of an uncontrolled outbreak of FMD, CSF, SVD, ASF, or rinderpest could be extremely high if such an outbreak were to occur in the United States.  Animal illness and mortality from outbreaks of these diseases elsewhere have devastated susceptible wild and domestic populations, polluted the environment, and indirectly impacted humans and other animals depending upon them as a resource.  
</p>
<p>The no action alternative would leave the current importation regulations unchanged.  Under this alternative, the entire country of Brazil would continue to be prohibited from importing commodities, under 9 CFR 94, into the United States.  The current import regulations, however, do not
</p>
<p>reflect Santa Catarina, Brazil, as being free of the five diseases of concern (FMD, CSF, SVD, ASF, and rinderpest).  Under international trade agreements, the continuation of unsupported trade restrictions is contrary to U.S. obligations; this makes the no action alternative unacceptable.  </p>
<p><b>B.  Preferred Alternative </b></p>
<p>Compliance with NEPA requires APHIS to consider all potential effects to the human environment from a proposed action.  In addition to the consideration of disease issues related to livestock, this document analyzes potential effects to humans, wildlife, and environmental quality.  This section of the EA considers issues pertaining to the regulatory control process, the disease transmission mechanism as related to wildlife, and the persistence of disease causal agents under various environmental conditions on or in environmental media, such as soil, water, plants and plant material, and abiotic surfaces.  The environmental consequences from implementation of the preferred alternative are largely contingent upon the ability of various mitigation measures and program treatment procedures to (1) preclude exposure of Santa Catarina, Brazil’s animal population to the five diseases of concern, and (2) exclude the importation to the United States of any animals or animal products from Santa Catarina that are potentially infected with any of the causal viruses.  APHIS’ evaluation of the disease status of Santa Catarina, Brazil (USDA–APHIS, 2009) examined the sanitary issues associated with fulfilling the change-in-status request from Santa Catarina, Brazil.  The risk analysis assessed the likelihood of exposure to and infection from FMD, CSF, SVD, and ASF for susceptible livestock in the United States following implementation of the rule.  </p>
<p>The absence of the five diseases of concern in the Santa Catarina region, coupled with the probability of quick detection of clinical signs (should disease be introduced in the absence of vaccination) are supporting evidence of continued freedom from these diseases in the State of Santa Catarina.  No adverse environmental consequences are expected to occur in Brazil or the United States as a result of implementation of the preferred alternative, as the risk of introduction of any of these diseases to the United States through implementation of the proposed rule is low, and both countries have effective systems in place to prevent and contain outbreaks of the five diseases of concern.</p>
<p>Foot-and-mouth disease virus (FMDV) is the micro-organism that causes FMD.  FMDVs are members of the <i>Picornaviridae </i>family, and viruses of the genus <i>Aphthovirus</i>.  FMDV is a small virus which is very infectious, multiplying in and causing damage to cells throughout the body of susceptible animals, and it can survive in the environment for extended periods of time.  FMD is an acute, highly contagious viral disease, mainly, but not exclusively, of cloven-footed animals.  The risk to humans from 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.  
</p>
<p>FMD causes significant distress and suffering to animals, regardless of the size and sophistication of their livestock unit.  Very high mortality rates in young animals can occur, particularly among pigs and sheep.  Mortality in older animals occurs less frequently but may be significant with certain virus strains (USDA–APHIS, 2009).
</p>
<p>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 disease is allowed to run its course.  In addition, FMD can cause a reduction in the growth rate of animals raised for meat.  The comparatively greater severity of FMD in pigs would imply at least similar losses to those described for cattle (USDA–APHIS, 2009).</p>
<p>FMD is characterized by the formation of lesions on the feet and mouth, damage to the mucous membrane lining the gastrointestinal system, and high fever.  Damage from FMDV may also occur to the heart muscle cells (particularly in young animals), the milk-secreting cells of the udder, and hormone-producing cells.  For FMD to remain in a population, each infected animal must infect at least one other animal.  The primary methods in which FMDV moves out of an infected animal are in air-borne droplets from the lungs and the fluid-filled vesicles; in the saliva, urine, feces, semen, and milk; secretions from the eyes, nose, prepuce, and vagina; and through direct contact with skin or pieces of infected skin that may drop off the animal (WIN, 2001).  
</p>
<p>It is also possible to transmit FMDV in infected carcasses, meat, hides, and bones (WIN, 2001).  FMDV is commonly spread by the movement of infected animals; however, the virus may also move independently outside of the animal.  Humans, birds, rodents, dogs, and cats may carry and spread the virus if they contact any of the above-mentioned body substances and, particularly with humans and probably other vertebrates, for a short time after they have breathed in the infected airborne droplets.  The wind may move the airborne droplets containing the virus up to 250 kilometers (km) over water, and shorter distances over land (WIN, 2001).  The virus must reenter a susceptible animal in which it can multiply; this can be through inhalation, ingestion, sexual transmission, conjunctival membranes, inoculation, and damaged skin.  
</p>
<p>It is possible for animals to carry FMDV without appearing clinically ill under certain conditions, such as recovery from clinical disease and undetected subclinical disease.  However, development of a permanent carrier status for animals infecting susceptible animals is now less likely.  Vaccination does not make animals into FMDV carriers.  Properly inactivated vaccine, when injected into animals, does not give rise to the carrier state (WIN, 2001).  
</p>
<p>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
 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
 and establish an immune response to those antigens.  A virus will modify specific antigens or proteins so as to evade the host’s immune system, thereby establishing persistent infection in the host.  The modification of specific antigens or proteins gives rise to substrains of the virus. </p>
<p>Documenting surveillance systems sufficient to ensure early detection of the diseases under consideration has been integral in assessing the level of risk from implementation of the preferred alternative.  The next section explains the characteristics of FMD and its associated safeguards (e.g., surveillance programs) in the State of Santa Catarina. 
</p>
<p><b> SEQ CHAPTER \h \r 1FMD Safeguards</b></p>
<p>The last outbreak of FMD in the State of Santa Catarina, Brazil, occurred in 1993; since 2007, the World Organization of Animal Health (OIE) recognized Santa Catarina as an FMD-free zone where vaccination is not practiced (USDA–APHIS, 2009).  The country of Brazil employs both passive and active surveillance strategies designed to demonstrate freedom from FMD, with differing emphases depending on the phase of the eradication process within a given State or zone.  Active surveillance is used to demonstrate freedom from disease within a specific area.  Passive surveillance is the primary type of surveillance used once freedom from infection has been established and the area is recognized as free of FMD by the OIE, either with or without vaccination (in the case of Santa Catarina it is recognized as free without vaccination).  Active surveillance complements passive surveillance primarily by targeting specific “high-risk” areas within the area for serological sampling and more in-depth investigations.  </p>
<p>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 and viral activity in the State.  APHIS considers the risk of introduction of FMD to the United States through the importation of infected animals and animal products from Santa Catarina to be low (USDA–APHIS, 2009).   Therefore, APHIS does not expect that such importation will have a consequential impact on the human environment.</p>
<p>Acute and chronic cases of CSF have been described in scientific literature.  The severity of the disease depends largely on the age of the animal and virulence of the viral strain, with young animals usually more severely affected than older animals.  In older breeding pigs, the course of infection is often mild, or even subclinical, whereas mortality rates may reach 90 percent in young pigs.  Low virulence strains may manifest primarily as poor reproductive performance and birth of piglets with neurologic defects (USDA–APHIS, 2009).  </p>
<p>Clinical signs of CSF may include viremia (presence of virus in the blood) characterized by persistent fever, skin discoloration, conjunctivitis (inflammation of the eye), abortion, and/or diarrhea that is unresponsive to antibiotics.  Leucopenia (decrease in the number of white blood cells in the blood) is a consistent clinical laboratory finding.  Severity of CSF is variable.  Three common forms are acute, chronic, and late onset—</p>
<p>· <b>Acute</b>—illness in weaned pigs under 12 weeks of age that is unresponsive to antibiotics and characterized by fever, skin discoloration, conjunctivitis, hind-limb weakness, and/or diarrhea. 
</p>
<p>· <b>Chronic</b>—characterized by subdued acute infection, followed by brief recovery before relapse of fever, anorexia leading to wasting and death 1 to 3 months after onset. 
</p>
<p>· <b>Late onset</b>—pigs born to sows infected after day 50–70 of gestation may be persistently infected and appear normal for several months before dying, or born with congenital tremors.  (Sows infected prior to day 50–70 of gestation may abort or give birth to stillbirths, mummies, or pigs with congenital defects.)  (USDA–APHIS, 2007a).   
</p>
<p>APHIS considers that a case of CSF is confirmed when it meets the clinical case definition and is laboratory-confirmed via virus isolation with sequence confirmation (USDA–APHIS, 2007a).  
</p>
<p><b> SEQ CHAPTER \h \r 1CSF Safeguards</b></p>
<p>Passive surveillance for CSF is carried out within Brazil, particularly at the border between the CSF-free zone and the infected region.  This work is facilitated by the fact that the border of the CSF-free zone corresponds to that of the FMD-free zone for FMD in Brazil; therefore, the staff and structures of the sanitary defense in place at this line for the control of the entry of susceptible animals and products is utilized for both diseases at the same time (USDA–APHIS, 2009).  
</p>
<p>In order to delineate and maintain the free zone, serologic surveys are carried out under the coordination of MAPA in accordance with the statistical parameters set by OIE.  The target population includes the entire population of hogs and wild boars within the free area, except for those in swine breeding farms that have been officially and individually certified as free from diseases (i.e., Farms of Certified Swine Breeders (GRSC) (USDA–APHIS, 2009)).  </p>
<p>Screening and diagnostic tests are conducted at official public service laboratories.  Screening tests are performed using an enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies of the CSF virus.  Any reactive or suspicious samples are submitted for differential diagnosis using virus-neutralization tests in cell cultures (USDA–APHIS, 2009).  
</p>
<p>As with FMD and other vesicular diseases, every Brazilian citizen is obligated to report the suspicion of CSF to the nearest local veterinary unit.  If the owner of the animal(s) fails to report the suspicion of disease, he or she will lose a claim to indemnity in the event that the herd must be destroyed for disease control purposes.  In addition, veterinarians and other field professionals may be subject to legal action before their respective trade guilds (USDA–APHIS, 2009).   </p>
<p>In the event that a sanitary emergency or documented disease event occurs, samples are collected from all susceptible animals present on the farm.  All suspicious cases of CSF or other diseases with similar clinical signs must be investigated promptly by the official veterinarian.  If indicated, a quarantine and additional sampling will be initiated.  Additional procedures performed by the official veterinarian include (USDA–APHIS, 2009)—
</p>
<p>· filling out the initial disease investigation form, </p>
<p>· collecting information on the establishment under suspicion, </p>
<p>· prohibiting the movement of hogs and  their products and byproducts from the property, </p>
<p>· cleaning and disinfecting the equipment and materials utilized in exams and collection of specimens, </p>
<p>· incinerating expendable work clothes, and, </p>
<p>· prohibiting the admittance of outsiders to the facilities.
</p>
<p>In Santa Catarina over the last 4 years, there were three notifications of CSF.  Follow-up tests were negative for CSF, and the implicated farms received follow-up evaluations by the official veterinary service (USDA– APHIS, 2009).  
</p>
<p>SVD is an acute, contagious, viral disease of swine caused by an enterovirus.  It is characterized by fever and vesicles with subsequent ulcers in the mouth and on the snout, feet, and teats.  The pathogen is relatively resistant to heat and can persist for a long time in salted, dried, and smoked meat products.  People coming into contact with the swine vesicular disease virus (SVDV) should exercise caution as human infection has been reported in laboratory staff working with the virus (USDA–APHIS, 2003b).   
</p>
<p>This disease can be introduced into a herd by feeding it garbage containing infected meat scraps, by bringing in infected animals, or by direct contact with infected feces (e.g., in an improperly cleaned truck).  After the initial infection, the disease spreads through the contact of susceptible pigs with infected pigs and infected feces (USDA–APHIS, 2003b).
</p>
<p>Clinical signs are very similar to those of FMD and other vesicular diseases (USDA–APHIS, 2003b) and include: 
</p>
<p>· fever;</p>
<p>· vesicles in the mouth, and on the snout and feet;</p>
<p>· lameness and an unsteady gait, shivering and jerking–type leg movements; and/or</p>
<p>· ruptured vesicles which can cause ulcers on limbs and feet, and foot pads may be loosened.</p>
<p>SVD is typically a transient vesicular disease of pigs.  Young animals are more severely affected; however, essentially, the virus causes no mortality.  Infected pigs generally recover within 1 week but recovery can take up to 3 weeks.  Some strains produce only mild clinical symptoms or are asymptomatic.  Morbidity rates may be low throughout a whole herd but high in certain pens (USDA–APHIS, 2009).</p>
<p><b> SEQ CHAPTER \h \r 1SVD Safeguards</b></p>
<p>There is no routine testing for SVD as it is exotic to Brazil.  However, passive surveillance for this disease is carried out similarly to other vesicular diseases, such as FMD, as detailed above.  If FMD is ruled out as a diagnosis in clinically affected pigs, evaluation for SVD is included as part of the follow-up testing.  It is important to note that, in suspicious cases, movement of animals from the involved farms and the region will be restricted until a definitive diagnosis is reached.</p>
<p>There is no vaccine for SVD.  Prevention measures are similar to those for FMD—controlling animals imported from infected areas, sanitary disposal of garbage from international aircraft and ships, and prohibitions on feeding garbage to animals.  Suspect animals will be placed in strict quarantine while an investigation is carried out.  Eradication measures for the disease include quarantining infected areas, depopulation and disposal of infected and contact pigs, and cleaning and disinfecting contaminated premises (USDA–APHIS, 2003).
</p>
<p>ASF is a serious viral disease of pigs that can spread very rapidly in pig populations by direct contact with infected animals or indirect contact with fomites (any inanimate object or substance capable of carrying infectious organisms) and tick vectors.  Humans are not susceptible to the African swine fever virus (ASFV).  ASF affects members of the pig family (Suidae) and can have 100 percent mortality in native herds.  Species that can be infected include domesticated swine, European wild boars, warthogs (<i>Phacochoerus africanus</i>), bush pigs (<i>Potamochoerus porcus</i>), giant forest hogs (<i>Hylochoerus </i>spp.), and peccaries (<i>Tayassu </i>spp.).  Symptomatic infections occur in domesticated pigs, feral pigs, and European wild boars.  ASFV infections are generally asymptomatic in warthogs, bush pigs, and giant forest hogs; these species are thought to be the reservoirs for the virus in Africa.  Other species that may be able to carry the virus asymptomatically include the collared peccary (<i>Tayassu tajacu</i>) and the white-lipped peccary (<i>Tayassu albirostris</i>), both found in the Americas (CFSPH, 2006). </p>
<p>ASFV, formerly classified as a member of the family Iridoviridae, is currently the sole member of the new genus <i>Asfivirus </i>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 <i>Ornithodoros </i>ticks.  ASFV isolates vary in virulence from highly pathogenic strains (that cause near 100 percent mortality) to low-virulence isolates that can be difficult to diagnose.  There is no vaccine or treatment for ASF (CFSPH, 2006). </p>
<p>Disease outbreaks have occurred in Africa, Europe, South America, and the Caribbean; the cost of eradication has been significant.  During outbreaks in Malta and the Dominican Republic, the swine herds of these countries were completely depopulated.  In Spain and Portugal, ASFV became endemic in the 1960s; complete eradication took more than 30 years.  Outside Africa, ASFV is currently endemic only in feral pigs in Sardinia, Italy; however, changes in production practices and increased globalization have increased the risk of ASF being introduced into North America (CFSPH, 2006).  Severe epidemics of ASF occurred in Brazil from 1978 to 1981 (OIE, 2009a).</p>
<p>ASF is a highly contagious hemorrhagic disease.  All age groups of pigs are equally susceptible.  With highly virulent forms of the virus, ASF is characterized by high fever, loss of appetite, hemorrhages in the skin and internal organs, and death in 2 to 10 days, on average.  Mortality rates may be as high as 100 percent (OIE, 2009a).  SEQ CHAPTER \h \r 1 </p>
<p>Transmission during direct contact is usually by mouth or nose.  Aerosol transmission is thought to be unimportant, and only seems to occur over short distances when pigs are in close contact.  ASFV can be found in all tissues and body fluids, but particularly high levels are found in the blood.  Massive environmental contamination may result if blood is shed during necropsies or pig fights, or if a pig develops bloody diarrhea.  The virus can also spread on fomites, including vehicles, feed, and equipment.  There is evidence that some pigs may become carriers.
</p>
<p>ASF often spreads to new areas when pigs are fed uncooked scraps that contain ASFV-infected pork.  In one outbreak, pigs became infected after being fed the intestines of guinea fowl that had eaten infected ticks.  Individual ticks can apparently remain infected for life, and infected soft tick colonies can maintain this virus for years.  Other bloodsucking insects, such as mosquitoes and biting flies, may also be able to transmit the virus mechanically.  Stable flies (<i>Stomoxys calcitrans</i>) can carry high levels of the virus for 2 days.  Under experimental conditions, these flies could transmit ASFV 24 hours after feeding on infected pigs (CFSPH, 2006).</p>
<p>ASFV is highly resistant to environmental conditions.  It can survive for a year and a half in blood stored at 4 oC (39 oF), 11 days in feces at room temperature, and at least a month in contaminated pig pens.  The virus will also remain infectious for 150 days in boned meat stored at 3.9 oC (39 oF), 140 days in salted dried hams, and several years in frozen carcasses (CFSPH, 2006).</p>
<p>ASF can be a peracute, acute, subacute, or chronic disease.  Less virulent strains of ASFV produce milder symptoms that are easily confused with other diseases, and can take several weeks to spread through the herd.  Animals infected with isolates of low virulence may be able to destroy the virus via an immune response without symptoms, abort, or develop chronic ASF (CFSPH, 2006).</p>
<p>Highly virulent strains produce peracute or acute disease, and may affect the entire herd within a few days.  Sudden deaths with few lesions are characteristic of the peracute form, and may be the first sign of an infection in a herd (CFSPH, 2006). </p>
<p>Acute disease is characterized by a high fever, moderate anorexia, lethargy, weakness, recumbency (the state of leaning, resting, or reclining), and erythema (abnormal redness of the skin) that is most apparent in white pigs.  Some pigs develop cyanotic skin (bluish or purplish discoloration of skin), blotching on the ears, tail, lower legs, or hams.  Pigs may also have abdominal pain, constipation, or diarrhea; the diarrhea is initially mucoid, and later may become bloody.  Generalized hemorrhages can occur in the skin or internal organs.  Difficulty breathing, vomiting, nasal and eye discharges, and neurologic signs have also been reported.  Pregnant animals frequently abort; in some cases, abortions may be the first signs of an outbreak.  Leukopenia can be seen in laboratory tests.  In acute ASF, death often occurs within 7 to 10 days (CFSPH, 2006). </p>
<p>Subacute ASF, which is caused by moderately virulent isolates, is similar to acute ASF but less severe.  In this form of the disease, the death rate is generally lower in adult swine, but may still be very high in very young animals.  In subacute disease, fever, thrombocytopenia, and leukopenia may be transient; affected pigs usually die or recover within 3 to 4 weeks (CFSPH, 2006). </p>
<p>The symptoms of chronic disease include an intermittent low fever, appetite loss, and depression.  Pigs may become emaciated and develop respiratory problems and swollen joints.  Coughing is common, and diarrhea and occasional vomiting have been reported.  Ulcers, reddened or raised tissue, or death of tissue in localized areas may appear over body protrusions and other areas subject to trauma.  In some cases, the only symptoms may be emaciation and stunting.  Chronic ASF can be fatal (CFSPH, 2006). </p>
<p> SEQ CHAPTER \h \r 1<b>ASF Safeguards</b></p>
<p>For ASF, which is an exotic disease to Brazil, no specific surveillance is conducted.  Instead, if CSF is ruled out in a susceptible pig population, ASF is considered as a possibility and investigated as such.  As with SVD and other notifiable diseases, any implicated farms, as well as those they are associated with, undergo movement restrictions until the investigation has been completed and a final diagnosis achieved (USDA–APHIS, 2009).  </p>
<p>ASF can be diagnosed by virus isolation in blood and tissue samples collected from suspect pigs.  Nucleic acids can be detected with a polymerase chain reaction (PCR) assay, or by the hybridization of nucleic acid probes to tissue sections.  PCR is particularly useful in putrefied samples that cannot be used for virus isolation and antigen detection.  A rapid, real time PCR technique using tonsil scraping samples has recently been published.  This test can detect the virus a few days before the onset of symptoms (CFSPH, 2006). </p>
<p>Serology is also useful for diagnosis, particularly in endemic regions.  ELISA is prescribed for diagnosis of animals or materials destined for international trade.  Animal inoculation, performed in pigs, was used in the past to distinguish ASF from CSF.  This test is no longer recommended by OIE due to humane considerations and the complexity of the test (CFSPH, 2006). </p>
<p>To prevent introduction of ASFV into areas free of the disease, international standards are consistent in saying that all garbage fed to pigs should be cooked.  Although Brazilian law allows some feeding with inactivation of waste, this practice is forbidden by State law in Santa Catarina (USDA–APHIS, 2009).  
</p>
<p>Unprocessed meat must be heated to at least 70 oC (158 oF) for 30 minutes to inactivate the virus; 30 minutes at 60 oC (140 oF) is sufficient for serum and bodily fluids.  Eradication is by slaughter of infected and in-contact animals, and disposal of carcasses, often by burying, rendering, or burning.  Rapid diagnosis and the prevention of disease spread to feral or wild pigs are very important.  Strict quarantines must be imposed.  Many common disinfectants are ineffective—care should be taken to use a disinfectant specifically approved for ASF.  Sodium hypochlorite and some iodine and quaternary ammonium compounds are effective. </p>
<p>Potential tick vectors should be controlled with acaricides (pesticides that kill mites and ticks).  During an outbreak, a detailed entomological investigation should be conducted to investigate the possible role of local soft tick vectors and their potential for becoming long-term carriers.  So far, however, <i>Ornithodoros </i>ticks have not become chronically infected during outbreaks in South America.  Nonetheless, ticks and other biting insects which may be able to transmit the virus mechanically should be controlled.  No treatment or vaccine exists for this disease (CFSPH, 2006).
</p>
<p>The proposed rule will amend 9 CFR 94 to recognize the region of Santa Catarina, Brazil, as free from rinderpest.  Rinderpest has never become established in the Americas and will not be considered a threat to the human environment as a result of implementing the preferred alternative.  Passive surveillance by Brazil for rinderpest is carried out similarly to other vesicular diseases.  Differential diagnosis
 of vesicular diseases in clinically affected animals includes FMD, mucosal disease of cattle, bluetongue, vesicular stomatitis, and irnderpest (USDA–APHIS, 2009).  It is important to note that, in suspicious cases, movement of animals from the involved farms and from the export region will be restricted until a definitive diagnosis is reached (Kreindel, pers. com. 2009).</p>
<p>OIE recognizes Brazil as a rinderpest-free country (OIE, 2008a).  Rinderpest-free countries are included on the OIE list only after submitted evidence of no rinderpest vaccinations, adequate ongoing surveillance, and outbreak reporting has been accepted by OIE.  Retention on the list requires that the information be resubmitted annually, and changes in the epidemiological situation or other significant events be reported according to OIE requirements (OIE, 2008b).  
</p>
<p>In addition, OIE considers rinderpest close to being eradicated worldwide (OIE, 2009b); however, because surveillance is difficult in countries with civil strife or other calamities, disease-free countries (such as Brazil and the United States) may continue to restrict the movement of susceptible animals and uncooked meat products from areas where rinderpest might still be found (CFSPH, 2008).  The Global Rinderpest Programme (GREP), introduced by the Food and Agriculture Organization (FAO) of the United Nations, is considered to be a primary instrument for successfully eradicating this disease (CFSPH, 2008).  GREP is working to eliminate the last reservoir of infection, which is suspected to be persisting in Africa in the border area between Kenya and Somalia.  GREP has set the year 2010 as the time by which all countries need to be accredited by OIE as free from rinderpest.  There is no known technical reason global eradication should not be achieved (FAO, 2009).</p>
<p>Rinderpest is a fatal viral disease of cattle, domesticated buffalo, and some species of wildlife (OIE, 2008a).  It also affects sheep, goats, and some breeds of pigs (Asian pigs seem more susceptible than African and European pigs).  Rinderpest can infect a large variety of wildlife species, including African buffaloes, eland, kudu, wildebeest, various antelopes, bushpigs, warthogs, and giraffes; however, it is rare among camelids (USDA–APHIS, 2009), and it has not been reported to infect humans (CFSPH, 2008).
</p>
<p>Rinderpest virus (RPV) is the micro-organism that causes rinderpest.  RPV is a single-stranded RNA virus in the family <i>Paramyxoviridae</i>, genus <i>Morbillivirus</i>.  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).
</p>
<p>Transmission of rinderpest can occur through direct or close indirect contacts.  The usual route of infection is via the respiratory tract, with an incubation period of generally 4 to 5 days following natural exposure, but it may range from 3 to 15 days.  Viral shedding begins 1 to 2 days before pyrexia (fever) through tears, nasal secretions, saliva, urine, and feces, and this typically continues for 8 to 9 days after the onset of clinical signs.  Blood and all tissues are infectious before the appearance of clinical signs (USDA–APHIS, 2009).  
</p>
<p>Rinderpest can take several clinical presentations—classic, peracute, subacute, and atypical.  There is no carrier state following infection.  The classic form is characterized by a 2- to 3-day period of symptoms, including high fever, depression, anorexia, increased respiratory and cardiac rate, congested mucus membranes, and excessive salivation.  When the fever drops, gastrointestinal signs appear with profuse hemorrhagic diarrhea.  Dehydration, abdominal pain, abdominal respiration, weakness, and death generally occur within 8 to 12 days.  In rare cases, clinical signs regress by day 10, and recovery occurs by day 20 to 25 (USDA–APHIS, 2009).  
</p>
<p>The peracute form of rinderpest has no preceding signs and is characterized by high fever (>40 to 42 °C) and death.  The peracute form occurs in highly susceptible young and newborn animals.  The subacute form has a low mortality rate and a clinical presentation similar to the classic form.  The atypical form is characterized by irregular pyrexia with mild or no diarrhea (USDA–APHIS, 2009).  RPV is relatively resistant and is stable between pH 4.0 and 10.0, but is susceptible to most common disinfectants, including lipid solvents.  The virus remains viable for long periods in chilled or frozen tissues.  Small amounts of RPV may survive relatively high temperatures, for example, 56 °C (133 oF) for 60 minutes or 60 °C (140 oF) for 30 minutes (USDA–APHIS, 2009).  
</p>
<p class="cM24"><b>a.  Santa Catarina, Brazil
</b></p>
<p>In order to ensure compliance with the appropriate controls for FMD, APHIS 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 APHIS considers to be FMD-affected.  Specifically, APHIS will require the following certifications for beef or pork products exported to the United States from the State of Santa Catarina:  
</p>
<p>· The beef or pork comes from animals that have been born, raised, and slaughtered in the State of Santa Catarina; and</p>
<p>· The beef or pork comes from animals that originated on premises where FMD has not been present during the lifetime of any of the animals that are slaughtered for export of meat to the United States.
</p>
<p>There is a potential risk from illegal introduction of affected animals or animal products from affected regions.  Santa Catarina contains several posts located in internal and external border areas.  Even where there are barriers or checkpoints, there is the potential that people, cars, and animal products could cross both domestic and international borders illegally.  The potential for viruses under evaluation to transit the border during these times is increased, particularly via passenger car.  Despite this possibility, Santa Catarina’s controls, biosecurity procedures, and quarantine procedures have been successful in mitigating this risk.  APHIS evaluated Santa Catarina’s controls for the movement of animals into the State and concluded that risk from illegal importations from affected regions to be sufficiently mitigated (USDA–APHIS, 2009).  </p>
<p>Were FMD or the swine diseases under evaluation to be reintroduced into the State of Santa Catarina, disease might be spread through animals scavenging unmonitored garbage dumps.  Brazilian laws prohibit the feeding of untreated garbage to animals, while Santa Catarina goes even farther and prohibits garbage feeding outright, regardless of treatment.  These laws are enforced effectively with the result that feeding of garbage to animals is unlikely to occur in Santa Catarina.  </p>
<p><b>b.  The United States</b></p>
<p class="cM24">In the United States, APHIS provides Federal regulation, assistance, and information concerning animal diseases, and operates an ongoing system of emergency response and disease controls.  The export requirements of the proposed rule reflect norms and procedures which allow for the safe export of uncooked meat and meat products.  Recent outbreaks of FMD in the United Kingdom and an suspected case of the disease in a domestic herd of swine in Minnesota provided opportunities to test the FMD programs in place in the United States (USDA–APHIS, 2007b; DJIN, 2007).  A similar response scenario is likely should a disease epidemic be caused by imports from Santa Catarina.  For example, should an inspector, farmer, or other individual report a suspicious case, Federal agriculture and national security personnel would be deployed, followed by involvement, as necessary, of the Departments of State, Transportation, and Health and Human Services.  A quarantine area would be established, tissue samples would be analyzed, and laboratory determinations would be published.  Depending on jurisdiction, Federal or State authorities regulate the methods and materials used for animal movement, vaccination, culling and carcass disposal, cleaning and disinfection, and surveillance.  
</p>
<p>Based on evaluation of the 11 regionalization factors and observations from the site visits, APHIS considers the State of Santa Catarina to possess the detection capabilities, reporting systems, and emergency response systems that are necessary for combating FMD, CSF, SVD, and ASF.  APHIS considers the likelihood of introduction and establishment of the FMD, CSF, SVD, or ASF viruses into the United States via susceptible species or animal products from Santa Catarina, Brazil, to be low.  Implementation of the preferred alternative and adherence to its stipulated risk mitigations is not expected to result in any consequential impact on the human environment. </p>
<p class="cM24"><b> SEQ CHAPTER \h \r 1</b>There are several ways that the FMD, CSF, SVD, ASF and rinderpest viruses may be transferred between wildlife and susceptible livestock (USGS, 2001; WDNR, 2003)—
</p>
<p>· exposure to infected saliva, feces, urine, milk, semen, meat, and meat byproducts of infected animals;</p>
<p>· exposure to viral particles carried via wind, animals, or on virtually any object (farm equipment, hay, shoes, etc.);</p>
<p>· drinking from a common source of contaminated water; and</p>
<p>· exposure to raw or improperly cooked infected garbage. 
</p>
<p>The likelihood of exposure of susceptible species to infected live animals to the viruses of concern under this rulemaking was evaluated by briefly reviewing virus persistence and shedding in live swine and ruminants, as well as standard import requirements for these species.  The risk analysis (USDA–APHIS, 2009) focuses on breeding animals because transportation costs are prohibitive for export of other live animals (e.g. feeder pigs or cattle) to the United States from Brazil.  APHIS considers exposure of susceptible U.S. animals to illegally imported infected live animals from Santa Catarina to be highly unlikely (USDA–APHIS, 2009).</p>
<p>The survival period of the CSF virus within live swine ranges from 1 week to greater than 6 months, depending on various host-pathogen factors.  Similarly, up to 50 percent of ruminant animals may become carriers of the FMD virus (USDA–APHIS, 2009).  The maximum reported duration of the carrier state is 3.5 years in cattle, 9 months in sheep, and 4 months in goats.  Carrier virus is fully infectious and, consequently, the carrier state is associated with at least a theoretical risk of introducing FMD into a susceptible population.  ASF may also exhibit a chronic carrier state. While the SVD virus is not known to cause persistent infection, a large percentage of infections are subclinical and, therefore, may remain undetected without diagnostic testing prior to export (USDA–APHIS, 2009).
</p>
<p>Consequently, APHIS considers this potential pathway for disease introduction to have high risk without mitigation.  However, current U.S. regulations require certification that ruminants and swine have been kept in a region entirely free of FMD, CSF, SVD, and ASF for 60 days prior to export (9 CFR 93.405 and 93.505).  The regulations also require a minimum quarantine of 30 days for most imported ruminants (9 CFR 93.411), and 15 days for all imported swine (9 CFR 93.510).  These requirements serve to partially mitigate the risk of exposure by increasing the likelihood of disease detection (USDA–APHIS, 2009).
</p>
<p>Based on the results of the release assessment, APHIS considers the likelihood of entry of animals infected with the FMD, CSF, SVD, or ASF viruses into the United States via live animals from Santa Catarina, Brazil, to be low; therefore, the resultant likelihood of susceptible exposure to the FMD, CSF, SVD, and ASF viruses via this pathway is similarly low (USDA–APHIS, 2009).  
</p>
<p><b>Genetic Material
</b></p>
<p>Genetic material (e.g., swine semen) has been implicated in the introduction of foreign animal disease into susceptible populations, as well as the spread of established disease epidemics over considerable distances.  For example, two semen collection centers became infected during the course of the 1997–98 CSF epidemic in the Netherlands (USDA–APHIS, 2009).  Potentially contaminated semen was distributed to 1,680 swine herds over the course of 5 weeks, during which the disease remained undetected in the donor boars.  Although investigators concluded that only 36 farms had been infected through artificial insemination, all suspect farms were subjected to quarantine and testing, resulting in a tremendous expenditure of resources.
</p>
<p>Survival of the CSF virus in semen has been estimated in experimental studies to be 12 to 72 hours at 20 oC but ranges from 1 month to several years at 4 oC or below (USDA–APHIS, 2009).  Survival in embryos and ova is unknown (USDA–APHIS, 2009).  The FMD virus may be present in semen up to 4 days before clinical signs become apparent (USDA–APHIS, 2009).  Survival of both the SVD and ASF viruses in genetic material is possible but is not considered to be a primary mode of transmission (USDA–APHIS, 2009).  The likelihood of release of the CSF or FMD viruses via infected semen from Santa Catarina, Brazil, is considered to be low; therefore, the likelihood of exposure of domestic livestock would be similarly low (USDA–APHIS, 2009).
</p>
<p class="bullets">Direct public health consequences are insubstantial because the occurrence of the FMD, CSF, SVD, or ASF virus in humans is quite rare.  In fact, the number of cases reported is so small when compared with the number of persons exposed to these viruses that the World Health Organization generally does not consider FMD, CSF, SVD, or ASF to be a threat to humans (USDA–APHIS, 2009).  FMD may affect humans; however, its occurrence is quite rare.  FMDV has been isolated and typed in only 40 patients during the last century.  Symptoms in humans are mostly mild, and mainly include fever, and blisters on the hands, feet, mouth, and tongue.  CSF, ASF, and rinderpest are not known to cause infection in humans (CIDRAP, 2009; CFSPH, 2004a; and CFSPH, 2004b).  SVD has been accidentally transmitted to laboratory workers.  Clinical signs of SVD include mild influenza-like symptoms, generalized abdominal and muscle pain, and meningitis (occurred in one case) (CFSPH, 2004c).</p>
<p>Perhaps more importantly, a substantial foreign animal disease outbreak can result in severe psychosocial effects on farmers and farming communities.  Farmers and their families can suffer from grief over losing animals and blood lines kept over many generations, as well as loss of control over their lives due to movement restrictions, disruptions in community life, and short- and long-term stress over their financial future.  For example, a study of the social consequences of the 2001 FMD outbreak in the Cumbria community of the United Kingdom revealed high rates of depression, alcohol consumption, and mortality among farmers during the crisis (USDA–APHIS, 2009).
</p>
<p class="bullets"><b> SEQ CHAPTER \h \r 1</b> SEQ CHAPTER \h \r 1<b>IV.  Other Environmental Issues 
</b></p>
<p class="bullets"> SEQ CHAPTER \h \r 1<b>A.  Environmental Justice and the Preferred Alternative</b></p>
<p> SEQ CHAPTER \h \r 1Executive 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.  </p>
<p>The proposed rule allows for the importation of live ruminants, ruminant products, live swine, and swine products to the United States.  FMD, CSF, SVD, ASF, and rinderpest outbreaks in the United States have the potential to cause severe adverse consequences for domestic livestock and wildlife populations, and to disrupt the flow of animals and related commodities to consumers.  As mentioned at the beginning of this document, rinderpest is not considered to be a disease of concern.  The risk analysis concluded that the proposed mitigations for FMD, CSF, SVD, and ASF in the State of Santa Catarina, Brazil, are sufficient to prevent the introduction of these diseases into the United States and are adequate to initiate trade with Santa Catarina in susceptible animals and products.  The risk analysis also concluded that the volume of animals and animal products likely to be imported into the United States from the State of Santa Catarina would be very small relative to overall U.S. supply of those commodities (production and imports from all foreign sources).  Most of the modest impact-generating compliance actions under the proposed rule occur outside of the United States (in Brazil), and none have any disproportionate adverse effects on minority or low-income populations.  Although one could design scenarios involving the introduction of FMD, CSF, SVD, ASF, or rinderpest to the United States, these are primarily remote and hypothetical.  </p>
<p class="bullets"> SEQ CHAPTER \h \r 1<b>B.  Protection of Children and the Preferred Alternative</b></p>
<p> SEQ CHAPTER \h \r 1Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Factors,” requires each Federal agency to address disproportionate environmental health risks or safety risks to children from implementation of proposed policies, programs, activities, and standards.  The proposed rule changes do not pose greater risks to children than to other parts of the affected populations.  The risks from importation depend primarily upon adherence to the sanitary requirements for entry of live ruminants, ruminant products, live swine, and swine products and this adherence precludes potential for adverse effects to humans, and makes other introduction-related risks remote and of negligible concern in regard to the protection of children. 
</p>
<p class="bullets"> SEQ CHAPTER \h \r 1<b>C.  Threatened and Endangered Species and the Preferred Alternative 
</b></p>
<p>Section 7 of the Endangered Species Act and its implementing regulations require Federal agencies to ensure that their actions are not likely to jeopardize the continued existence of endangered or threatened species or result in the destruction or adverse modification of critical habitat.  APHIS has considered the potential effects of implementation of the preferred alternative on threatened and endangered species and designated critical habitat. 
</p>
<p>CSF, SVD, and ASF are host specific, and there are no known federally listed or proposed endangered or threatened species in the United States that would be affected by CSF, SVD, or ASF.  Rinderpest has never been established in Brazil.  However, FMD has been present in Santa Catarina, and six endangered ruminant species in the United States are susceptible to that disease (see table 1).  </p>
<p>APHIS conducted a risk assessment and determined that Santa Catarina is free of FMD, CSF, SVD, and ASF, and has the infrastructure to prevent, rapidly detect, and effectively eradicate the diseases if they were to be introduced (USDA–APHIS, 2009).  In that risk assessment, APHIS also determined that the likelihood of outbreaks occurring in the United States via exposure of the domestic livestock population to swine or other susceptible species or their related unprocessed products imported from the State of Santa Catarina, Brazil, to be very low (USDA–APHIS, 2009).  Therefore, the proposed rulemaking is expected to have no effect on endangered ruminants or their designated critical habitats.  </p>
<p><b>Table 1.  
Endangered Species in the United States Susceptible to </b></p>
<p><b>
Foot-and-Mouth Disease. </b></p>
<table><tbody><tr>	<td><p><b>Common Name</b></p>
</td>	<td><p><b>Scientific Name</b></p>
</td>	<td><p><b>Critical Habitat</b></p>
</td>	<td><p><b>Listing Status</b></p>
</td></tr>
<tr>	<td><p>Woodland caribou</p>
</td>	<td><p><i>Rangifer tarandus caribou</i></p>
</td>	<td><p>No</p>
</td>	<td><p>Endangered</p>
</td></tr>
<tr>	<td><p>Columbian white-tailed deer</p>
</td>	<td><p><i>Odocoileus virginianus leuceurus</i></p>
</td>	<td><p>No</p>
</td>	<td><p>Endangered</p>
</td></tr>
<tr>	<td><p>Key deer</p>
</td>	<td><p><i>Odocoileus virginianus clavium</i></p>
</td>	<td><p>No</p>
</td>	<td><p>Endangered</p>
</td></tr>
<tr>	<td><p>Sonoran pronghorn</p>
</td>	<td><p><i>Antilocapra americana sonoriensis</i></p>
</td>	<td><p>No</p>
</td>	<td><p>Endangered</p>
</td></tr>
<tr>	<td><p>Sierra Nevada bighorn sheep</p>
</td>	<td><p><i>Ovis canadensis californiana</i></p>
</td>	<td><p>Yes</p>
</td>	<td><p>Endangered</p>
</td></tr>
<tr>	<td><p>Peninsular bighorn sheep</p>
</td>	<td><p><i>Ovis canadensis nelsonii</i></p>
</td>	<td><p>Yes</p>
</td>	<td><p>Endangered</p>
</td></tr>
</tbody></table>
<p class="bullets"><b> SEQ CHAPTER \h \r 1D.  Potential Cumulative Impacts </b></p>
<p class="bullets"> SEQ CHAPTER \h \r 1The potential impacts from the proposed rule in combination with similar actions are referred to as cumulative impacts.  Based upon the findings of the risk analysis, these impacts are not expected to pose any substantial risks (USDA–APHIS, 2009).  Although importation of live ruminants, ruminant products, live swine, and swine products does increase the potential for introduction of FMD, CSF, SVD, ASF, and rinderpest to the United States, the mitigations required of Santa Catarina, Brazil, make introduction of the diseases of concern extremely unlikely, even when considering the current and future importations of the same animals and their products from other regions.  It is difficult to precisely quantify the potential cumulative impacts which are dependent upon disease conditions and compliance with importation conditions in Santa Catarina, Brazil, and other regulated countries.  The nature of disease mitigation is of principal concern for this issue, and the constraints provided by program mitigations are considered to provide adequate protection.</p>
<h1>V.   SEQ CHAPTER \h \r 1Agencies and Persons Consulted</h1>
<p> SEQ CHAPTER \h \r 1Environmental and Risk Analysis Services
</p>
<p>Policy and Program Development
</p>
<p>Animal and Plant Health Inspection Service</p>
<p>U.S. Department of Agriculture
</p>
<p>4700 River Road, Unit 149
</p>
<p>Riverdale, MD  20737</p>
<p>Regionalization Evaluation Services
</p>
<p>National Center for Import & Export
</p>
<p>Veterinary Services
</p>
<p>Animal and Plant Health Inspection Service
</p>
<p>U.S. Department of Agriculture
</p>
<p>4700 River Road, Unit 38
</p>
<p>Riverdale, MD  20737</p>
<p>Regulatory Analysis and Development
</p>
<p>Policy and Program Development
</p>
<p>Animal and Plant Health Inspection Service</p>
<p>U.S. Department of Agriculture
</p>
<p>4700 River Road, Unit 118</p>
<p>Riverdale, MD  20737
</p>
<h1> SEQ CHAPTER \h \r 1VI. References </h1>
<p>CIDRAP—See Center for Infectious Disease Research and Policy
</p>
<p>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].</p>
<p>CFSPH—The OIE Collaborating Centre on Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas.  See Iowa State University, College of Veterinary Medicine, Center for Food Security and Public Health. </p>
<p>DJIN—See Dow Jones International News</p>
<p>Dow Jones International News, 2007.  Associated Press.  White House got secret summer briefings on foot-mouth concern.  Source:  APHIS NewsAlert.  October 15, 2007.
</p>
<p>FAO—See Food and Agriculture Organization of the United Nations, Agriculture Department, Animal Production and Health Division.  
</p>
<p>Fields, B.N., Knipe, D.M., and Howley, P.M., 1996.  Fundamental virology, 3rd Edition.
</p>
<p>Food and Agriculture Organization of the United Nations, Agriculture Department, Animal Production and Health Division, 2009.  Global rinderpest eradication program: questions and answers.  [Online.]  Available:  http://www.fao.org/Ag/againfo/programmes/en/grep/qa_rinder.html </p>
<p>[2009, May 6].
</p>
<p>Iowa State University, College of Veterinary Medicine, Center for Food Security and Public Health, 2004a  Classical Swine Fever.  [Online.]  Available: www.cfsph.iastate.edu/diseaseinfo/ppt/ClassicalSwineFever.ppt  [2009, May 26].</p>
<p>Iowa State University, College of Veterinary Medicine, Center for Food Security and Public Health, 2004b African Swine Fever.  [Online.]  Available:   www.cfsph.iastate.edu/DiseaseInfo/ppt/AfricanSwineFever.ppt  [2009, May 26].</p>
<p>Iowa State University, College of Veterinary Medicine, Center for Food Security and Public Health, 2004c.  Swine Vesicular Disease.  [Online.]  Available:   www.cfsph.iastate.edu/DiseaseInfo/ppt/SwineVesicularDisease.ppt  [2009, May 26].</p>
<p>Iowa 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 </p>
<p>[2009, May 4].</p>
<p>Iowa 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].</p>
<p>Kreindel, S.  Telephone conversation with author, 30 April 2009.</p>
<p class="plain_Text">OIE—See World Organization of Animal Health
</p>
<p>USDA–APHIS—See U.S. Department of Agriculture, Animal and Plant Health Inspection Service</p>
<p>U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 2003a. Importation of Solid Wood Packing Material. Final Environmental Impact Statement—August 2003.  Riverdale, MD.   
</p>
<p>U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 2003b.  Veterinary Services Factsheet:  Swine Vesicular Disease.  June 2003.  [Online}  Available:   http://www.aphis.usda.gov/publications/animal_health/content/printable_version/fs_ahswinevd.pdf  [2009, May 4].</p>
<p>U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 2007a.  Procedure Manual for Classical Swine Fever (CSF) Surveillance.  Appendix A: Classical Swine Fever (CSF) Case Definition.  Version 2.0 - April 1, 2007.  Accessed 5/4/09 at 
</p>
<p>http://www.aphis.usda.gov/vs/nahss/swine/csf/CSF_PM_2007_AppendA_CaseDef.pdf  [2009, May 4].</p>
<p>U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 2007b.  APHIS Veterinary Services, Centers for Epidemiology and Animal Health info sheet: CEI impact worksheet foot-and-mouth disease, United Kingdom.  
</p>
<p>U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 2009.  Risk analysis: APHIS Evaluation of the Status of the Brazilian State of Santa Catarina Regarding Foot-and-Mouth Disease, Classical Swine Fever, Swine Vesicular Disease, and African Swine Fever.  </p>
<p>USGS—See U.S. Geological Survey
</p>
<p>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].</p>
<p>WIN—See Wildlife Information Network
</p>
<p>Wildlife Information Network, 2001.  Picornaviridae: foot-and-mouth disease virus. Online database.  [Online]  Available: http://www.wildlifeinformation.org/Subdirectories_for_Search2/SampleSpecies/picornaviridae/Picornaviridae_FMDVirus.htm  [2009, May 11]. </p>
<p>WDNR—See Wisconsin Department of Natural Resources
</p>
<p>Wisconsin Department of Natural Resources, 2003. Foot-and-mouth disease: issues for Wisconsin wildlife. Last modified: April 17, 2003. Online. Available: http://www.dnr.state.wi.us/org/land/wildlife/whealth/issues/fmd.htm [2004, Sept. 15].</p>
<p>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].</p>
<p>World Organization of Animal Health, 2008b.  Terrestrial Animal Health Code.  Chapter 8.13.  Rinderpest.  [Online.]  Available: <a href="http://www.oie.int/eng/normes/mcode/en_chapitre_1.8.13.htm" \l "rubrique_peste_bovine_surveillance">http://www.oie.int/eng/normes/mcode/en_chapitre_1.8.13.htm#rubrique_peste_bovine_surveillance</a>  [2009, May 11].</p>
<p>World Organization of Animal Health, 2009a.  Media Resources.  Animal Disease Information Summaries: African Swine Fever.  Last updated March 16, 2009.  3 pp.  [Online.]  Available:   http://www.oie.int/eng/ressources/ASF-EN.pdf    [2009, May 8].</p>
<p>World Organization of Animal Health, 2009b.  Media Resources.  Animal Disease Information Summaries: Rinderpest.  Last updated March 16, 2009.  3 pp.  [Online.]  Available:   http://www.oie.int/eng/ressources/RDP_EN_DC.pdf   [2009, May 11].</p>
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