**United States**

**Department of Agriculture**  **Marketing and Regulatory**  **Programs** Animal and Plant Health Inspection Service 

# Final **Rulemaking for Importation of**  **S wine and**  **Swine Commodities from**  **Slovakia**

**Environmental Assessment,**  **May 2011** 

# Final **Rulemaking for**

**Importation of Swine and Sw**  **ine Commodities from Slovakia** 

**Env ironmental**  **As sessment,**  **May 2011**

**Ag ency** **Contact for the Rulemaking:** Donald Link Import Risk Analyst, Regionalization Evaluation Services National Center for Import and Export, Veterinary Services Animal and Plant Health Inspection Service U.S. Department of Agriculture 9 2 0 Main Campus Drive, Suite 200 Raleigh, NC 27606

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## Table of Contents
**I. Need for the Proposed A ction** 

**................................ ...............**  **1 II. A**  **lternatives**

**................................ ................................**  **............. 3**  **III. Potential Environmental Impacts**

**................................ ..........**  **4 IV. A** **gencies or Persons Contacted**

**................................ .........**  **1 4**  **V. References**

**................................ ................................**  **............ 1**  **4 1**  

## I. Need for the Proposed **Action**

The United State s Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases. APHIS’ regulations allow for the i mportation of animal products from regions considered as free of or low risk for classical swine fever (CSF) and free of swine vesicular disease (SVD) and foot and mouth disease (FMD). The Republic of Slovakia (hereafter referred to as Slovakia) submitted a request to APHI S to be recognized as a region free of CSF, SVD, FMD , and rinderpest . This recognition would allow Slovakia to export live swine , and swine

- derived products including semen, pork , and other pork products (hereafter referred to as “swine and swine commodities”) to the United States. Slovakia would also be eligible to export ruminant s and ruminant

- derived products to the United S tates , based on the FMD and rinderpest status, if they meet all other ruminant health requirements. In response to Slovakia’s request , APHIS prepared a risk anal ys is to anal yz e the potential disease risks (in “ APHIS Evaluation of the Status of Slovakia Regarding Classical Swine Fever, Swine Vesicular Disease, Foot and Mouth Disease , and Rinderpest ” ) (USDA, APHI S, 2 00 9 ) associated with this action. Insummarizing the evaluation of Slovakia’s status with regard to CSF, SVD, FMD and rinderpest, APHI S considers the risk of infected live swine and ruminants, or commodities derived from these species, entering the United States from Slovakia and exposing U.S. livestock to be low. This risk is further mitigated if Slovakia is subject to the same mitigation measures specified for other EU Member States in 9 CFR §§ 94.11, 94.13, 94.24, and 98.38. Based on the findings of the evaluation, APHIS is proposing to amend its import regulations to add Slovakia to the list of European Union (EU) Member States that comprise the APHIS

- defined EU CSF region (9 CFR § § 9 3.500, 94.0, and 98.30)

— which APHIS considers low risk for CSF (9 CFR § § 94.9, 94.10)

—and thereb y allow importation of swine commodities from this country (9 CFR § § 94.10, 94.24, and 98.38). APHI S further proposes to add Slovakia to the list of countries recognized as free of SVD (9 CFR § § 94.12 and 94.13) , FMD , and ri nderpest (9 CFR § 94.1 ). The proposed action is needed to allow the importation of swine commodities from Slovakia because there is no scientific basis for prohibiting trade based on the CSF, SVD, FMD , and rinderpest status of Slovakia . Allowing the tra de of these commodities would be consistent with the World Organization for Animal Health (commonly referred to as the Office of International des Epizooties (OIE)) Terrestrial Animal Health Code for CSF, SVD, and FMD.**2** This environmental assessment (EA) addresses potential environmental impacts related to the amendment of APHIS’ regulations to include Slovakia in the APHI S

- defined EU CSF region (which APHI S recognizes as low risk for CSF) and recognize it as free of SVD , FMD , and rinderpest

. This EA has b een prepared to comply with the provisions of the National Environmental Policy Act of 1969 (NEPA) (42 United States Code (U.S.C.) 4321, et seq .) as prescribed in implementing regulations adopted b y the Council on Environmental Quality (40 Code of Federal Regulations (CFR) §§ 1500

– 1508), USDA’s NEPA regulations (7 CFR part 1b), and APHI S’ NEPA implementing procedures (7 CFR part 372). In accordance with requirements under the APHIS NEPA regulations, this EA was made available for public review and comment along with APHI S’ risk evaluation and proposed rulemaking for this matter

. APHIS received no comments on this EA. APHI S also welcomed public comments on the approach for future proposed actions of the same nature as in this EA, discussed in the following two paragraphs; no comments were received on the approach. Based upon (1) the Findings of No Significant Impact for EAs prepared for a rulemaking to allow the importation of swine and swine commodities from EU Member States in the past , 1 (2) the determin ation from an APHI S evaluation that Slovakia is low risk for CSF and free from SVD , FMD, and rinderpest, and (3) APHI S determinations that measures are in place to mitigate the risk of CSF, SVD, FMD, and rinderpest introduction into the United States through importation of swine, swine commodities , ruminants, and ruminant commodities from countries or regions that APHI S recognizes as low risk for CSF or free of SVD, FMD, and rinderpest, such as Slovakia , APHI S will consider th at future proposed actions of this nature 2 would pose negligible environmental impact

. This consideration applies to each EU Member State or country that has entered into an agricultural equivalency agreement with the European Union, provided that a disease status assessment finds th em to be free of or a low risk for the relevant diseases. Accordingly, APHIS plans to consider future actions of this nature as posing negligible environmental impact and included under this environmental assessment. We would do so provided that, based o n our evaluation of the disease status of the country , no extraordinary circumstances exist that require the preparation

1 The Czech Republic, Latvia, Lithuania, and Poland (72 Federal Register (FR) 67227

– 67233; November 28, 2007). 2 By “of this nature,” we mean that the same disease concern is being considered, the same or comparable commodities are being considered for importation, the same or equivalent risk mitigation measures are in place in the exporting country and in APHIS import regulations, and our risk evaluation determines that the importat ion of the commodities into the United States would pose no greater risk than those authorized importation from previously assessed countries.**3** of an environmental assessment or environmental impact statement, the proposed action does not trigger the need for other environmental review under NEPA, and the proposed action would not individually or cumulatively

have a significant environmental impact. 

## II. **Al ternati**  **ve s** 
Two alternatives are considered in this EA . They include

— (1) the “ no action ” alternative , in which the current regulations would remain unchanged, continuing to omit Slovakia from the list of EU Member States comprising the APHI S

- defined EU CSF region ( considered as low risk for CSF ) and from the list of countries considered free of SVD, FMD , and rinderpest, and, therefore, continuing to not allow the importation of swine and ruminant commodities from Slovakia to the United States, and (2) the rule amendment of 9 CFR §§ 94.1, 94.9, 94.10, 94.11, 94.12, 94.13, 94.24, and 98.38, which would add Slovakia to the AP HI S

defined EU CSF region (considered low risk for CSF) and designate Slovakia free of SVD, FMD , and rinderpest, and would, therefore, allow the importation of swine and ruminant commodities from Slovakia under certain conditions. 

### A. **No Ac**  **tion**
The no a ction alternative would leave the current APHI S importation regulations unchanged. Under this alternative, Slovakia would continue to not be listed as part of the APHI S

- defined EU CSF region considered low risk for CSF and also would not be listed as free of SVD, FMD , and rinderpest . T herefore, Slovakia would not be allowed to export swine and ruminant commodities to the United States. The status of Slovakia as low risk for CSF and free of SVD, FMD , and rinderpest is not reflected in the current import r egulations and would continue as such . The continuance of such unsupported trade restrictions would be contrary to U.S. obligations under international trade agreements. 

### B. Rule A **mendment** The rule amendment alternative would amend the current regulati ons to add Slovakia to the APHIS

- defined European Union (EU) CSF region c onsidered low risk for CSF and also add Slovakia to the list of regions that are free of SVD, FMD , and rinderpest . In doing so, this alternative would allow the importation of swine and ruminant commodities from**4** Slovakia if certain conditions are satisfied. The rule amendment would accomplish the following actions:

 A dd Slovakia to the list of EU Member States in 9 CFR §§ 93.500, 94.0, and 98.30 3 and include it as one of the Member S tates in a region that APHI S consider s as low risk for CSF under 9 CFR §§ 94.9 and 94.10 and therefore subject to the import conditions specified under 9 CFR §§ 94.24 and 98.38.

 A dd Slovakia to the regions listed under 9 CFR §§ 94.1 as free of FMD and ri nderpest but subject to the import conditions specified under 9 CFR §§ 94.11 , and

 Add Slovakia to the regions listed under 9 CFR §§ 94.12 as free of SVD but subject to the import conditions specified under 9 CFR §§ 94.13. 

### C. **Al ternatives Eliminated fro**  **m Further Consideration**  Alternatives differing from those mentioned above were eliminated from consideration because changes in the requirements either would not mitigate the potential risk from the region or would place excessive restrictions on the impo rts that would serve as a de facto trade barrier. The certification requirements in the rule provide sufficient mitigation measures without being overly restrictive. 

## III. **Potential Env ironmental Impacts** 
The animal diseases of concern for this evaluation with regard to allowing the importation of swine and ruminant commodities from Slovakia are CSF, SVD, FMD , and rinderpest . APHIS evaluated the ri sk of CSF, SVD, FMD , and rinderpest introduction to U.S. animals from allowing these commodities from Slovaki a (USDA, APHIS, 200 8 ). APHI S evaluated the disease risk status of Slovakia with regard to its infrastructure and control measures in place for these diseases, including an assessment of disease surveillance measures, import practices, laboratory capacity , emergency response procedures, and other factors that could influence the risk of disease introduction into the United States.

3 The APHIS

- defined EU CSF region currently consists of Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, the Republic of Ireland, Spain, Sweden and the United Kingdom (England, Scotland, Wales, the Isle of Man and Northern Ireland).**5** Slovakia , as a Member State of the EU s in ce May 2004, adopted the legislation of the European Commission (EC) regarding anim al health, welfare, and identification including legislation pertaining to CSF, SVD, and FMD. Slovakia also adopted the harmonized EC legislation regarding import, export, and trade of live animals, meat, and animal products. T he APHI S

- defined EU CSF reg ion is considered as low risk with respect to CSF. APHI S considers large portions of the EU to be free of SVD and FMD as well (USDA, APHI S, 200 8 ). 

### A. **Background** CSF is a highl y contagious viral disease affecting swine and wild boar. The incubation period for CSF is 2 to14 day s. CSF is transmitted by direct contact from pig to pig; through ingestion of products, including fresh, frozen, or cured pork, that contain the virus; and by aerosols. CSF also can be introduced or spread b y infected swine semen. Indirect contact with body secretions and excretions from infected animals (including dead animals) and viral contamination of objects may lead to mechanical transfer of the virus. Thus, movement of people, wild animals, and inanimate objects, such as trucks used to transport animals, may indirectly

transmit the CSF virus ( as cited in USDA, APHI S, 200 8 )

. The CSF virus is hardy, being stable between pH 4 and 10 and also stable at low temperatures (thus, it is unlikely to be destroyed b y the post

mortem decrease in muscle pH that accompanies carcass maturation), and is unlikely

to be destroyed by

transport or cold storage ( as cited in USDA, APHI S, 200 8 ). SVD also is a highl y contagious viral disease affecting swine and wild boar. The incubation perio d for SVD is 2 to 7 days. SVD may be introduced into a herd b y infected animals , by feeding garbage containing infected meat scraps , or by contacting infected feces ( as cited in USDA, APHI S, 200 8 ) . After the initial introduction, the disease spreads thro ugh contact of susceptible pigs with infected pigs and infected feces (such as from an improperl y cleaned truck). The virus is hardy, resistant to pH changes between 2.5 and 12 (thus, it is unlikely to be destroyed b y the post

- mortem decrease in muscle pH that accompanies carcass maturation), and is very

stable under cold conditions. The virus also is resistant to fermentation and smoking processes and may remain in hams for 180 day s, sausages for more than 1 year, and processed intestinal casings for mo re than 2 ye ars ( as cited in USDA, APHI S, 200 8 ). FMD is a contagious disease affecting cloven

- hoo f ed animals, including sheep, goats, cattle, and pigs, and well over 70 wildlife species, such as deer and wild boar. The incubation period for FMD is 2 to 14 day s. FMD virus is capable of aerosol transmission, and s aliva, feces, and urine are**6** sources of FMD virus

. FMD virus m ay also be present in milk and semen up to 4 day s before clinical signs appear ( as cited in USDA, APHI S, 200 8 ). The virus can be transmitted by direct or indirect contact with infected animals or an infected environment, such as movement of people, wild or domestic animals, or inanimate objects (such as vehicles, farm implements, and clothing) ; long

- range airborne transmission is also possible (USDA, APHI S, 2007) . The virus can survive in meat and meat products in which the pH has remained above 6.0 and thus can be transmitted by

infected meat and meat products and through infected meat that has been discarded as garbage. Meat from p igs does not consistentl y reach as low an ultimate pH during carcass maturation as does beef, so the inactivation of FMD virus in pig meat may not be as complete as that occurring in beef ( as cited in USDA, APHI S, 200 8 ). Rinderpest is an infectious diseas e of cattle, domestic buffalo, and certain other species. Itis characterized by fever, oral erosions, diarrhea, ly mphoid necrosis, and high mortality

. More information about the characteristics of the diseases of concern is available in APHIS’ evaluatio n related to this matter (USDA, APHI S, 2008). The potential for impacts on the human environment from the importation of swine and ruminant commodities from Slovakia is dependent upon the ability of mitigative factors and mitigation measures to prevent th e introduction of the diseases of concern via the biological pathway s of disease transmission. This section addresses the potential environmental impacts that could occur under the alternatives considered. 

### B **. No A ction**  **Al ternative** 
The “ no action ” alter

native would not allow swine , ruminants, or swine and ruminant commodities to be imported from Slovakia ; the current APHI S regulations governing the importation of these commodities would remain unchanged with regard to Slovakia . This alternative would have no potential effect on U.S. animal health, public health, or the phys ical environment. However, based upon APHIS’ evaluation of the risk status of Slovakia for CSF, SVD, FMD, and Rinderpest, this alternative, however, is inconsistent with the requirements of international trade agreements. 

### C

**. Rule A**  **mendment A lternative**  The rule amendment alternative would allow the importation of swine and ruminant commodities from Slovakia ac cording to certain requirements that are designed to prevent th e introduction of CSF, SVD, FMD , and rinderpest . An y potential for impacts to the human environment would be**7** the result of exposure to the CSF, SVD, FMD , or rinderpest virus via a breakdown in the requirements that are designed to mitigate the risk of exposure of U. S. livestock to these viruses. Animal health, the phys ical environment, and public health are addressed in this document as components of the U.S. human environment that have the potential to be impacted in the event that the CSF, SVD, FMD , or rinderpest virus were to be introduced as a result of the rule amendment. Also, other environmental review considerations for the protection of the human environment are addressed in this section of the EA. When allowing imports of live animals or animal products from other regions , the health of animals in the region of origin and the region’s ability to prevent introduction of animal diseases is important in determining the risk to the health of U.S. animals. APHI S evaluated the animal health status of the expor ting region , Slovakia , the results of which are provided in a risk analy sis (USDA, APHIS, 200 8 ). In summarizing from the APHI S risk anal ys is, three outbreaks of CSF occurred in domestic swine in Slovakia between April and July 2008 (USDA, APHIS, 200 8 ) ; p rior to th ese occurrence s , August 2005 was the last time CSF virus had been detected in domestic swine in Slovakia

. CSF continues to be found in Slovakia ’s wild boar populat ion

. A ll outbreaks in domestic swine from 2003 forward have been controlled by st amping out 4 without vaccination

. Slovakia has never reported SVD in indigenous swine; however, in 1972, SVD was reported in imported pigs on three holdings , resulting in a total of 16 diagnosed cases. The outbreaks were handled b y stamping out , and no other cases have been reported since

. SVD has never been reported in wild boar in Slovakia. Slovakia has been free of FMD since 1973 and is recognized by the OIE as an OIE

- m ember country that is FMD

- free where vaccination is not practiced (OIE, 2008)

. Rinderpest has never been reported in Slovakia.
Slovakia shares its border with five countries: Austria to the west , the Czech Republic to the northwest, Poland to the northeast, Ukraine to the east, and Hungary

to the south. APHI S considers Austria, the Czech Republic, and Poland as low risk for CSF and free of SVD and FMD (as reflected in 9 CFR 94.1, 94.11, and 94.13). APHIS has evaluated and determined that Hungary i s free of CSF, SVD, FMD, and rinderpest, although th e rulemaking process for recogn izing its CSF status has not been completed. APHI S has not evaluated Ukraine’s risk status for these diseases ; however, Ukraine has not reported an outbreak of either SVD or FMD for more than a quarter century

. As reported in APHI S’ evaluation,

4 I mposing animal movement restrictions and eradicating the disease immediately. **1. An**  **imal Health** **8** the likel ihood of intro duction into Slovakia of SVD, FMD , or rinderpest from neighboring countries is thus considered to be low. Introduction of CSF from one of the neighboring countries via wild boar is more likel y. However, the likelihood of disease introductio n to domestic swine via this pathway is considerably

less than that posed by

native infected wild boar populations. More details about the disease status of these countries are provided in the risk anal ysis for Slovakia (USDA, APHI S, 2008), Austria (USDA, APHIS, 2004), the Czech Republic (USDA, APHI S, 2006a), and Poland (USDA, APHI S, 2006b)

. APHI S’ evaluation of Slovakia (USDA, APHI S, 200 8 ) assessed potential pathway s of concern 5 for CSF, FMD, SVD , or rinderpest introduction into Slovakia , whereb y potential risk could occur to U.S. animal health by allowing the importation of swine and ruminant commodities from Slovakia . The introduction of these diseases into Slovakia by the identified pathway s would only affect export risk to the United States if a su sceptible domestic animal population became infected and this infection was not detected prior to export. However, Slovakia has in place mitigating factors and mitigation measures, including requirements under EC legislation, that are designed to reduce the risk of disease introduction. These include, but are not limited to, the following:

- Comprehensive EC requirements for import, transit, or trade in live animals, including signature of an official veterinarian of the country of origin

.

- Inspection of s wine semen collection centers by official veterinarians twice annuall y , swine admitted to a collection center must originate from a herd that is not located in an area restricted because of disease in domestic swine, and the swine must be quarantined for at least 30 day s prior to entry

to the collection center.

- Bovine semen collection centers must be EC

- approved, the animals must be isolated for 28 day s prior to entry and the collection center must be located in a region that has been free of FMD for 3 months with no outbreaks within a 20 kilometer radius for at least 30 day s.

- Cleaning and disinfection of transport vehicles used to move live swine.

- EC requirements for isolation, observation, and veterinary inspection of live animals prior to tran sport.

- Veterinary

inspection practices at the point of entry for live animals and animal products

.

- A comprehensive and rigorous approval process for exporting establishments (including slaughter establishments and semen collection centers);

- A mandatory o bservation period for imported live animals and

5 (1) natural movement of wild boars, (2) import and trade of live swine, (3) import and trade of swine products, (4) incoming vehicular and human traffic, and (5) agricultural commodities for person al consumption.**9** veterinary

inspection prior to shipment and another veterinary inspection at the port of entry into the EU ; and

- D isinfection of live

- haul trucks and rail cars at the point of destination. Such vehicles from third 6 countries must be accompanied b y a certificate indicating that they were disinfected prior to loading.
The risk estimation conclu de s that the risk potential of infected live swine and/or swine commodities entering the United States from Slovakia an d exposing U.S. livestock is low (USDA, APHIS, 200 8 ). This risk is further mitigated if Slovakia is subject to the same requirements specified for other EU Member States in APHI S’ regulations under 9 CFR § 94.11 for meat and meat products from ruminants o r swine, §§ 94.13 and 94.24 for pork and pork products, § 94.24 for breeding swine, and § 98.38 for swine semen. The requirements specified in APHIS regulations are designed to prevent the introduction of CSF, SVD, FMD , or rinderpest into the United State s from free or low

- risk regions and include, but are not limited to, the following:

- O fficial certification of the CSF

- , SVD

- , and/or FMD and rinderpest

free origin of swine , ruminants, and swine and ruminant commodities is required ;

- Approval of exporting slaughtering establishments by USDA’s Food Safety and Inspection Service is required and an official veterinarian of the exporting country

must certify

that this condition has been met;

- T he slaughtering establishment is not permitted to receive swine or r uminants, meat, or other animal products derived from swine or ruminants, which originated in a rinderpest

- or FMD

- infected region;

- T he slaughtering establishment is not permitted to receive meat or other animal products from a rinderpest

- or FMD

- free regi on transported through a rinderpest

- or FMD

- infected region except in sealed containers;

- M eat and other animal products derived from swine or ruminants may not be commingled or otherwise come into contact with meat or other animals products which originate d in a rinderpest

- or FMD

infected region;

- S wine, pork, or pork products may not be commingled or otherwise come into contact with swine, pork, or pork products from CSF

- or SVD

- affected regions;

- S emen must originate from animals at an approved collection center; and

- C ertain restrictions on the use of transportation equipment for live swine and movement of the commodities are in place

.

6 Countries other than EU Member States.**10** Based on the results of the release assessment discussed in APHI S’ evaluation (USDA, APHIS, 200 8 ) , APHI S considers the likelihood of exposure of susceptible animals to CSF virus via live animals from Slovakia to be low. AP HIS has no evidence that SVD, FMD , or rinderpest currentl y exist s in Slovakia

. Applying mitigation measures for Slovakia equivalent to those specified for other EU Member States in 9 CFR §§ 94.11, 94.13, 94.24, and 98.38 would result in a level of risk that is equivalent to the portion of the EU that is authorized to export breeding swine, swine semen, and fresh pork to the United States (USDA, APHI S, 2 00 8 ). If the proposed action were implemented and an incursion of CSF, SVD, FMD , or rinderpest were to occur in an area of Slovakia , APHIS regulations would prohibit for a specified period of time the exportation of swine commodities and, in the case of FMD or rinderpest , ruminants or ruminant commodities as well, from the affected area that could be effectivel y regionalized for disease status. 7 For a CSF outbreak in domestic swine, restrictions would be lifted once the designation as a restricted zone i s lifted by the competent veterinary authority of Slovakia or 6 months following depopulation of the swine on the affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone , whichever is later . For a CSF outbreak in wild boar, restrictions would remain in place from the time of detection until the designation of the zone as a restricted zone is removed by the Member State’s competent veterinary authority . For an outbreak of SVD, FMD, or rinderpest, restrictions would remain in place until the restricted region was re - evaluated for disease

- free status. If CSF, SVD, FMD , or rinderpest were introduced into the United States, APHI S would implement disease eradication measures, which could include quarantine and depopulation in areas where an effective barrier to the introduction of the disease can be established, surveillance of the area around an outbreak, and measures aimed at preventing any virus spread b y swine or ruminant commodities , contaminated material, and vehicles. FMD or rinderpest could have more of an impact on U.S. animal health than CSF or SVD in that FMD or rinderpest could s pread to other livestock species, such as cattle, sheep, and goats, and wildlife species, such as deer, elk, caribou, and bison.

7 According to the associated risk analysis, exclusively for veterinary purposes, Slovakia is divided into 40 veterinary districts. APHIS considers the district to constitute the smallest administ rative jurisdiction for Slovakia , ensuring effective oversight of normal animal movements into, out of, and within that jurisdiction, and that, in association with national authorities, if necessary, has effective control over animal movements and animal d iseases locally. This is the smallest unit to which APHIS can effectively regionalize for animal disease status under its current regulations.**11** If the introduction of CSF, SVD, FMD , or rinderpest to U.S. swine were to occur, potential for impacts to the phy sical environment could occur in relation to disposal of carcasses due to death from disease and depopulation of infecte d animals or disposal of contaminated bedding and manure. Disposal methods could include rendering, burial, and incineration. If not handled properl y, disposal of infected animals and materials could impact air, water, and soil quality and potentially

co ul d release the live CSF, SVD, FMD , or rinderpest virus into the environment. Factors influencing proper disposal methods include the volume of infected animals and contaminated materials, geographic features of the area (e.g., water resources and soil ty pe), other phy sical environment considerations (such as weather and temperature), and available funds, equipment, and personnel. Potential for impacts to the phy sical environment from the introduction of CSF, SVD, FMD , or rinderpest could occur in relation to the use of disinfectants to prevent the transfer of the CSF, SVD, FMD , or rinderpest virus from surfaces. As part of an eradication program, measures aimed at preventing spread of the CSF, SVD, FMD , or rinderpest virus, including disinfection of e quipment, transport vehicles, and/or premises where infected swine or ruminants were maintained, would be required in order to prevent mechanical transfer of the virus. Disinfectants used for such purposes would have to be approved for the specific use wi th the U.S. Environmental Protection Agency and used according to registration requirements. Label instructions for disinfectants would be provided for their proper application to prevent potential environmental impacts associated with the use of the regi stered product.
The risk anal ys is that evaluates the animal health status of swine in Slovakia concludes from the release assessment that Slovakia is low risk for CSF and free of SVD, FMD , and rinderpest (USDA, APHI S, 200 8 )

. APHI S further concludes from the exposure assessment in the risk anal ys is that the likelihood of exposure of susceptible U.S. livestock to CSF, SVD, or FMD viruses via imported meat or meat products (e. g. , infected food waste) , live animals, or genetic material from Slovakia is low. Implementation of mitigation measures specified in 9 CFR § 94.11 for FMD and rinderpest , in 9 CFR § 94.13 for SVD, and in 9 CFR §§ 94.24 and 98.38 for CSF further mitigate the risk. The c onditions, or mitigation measures, that would be required to be met in order to compl y with APHI S import regulations for swine commodities from Slovakia are designed to prevent th e introduction of CSF, SVD, FMD , and rinderpest into the United States. Under the proposed action, no significant impact on the phy sical environment as a result of allowing the importation of swine or swine products from S lovakia according to the requirements is reasonabl y foreseeable. **2. Phy sical**  **Environ**   ** ment****12** CSF, SVD, FMD , and rinderpest virus strains are host

- specific, and, therefore, CSF, SVD, FMD , and rinderpe st infections are not a public health issue (USDA, APHI S, 2008) . The occurrence of the SVD virus in humans is rare; human infection has been reported in laboratory personnel working with the SVD virus, and caution should be taken when working with infecte d material. CSF does not affect humans (The Center for Food Security & Public Health, 2005). FMD infection in humans, spread through contact with infected animals, is rare (Centers for Disease Control and Prevention, 2006).
Other Federal agencies have direct authority over public health issues involving the importation of food products. The USDA’s Food Safety and Inspection Service (FSIS) enforces provisions under the Federal Meat Inspection Act (FMIA) (26 U.S.C. 601 et seq.) that are intended to prot ect public health through food safety requirements. These provisions extend to imported c arcasses, parts of carcasses, and meat or meat food products , including from swine . P roducts that are allowed to be imported must be processed in a facility

that has been inspected and approved b y FSI S and meets requirements equivalent to those under the U.S. FMIA. Under section 304(h) of the Federal Food, Drug, and Cosmetic Act , the U.S. Department of Health and Human Services, Food and Drug Administration ( FDA ) has authority to detain an article of food for which there is credible evidence or information indicating such article presents a threat of serious adverse health consequences or death to humans or animals. This authority

provides an added measure to ensure the safety of the nation's food suppl y ( U.S. Food and Drug Administration, 2004). **a. Environmental Executive Orders** Some executive orders such as Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks, and Executi ve Order 12898, Federal Actions to Address Environmental Justice in Minority

Populations and L ow - In come Populations, and departmental or agency directives require special environmental reviews in certain circumstances. In considering these additional revi ew requirements, no circumstance that would trigger the need for special environmental reviews is involved in implementing the proposed action considered in this document. The rule amendment alternative presents no risk to the health or safety of children and will not result in disproportionately high and adverse human health and/or environmental effects on any minority populations and/or low

- income populations in the United States. **3. Public**  **Health**

**4. Ad**  **ditional Environ**  **** **mental Review**  **Consider**   ** a** **tions 13**  **b. Endangered Species A** **ct** Section 7 of the Endangered Species Act (ESA) 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. APH IS has considered the potential effects of the proposed action on endangered and threatened species and designated critical habitat. CSF and SVD 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 or SVD; therefore, the rule amendment will have no effect on endangered or threatened species in the United States or critical habitat. However, six endangered species are susceptible to FMD (see table 1).
**Tab le 1.**  **Endangered species in the United States susceptible to foot and mouth disease.** 

APHI S conducted a risk anal ys is and determin ed that the risk of infected swine and ruminant commodities entering the United States from Slovakia an d exposing U.S. livestock to FMD is low (USDA, APHI S, 200 8 ). This risk would be further mitigated b y requiring implementation of the measures outlined i n 9 CFR § 94.11 that place restrictions on the importation of meat and other animal products derived from ruminants and swine that originate from regions which are free of FMD but share a common land border with regions designated as infected with FMD.
Ba sed upon the effectiveness of the mitigation measures included in 9 CFR § 94.11 and the low likelihood of exposure of U.S. livestock to FMD virus, implementation of the rulemaking is expected to have no effect on federall y listed endangered species or des ignated critical habitat. **Common Name Scientific Name**  **Critical Habitat**  **Listing**

**Status** Wo odland caribou Rangifer tarandus caribou No Endangered Columbian white

- tailed deer Odocoileus virginianus leuceurus No
Key deer Odocoileus virginianus clavium No
Sonoran pronghorn Antilocapra americana sonoriensis No
Bighorn sheep Ovis canadensis Yes Sierra Nevada bighorn sheep Ovis canadensis sierrae Yes**14** 

## IV. **Ag encies or Persons Contacted** 
Environmental and Risk Analy sis Services Policy and Program Development, APHI S, USDA 4700 River Road, Unit 149 Riverdale, MD 20737

- 1238 

## V. References
Centers for Disease Control and Pre vention, 2006. Foot

- and

- mouth disease. Available at http://www.cdc.gov/doc.do/id/0900f3ec8024f90b

. OI E

— See World Organization for Animal Health. The Center for Food Security and Public H ealth, 2005. Classical swine fever. College of Veterinary Medicine, Iowa State University. Ames, IA. Last updated August 2, 2005. Available at http://www.cfsph.iast ate.edu/Factsheets/pdfs/classical_swine_fever.pdf

. Accessed 7 /1 7 /200 8

. USDA, APHI S

— See U.S. Department of Agriculture, Animal and Plant Health Inspection Service. U.S. Department of Agriculture, Animal and Plant Health Inspection Service , 2004. APHIS risk considerations on importation of classical swine fever (CSF) virus in breeding swine, swine semen, and fresh pork from a European Union region of fifteen Member States. U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import and Export. September 2004. U.S. Department of Agriculture, Animal and Plant Health Inspection Service , 2006a. Evaluation of the Czech Republic regarding classical swine fever and swine vesicular disease

. U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import and Export. January 2006. U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 2006b. APHIS evaluation of Poland regarding classical swine fever and swine vesicular disease. U.S. Department of Agriculture, Animal and Plant Health Inspection Service , Veterinary Services, National Center for Import and Export. January 2006. U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 200 9

. APHIS e valuation of the s tatus of Slovakia regarding**15** c lassical s wine f

ever, s wine v esicular disease, and f oot and m outh disease

. Veterinary

Services, National Center for Import and Export. March 2009

. World Organization for Animal Health, 2008. List of foot and mouth disease free countries. Adopted by the International Committee of the OI E on May 27, 2008. Available at http://www.oie.int/eng/info/en_find.htm?eld6#Liste

. Update d 10/28/08; accessed 11/07/08.