**United States**

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

# Final **Rulemaking for the**  **Importation of Swine Commodities**  **from Estonia** 

**Environmental Asses sment,**  **May 2011** 

# Final **Rulemaking for the** 

**Importation of Sw**  **ine Commodities**  **from Estonia** 

**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 92 0 Main Campus Drive, Suite 200 Raleigh, NC 27606

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## Table of Con **tents**
I. Need for the Proposed Action

................................ .................. 1 II. Alternatives

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

................................ .............. 4 IV. Agencies or Persons Contacted

................................ ............. 1 1 V. References

................................ ................................ ............. 1 1**1** 

## I. **Need for the Proposed Ac**  **tion** The United States Department of Agriculture (US DA), 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 importation of animal products f rom regions that are free of or low risk for classical swine fever (CSF) and free of swine vesicular disease (SVD). The Republic of Estonia submitted a request to APHI S to be recognized as a region free of both CSF and SVD, which would allow Estonia to export live swine and swine

- derived products including semen, pork , and pork products (hereafter referred to as “swine commodities”) to the United States. CSF and SVD are highl y contagious viral diseases of swine. CSF and SVD are exotic to the United State s and are among the diseases of concern to APHI S in its regulation of animal and animal product importation into the United States. In response to Estonia’s request , APHI S conducted a risk anal ys is to a ssess the risk of introduction of CSF and SVD into th e United States from Estonia (in “APHIS Evaluation of the Status of Estonia Regarding Classical Swine Fever and Swine Vesicular Disease” (USDA, APHI S, 200 7 ) )

. APHIS’ evaluation found that Estonia meets the requirements for being recognized as low risk for CSF and free of SVD. Therefore, APHI S proposes to amend its regulations to add Estonia 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 APHI S consider s low risk for CS F (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 Estonia to the list of countries recognized as free of SVD (9 CFR § § 94.12 and 94.13).
Allowi ng the trade of swine commodities from Estonia would be consistent with the World Organization for Animal Health (commonl y referred to as the Office International des Epizooties (OIE)) Terrestrial Animal Health Code for CSF and SVD. CSF and SVD are among the OI E

- listed diseases of concern for international trade. The proposed rulemaking action is needed to allow the importation of swine commodities from Estonia because there is no scientific basis for prohibiting trade based on the CSF and SVD disease status in Estonia

. This environmental assessment ( EA ) has been prepared to compl y 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 by the Council on Environmental Quality (40 Code of Federal Regulations (CFR) §§ 1500

– 1508), USDA’s**2** NEPA regulations (7 CFR part 1b), and APHIS’ NEPA implementing procedures (7 CFR part 372 ). This EA evaluates the potential effects on the quality

of the human environment 1 from a rulemaking that seeks to allow the importation of swine commodities according to APHIS import requirements . The import requirements are designed to manage animal health risks associated with the presence of diseases in swine. APH IS ’ NEPA implementing procedures classify rulemakings that seek to remedy specific animal health risks as actions normall y requiring preparation of EAs. 2 In accordance with requirements under the APHIS NEPA regulations, th e EA was made available to the public for 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 th e 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 State s in the past , 3 (2) the determination from an APHI S evaluation that Estonia is low risk for CSF and free from SVD , and (3) APHI S determinations that measures are in place to mitigate the risk of CSF or SVD introduction into the United States through import ation of swine and swine commodities from countries or regions that APHIS recognizes as low risk for CSF or free of SVD, such as Estonia , APHIS will consider th at future proposed actions of this nature 4 would pose negligible environmental impact

. This c onsideration 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 them 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 on our evaluation of the disease status of the country , no extraordinary circumstances exist that require the preparation of an environmental assessment or environmental impact statement, the

1 Th e “human environment” is interpreted comprehensively to include the natural and physical environment and the relationship of people with that environment (40 CFR § 1508.14). 2 7 CFR § 372.5(b)(1)

. 3 The Czech Republic, Latvia, Lithuania, and Poland (72 F ederal Register (FR) 67227

– 67233; November 28, 2007). 4 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 measure s are in place in the exporting country and in APHIS import regulations, and our risk evaluation determines that the importation of the commodities into the United States would pose no greater risk than those authorized importation from previously assessed countries.**3** proposed action does not trigger the need for other environmental review under NEPA, and the proposed action would not individuall y or cumulatively

have a significant environmental impact. 

## II. **Al ternati**  **ve s** 
The two alternatives considered in this EA include: (1) the no action alternative in which the current regulations would remain unchanged, continuing to omit Estonia from the l ist of EU Member States comprising the APHI S

- defined EU CSF region (a region considered low risk for CSF ) and from the list of countries considered free of SVD and, therefore, continuing to not allow the importation of swine commodities from that region to the United States, and (2) the rule amendment, which would designate Estonia as low risk for CSF and free of SVD and would, therefore , allow the importation of swine commodities from Estonia according to certain conditions. 

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

- defined EU CSF region considered low risk for CSF , and would also not be listed as free of SVD ; con sequently , Estonia would not be allowed to export swine commodities to the United States. The status of Estonia as low risk for CSF and free of SVD is not reflected in the current import regulations. The continuance of such unsupported trade restrictions would be contrary to U.S. obligations under international trade agreements. 

### B. Rule A **mendment**
The rule amendment alternative would amend the current regulations to add Estonia to the list of EU Member States comprising the APHIS

defined EU CSF region in 9 CFR §§ 93.500, 94.0, and 98.30, 5 and include it as one of the Member States 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. Th e amendment also would add Estonia 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. Import conditions are necessary because, although

5 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 ).**4** APHI S has determined region s listed under 9 CFR § 94.12 as being free of SVD, the region s either import fresh pork meat from regions where SVD is considered to exist, have a common land border with such regions, or have trade practices that are less restrictive than are acceptable to the United States

. This alternative would allow the importation of swine and swine commodities from Estonia if certain conditions are met

. 

### C. A **lternatives Eliminated**  **from Further Consideration**  Alternatives differing from those mentioned above were eliminated from c onsideration because changes in the requirements either would not mitigate the potential risk from the region or would place excessive restrictions on the imports that would serve as a de facto trade barrier. The certification requirements in the rule pro vide sufficient mitigation measures without being overly restrictive. 

## III. **Potential Env ironmental Impacts**  The diseases of concern with regard to allowing the importation of swine commodities from Estonia are CSF and SVD. APHI S prepared a risk anal ys is , “APHIS Evaluation of the Status of Estonia Regarding Classical Swine Fever and Swine Vesicular Disease,” to evaluate the risk of CSF and SVD introduction to U.S. animals from allowing these commodities from Estonia (USDA, APHI S, 200 7 ). In preparing the risk anal ys is , APHI S evaluated the status of Estonia 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 proc edures, and other factors that could influence the risk of disease introduction into the United States.
Estonia , a Member State of the EU , adopted the legislation of the European Commission (EC) regarding animal health, welfare, and identification inclu ding legislation pertaining to CSF and SVD. Estonia also adopted the harmonized EC legislation regarding import, export, and trade of live animals, meat, and animal products. The APHI S

- defined EU CSF region is considered low risk with respect to CSF. Es tonia’s only land borders are with EU Member State Latvia to the south and Russia to the east

. In a previous and separate evaluation of Latvia, APHI S determined that the CSF risk profile for Latvia was equivalent to that of 15 EU Member States that APHI S recognized at the time as a single region of low risk for CSF. APHIS has not formally evaluated the CSF or SVD risk status of Russia.**5** 

### A. **Background** CSF is a highl y contagious viral disease affecting swine and wild boar. The incubation period for CS F 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. Indirec t 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 use d to transport animals, may indirectly

transmit the CSF virus. The CSF virus is hardy , being stable between pH 4 and 10 and also stable at low temperatures (thus, it is unlikely to be destro ye d by

the post

- mortem decrease in muscle pH that accompanies carcass maturation), and is unlikely to be destroyed b y transport or cold storage (USDA, APHIS, 200 6 ). More information about the characteristics of CSF is provided in the APHIS risk anal ys is (USDA, APHI S, 2007) for this matter

. SVD also is a highl y contag ious viral disease affecting swine and wild boar. The incubation period for SVD is 2 to 7 days. SVD may be introduced into a herd b y infected animals or b y feeding garbage containing infected meat scraps. After the initial introduction, the disease spre ads through 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 by

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 more than 2 years (USDA, APHIS, 200 6 ). More information about the characteristics of SVD is provided in the APHI S risk anal ys is (USDA, APHIS, 2007) for this matter. The potential for impacts on the human environment from the importation of swine commodities from Estonia is dependent upon the ability of mitigative factors and mitigation measures to prevent the introduction of the diseases of concern via the biological pathways of transmission of the diseases. This section addresses the potential envi ronmental impacts that could occur under the alternatives considered. 

### B **. No A ction** 
The “no action ” alternative would not allow swine commodities to be imported from Estonia ; the current rules governing the importation of**6** these commodities would remain unchanged with regard to Estonia . This alternative would have no potential effect on U.S. animal health, public health, or the ph ys ical environment. This alternative, however, is inconsistent with the requirements of international trade agreements. 

### C

**. Rule A**  **mendment** The rule amendment alternative would allow the importation of swine commodities from Estonia according to certain requirements that are designed to prevent the introduction of CSF and SVD. An y potential for impacts to the human env ironment would be the result of exposure to the CSF or SVD 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 ph ys 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 or SVD 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 swine commodities, 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. The animal health status of the exporting region was evaluated and the results reported in a risk anal ys is (USDA, APHIS, 200 7 ). CSF was last reported in domestic swine in Estonia in January 1994. Prior to January 1994, CSF occurred in Estonia in 1958 and did not occur again until the outbreak in 1994. Estonia officiall y prohibits general preventive vaccination against CSF and SVD ; emergency vaccination against CSF is permitted only under exceptional circumstances to prevent spread of the disease and only when authorized b y the Minister of Agriculture. During its evaluation of Estonia, APHI S found no evidence that CSF or SVD is present in wild boar, a potential pathway for disease transmi ssion to domestic swine i n Estonia. The patterns of geographical distribution of domestic swine and wild boar in Estonia limit the potential for contact between them. CSF has not occurred since at least 2000 in any of the regions of Russia or Latvia that are adjacent to Estonia, and SVD has never been reported to have occurred in those regions. The regions adjacent to Estonia do not appear to pose a high risk as potential sources of CSF and SVD introduction into Estonia. SVD has never been diagnosed in Estonia. **1. A nimal**  **Health 7**  The risk anal y sis (USDA, APHI S, 200 7 ) assessed potential pathway s 6 by which either the CSF or SVD virus could be introduced into Estonia from other EU Member States or affected third countries, thereb y potentiall y resulting in risk to U.S. animals by allowing the import ation of swine commodities from Estonia . The risk analy sis noted that for each of the pathway s identified, Estonia has in place numerous mitigating factors and safeguards , including requirements under EC legislation that are designed to reduce the risk of disease introduction. These factor s or safeguards include, but are not limited to, the following:

- Lack of high risk of the disease in the regions bordering Estonia as potential sources of CSF and SVD introduction into Estonia

.

- Implementation of biosecurity measures for vehicles and people entering high production farms.

- Strict EC and Estonian legislation governing importation of animals and animal products from third countries (those not part of the EC).

- Prohibition on the entering of dirty trucks or trucks carrying manure into Estonia

.

- Certification of cleaning and disinfection of transport vehicles carryi ng live animals entering Estonia prior to entry

.

- Strict regulation of a gricultural commodities entering Estonia for personal consumption (must origi nate from EC

- authorized third countries or from other EU Member States )

.

- Awareness efforts among the traveling public and training of Customs, Border Guard, and Postal officials pertaining to illegal consignments of meat and meat products.

- V eterinary

ins pection of most agricultural commodities at the ports of entry into Estonia

.

- Prohibition against garbage feeding to domestic swine

. The risk estimation conclusion suggested that, with the mitigating factors, the likelihood of release of CSF and SVD virus from Estonia is low and that Estonia also would be subject to the same requirements specified for other EU Member States in APHI S’ regulations under 9 CFR §§ 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 APHI S regulations are designed to prevent the introduction of CSF and SVD into the United States from low

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

- O fficial certification of the CSF

- free and SVD

- free origin of swine

6 (1) migration of wild boar , (2) trade of swine and swine products, ( 3 ) incoming vehic le and human traffic, and ( 4 ) import ation of swine products for perso nal consumption.**8** commodities;

- Approval of exporting slaughtering establishments by USDA’s Food Safety and Inspection Service and certification by an official veterinarian of the exporting country that this condition has been met;

- No commingling or contact of s wine, pork, or pork products with swine, pork, or pork products from CSF

- or SVD

- affected regions;

- Origin of swine s emen must be from animals at an approved collection center; and

- R estrictions on the use of transportation equipment for live swine and movement of the commodities to prevent CSF or SVD infection

. APHI S considers the risk potential for introduction of CSF or SVD from Estonia into the United States via export of swine commodities to be low and the probability

of exposure of susceptible U.S. livestock to these diseases via meat or meat products, live animals, or genetic material from Estonia to also be low. Applying mitigation measures for Estonia equivalent to those specified for other EU Member States in 9 CFR §§ 94.13, 94.24, and 98.3 8 would further reduce the risk (USDA, APHIS, 200 7 )

. If the proposed action were implemented and an incursion of CSF or SVD were to occur in an area of Estonia , APHI S regulations would prohibit for a specified period of time the exportation of swine commo dities 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 without rulemaking once the designation as a restricted zone is lifted by the competent veterinary authority of Estonia 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, restric tions 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, restrictions would remain in place until the restricted region was re

- evaluated for free status and th e appropriate follow

- up action wa s taken.
If CSF or SVD 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

7 The national animal health authority of Estonia is the Veterinary and Food Board (VFB). The VFB is responsible for enforcing and supervising the implementation of legislation governing veterinary medicine, food safety, market organizat ion, animal welfare, and farm animal breeding. The V FB is o rganized into one central office, which coordinates the supervisory activities of the VFB , and 15 local Veterinary Center offices, one in each of the 15 counties of Estonia. In the event of an ani mal disease outbreak, APHIS considers the counties in Estonia to be the smallest administrative unit s for animal disease status recognition purposes

.**9** the disease can be established, surveillance of the area around an outbreak, and measures aimed at preventing any virus spread by swine commodities , contaminated material, and vehicles.
If the introduc tion of CSF or SVD to U.S. swine were to occur, potential for impacts to the phys ical environment could occur in relation to disposal of carcasses due to death from disease and depopulation of infected 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 could release the live CSF or SVD 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 or SVD could occur in relation to the use of disinfectants to prevent the transfer of the CSF or SVD virus from surface s. As part of an eradication program, measures aimed at preventing spread of the CSF or SVD virus, including disinfection of equipment, transport vehicles, and/or premises where infected swine were maintained, would be required in order to prevent mechani cal transfer of the virus. Disinfectants used for such purposes would have to be approved for the specific use with 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 registered product.
The risk anal ys is that evaluates the animal health statu s of swine in Estonia concludes that the likelihood of CSF or SVD vir us release into the United States from swine and swine product imports from Estonia appears to be low (USDA, APHIS, 2007). The anal ys is provides that risk would be further mitigated b y application of the controls that applied to the EU

- 15

—and which curre ntly appl y to the APHIS

- defined EU CSF region

— regarding imports of swine, pork, pork products , and swine semen from the APHIS

- defined EU CSF region (9 CFR §§ 94.24 and 98.38), and to the SVD

- free regions specified in 9 CFR § 94.13

. Conditions, or mitigati on measures, that would be required to be met in order to compl y with APHI S import regulations for swine and swine products from Estonia are designed to prevent the introduction of CSF and SVD into the United States. Under the proposed action, n o signific ant i mpact on the phy sical environment as a result of allowing the importation of swine or swine products from Estonia is reasonably foreseeable

. **2. Phy** **sical E**  **nvironment 10**  CSF and SVD virus strains are host

- specific, and, therefore, CSF and SVD infections are not a public health issue (USDA, APHI S, 200 6) . 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 infected material. CSF does not affect hum ans (The Center for Food Security & Public Health, 2005). Impacts on public health according to conditions of APHIS’ import regulations to prevent the introduction and spread of CSF and SVD and allowing the importation of swine or swine products from Esto nia are not reasonabl y foreseeable. **a. Environmental Executive Orders** Some executive orders such as Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks, and Executive 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 review requirements, no circumstance that would trigger the need for special environmental reviews is involved in implementing the action considered in this document. Neither i mpacts on the health or safety of children nor disproportionately

high and adverse human health and/or environmental effects on any minority populations and/or low

- income populations in the United States as a result of CSF and SVD exposure are reasonabl y foreseeable as a result of the rule amendment to allow the importation of swine or swine products from Estonia

. **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. APHI S has considered the potential effects of the 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 w ould have no effect on endangered or threatened species in the United States or critical habitat. **3. P**  **ublic H**  **ealth**

**4. Ad**  **ditional Environ**  **** **mental Review**  **Consider a**  **** **tions 11**  

## IV. **Ag encies or Persons**  **Contacted**
Environmental and Risk Analy sis Services Policy and Program Development Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 149 Riverdale, MD 20737

– 1238 

## V. References The Center for Food Security and Public Health, 2005. Classical swine fever. College of Veterinary Medicine, Iowa State University. Ames, IA. Last updated August 2, 2005. Available at http://www.c fsph.iastate.edu/Factsheets/pdfs/classical_swine_fever.pdf

. Accessed on 7/17/2008

. 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, 2 00 6 . APHIS evaluation of the status of Lithuania regarding classical swine fever , swine vesicular disease , and foot and mouth disease

. January 2006 . Veterinary

Services, National Center for Import and Export, Riverdale, MD. U.S. Department of Agriculture, Animal and Plant Health Inspection Service, 200 7 . APHIS evaluation of the status of Estonia regarding classical swine fever and swine vesicular disease. October 2007

. Veterinary

Services, National Center for Import and Export, Riverdale, MD.