**United States**

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

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

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

# Final **Rulemaking for the** 

**Importation of Sw**  **ine Commodities**  **from Hungary** 

**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

The U.S. Department of Agriculture (USDA) prohibits d iscrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.) Perso ns 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). To file a complaint of discrimination, write USDA , Director, Office of Civil Rights, Room 326

–

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

– 9410 or call (202) 720

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

## Table of Cont **ents**
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 (USD A), 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 from regions that are free of or low risk for classical swine fever (CSF). The country of Hungary submitted a request to APHI S seeking recognition as a region free of CSF in order to export live swine and swine

- derived products including semen, pork , and po rk products (hereafter referred to as “swine commodities”) to the United States according to requirements in APHI S import regulations

. CSF is a highl y contagious viral disease of swine. CSF is exotic to the United States and is one of the diseases of con cern to APHI S in its regulation of animal and animal product importation into the United States. In response to Hungary ’s request , APHIS conducted a risk analy sis to a ssess the risk of introduction of CSF into the United States from Hungary (in “ APHI S Ris k Analy sis of the Status of Hungary Regarding Classical Swine Fever”) (USDA, APHI S, 200 8 ) )

. APHIS’ evaluation found that Hungary meets the requirements for being recognized as low risk for CSF. Based on this finding , APHI S proposes to amend its regulatio ns to add Hungary to the list of European Union (EU) Member States that comprise the APHI S

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

— which APHI S consider s low risk for CSF (9 CFR § § 94.9, 94.10)

— and thereb y allow importation of swine commodi ties from this country (9 CFR § § 94.10, 94.24, and 98.38). Allowing the trade of swine commodities from Hungary would be consistent with the World Organization for Animal Health (commonl y referred to as the Office International des Epizooties (OIE)) Ter restrial Animal Health Code for CSF. CSF is among the OIE

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

. 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 b y the Council on Environmental Quality (40 Code of Federal Regulations (CFR) §§ 1500

– 1508), USDA’s NEPA regulations (7 CFR part 1b), and APHIS’ NEPA implementing procedures (7 CFR part 372 ). This EA evaluates the potentia l effects on**2** 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 pr esence of diseases in swine. APHI S’ 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, 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 o f 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 comm odities from EU Member States in the past , 3 (2) the determination from an APHI S evaluation that Hungary is low risk for CSF, and (3) APHI S determinations that measures are in place to mitigate the risk of CSF introduction into the United States through imp ortation of swine and swine commodities from countries or regions that APHIS recognizes as low risk for CSF, such as Hungary , APHIS will consider th at future proposed actions of this nature 4 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 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 proposed action does not trigger the need for other environmental review under NEPA, and the proposed action would not individually or cumulat ively

have a significant environmental impact.

1 The “human environment” is interpreted comprehensi vely 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 Federal Register (FR) 67227

– 67233; November 28, 2 007). 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 measures are in place in the exporting country and in A PHIS 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** 

## 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 Hungary from the list of EU Membe r States comprising the APHI S

- defined EU CSF region (a region considered low risk for CSF ) 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 Hungary as low risk for CSF and would, therefore , allow the importation of swine commodities from Hungary according to certain conditions. 

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

- defined EU CSF region considered low risk for CSF ; consequently , Hungary would not be allowed to export swine commodities to the United States. The low

- risk CSF status of Hungary is
n ot 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 Hungary 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. T his alternative would allow the importation of swine and swine commodities from Hungary if certain conditions are met and would be consistent with U.S. ob ligations under international trade agreements

. 

### C. **Al ternatives**  **Eliminated from Further**  **C onsideration**  Alternatives differing from those mentioned above were eliminated from consideration because changes in the requirements either would not

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, Republic of Ireland, Spain, Sweden , and the United Kingdom (England, Scotland, W ales, the Isle of Man , and Northern Ireland ).**4** 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 provide sufficient mitigation measures without being overly restrictive. 

## III. **Pot ential Env**  **ironmental Impacts**
**A. Background**  The disease of concern with regard to allowing the importation of swine commodities from Hungary is CSF. CSF is a highly

contagious viral disease affecting swine and wild boar. The incubation period for CSF i s 2 to 14 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 by 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. 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 carc ass maturation), and is unlikely

to be destroyed by

transport or cold storage (USDA, APHIS, 200 6 ). More information about the characteristics of CSF is provided in the APHI S risk anal ys is (USDA, APHI S, 2008) for this matter.
The risk anal ys is , “APHIS Ri sk Analy sis of the Status of Hungary Regarding Classical Swine Fever,” evaluate s the risk of CSF introduction to U.S. animals from allowing these commodities from Hungary (USDA, APHI S, 200 8 ). In preparing the risk anal ys is , APHI S evaluated the status of Hungary 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 influenc e the risk of disease introduction into the United States. Hungary , a Member State of the EU since 2004 , adopted the legislation of the European Commission (EC) regarding animal health, welfare, and identification including legislation pertaining to CSF

. Hungary 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 region is considered low risk with respect to CSF.**5** As discussed in APHI S’ evaluation of Hungary ’s CSF status, Hungary shares borders with seven countries, four of which are EU M ember States : Austria, Slovakia, Slovenia, and Romania. Of the bordering EU Member States, APHI S currentl y recognizes Austria in 9 CFR §§ 94.9 and 94.10 as part of the EU region that is low risk for CSF, and APHI S evaluations have been completed to determine the CSF risk status of Slovenia and Slovakia. Romania, which joined the EU in January 2007, continues to experience CSF outbreaks in wild boar and domestic swine; Hun gary provides for enhanced checks for forbidden pork products from Romania in passenger baggage at and near the Hungary /Romania border. The other three border countries , Croatia, Ser b ia and Montenegro, and the Ukraine , are EC

- designated third countries

— co untries that are approved b y the EU’s Food and Veterinary Office to export live animals or animal products to EU Member States because they meet certain requir e ments, including animal health standards that are at least equivalent to those required of EU Me mber States

. However, these three countries are not necessarily

approved to export live swine or pork to EU M ember S tates. Animals and animal products from the third countr ies must meet certain requirements and can only enter through certain border inspe ction points. While CSF outbreaks have occurred in domestic and/ or wild boar populations in five of the adjacent countries (details of which are provided in APHI S’ evaluation of Hungary ’s CSF status (USDA, APHI S, 2008 ) , Hungary enforces E C legislation reg arding import prohibitions on animals and products from non

- EU countries as well as CSF

- affected regions within EU countries, implemented surveillance practices for CSF in wild boar that have demonstrated the ability to detect evidence of circulation of th e virus within this population , implement ed effective biosecurit y practices in domestic swine facilities, and has not had a CSF case in its domestic swine population since 1993. The potential for impacts on the human environment from the importation of swine commodities from Hungary is dependent upon the ability of mitigative factors and mitigation measures to prevent the introduction of CSF via the biological pathway s of transmission of the disease. 

### B **. No A ction**  **Al ternative** 
The “ no action ” al ternative would not allow swine commodities to be imported from Hungary ; the current rules governing the importation of these commodities would remain unchanged with regard to Hungary . 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.**6** 

### C

**. Rule A**  **mendment (Proposed A** **ction)** The rule amendment alternative would allow the importation of swine c ommodities from Hungary according to certain requirements that are designed to prevent the introduction of CSF. An y potential for impacts to the human environment would be the result of exposure to the CSF 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 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 importation of swin e commodities from a foreign region , 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. CSF was last reported in domestic sw ine in Hungary in 1993. CSF virus was detected in w ild boar that were hunted and killed in January 2007 in Nógrád County

of Hungary , adjacent to the border with Slovakia, with additional finds in 2007 and through July 2008 in both Nógrád and Pest counties

. APHI S evaluated the CSF status of the potential exporting region and found that Hungary appears to have addressed this disease incursion in a timely and effective manner and has implement ed necessary

measures to prevent CSF transmi ssion to domestic swin e in Hungary

. The results of the evaluation are reported in a risk anal ys is (USDA, APHIS, 200 8 )

. The risk anal ys is assessed potential pathway s 6 by which the CSF virus could be introduced into Hungary from other EU Member States or affected third countrie s, thereby potentiall y resulting in risk to U.S. animals by

allowing the importation of swine commodities from Hungary

. The risk anal ys is noted that for each of the pathway s identified, Hungary 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:

- Hunting restrictions for wild boar in the infected area, including the requi rement that all shot boar must be serologically and virologicall y evaluated.

6 (1) through contact with infected wild boar , either in Hungary or from adjacent countries , (2) through exposure to infected swine or swine products from other EU Member States or third countries , and ( 3 ) through exposure to contaminated objects (e.g., vehicles or passengers) from other EU Member States or third countries that are experiencing outbreaks of CSF, again either due to direct contact, or secondary contact via wild boar.

. **1. A nimal**  **Health 7**  - Combination of control activities aimed at affected wild boar populations, including enhanced biosecurit y measures on farms in the infected area, such as disinfection of personn el entering and exiting pig holding buildings, mandatory indoor housing of swine, enhanced reporting requirements for signs of disease in domestic swine, and a prohibition on the movement of swine and pork products, including semen and embryos or ova from the infected area for intra

- community trade.

- Public outreach programs, e.g., awareness campaigns for the public and informational fl ye rs for hunters

.

- T raining in emergency response aimed at disease experts and training for customs officers, veterinarians, technicians, and administrative staff at border inspection points

.

- Prohibition against garbage feeding to domestic swine

. The risk estimation component of the APHIS risk anal ys is conclu des that the likelihood of live swine, pork, pork products, or swine semen entering the United States from Hungary and exposing U.S. livestock to the CSF virus, considering the mitigation measures that have to be met for all EU Member States in APHI S’ regulations (under 9 CFR §§ 94.24 for pork and pork products, 94.24 for breeding swine, and 98.38 for swine semen ) to be very low (USDA, APHI S, 2008)

. I f CSF transmission were to occur in domestic swine in Hungary after receiving recognition as a region considered low risk for CSF , importation of infected swine commodities would be mitigated by requirements that must be met in 9 CFR §§ 94.24 and 98.38. The requirements specified in APHI S regulations are designed to prevent the introduction of CSF into the United States from low

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

- O fficial certification of the CSF

- free origin of swine 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

- 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 infection

. If the proposed action ( to add Hungary to the list of EU Member States comprising the APHI S

- defined EU CSF region) were implemented and an incursion of CSF were to occur in domestic swine in an area of Hungary , APHI S regulations would prohibit for a specified period of time the**8** importation of swine commodities from the affected area that could be effectivel y regionalized for disease status. 7 For a CS F 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 Hungary 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 b y the Member State’s competent veterinary authority. Additional requirements under APHIS’ import re gulations further mitigate the risk of exposure of U.S. swine to any potentially

infected swine from Hungary or decrease the likeliho od of infected swine being chosen for import as follows:

 a minimum quarantine of 15 day s for all imported swine (9 CFR § 93.510).

 swine imports are limited to breeding swine onl y and prohibit imported swine originating or commingling with swine from an y region in which CSF is known to exist or any restricted areas within the EU due to the detection of CSF in domestic swine or wild boar (9 CFR § 94.24)

. If CSF 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 an y virus spread by swine commodities , c ontaminated material, and vehicles.
If the introduction of CSF 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 infected animal s or disposal of contaminated bedding and manure. Disposal methods could include rendering, burial, and incineration. If not handled properly , disposal of infected animals and materials could impact air, water, and soil quality and potentiall y could rele ase the live CSF 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 type), other ph ys ical environment c onsiderations (such as weather and temperature), and available funds, equipment, and personnel.

7 In the event of an a nimal disease outbreak, APHIS considers the counties in Hungary to be the smallest administrative unit s for animal disease status recognition purposes

. **2. Phy** **sical E**  **nvironme nt** **9** Potential for impacts to the phy sical environment from the introduction of CSF could occur in relation to the use of disinfectants to prevent the transfer of the CSF virus from surfaces. As part of an eradication program, measures aimed at preventing spread of the CSF virus, including disinfection of equipment, transport vehicles, and/or premises where infected swine were maintained, would be required in orde r to prevent mechanical 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 disin fectants would be provided for their proper application to prevent potential environmental impacts associated with the use of the registered product. Conditions or mitigation measures that would be required to be met in order to compl y with APHI S import r egulations for swine and swine products from Hungary are designed to prevent the introduction of CSF into the United States. Under the proposed action and according to the finding in APHIS’ evaluation that CSF does not exist in domestic swine populations in Hungary , n o significant i mpact on the phy sical environment as a result of allowing the importation of swine or swine products from Hungary is reasonabl y foreseeable

. The CSF virus is not known to affect humans (USDA, APHI S, 200 8; The Center for Food Security

& Public Health, 2005). Indirect transmission of the CSF virus to swine may occur via movement of people and inanimate objects such as live

- haul trucks ( as cited in USDA, APHI S, 2008)

. Impacts on public health according to conditions of APHI S’ import regulations to prevent the introduction and spread of CSF from swine or swine products from Hungary are not reasonabl y foreseeable.
Other Federal agencies have direct authorit y over public health issues involving the importation of food products. T he 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 protect 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 by FSI S and meets requirements equivalent to those under th e 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 informati on 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)

. **3. P**  **ublic H**  **ealth 10**  **a. En vironmental 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 re views is involved in implementing the proposed 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 an y minority populations and/or low

- income populations in the United States as a result of CSF exposure are reasonably foreseeable as a result of the rule amendment to allow the importation of swine or swine products from Hungary

. **b. Endangered Species A** **ct** Section 7 of the Endangered Spe cies 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 proposed action on endangered and threatened species and designated critical habitat. CSF is host

- specific, and there are no known federall y listed or proposed endangered or threatened species in the United States that would be affected b y CSF; therefore, the rule amendment w ould have no effect on endangered or threatened species in the United States or critical habitat. **4. A dditional**  **Environ**   ** mental** **Review Consider** **a**   ** tions****11** 

## IV. **Ag encies or Persons Contacted** 

Environmental and Risk Analy sis Services Pol icy 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. Colle ge of Veterinary Medicine, Iowa State Universit y. Ames, IA. Last updated May

5 , 200 8 . Available at http://www.cfsph.iastate.edu/Factsheets/pdfs/classical_swine_fever. pdf

. Accessed on 11 / 04 /08

. 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, 200 6 . APHIS evaluation of the status of Lithuania regard ing 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 8 . AP HI S risk analy sis of the status of Hungary regarding classical swine fever. September 2008 . Veterinary Services, National Center for Import and Export, Riverdale, MD. U.S. Food and Drug Administration, 2004. Protecting the food suppl y. Fact s heet on FDA 'S n ew f ood b ioterrorism r egulation. Final Rule: Administrative Detention. Center for Food Safety and Applied Nutrition. Available at http://www.cfsan.fda.gov/~dms/fsbtac21.html

. Accessed 10/30/08.